| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
NDA Submission example | Anaphylm (dibutepinephrine) Sublingual Film (AQST-109) Treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more Fast Track | NDA | — | Subscribe to access the data. | Small Molecules | Immunology | |
NDA Submission example | Anaphylm (dibutepinephrine) Sublingual Film (AQST-109) Treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more Fast Track | NDA | — | Subscribe to access the data. | Small Molecules | Immunology | |
NDA Submission example | Anaphylm (dibutepinephrine) Sublingual Film (AQST-109) Treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more Fast Track | NDA | — | Subscribe to access the data. | Small Molecules | Immunology |
Recent Updates
Recently added Catalysts
Aquestive Therapeutics, Inc.
$5.24
+0.16 (+3.15%)
C 43Pipeline Score Overvalued Pharma · Commercial
Market Cap
658.31 M
EPS
-0.62
P/E Ratio
-
Value Trade
32.29 M
15.36 %
Week
41.96 %
1 Month
32.38 %
3 Month
27.9 %
6 Month
18.05 %
5 Year
-72.62 %
All Time
Cash Data
Cash Position
-
Monthly Burn
-
Runway
-
Overview
Volume
1.35 M
52 Week Range
2.93 - 7.55
% held by Insiders
5.22 %
% held by Institutions
55.28 %
Enterprise Value
617.33 M
Total Shares
125.51 M
Short %
17.61 %
Float Shares
99.96 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Aquestive Therapeutics, Inc.
599Total events
9Upcoming
162Tier-1 (high impact)
2018 – 2037Coverage
Upcoming catalysts 2
TBD
T2Product Launch
Subscribe to view catalyst details
TBD
T1FDA Approval
Subscribe to view catalyst details
Event history 2
TBD
●Quarterly UpdateCorporate
Subscribe to view catalyst details
TBD
▲Trial CompletionAnaphylmFiledTrial
Subscribe to view catalyst details
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2026-01-31 | Anaphylm™ (epinephrine) Sublingual Film | PDUFA Date | PDUFA | CRL | – | – | – |
2026-01-31 | Anaphylm™ (epinephrine) Sublingual Film | PDUFA Date | PDUFA | CRL | – | – | – |
2026-01-31 | Anaphylm™ (epinephrine) Sublingual Film | PDUFA Date | PDUFA | CRL | – | – | – |
Drug Pipeline Intelligence
C43
Pipeline Score $247M
Pipeline ValueOvervalued
Valuation Signal4
Drugs Scored0.4x
rNPV / MCap Top 68%
Micro Cap (rank 300 of 933)
Percentile RankAquestive Therapeutics, Inc. carries a moderate pipeline score (43/100), with $1.2B risk-adjusted pipeline value, led by DESF in Allergic Reaction (Phase 2).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DESF Small molecule | Allergic Reaction | Phase 2 | NCT07703982 | 17% | $836M | COMPLETED | 68 | - | - | May 21, 2025 | - | MEDIUM Aug 15, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
Anaphylm™ (epinephrine) Sublingual Film | severe allergic reactions, including anaphylaxis | — | 2025-06-25 | Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses Read More | Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit Read More | |
Anaphylm™ (epinephrine) Sublingual Film | severe allergic reactions, including anaphylaxis | — | 2025-06-25 | Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses Read More | Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit Read More | |
Anaphylm™ (epinephrine) Sublingual Film | severe allergic reactions, including anaphylaxis | — | 2025-06-25 | Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses Read More | Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in AQST
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
AQST Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
| 2026-10-16 | 0.00 | 0 | - | - | - | - | - | - | ||||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
AQSTAquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Aquestive Therapeutics has reported its financial results for Q2 2026, highlighting the successful completion of a human factors validation study and a pharmacokinetic study for its Anaphylm sublingual film. The company remains on track to resubmit its New Drug Application (NDA) to the FDA in the third quarter of 2026 and is actively engaging in pre-launch activities.
Read more →AQST▲ +8.9%on this newsshared move
Aquestive Therapeutics Announces Positive Topline Human Factors and Pharmacokinetic Study Results for Anaphylm™ (dibutepinephrine) Sublingual Film
Aquestive Therapeutics announced positive results from its human factors and pharmacokinetic studies for Anaphylm™ (dibutepinephrine) sublingual film. The studies support the planned resubmission of the New Drug Application (NDA) to the FDA in Q3 2026. Key improvements include faster pouch opening and reduced incorrect film placement, enhancing usability for patients at risk of anaphylaxis.
Read more →AQSTAquestive Therapeutics to Report Second Quarter 2026 Financial Results and Recent Business Highlights on August 11 and Host Conference Call on August 12 at 8:00 a.m. ET
Aquestive Therapeutics will report its second quarter 2026 financial results on August 11, 2026, and host a conference call for investors on August 12. The company is focused on advancing its product candidates, including Anaphylm™ and AQST-108, which target severe allergic reactions and dermatological conditions. A live webcast of the call will be available on its website.
Read more →AQSTAquestive Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
Aquestive Therapeutics reported strong financial results for Q1 2026, with a revenue increase of 66% year-over-year. The company reaffirmed its plans to resubmit the Anaphylm NDA in Q3 2026 after a successful FDA Type A meeting. Additionally, AQST-108's phase 1 study showed no safety issues, supporting its potential in treating dermatological conditions. A new $150 million debt facility enhances the company's financial position for upcoming initiatives.
Read more →AQSTAquestive Therapeutics Completes $150 Million Debt Refinancing with Oaktree
Aquestive Therapeutics has successfully refinanced its debt with a new $150 million facility from Oaktree Capital Management. This refinancing will support the potential launch of Anaphylm, an investigational treatment for severe allergic reactions, pending FDA approval. The new agreement reduces the company's principal debt repayments significantly and provides additional capital for growth.
Read more →AQSTAquestive Therapeutics to Report First Quarter 2026 Financial Results and Recent Business Highlights on May 13 and Host Conference Call on May 14 at 8:00 a.m. ET
Aquestive Therapeutics will report its first quarter 2026 financial results on May 13, 2026, and host a conference call for investors on May 14, 2026. The company aims to provide updates on its business developments and product candidates, including Anaphylm and AQST-108. A live webcast will be available for interested parties.
Read more →AQSTAQUESTIVE DEADLINE MONDAY: Bragar Eagel & Squire, P.C. Reminds Aquestive Therapeutics, Inc. Investors with Large Losses They Have Until Monday May 4th to Seek Lead Plaintiff Role
Bragar Eagel & Squire, P.C. has announced a class-action lawsuit against Aquestive Therapeutics, Inc., involving investors who acquired shares between June 16, 2025, and January 8, 2026. The lawsuit alleges that Aquestive misrepresented its progress toward FDA approval for the New Drug Application (NDA) for Anaphylm. After receiving a letter from the FDA detailing deficiencies that precluded discussions of labeling and marketing, the company saw a significant decline in its stock price. Investors are encouraged to seek lead plaintiff status by the court's deadline on May 4, 2026.
Read more →AQSTAQUESTIVE DEADLINE: ROSEN, LEADING INVESTOR COUNSEL, Encourages Aquestive Therapeutics, Inc. Investors to Secure Counsel Before Important May 4 Deadline in Securities Class Action – AQST
Rosen Law Firm has issued a reminder for investors of Aquestive Therapeutics, Inc. to seek counsel before the upcoming lead plaintiff deadline on May 4, 2026, in relation to a securities class action. The lawsuit alleges that the company made false and misleading statements about its New Drug Application for Anaphylm, potentially leading to investor losses. This class action case is crucial as it seeks accountability for the alleged concealment of risks involved with the company's product.
Read more →AQSTAQUESTIVE THERAPEUTICS, INC. (AQST) DEADLINE ALERT Bernstein Liebhard LLP Reminds Aquestive Therapeutics, Inc. Investors of Upcoming Deadline
Bernstein Liebhard LLP has informed المستثمرين في AQUESTIVE THERAPEUTICS, INC. (NASDAQ: AQST) of an upcoming deadline related to a class action lawsuit. The lawsuit alleges that the company made misrepresentations regarding its New Drug Application for Anaphylm (Dibutepinephrine). Investors who purchased shares between June 16, 2025, and January 8, 2026, are encouraged to consider their legal options before the May 4, 2026 deadline. The firm operates on a contingency fee basis, meaning no upfront costs for shareholders.
Read more →AQSTAQUESTIVE THERAPEUTICS, INC. (AQST) SHAREHOLDER ALERT Bernstein Liebhard LLP Reminds Aquestive Therapeutics, Inc. Investors of Upcoming Deadline
Aquestive Therapeutics, Inc. is facing a class action lawsuit regarding securities fraud, specifically related to alleged misrepresentations made about its New Drug Application for Anaphylm (Dibutepinephrine). The lawsuit involves investors who purchased shares between June 16, 2025, and January 8, 2026. Shareholders are urged to act before the deadline of May 4, 2026, if they wish to serve as lead plaintiffs. Bernstein Liebhard LLP is handling the case, emphasizing that representation is on a contingency fee basis.
Read more →AQSTAquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm™ (dibutepinephrine) Sublingual Film
Aquestive Therapeutics has completed a Type A meeting with the FDA regarding the resubmission of its NDA for Anaphylm, a sublingual film for treating Type 1 allergic reactions. The company received valuable feedback on pharmacokinetic and human factor study designs, which will aid in their upcoming studies. The NDA resubmission is planned for Q3 2026, with further regulatory submissions also progressing in Canada and the EU.
Read more →AQSTAquestive Therapeutics Announces New Role of Lori J. Braender and Appointment of Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer
Aquestive Therapeutics has appointed Thomas A. Zalewski as Chief Legal Officer and Chief Compliance Officer, effective April 2, 2026. He succeeds Lori J. Braender, who will remain as Corporate Secretary after nearly eight years in her previous roles. Zalewski's extensive experience in life sciences law is expected to support the company's mission, particularly in advancing Anaphylm, an oral epinephrine medication.
Read more →AQSTAquestive Therapeutics Announces Grant of Inducement Award Pursuant to Nasdaq Listing Rule 5635(c)(4)
Aquestive Therapeutics has announced an inducement equity grant for Dr. Matthew Greenhawt, the newly appointed Chief Medical Officer. The grant includes 75,000 Restricted Stock Units and 50,000 non-qualified stock options, which will vest over a period of three years. This award is part of the company's 2022 Equity Inducement Plan and was approved by the Compensation Committee. The grants, scheduled for March 9, 2026, are intended to serve as a significant incentive for Dr. Greenhawt as he joins the company.
Read more →AQSTAQUESTIVE INVESTOR ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Aquestive Therapeutics, Inc. and Encourages Investors to Contact the Firm
A class action lawsuit has been initiated against Aquestive Therapeutics, stemming from allegations that the company misled investors about the approval status of their drug Anaphylm. The lawsuit pertains to a period where the FDA identified critical deficiencies in the NDA that hindered approval. Following the revelation, the company's stock experienced a dramatic decline of over 37%. Investors affected by the situation are encouraged to reach out for legal assistance ahead of the May 4, 2026 deadline to appoint a lead plaintiff.
Read more →AQSTAQUESTIVE THERAPEUTICS, INC. (AQST) INVESTOR ALERT Investors With Large Losses in Aquestive Therapeutics, Inc. Should Contact Bernstein Liebhard LLP To Discuss Their Rights
Investors in Aquestive Therapeutics, Inc. have been alerted to a securities class action lawsuit filed on their behalf by Bernstein Liebhard LLP. The lawsuit targets alleged misrepresentations made by the company concerning its New Drug Application for Anaphylm. Affected shareholders are advised to file papers by May 4, 2026, if they wish to serve as lead plaintiffs. Legal representation for the class action is provided on a contingency fee basis, meaning no fees are incurred unless successful.
Read more →AQSTAquestive Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Aquestive Therapeutics reported its financial results for Q4 and full year 2025, highlighting progress on Anaphylm, an oral epinephrine medication. The company received a Complete Response Letter from the FDA, necessitating further studies before resubmission. Despite challenges, Aquestive remains optimistic about Anaphylm's potential, bolstered by new leadership and a growing allergy market.
Read more →AQSTAquestive Therapeutics to Participate in Upcoming March Investor Conferences
Aquestive Therapeutics announced its participation in four investor conferences in March 2026. The company aims to showcase its advancements in innovative medicines and delivery technologies. A webcast of the presentations will be available for 30 days post-event. The company is known for its proprietary products and contract development services.
Read more →AQSTAquestive Therapeutics to Report Fourth Quarter 2025 Financial Results and Recent Business Highlights on March 4 and Host Conference Call on March 5 at 8:00 a.m. ET
Aquestive Therapeutics will report its fourth quarter 2025 financial results on March 4, 2026, and host a conference call for investors on March 5, 2026. The company aims to provide updates on recent business developments during this call. Their innovative product pipeline includes treatments for severe allergic reactions and dermatological conditions.
Read more →AQSTAquestive Therapeutics to Participate in Oppenheimer 36th Annual Healthcare Life Sciences Conference
Aquestive Therapeutics will participate in the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, 2026. The management team is scheduled to present on February 26 at 12 pm ET and will also conduct one-on-one meetings with investors. A webcast of the presentation will be available for 30 days post-event.
Read more →AQSTAquestive Therapeutics to Present New Clinical Data on Anaphylm™ (dibutepinephrine) Sublingual Film at the 2026 AAAAI Annual Meeting
Aquestive Therapeutics announced that it will present new clinical data on Anaphylm™ (dibutepinephrine) sublingual film at the 2026 AAAAI Annual Meeting. The data highlights Anaphylm's potential to improve anaphylaxis management without the diastolic blood pressure dip associated with traditional epinephrine treatments. The meeting is scheduled for February 27 to March 2, 2026, in Philadelphia, PA.
Read more →AQSTAquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical Officer
Aquestive Therapeutics has appointed Dr. Matthew Greenhawt as Chief Medical Officer, enhancing its leadership as it prepares to resubmit the Anaphylm NDA to the FDA. Dr. Greenhawt, an expert in allergy and immunology, will leverage his experience to advance the company's clinical pipeline and address barriers to epinephrine use. His appointment is seen as a significant step for the company at this critical juncture.
Read more →AQST▲ +39%on this news
Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™
Aquestive Therapeutics announced it received a Complete Response Letter from the FDA for its Anaphylm Sublingual Film application, highlighting human factors issues. The company is optimistic about addressing these concerns and plans to conduct a new validation study. They also aim for rapid resubmission in Q3 2026 while expanding regulatory efforts in international markets.
Read more →AQST▲ +5.1%on this news
AQUESTIVE ALERT: Bragar Eagel & Squire, P.C. is Investigating Aquestive Therapeutics, Inc. on Behalf of Aquestive Stockholders and Encourages Investors to Contact the Firm
Bragar Eagel & Squire, P.C. is investigating Aquestive Therapeutics, Inc. on behalf of its stockholders due to potential violations of federal securities laws. This follows a notice from the FDA regarding deficiencies in Aquestive's New Drug Application for its drug candidate, Anaphylm, which is intended for treating severe allergic reactions. The communication from the FDA has led to a decline in the company's stock price. Investors who have suffered losses are encouraged to reach out for legal options.
Read more →AQST▼ -37%on this news
Aquestive Therapeutics Announces Regulatory Development for Anaphylm™ (dibutepinephrine) Sublingual Film and Provides Business Update
Aquestive Therapeutics provided an update on the regulatory status of Anaphylm, its sublingual film for severe allergies. The FDA has identified deficiencies in the NDA, preventing further discussions on labeling. Despite this, the company remains confident in Anaphylm's potential and is planning regulatory submissions in Canada, Europe, and the UK in 2026. The company also reported a strong cash position to support its growth strategy.
Read more →AQSTAquestive Therapeutics to Participate in the Piper Sandler 37th Annual Healthcare Conference
Aquestive Therapeutics will participate in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025. The management team will hold a fireside chat on December 4 to discuss their product candidate Anaphylm™ and its regulatory progress. A webcast of the chat will be available for 30 days post-event.
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Aquestive Therapeutics reported its Q3 2025 financial results, highlighting progress towards the FDA approval of Anaphylm, a sublingual film for severe allergic reactions. The FDA has confirmed no Advisory Committee meeting is necessary, keeping the NDA on track for a January 2026 decision. Despite a net loss of $15.4 million, the company is preparing for a potential U.S. launch and expanding its patent portfolio.
Read more →AQST▼ -6.3%on this newsshared move
Aquestive Therapeutics Announces Leadership Expansion to Support Growth
Aquestive Therapeutics announced a leadership expansion to enhance its growth strategy, particularly for the anticipated launch of Anaphylm™, pending FDA approval. The company appointed Dr. Matthew Davis to lead research and development, while Dr. Gary Slatko will strengthen medical affairs. These changes aim to bolster the company's pipeline and market presence in the allergy community.
Read more →AQSTAquestive Therapeutics to Participate in a Fireside Chat Hosted by Piper Sandler
Aquestive Therapeutics will participate in a fireside chat hosted by Piper Sandler on November 6, 2025. The discussion will focus on their product candidate Anaphylm™ (dibutepinephrine) Sublingual Film, which aims to provide an oral treatment for severe allergic reactions. Key management members will be present to discuss regulatory progress and commercial readiness.
Read more →AQSTAquestive Therapeutics to Attend 2025 ACAAI Annual Meeting
Aquestive Therapeutics will showcase its investigational product Anaphylm™ at the 2025 ACAAI Annual Meeting. The presentations will include an oral session on pharmacokinetics and safety in pediatric patients, as well as poster presentations on pharmacokinetics in adults and unmet needs in anaphylaxis care. Anaphylm™ aims to provide a novel oral alternative for treating severe allergic reactions.
Read more →AQSTAquestive Therapeutics to Report Third Quarter 2025 Financial Results and Recent Business Highlights on November 5 and Host Conference Call on November 6 at 8:00 a.m. ET
Aquestive Therapeutics will report its third quarter 2025 financial results on November 5, 2025, and will host a conference call for investors on November 6, 2025, at 8:00 a.m. ET. The company is focused on developing innovative delivery technologies and has several products in its pipeline, including treatments for severe allergic reactions and dermatological conditions.
Read more →AQSTAquestive Therapeutics Broadens Patent Estate for Anaphylm™
Aquestive Therapeutics has received two new U.S. patents for Anaphylm, its sublingual epinephrine film, extending patent protection until 2037. The patents cover formulations designed for oral mucosal absorption, addressing the need for a needle-free alternative for anaphylaxis treatment. The FDA's target action date for Anaphylm is set for January 31, 2026.
Read more →AQST▲ +28.1%on this news
Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™
Aquestive Therapeutics announced that the FDA has determined that an advisory committee meeting is not necessary for the approval of Anaphylm™ (dibutepinephrine) Sublingual Film. This product could become the first non-invasive, orally delivered epinephrine option for treating severe allergic reactions. The PDUFA target action date for Anaphylm is set for January 31, 2026.
Read more →AQSTAquestive Therapeutics to Participate in Upcoming September Investor Conferences
Aquestive Therapeutics will participate in three investor conferences in September 2025. The management team will present at the Cantor Healthcare Conference and the H.C. Wainwright 26th Annual Global Investor Conference. Webcasts of these events will be available on the company's website, showcasing their commitment to transparency and investor relations.
Read more →AQSTProject Academy Corporate Presentation Strictly Confidential. Do Not Distribute. Disclaimer This presentation and the accompanying oral commentary have been prepared by Aquestive Therapeutics, Inc. ("Aquestive", the "Com
Aquestive Therapeutics, Inc. has prepared a confidential corporate presentation detailing forward-looking statements regarding its product candidate Anaphylm (epinephrine) Sublingual Film. Key topics include the timeline for New Drug Application (NDA) submission to the FDA, the anticipated launch activities, and the potential market growth associated with Anaphylm and other products like AQST-108. The company also outlines risks such as delays in regulatory processes and the competitive landscape affecting market acceptance.
Read more →AQSTAquestive Therapeutics Announces Pricing of $85 Million Underwritten Offering of Common Stock
Aquestive Therapeutics has announced the pricing of an underwritten offering of 21.25 million shares at $4.00 each, aiming to raise $85 million. The proceeds will primarily fund the launch of Anaphylm™ for treating severe allergic reactions, pending FDA approval. The offering is expected to close around August 15, 2025, subject to standard conditions.
Read more →AQSTAquestive Therapeutics Announces $75M Strategic Funding Agreement with RTW to Support the Potential Launch of Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics has secured a $75 million strategic funding agreement with RTW Investments to support the potential launch of Anaphylm™ (epinephrine) Sublingual Film, pending FDA approval. This financing aims to enhance the company's ability to bring Anaphylm to market, which could be the first oral treatment for severe allergic reactions. The investment reflects confidence in Anaphylm's commercial prospects.
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update FDA accepts NDA submission for Anaphylm PDUFA date set for
Aquestive Therapeutics reported its second quarter 2025 financial results, highlighting key developments including the FDA's acceptance of its NDA for Anaphylm, a potentially transformative epinephrine delivery product. If approved, Anaphylm could launch in the U.S. by January 2026, with plans for global expansion into Canada and the EU. Despite a net loss of $13.5 million for the quarter, the company remains focused on its commercial and regulatory strategies to prepare for Anaphylm's potential launch and continues to develop other products like AQST-108 for alopecia areata.
Read more →AQST▲ +5.2%on this news
Aquestive Therapeutics to Report Second Quarter 2025 Financial Results and Recent Business Highlights on August 11 and Host Conference Call on August 12 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. announced that it will release its financial results for the second quarter of 2025 on August 11, with a subsequent investor conference call scheduled for August 12. The event showcases the company's commitment to transparency and investor engagement as they update on their recent business developments. The earnings call will also be accessible via a live webcast, highlighting the company’s efforts to keep its stakeholders informed. Additionally, this announcement aligns with the company's focus on enhancing patient outcomes through innovative science and delivery technologies.
Read more →AQST▼ -6.1%on this news
Aquestive Therapeutics Names Sherry Korczynski as Chief Commercial Officer
Aquestive Therapeutics has appointed Sherry Korczynski as Chief Commercial Officer, effective July 22, 2025. Korczynski, who previously served as Senior Vice President of Sales and Marketing, brings over two decades of expertise in commercial leadership, particularly within the allergy market. She will oversee the launch of Anaphylm, an innovative epinephrine delivery system that is expected to significantly improve patient care. The company is focusing on successfully bringing this product to market while also managing forward-looking statements regarding regulatory approval and commercialization efforts.
Read more →AQSTAquestive Therapeutics Provides International Expansion Update for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics has announced that Health Canada has scheduled a meeting for its New Drug Submission (NDS) for Anaphylm™ in the third quarter of 2025. The company has also submitted an initial briefing book to the European Medicines Agency (EMA) as part of its global regulatory strategy. The CEO emphasized the importance of these steps in expanding access to the innovative oral epinephrine treatment, addressing significant unmet medical needs for patients with severe allergies. Furthermore, the company highlights its regulatory experience and aims to establish Anaphylm as a new standard of care in both Canada and Europe.
Read more →AQSTAquestive Therapeutics to Participate in Leerink Partners Therapeutics Forum: I&I and Metabolism
Aquestive Therapeutics, Inc. announced its participation in the Leerink Partners Therapeutics Forum, focusing on immunology, inflammation, and metabolism. The management team will also host 1x1 investor meetings on July 9, 2025. This engagement could enhance the company's visibility and foster relationships with investors. The forum will feature discussions on key therapeutic themes, highlighting the company's innovative approach to medicine delivery and patient care.
Read more →AQSTAquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit
Aquestive Therapeutics has announced the positive outcomes of its pharmacokinetic and pharmacodynamic studies on Anaphylm™, an epinephrine sublingual film, which will be presented at the CFAAR Food Allergy Summit. If approved by the FDA, Anaphylm will be the first orally delivered option for treating severe allergic reactions in the U.S. The product is designed for convenience, being small and portable. Detailed studies will be shared at the summit taking place from June 27-29 in Chicago.
Read more →AQSTAquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions
Aquestive Therapeutics announced that the FDA has accepted its New Drug Application for Anaphylm™, aimed at treating severe Type 1 allergic reactions, including anaphylaxis. A PDUFA date has been set for January 31, 2026, and if approved, Anaphylm would be the first orally delivered epinephrine treatment in the U.S. The product, which is device-free and smaller than a credit card, seeks to address challenges faced by patients regarding bulky or inconvenient delivery methods for epinephrine. There are, however, uncertainties related to the required regulatory processes ahead of full approval.
Read more →AQST▼ -19.6%on this news
Aquestive Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update Submitted NDA for Anaphylm (epinephrine), the first and only oral sublingual film for patients with severe allergic reactio
Aquestive Therapeutics has reported its first quarter 2025 financial results, highlighting the submission of a New Drug Application (NDA) for Anaphylm, an innovative oral sublingual film for patients with severe allergic reactions. The company aims to launch Anaphylm in Q1 2026, pending FDA approval, and is focused on commercial readiness in anticipation of a potentially significant market impact. However, the financial report revealed a 28% decrease in total revenues compared to the same quarter last year, caused by a drop in manufacturing and supply revenues. Additionally, a recent court decision has affected the regulatory status of Libervant, causing further complications.
Read more →AQST▼ -5.7%on this news
Aquestive Therapeutics to Participate in Citizens Life Sciences Conference
Aquestive Therapeutics, Inc. announced its participation in the Citizens Life Sciences Conference scheduled for May 7-8 in New York City. The management team will hold a fireside chat on May 8, providing an opportunity for direct engagement with investors. A webcast of the chat will be accessible for 30 days following the event, indicating the company's commitment to transparency and communication.
Read more →AQSTAquestive Therapeutics to Report First Quarter 2025 Financial Results and Recent Business Highlights on May 12 and Host Conference Call on May 13 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. announced that it will report its financial results for the first quarter of 2025 on May 12, followed by a conference call on May 13 at 8:00 a.m. ET. This call will provide updates on the company's recent business developments and is part of their commitment to transparency with investors. A live webcast of the call will be available, and a replay will be accessible for 30 days thereafter.
Read more →AQST▲ +8.9%on this news
Aquestive Therapeutics to Participate in Piper Sandler Spring Biopharma Symposium
Aquestive Therapeutics announced its participation in the Piper Sandler Spring Biopharma Symposium in Boston, scheduled for April 17. The company aims to engage with investors during this event, showcasing its innovative approaches to medicine. This engagement highlights the company's commitment to advancing its pharmaceutical developments. Additionally, the announcement includes forward-looking statements that indicate potential risks associated with its product development activities.
Read more →AQSTAquestive Therapeutics Announces Positive Topline PK Results from its Pediatric Study and Completes the NDA Submission for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics has announced positive topline pharmacokinetic results from its pediatric study for Anaphylm™ (epinephrine) sublingual film. The study involved patients aged seven to seventeen with a history of allergic reactions and included thirty-two participants. The NDA for Anaphylm has been submitted to the FDA, with expectations for acceptance in Q2 2025. The company aims for a launch in the first quarter of 2026 if the FDA approves the product.
Read more →AQSTAquestive Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Initiated Anaphylm (epinephrine) Sublingual Film NDA filing process with FDA Anaphylm pre-commercial activit
Aquestive Therapeutics reported its financial results for Q4 and the full year 2024, along with important business updates. The company has initiated the NDA filing process for its Anaphylm sublingual epinephrine product, with pre-commercial activities underway and a launch expected in Q1 2026, pending FDA approval. Additionally, initial clinical trial results for Anaphylm in pediatric patients are in line with expectations. However, the company also faced a 10% decrease in total revenues and ongoing legal challenges regarding the approval of Libervant, its rescue product for children with seizure activity.
Read more →AQSTAquestive Therapeutics to Participate in Two Upcoming Conferences in March
Aquestive Therapeutics, Inc. announced its participation in two upcoming investor conferences in March 2025, namely Leerink's Global Biopharma Conference and Barclays 27th Annual Global Healthcare Conference. The management team will engage in a fireside chat and hold 1x1 meetings at these conferences, facilitating direct communication with investors. A webcast of the Leerink conference presentation will also be available, enhancing accessibility. The move reflects the company’s commitment to transparent investor relations and growth opportunities.
Read more →AQSTAquestive Therapeutics to Report Fourth Quarter 2024 Financial Results and Recent Business Highlights on March 5 and Host Conference Call on March 6 at 8:00 a.m. ET
Aquestive Therapeutics announced it will report its fourth quarter financial results for 2024 on March 5, 2025. A conference call for investors is scheduled for March 6 at 8:00 a.m. ET. The call will provide updates on recent business developments and will be accessible via a live webcast. The company aims to advance various product candidates, including those for severe allergic reactions and dermatological conditions.
Read more →AQST▲ +14.1%on this news
Aquestive Therapeutics to Present New Findings on Anaphylm™ (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting
Aquestive Therapeutics announced they will present new findings on their investigational product, Anaphylm, at the 2025 AAAAI Annual Meeting. Key results indicate Anaphylm maintains potency and stability under extreme environmental conditions and performs comparably to traditional epinephrine injections in resolving symptoms of severe allergic reactions. The study reported a significant reduction in symptom resolution time, highlighting Anaphylm's potential as a reliable, portable, and effective treatment option for anaphylaxis without the need for injections.
Read more →AQST▲ +6.2%on this news
Aquestive Therapeutics to Participate in Oppenheimer 35th Annual Healthcare Conference
Aquestive Therapeutics is set to participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference from February 11-12, 2025. The company's management team will hold a fireside chat on February 11th, providing updates and insights on its innovative pharmaceutical developments. Webcast details will be available on the investors' section of the company's website, and a replay will be accessible for 30 days following the event. The press release includes forward-looking statements regarding the company's expectations and the potential risks involved.
Read more →AQSTAquestive Therapeutics Provides Business Update and Outlines Key 2025 Objectives
Aquestive Therapeutics provided a business update outlining key objectives for 2025, including the NDA submission for Anaphylm in Q1 2025 and the initiation of a Phase 2a trial for AQST-108 in alopecia areata. The company aims to expand its product offerings, notably with Anaphylm addressing severe allergies. Additionally, Libervant has received FDA approval to treat seizure clusters in young pediatric patients, bolstering this segment of the company's portfolio. With a strong cash position of approximately $70 million, Aquestive is poised for growth and development in the coming years.
Read more →AQST▲ +5.2%on this news
Aquestive Therapeutics Receives U.S. FDA Orphan Drug Exclusivity for Libervant (diazepam) Buccal Film in Pediatric Patients with Seizure Clusters Ages Two to Five
Aquestive Therapeutics has announced that the U.S. FDA has granted orphan drug exclusivity to its product Libervant (diazepam) Buccal Film for treating seizure clusters in pediatric patients aged two to five. This designation provides significant market advantages for the company, allowing them to exclusively market the product until April 2031. Libervant is noted for being the first orally administered rescue therapy for this specific group, presenting a non-invasive alternative to existing treatments. However, the medication carries risks of misuse and serious side effects that healthcare providers and caregivers should be aware of.
Read more →AQST▼ -5.5%on this news
Aquestive Therapeutics Announces Positive FDA Feedback and Reaffirms NDA Submission Guidance for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics announced positive feedback from the FDA regarding its New Drug Application (NDA) for Anaphylm™ (epinephrine) Sublingual Film, which is positioned to be a revolutionary orally delivered treatment for anaphylaxis. The company confirmed that no additional trial data on adults is necessary prior to submission. They have also started a pediatric trial in both the U.S. and Canada, with a planned NDA submission in the first quarter of 2025. The feedback reinforces the significance of Anaphylm in improving patient accessibility to emergency care for severe allergic reactions.
Read more →AQSTAquestive Therapeutics to Participate in Two Upcoming Investor Conferences
Aquestive Therapeutics, Inc. announced its participation in two upcoming investor conferences in November and December 2024. Management will engage in one-on-one meetings at the Jefferies London Annual Healthcare Conference and will hold a fireside chat at the Piper Sandler’s 35th Annual Healthcare Conference. A webcast of the latter event will also be made available on the Company's website afterwards. These events aim to enhance investor relations and showcase the Company's innovative approaches in the pharmaceutical sector.
Read more →AQST▼ -7.7%on this news
Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update Anaphylm (epinephrine) Sublingual Film pre-NDA meeting scheduled for fourth quarter 2024 AQST-108 (epinephrine) Topical Gel
Aquestive Therapeutics reported its third quarter 2024 financial results, highlighting advancements in its epinephrine platforms, Anaphylm and AQST-108. The company is scheduled for a pre-NDA meeting for Anaphylm this quarter, while AQST-108 is poised for a pre-IND meeting also in the fourth quarter. Additionally, Aquestive continues to expand the distribution of Libervant, an FDA-approved treatment for seizure clusters in young children. With approximately $78 million in cash, the company projects a financial runway into 2026 as it pursues growth opportunities in both existing and new product pipelines.
Read more →AQSTAquestive Therapeutics to Present Subsequent Analysis of Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Demonstrating Comparable PK and PD Data to Epinephrine Injection Regardless of Variable Placement or Intraoral Movement at American College of Allergy Asthma and Immunology (ACAAI) 2024 Annual Meeting
Aquestive Therapeutics announced that new analysis data of its Anaphylm Sublingual Film, which is being presented at the ACAAI 2024 Annual Meeting, demonstrates comparable pharmacokinetics and pharmacodynamics to traditional epinephrine injections. This analysis shows that the initial placement or movement of the film does not impact drug delivery. Should the product receive FDA approval, it could become the first oral epinephrine alternative, aimed at treating severe allergic reactions. The findings support the product's innovative delivery system, which provides a reliable option for patients in emergency situations.
Read more →AQSTAquestive Therapeutics Announces Positive Topline Results from Oral Allergy Syndrome (OAS) Challenge Study for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics announced positive topline results from the Oral Allergy Syndrome (OAS) challenge study for its Anaphylm™ sublingual film. The study met both primary and secondary endpoints, demonstrating rapid resolution of allergen-related symptoms, with some subjects starting to feel relief as early as two minutes post-administration. The pharmacokinetic profile of Anaphylm remained consistent regardless of allergen exposure. The company plans to meet with the FDA in Q4 2024 and is moving towards submitting a New Drug Application in Q1 2025, aiming for a full product launch in Q1 2026.
Read more →AQSTAquestive Therapeutics to Report Third Quarter 2024 Financial Results and Recent Business Highlights on November 4 and Host Conference Call on November 5 at 8:00 a.m. ET
Aquestive Therapeutics has announced that it will report its third-quarter financial results for 2024 on November 4. The company will provide updates on its recent business developments during a conference call scheduled for November 5 at 8:00 a.m. ET. Investors can participate by registering in advance and access a live webcast through the company's website. A replay of the call will be available for 30 days.
Read more →AQST▼ -5.6%on this news
Aquestive Therapeutics Spotlights its Innovative Epinephrine Delivery Pipeline at Virtual Investor Day
Aquestive Therapeutics recently hosted a virtual investor day showcasing its innovative epinephrine delivery pipeline, specifically highlighting Anaphylm™ Sublingual Film and AQST-108 Topical Gel. The company announced completion of enrollment in a key study for Anaphylm and detailed its development strategy for AQST-108, aimed at treating Alopecia areata. Management expressed optimism about upcoming regulatory milestones, including a pre-NDA meeting with the FDA and the expected launch timelines for both product candidates. The advancements suggest a promising future for Aquestive's product development and address significant patient needs.
Read more →AQST▲ +12.2%on this news
Aquestive Therapeutics to Hold Virtual Investor Day to Provide Pipeline Updates on September 27th
Aquestive Therapeutics will hold a virtual investor day on September 27, 2024, to provide updates on its product pipeline, including Anaphylm and AQST-108. Anaphylm, a sublingual film, has received conditional FDA approval for its trade name. AQST-108, a topical gel, has completed its first human study, showcasing advancements in the company's epinephrine prodrug platform. The event will feature presentations from company management and a key opinion leader from UT Southwestern Medical Center.
Read more →AQSTAquestive Therapeutics Comments on Recent FDA Approval of Non-Injection-Based Epinephrine Product for the Treatment of Anaphylaxis and Reiterates Expected Timing for NDA Filing of Anaphylm™
Aquestive Therapeutics has applauded the FDA's recent approval of a new non-injection-based device for delivering epinephrine, which addresses severe allergic reactions such as anaphylaxis. CEO Daniel Barber has expressed optimism regarding the potential for improved patient adherence with less invasive treatment options. Moreover, the company is on track to submit a New Drug Application for its Anaphylm sublingual film in Q1 2025, with a potential product launch by late 2025 or early 2026. The Anaphylm product aims to offer a more convenient and user-friendly administration method for epinephrine.
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update Late-stage pipeline program, Anaphylm (epinephrine) Sublingual Film, remains on track for a near-term New Drug Application
Aquestive Therapeutics reported its financial results for Q2 2024, highlighting significant progress in its pipeline. The company is nearing a New Drug Application submission for Anaphylm, the first oral epinephrine product, and is expanding sales of Libervant for young epilepsy patients. With an increase in revenue to $20.1 million, Aquestive continues to demonstrate a solid financial standing with a cash runway projected until 2026. The company also plans an investor day to discuss its epinephrine prodrug technology in the coming months.
Read more →AQSTAquestive Therapeutics Reports Positive Topline Data for Anaphylm™ (epinephrine) Sublingual Film from Self-Administration Study
Aquestive Therapeutics has reported positive topline data for Anaphylm™, an epinephrine sublingual film, from a self-administration study. The study demonstrated comparable pharmacokinetics whether Anaphylm is administered by subjects or healthcare providers. The company anticipates requesting a pre-New Drug Application meeting soon and projects a potential product launch by early 2026, pending FDA approval. Anaphylm could significantly improve emergency response for individuals at risk of severe allergic reactions.
Read more →AQST▲ +9.9%on this news· ran to +26% by day 3shared move
Aquestive Therapeutics to Report Second Quarter 2024 Financial Results and Recent Business Highlights on August 6 and Host Conference Call on August 7 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. announced it will release its financial results for the second quarter of 2024 on August 6, 2024, followed by a conference call on August 7 at 8:00 a.m. ET. During the call, the company will provide updates on its recent business developments. Investors can register for the call and will have access to a live webcast, along with an archived replay on the company's website.
Read more →AQSTAquestive Therapeutics Reports Positive Topline Data from Temperature / pH Study of Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics announced positive topline pharmacokinetic results for Anaphylm, its sublingual epinephrine film, indicating efficacy regardless of beverage temperature or pH. The company is set to complete further supportive clinical studies and plans to request a pre-NDA meeting with the FDA in Q3 2024. Additionally, the product aims to provide a non-invasive, easy-to-carry alternative for patients at risk of severe allergic reactions, if approved.
Read more →AQSTAquestive Therapeutics to Join the Russell 3000 and Russell 2000 Indexes Effective June 28, 2024
Aquestive Therapeutics announced its anticipated inclusion in the Russell 3000 and Russell 2000 Indexes, effective July 1, 2024. This news reflects the company’s recent successes, such as FDA approval of Libervant for young epilepsy patients and positive results from a pivotal study for Anaphylm. The CEO highlighted the benefits of increased visibility and liquidity due to the index memberships, further underscoring the company's growth trajectory and ongoing development efforts.
Read more →AQSTAquestive Therapeutics Announces Executive Appointments and Builds Commercial Capabilities
Aquestive Therapeutics has announced the appointment of Sherry Korczynski as Senior Vice President of Sales and Marketing, along with the promotions of Dr. Stephen Wargacki to Chief Science Officer and Cassie Jung to Chief Operating Officer. These changes come as the company prepares for the launch of Anaphylm, an innovative sublingual epinephrine product aimed at treating severe allergic reactions. The management changes are aimed at bolstering the company's commercialization efforts ahead of the expected FDA approval for this potentially groundbreaking treatment.
Read more →AQSTAquestive Therapeutics to Present Anaphylm™ (epinephrine) Sublingual Film Pharmacokinetic and Pharmacodynamic Data At 2024 Eastern Allergy Conference
Aquestive Therapeutics announced it will present pharmacokinetic and pharmacodynamic data for Anaphylm (epinephrine) sublingual film at the Eastern Allergy Conference from May 30 to June 2, 2024. The data highlights positive results from completed clinical studies, and the company is targeting an FDA New Drug Application filing by the end of 2024. Anaphylm is designed to provide a novel delivery method for treating severe allergic reactions. The presentations will showcase the efficacy of Anaphylm compared to traditional methods of epinephrine administration.
Read more →AQST▲ +6.6%on this news
Aquestive Therapeutics to Participate in The Citizens JMP Life Sciences Conference
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced its participation in The Citizens JMP Life Sciences Conference scheduled for May 13, 2024. The management team will conduct a fireside chat at 11:30 am ET and will be hosting investor meetings. A webcast of the chat will be made available on the company’s investor relations page, with a replay accessible for 30 days post-event.
Read more →AQST▼ -8.7%on this newsshared move
Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update Met all endpoints in Phase 3 pivotal study for Anaphylm (epinephrine) Sublingual Film in first quarter 2024 when compared t
Aquestive Therapeutics reported its financial results for Q1 2024, highlighting successful completion of the Phase 3 pivotal study for Anaphylm. The company received positive FDA feedback and aims to file a New Drug Application for Anaphylm by the end of 2024. Additionally, they gained FDA approval for Libervant (diazepam) for young children, while extending their cash runway through a $77.5 million public offering. Overall revenue saw an 8% increase year-over-year, primarily driven by the performance of licensed products.
Read more →AQST▼ -8.2%on this news· ran to -19% by day 3
Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics announced FDA approval for Libervant (diazepam) Buccal Film, designed for pediatric patients aged 2 to 5 suffering from seizure clusters. This approval makes Libervant the first orally administered product of its kind, with immediate availability in various dosages. The company has achieved four FDA approvals since 2018 and continues to progress with its Anaphylm epinephrine film program, expecting NDA submission by the end of 2024. Safety information highlights risks of misuse and side effects, especially in young children.
Read more →AQSTAquestive Therapeutics to Report First Quarter 2024 Financial Results and Recent Business Highlights on May 7 and Host Conference Call on May 8 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. will report its first quarter 2024 financial results after market close on May 7, 2024. The company will hold a conference call for investors the following day at 8:00 a.m. ET. The call aims to provide insights into recent business developments and results. A live webcast will also be available for those interested in the discussion.
Read more →AQSTAquestive Therapeutics to Present Crossover Study Data for Libervant™ (diazepam) Buccal Film at 76th Annual Meeting of the American Academy of Neurology
Aquestive Therapeutics will present data from a crossover study of Libervant™, a diazepam buccal film, at the 76th Annual Meeting of the AAN in April 2024. This product aims to provide an oral alternative treatment for pediatric epilepsy patients aged two to five experiencing seizure clusters. The FDA has granted tentative approval for Libervant for patients 12 years and older, pending expiration of market exclusivity for a competing product. The NDA review for younger patients is on track, with no outstanding information requests from the FDA.
Read more →AQSTAquestive Therapeutics Strengthens Board of Directors with Experienced Biotech Executive
Aquestive Therapeutics has appointed Abigail Jenkins to its Board of Directors, effective April 1, 2024. Jenkins brings over 20 years of experience in the biotech and pharmaceutical sectors, focusing on commercialization and corporate strategy. The company is optimistic that her background will assist in progressing its oral epinephrine candidate, Anaphylm. This appointment marks a key step in re-establishing Aquestive's commercial capabilities.
Read more →AQSTAquestive Therapeutics Announces Closing of Underwritten Public Offering of Common Stock
Aquestive Therapeutics has announced the successful closing of its underwritten public offering, raising approximately $75 million through the sale of 16,666,667 shares of common stock at a price of $4.50 per share. The offering was managed by Leerink Partners and Piper Sandler, with other financial advisors involved. The funds raised are intended to support the company's efforts in advancing innovative medicines and delivery technologies. The offering is part of Aquestive's strategy to enhance its pipeline, which focuses on treating central nervous system diseases and severe allergic reactions.
Read more →AQSTTherapeutics Announces Proposed Public Offering of Common Stock
Aquestive Therapeutics, Inc. has announced plans to conduct a public offering of its common stock, aiming to support the development of its product pipeline. The offering is to be underwritten by Partners and Piper Sandler, with an additional option for underwriters to purchase shares. Proceeds from the offering will be used to advance the commercialization of products for treating severe allergic reactions and seizure clusters, as well as for general corporate purposes. The completion of the offering is contingent on market conditions.
Read more →AQST▼ -15.6%on this newsshared move
Aquestive Therapeutics Announces Pricing of $75 Million Underwritten Public Offering of Common Stock
Aquestive Therapeutics has announced the pricing of its $75 million underwritten public offering of common stock at a price of $4.50 per share. The company will use the proceeds to advance its product pipeline, including therapies for severe allergic reactions and seizure clusters in young epilepsy patients. The offering is expected to close by March 22, 2024, subject to customary conditions. The move indicates a strategic effort to enhance the company's financial resources for future developments.
Read more →AQSTAquestive Therapeutics Announces Proposed Public Offering of Common Stock
Aquestive Therapeutics, Inc. has announced its intention to conduct a public offering of its common stock. The company plans to use the proceeds to further develop its product pipeline, notably Anaphylm™ for severe allergic reactions and Libervant™ for seizure clusters in young epilepsy patients. The offering remains subject to market conditions and there is no guarantee regarding its completion or terms. Leerink Partners and Piper Sandler are managing the offering, with Oppenheimer & Co. as the lead manager.
Read more →AQSTAquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting
Aquestive Therapeutics announced positive results from its pivotal Phase 3 clinical study of Anaphylm™ (epinephrine) Sublingual Film, which successfully met primary and secondary endpoints. The drug demonstrated faster absorption compared to autoinjectors and received favorable feedback from the FDA regarding its clinical development plan. The company aims to file a New Drug Application (NDA) by the end of 2024 following continued correspondence with the FDA. These results position Anaphylm as a promising alternative for treating severe allergic reactions, potentially addressing a significant need in the market.
Read more →AQST▲ +20%on this news· ran to +36% by day 1
Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 million Reaffirms expected release o
Aquestive Therapeutics has reported its full year 2023 financial results, showing a revenue increase to $50.6 million alongside a non-GAAP adjusted EBITDA loss of $11.6 million. The company reaffirmed its timelines for critical clinical advancements, including Anaphylm's expected data release in March 2024 and the FDA decision on Libervant in April 2024. Despite the positive outlook, the company's financial losses and regulatory hurdles present ongoing challenges.
Read more →AQST▼ -5.3%on this news
Aquestive Therapeutics to Report Fourth Quarter 2023 Financial Results and Recent Business Highlights on March 5 and Host Conference Call on March 6 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. will report its fourth quarter 2023 financial results on March 5, 2024, and host a conference call the following day at 8:00 a.m. ET. The company aims to update stakeholders on recent business developments and advancements in their pharmaceutical innovations. A live webcast of the call will be available, with a replay accessible for 30 days. This signifies the company's commitment to communicate with investors and provide updates on its progress and strategies.
Read more →AQSTAquestive Therapeutics to Present Anaphylm™ (epinephrine) Sublingual Film Pharmacokinetic and Pharmacodynamic Data at the 2024 AAAAI Annual Meeting
Aquestive Therapeutics announced that it will present data on Anaphylm™ (epinephrine) Sublingual Film at the 2024 AAAAI Annual Meeting. The data indicates that Anaphylm demonstrates pharmacokinetic and pharmacodynamic profiles comparable to traditional methods such as autoinjectors. A pivotal Phase 3 study is currently underway, with topline data expected in the first quarter of 2024. Anaphylm could be the first non-invasive option for treating severe allergic reactions, contingent on FDA approval.
Read more →AQSTAquestive Therapeutics to Participate in Oppenheimer 34th Annual Healthcare Conference
Aquestive Therapeutics, Inc. will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference on February 13th. At the conference, the management team will participate in a fireside chat at 3:20 pm ET and hold investor meetings. A webcast of the discussion will be accessible for 30 days post-event. This participation underscores the company's commitment to innovation and investor engagement.
Read more →AQSTAquestive Therapeutics Doses First Patient in Phase 3 Pivotal Clinical Study Evaluating Pharmacokinetics and Pharmacodynamics of Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics has commenced its initial Phase 3 pivotal clinical study for Anaphylm, an epinephrine sublingual film aimed at treating severe allergic reactions. The first patient has been dosed, with topline data expected in the first quarter of 2024, moving the company closer to FDA filing. The study's design includes comparative assessments against existing epinephrine delivery methods, focusing on pharmacokinetics and pharmacodynamics, and aims to address critical unmet patient needs for an easier-to-use epinephrine product.
Read more →AQSTAquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies for Anaphylm™ at American College of Allergy Asthma and Immunology (ACAAI) Annual Meeting
Aquestive Therapeutics announced the presentation of two posters at the ACAAI annual meeting, showcasing positive data from pharmacokinetic and pharmacodynamic studies for its product Anaphylm, an epinephrine sublingual film. The results indicate potential advancements in treating acute allergic reactions, pending FDA approval. CEO Dan Barber expressed excitement about sharing these findings with leaders in the allergy community. The product's design and ease of use may offer significant benefits for patients needing emergency treatment.
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update Reiterates commencement of pivotal pharmacokinetic (PK) study for Anaphylm (epinephrine) Sublingual Film expected in fourth
Aquestive Therapeutics reported a strong performance in the third quarter of 2023, with notable revenue growth and completion of successful debt refinancing. The company confirmed the start of their pivotal pharmacokinetic study for Anaphylm, an innovative epinephrine film, targeting topline results by early 2024. Positive feedback from the FDA regarding Anaphylm's clinical study design supports the company's optimistic outlook as they have raised their full-year revenue guidance. However, challenges remain, including a net loss for the quarter and regulatory hurdles for the approval of Libervant.
Read more →AQST▼ -6.5%on this newsshared move
Aquestive Therapeutics Completes $45 Million Debt Refinancing Warren, N.J., November X, 2023 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to p
Aquestive Therapeutics has successfully completed a $45 million debt refinancing, redeeming older senior secured notes in favor of new notes with institutional investors. The new financing will relieve about $28 million in principal and interest payments by June 2025. Moreover, it introduces tiered royalty agreements tied to the sales of their products Anaphylm and Libervant. The company aims to enhance its future financial stability and growth prospects through this move.
Read more →AQSTAquestive Therapeutics to Report Third Quarter 2023 Financial Results and Recent Business Highlights on November 6 and Host Conference Call on November 7 at 8:00 a.m. ET
Aquestive Therapeutics has announced plans to report its third quarter 2023 financial results on November 6, 2023, and will hold a conference call for investors on November 7, 2023, at 8:00 a.m. ET. The earnings report will include updates on recent business developments. The company emphasizes the potential risks and uncertainties that could affect their product development and clinical trials. Investors can register for the call in advance and a live webcast will be available on their website.
Read more →AQSTAquestive Therapeutics Provides Business Update
Aquestive Therapeutics provided a business update highlighting significant progress in its pipeline. The FDA has given positive feedback regarding the pivotal study protocol for Anaphylm, with the Phase 3 study set to begin in Q4 2023. The company also confirmed that the NDA for Libervant is under review without any open questions. Financially, Aquestive anticipates an increase in revenue for 2023 and a reduction in adjusted EBITDA loss.
Read more →AQST▲ +11.8%on this news
Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics has reaffirmed its timeline for the development of Anaphylm, an oral epinephrine product. The company plans to commence a pivotal PK clinical trial in the fourth quarter of 2023 and aims to file its NDA in 2024. Anaphylm, a sublingual film, has shown clinical results comparable to existing autoinjectors in studies, demonstrating effective delivery and safety. The product's innovative design focuses on portability and ease of use for the treatment of severe allergic reactions.
Read more →AQSTAquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients and Assignment of Prescription Drug User Fee Act (PDUFA) Date
Aquestive Therapeutics has announced the FDA's acceptance of its New Drug Application for Libervant (diazepam) Buccal Film aimed at treating seizure clusters in pediatric patients aged two to five. The Prescription Drug User Fee Act (PDUFA) date is set for April 28, 2024. While Libervant could provide a valuable treatment option, the company faces challenges related to orphan drug exclusivity and potential competition from other products. Tentative approval exists for older patients, highlighting a gap in treatment options for younger patients.
Read more →AQST▼ -5.4%on this news
Aquestive Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update Submitted proposed pivotal trial protocol for Anaphylm (epinephrine) Sublingual Film to the FDA Submitted an NDA to the FD
Aquestive Therapeutics reported its Q2 2023 financial results and business developments, showcasing a pivotal trial protocol submission for Anaphylm to the FDA. The net loss decreased to $5.8 million due to revenue growth from products like Libervant and Sympazan. However, challenges remain, including a market exclusivity block for Libervant until January 2027, impacting its market access. The company also noted a significant increase in license and royalty revenues, despite a drop in co-development and research fees.
Read more →AQSTAquestive Therapeutics to Participate in 2023 Wedbush PacGrow Healthcare Conference
Aquestive Therapeutics will participate in the 2023 Wedbush PacGrow Healthcare Conference in New York, scheduled for August 9th. The management team will host investor meetings during the event, aimed at enhancing engagement and visibility in the healthcare sector. This involvement underscores the company's commitment to advancing its therapeutic innovations, as it seeks to address current patient care challenges.
Read more →AQSTAquestive Therapeutics Announces Positive Topline Pharmacokinetic Data for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics announced positive topline pharmacokinetic data from its Study AQ109103 for Anaphylm (epinephrine) Sublingual Film. The study showed that Anaphylm delivers epinephrine effectively and safely, meeting key pharmacokinetic parameters. The company plans to submit a pivotal clinical study protocol to the FDA soon and aims to start the definitive trial in Q4 2023. These developments position Anaphylm as a promising alternative for individuals at risk of anaphylaxis.
Read more →AQSTAquestive Therapeutics to Report Second Quarter 2023 Financial Results and Recent Business Highlights on August 7 and Host Conference Call on August 8 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. announced it will report its second quarter 2023 financial results on August 7, 2023, followed by a conference call for investors on August 8, 2023. The call will include updates on the company's recent business developments. The company highlights its commitment to transparency and investor engagement while also acknowledging risks associated with product development and clinical trials. A live webcast of the call will be available on their website.
Read more →AQSTAquestive Therapeutics to Present Positive Topline Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm ™ (epinephrine) Sublingual Film at Aspen Allergy Conference
Aquestive Therapeutics has announced the presentation of positive topline data from its pharmacokinetic and pharmacodynamic studies of Anaphylm, an epinephrine sublingual film. The data will be shared at the upcoming Aspen Allergy Conference, where the company aims to highlight the advantages of this innovative treatment for severe allergic reactions, including its quick and easy administration. Anaphylm is significant as it represents a novel approach in managing anaphylaxis, a serious and potentially life-threatening condition affecting millions.
Read more →AQSTAquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies of Anaphylm™ (epinephrine) Sublingual Film at Global Food Allergy Prevention Summit
Aquestive Therapeutics has announced that it will present positive data on its Anaphylm™ (epinephrine) sublingual film at the Global Food Allergy Prevention Summit. The data relates to pharmacokinetic and pharmacodynamic studies that highlight the product's potential as a novel emergency treatment for severe allergic reactions, including anaphylaxis. If approved, Anaphylm could uniquely position itself as the first oral candidate designed for rapid delivery under the tongue. The summit is scheduled for July 7-9 in Chicago, IL, where clinicians and researchers will explore food allergy prevention strategies.
Read more →AQSTAquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment
Aquestive Therapeutics announced significant business developments, including the submission of a New Drug Application (NDA) for Libervant, a diazepam formulation intended for treating seizure clusters in young children aged two to five. The company also appointed Carl N. Kraus, M.D. as Chief Medical Officer, bringing extensive drug development experience. While the NDA aims to provide a new treatment option, the company faces challenges with existing orphan drug exclusivity affecting market access until 2027 and competition from other products. The FDA's response on the NDA submission is anticipated within two months.
Read more →AQSTAdvancing medicines. Solving problems. Improving lives. Corporate Presentation June 2023 1 Disclaimer This presentation and the accompanying oral commentary has been prepared by Aquestive Therapeutics, Inc. (the "Company
Aquestive Therapeutics, Inc. has provided a corporate presentation outlining its forward-looking strategies and product candidates, including Libervant and Anaphylm (AQST-109). The company emphasizes its commitment to advancing medicines and solving therapeutic challenges. However, the presentation also highlights several risks, particularly regarding FDA approval processes and market acceptance of its products. Overall, while there are optimistic advancements, the company faces numerous uncertainties and challenges in the biopharma landscape.
Read more →AQST▲ +12.1%on this news
Aquestive Therapeutics Reports Positive Results from Latest Clinical Studies Evaluating Pharmacokinetic and Pharmacodynamic Performance of Anaphylm ™ (epinephrine) Sublingual Film and Provides Findings from Recent Auto-Injector Clinical Study
Aquestive Therapeutics reported positive results from pilot studies of Anaphylm, a sublingual film for epinephrine delivery, demonstrating rapid absorption and pharmacodynamic effects. The data showed that Anaphylm achieves maximum blood concentrations similar to or exceeding competitor auto-injectors within minutes. The company intends to submit a pivotal study protocol to the FDA later this year, indicating progression in its development program. With significant improvements observed in drug performance, Anaphylm may offer a vital alternative in the emergency treatment of anaphylaxis.
Read more →AQST▲ +20.9%on this news· ran to +62% by day 3
Aquestive Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update Continues to advance development of AQST-109 (epinephrine sublingual film) received FDA conditional approval of brand name
Aquestive Therapeutics reported its first quarter 2023 financial results, highlighting a 10% year-over-year revenue increase to $11.1 million, driven by licensed products. The company received FDA conditional approval for its sublingual epinephrine film, Anaphylm, while also updating its financial guidance for the year. Furthermore, it successfully dismissed two shareholder lawsuits, reinforcing its focus on business operations and product development. Despite challenges with market exclusivities, Aquestive continues to advance key initiatives in its product pipeline.
Read more →AQSTAquestive Therapeutics Receives Conditional FDA Acceptance of Proprietary Name Anaphylm™ for Lead Candidate AQST-109 (Epinephrine Sublingual Film)
Aquestive Therapeutics announced that the FDA has conditionally accepted the brand name Anaphylm for its lead candidate AQST-109, a sublingual film designed to treat anaphylaxis. The acceptance is part of a marketing strategy developed through expert and patient feedback, aimed at enhancing patient and caregiver interaction with the product. Anaphylm is positioned as an easier alternative to traditional epinephrine autoinjectors, which often face issues of accessibility and usability. Approval of the name is contingent upon the successful approval of the product itself by the FDA.
Read more →AQST▼ -5.5%on this newsshared move
Aquestive Therapeutics to Report First Quarter 2023 Financial Results and Recent Business Highlights on May 2 and Host Conference Call on May 3 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. will report its first quarter 2023 financial results on May 2, 2023, after market close. The company will also provide business updates during a conference call on May 3 at 8:00 a.m. ET. A live webcast of the call will be accessible on the company's website, and a replay will be available for 30 days. The announcement contains forward-looking statements that highlight uncertainties and risks associated with product development and clinical trials.
Read more →AQST▲ +11.6%on this news· ran to +28% by day 1
Aquestive Therapeutics Expands License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to Additional Global Markets
Aquestive Therapeutics has expanded its license and supply agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film to include additional global markets, excluding the U.S., Canada, and China. This move aims to enhance patient access and provides a potentially significant alternative for individuals experiencing refractory seizures. The agreement allows Aquestive to serve as the exclusive manufacturer while Pharmanovia manages regulatory activities and commercialization. This expansion follows a strong start to their collaboration and highlights the importance of innovative delivery options in healthcare.
Read more →AQSTAquestive Therapeutics Reports Fourth Quarter Full Year 2022 Financial Results and Provides Business Update on Key 2023 Objectives Pivotal study for AQST-109 (epinephrine sublingual film) on track to start in third quart
Aquestive Therapeutics reported its financial results for Q4 and full year 2022, highlighting several key initiatives for 2023. The planned pivotal study for their lead candidate AQST-109 is on track to begin in Q3 2023, with recent FDA guidance providing clarity for the drug's evaluation. Financially, the company has made strides by reducing debt by 18% and acquiring $20 million in non-dilutive capital while still facing challenges such as a net loss of $12.4 million for Q4 2022. The company is also working with the FDA on the next steps for their Libervant product and has settled litigation with BioDelivery Sciences, securing an $8.5 million payment.
Read more →AQSTAquestive Therapeutics to Participate in Oppenheimer 33rd Annual Healthcare Conference
Aquestive Therapeutics, Inc. announced its participation in the Oppenheimer 33rd Annual Healthcare Conference scheduled from March 13th to March 15th. The company's management will present on March 13 at 4:40 PM ET and will host investor meetings throughout the conference. A webcast of their presentation will be available for 30 days to provide further insights to investors. This event highlights the company's efforts to engage with stakeholders and promote its pharmaceutical advancements.
Read more →AQSTAquestive Therapeutics to Report Fourth Quarter 2022 Financial Results and Recent Business Highlights on March 7 and Host Conference Call on March 8 at 8:00 a.m. ET
Aquestive Therapeutics, Inc. has announced that it will release its financial results for the fourth quarter ended December 31, 2022, on March 7, 2023. The company will also provide a business update that same day and will host a conference call for investors on March 8, 2023, at 8:00 a.m. ET. A live webcast of the call will be accessible on Aquestive's website, with a replay available for 30 days following the event.
Read more →AQSTAquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies for AQST-109 Epinephrine Sublingual Film at American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting
Aquestive Therapeutics announced positive findings from pharmacokinetic and pharmacodynamic studies of AQST-109, an epinephrine sublingual film. The data will be presented at the AAAAI Annual Meeting in San Antonio, Texas. The results indicate that AQST-109 may provide a rapid and effective alternative for managing anaphylaxis, a serious allergic reaction. The company anticipates engaging with professionals in the allergy community to discuss the potential of AQST-109 if approved by the FDA.
Read more →AQST▼ -5.5%on this news
Aquestive Therapeutics Provides Business Update and Outlines Key 2023 Objectives Anticipates commencing pivotal pharmacokinetic (PK) trial for AQST-109 (epinephrine sublingual film) in second half of 2023 Anticipates rec
Aquestive Therapeutics provided a business update for 2023, highlighting key initiatives such as advancing AQST-109 into a pivotal pharmacokinetic trial and enhancing collaborations with global partners. The company remains focused on overcoming market access challenges for Libervant due to Orphan Drug Exclusivity and is exploring out-licensing opportunities for both Libervant and AQST-109. Additionally, they aim to bolster their manufacturing capabilities and continue developing innovative treatments.
Read more →AQSTAquestive Therapeutics Provides Business Update and Outlines Key 2023 Objectives
Aquestive Therapeutics shared a business update outlining its key objectives for 2023. The company aims to start a pivotal pharmacokinetic trial for AQST-109 and is awaiting the FDA's response regarding the request for accelerated market access for Libervant. Additionally, Aquestive is focusing on strengthening its financial position and expanding collaborations. The company highlighted the potential for launching AQST-109 in 2025 if approved by the FDA.
Read more →AQSTAquestive Therapeutics Announces Completion of FDA End-of-Phase 2 Meeting For AQST-109 (epinephrine sublingual film)
FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance and patient administration attributes Company continues to anticipate a poten
Read more →AQSTAquestive Therapeutics Announces Publication of Crossover Food Effect Study of Diazepam Nasal Spray in Epilepsia
WARREN, N.J., Nov. 29, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, announced today the publication of a crossover food
Read more →AQSTAquestive Therapeutics to Present Positive Data from Pharmacokinetic Studies for AQST-109 (epinephrine sublingual film) at American Academy of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting
WARREN, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, will present three abstracts recapping positive data
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update Reported positive data from EPIPHAST II trial comparing AQST-109 (epinephrine sublingual film) to EpiPen 0.3mg (single dose
Aquestive Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Update Reported positive data from EPIPHAST II trial comparing AQST-109 (epinephrine sublingual film) to EpiPen 0.3mg (single dose) and AQST-109 to epi 0.3mg IM injection (repeat dose) Sch
Read more →AQSTAquestive Therapeutics Licenses Sympazan (clobazam) Oral Film to Assertio Holdings, Inc.
WARREN, N.J., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, announced today a transaction to license Sympazan® (
Read more →AQSTAquestive Therapeutics Announces Positive Decision in States’ Suboxone Antitrust Lawsuit on All Claims
WARREN, N.J., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, announced today that the United States District Cour
Read more →AQST▼ -6.9%on this newsshared move
Aquestive Therapeutics to Report Third Quarter 2022 Financial Results and Recent Business Highlights on November 1 and Host Conference Call on November 2 at 8:00 a.m. ET
WARREN, N.J., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, today announced that it will report results for thir
Read more →AQST▲ +5.9%on this news
Aquestive Therapeutics Receives Positive FDA Written Response for AQST-109 Epinephrine Sublingual Film
FDA’s End-of-Phase 2 written response provides positive feedback related to Chemistry, Manufacturing, and Controls (CMC) to support future NDA filing Supports approach to characterizing Aquestive’s proprietary novel prodrug form of epinephrine API Confirms Agency alignment on p
Read more →AQSTAquestive Therapeutics Enters License and Supply Agreement with Pharmanovia for Libervant™ (diazepam) Buccal Film for European and MENA Markets
WARREN, N.J., Sept. 28, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today an
Read more →AQSTAquestive Therapeutics Announces Positive EPIPHAST II Trial Data for AQST-109 When Compared to EpiPen
AQST-109 median time to maximum concentration (Tmax) of 12 minutes was faster than EpiPen® Tmax of 22.5 minutes AQST-109 repeat dosing provided significantly higher drug plasma concentrations with a Tmax of 8 minutes after administration Changes in systolic blood pressure and h
Read more →AQSTwainwrightpresenta Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. September 2022 Aquestive Therapeutics H.C. Wainwright Advancing medicines. Solving proble
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. September 2022 Aquestive Therapeutics H.C. Wainwright Advancing medicines. Solving problems. Improving lives. Forward-Looking Statement This presentation includes forw
Read more →AQSTAquestive Therapeutics Announces Expert Allergy Scientific Advisory Board
WARREN, N.J., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today the es
Read more →AQSTAquestive Therapeutics to Participate in Two Investor Conferences in September
WARREN, N.J., Aug. 31, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (Nasdaq: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that th
Read more →AQSTAquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film
Libervant provided tentative approval from the FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity Libervant U.S. Market Access currently subject to the expiration of Valtoco® orphan drug market exclusivity Company hosts conference cal
Read more →AQST▲ +12.5%on this news· ran to +54% by day 3
Aquestive Therapeutics Strengthens Team to Align with Strategic Focus on Allergy Space
Appoints Timothy E. Morris, a veteran biotech executive with over 35 years of experience in executive and financial leadership, to Board of Directors Names Kenneth Truitt, M.D., with over 25 years of clinical and regulatory experience across biotechnology and large pharmaceutica
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update Completed EPIPHAST trial successfully demonstrating rapid and significant epinephrine exposure under a variety of real-wor
Aquestive Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update Completed EPIPHAST trial successfully demonstrating rapid and significant epinephrine exposure under a variety of real-world conditions after administration of AQST-109 (epinephrine
Read more →AQST▼ -6.7%on this news
Aquestive Therapeutics to Participate in Wedbush PacGrow Healthcare Conference
WARREN, N.J., July 26, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that th
Read more →AQST▲ +6.2%on this news
Aquestive Therapeutics to Report Second Quarter 2022 Financial Results and Recent Business Highlights on August 2 and Host Conference Call on August 3 at 8:00 a.m. ET
WARREN, N.J., July 20, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it
Read more →AQST▲ +8.3%on this news
Aquestive Therapeutics Reports Positive Results from Final Two Arms of EPIPHAST Trial Supporting Performance and Real-World Functionality of AQST-109 Epinephrine Oral Film
Study results for the sublingual administration of AQST-109 epinephrine oral film after consuming a peanut butter sandwich demonstrates consistent Tmax of 12 minutes Study results for swallowing AQST-109 whole immediately with water showed an unexpectedly high level of gastroint
Read more →AQST▲ +5.9%on this news
Aquestive Therapeutics Reports Positive Initial Topline Data from Part 3 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film
AQST-109 is the first and only orally delivered epinephrine product candidate in clinical development Fastest median time to maximum concentration (Tmax) in studies to date at 12 minutes Study continues to show AQST-109 is safe and well tolerated Head-to-head comparison study
Read more →AQSTAquestive Therapeutics, Inc. Announces $8.5 Million Registered Direct Offering WARREN, N.J., JUNE 6, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to s
Aquestive Therapeutics, Inc. Announces $8.5 Million Registered Direct Offering WARREN, N.J., JUNE 6, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and
Read more →AQSTAquestive Therapeutics, Inc. Announces Closing of $8.5 Million Registered Direct Offering
WARREN, N.J., June 08, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it
Read more →AQSTAquestive Therapeutics to Participate in JMP Securities Life Sciences Conference
WARREN, N.J., June 07, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that th
Read more →AQST▼ -7.6%on this newsshared move
Aquestive Therapeutics, Inc. Announces $8.5 Million Registered Direct Offering
WARREN, N.J., June 06, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced that it
Read more →AQSTAquestive Therapeutics Announces CEO Transition Daniel Barber, current Chief Operating Officer of Aquestive, appointed as President and Chief Executive Officer and member of Board of Directors Keith Kendall, President an
Aquestive Therapeutics Announces CEO Transition WARREN, N.J., May 17, 2022 -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve thei
Read more →AQSTAquestive Therapeutics Announces CEO Transition
Daniel Barber, current Chief Operating Officer of Aquestive, appointed as President and Chief Executive Officer and member of Board of Directors Keith Kendall, President and Chief Executive Officer and member of Board of Directors, will be leaving the Company Keith Kendall enga
Read more →AQST▲ +9.7%on this news
Aquestive Therapeutics to Participate in H.C. Wainwright Global Investment Conference
WARREN, N.J., May 10, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that the
Read more →AQSTAquestive Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update FDA continues to consider orphan drug exclusivity issues regarding Libervant's NDA Common stock purchase agreement secured
Aquestive Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update FDA continues to consider orphan drug exclusivity issues regarding Libervant's NDA Common stock purchase agreement secured for up to $40 million Part 3 of EPIPHAST trial for AQST-1
Read more →AQST▼ -8.6%on this news
Aquestive Therapeutics to Report First Quarter 2022 Financial Results and Recent Business Highlights on May 3 and Host Conference Call on May 4 at 8:00 a.m. ET
WARREN, N.J., April 18, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that i
Read more →AQSTreleasexlincolnpar Aquestive Therapeutics Announces Common Stock Purchase Agreement for up to $40 Million with Lincoln Park Capital Provides Access to Additional Capital to Support Growth WARREN, N.J.
include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials for AQST-109 and our other product candidates; risk of delays in FDA ap
Read more →AQSTAquestive Therapeutics Announces Common Stock Purchase Agreement for up to $40 Million with Lincoln Park Capital
Provides Access to Additional Capital to Support Growth WARREN, N.J., April 13, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformativ
Read more →AQSTAquestive Therapeutics Reports Positive Topline Data from Part 2 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film
AQST-109 is the first and only orally delivered epinephrine product candidate in clinical development Rapid absorption with a median time to peak concentration (Tmax) of 15 minutes confirmed in a larger subject population Study continues to show AQST-109 is safe and well tolera
Read more →AQST▲ +10.3%on this news
Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-109 for Emergency Treatment of Allergic Reactions Including Anaphylaxis
WARREN, N.J., March 17, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today announced that th
Read more →AQSTAquestive Therapeutics Reports Full Year 2021 Results Exceeding Revenue and EBITDA Guidance Continues to interact with FDA regarding orphan drug review of the NDA for Libervant (diazepam) Buccal Film Reports start of Par
Aquestive Therapeutics Reports Full Year 2021 Results Exceeding Revenue and EBITDA Guidance Continues to interact with FDA regarding orphan drug review of the NDA for Libervant (diazepam) Buccal Film Reports start of Part 2 of EPIPHAST crossover study for AQST-109 epinephrine o
Read more →AQSTAquestive Therapeutics and Haisco Pharmaceutical Group Enter Licensing and Supply Agreement for Riluzole Oral Film for ALS Treatment in China
WARREN, N.J., March 03, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive”), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, announc
Read more →AQSTAquestive Therapeutics Presented Positive Topline Phase 1 Results for AQST-109 Epinephrine Oral Film at American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting
WARREN, N.J., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, presented a late breaki
Read more →AQST▲ +12.1%on this newsshared move
Aquestive Therapeutics Reports Positive Topline Data from Part 1 of EPIPHAST Trial Evaluating AQST-109 Epinephrine Oral Film
First and only orally delivered epinephrine product candidate AQST-109 continues to show rapid absorption with a median time to peak concentration (Tmax) of 13.5 minutes AQST-109 was safe and well tolerated Part 2 of the EPIPHAST trial commenced WARREN, N.J., Feb. 25, 2022 (GL
Read more →AQST▲ +12.1%on this newsshared move
Aquestive Therapeutics Announces FDA Clearance of Investigational New Drug Application (IND) for AQST-109 Epinephrine Oral Film
WARREN, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced the ope
Read more →AQST▼ -6.1%on this newsshared move
Aquestive Therapeutics to Report Fourth Quarter and Year End 2021 Financial Results and Recent Business Highlights on March 8 and Host Conference Call on March 9 at 8:00 a.m. ET
WARREN, N.J., Feb. 22, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company improving and advancing medicines to solve patients’ problems with current standards of care in order to better their lives with transformative products, announce
Read more →AQSTAquestive Therapeutics to Present at H.C. Wainwright BioConnect Virtual Conference
WARREN, N.J., Jan. 07, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQST▼ -29.3%on this news
Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant™ (diazepam) Buccal Film
WARREN, N.J., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that, regardi
Read more →AQSTAquestive Therapeutics Added to NASDAQ Biotechnology Index
WARREN, N.J., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that NA
Read more →AQSTaqst109epiphastpre Source: Aquestive Therapeutics, Inc.
Source: Aquestive Therapeutics, Inc. December 13, 2021 08:00 ET Aquestive Therapeutics Receives Written Response to Pre-IND Submission for AQST-109 (epinephrine prodrug sublingual film) and Begins Recruitment for its Epinephrine Film Pharmacokinetic and Safety Trial (EPIPHAST) FD
Read more →AQSTAquestive Therapeutics Receives Written Response to Pre-IND Submission for AQST-109 (epinephrine prodrug sublingual film) and Begins Recruitment for its Epinephrine Film Pharmacokinetic and Safety Trial (EPIPHAST)
FDA confirms 505(b)(2) pathway is acceptable for the development of AQST-109 FDA indicates AQST-109 has the potential for Fast Track designation Health Canada provides clearance to commence the adaptive design crossover study WARREN, N.J., Dec. 13, 2021 (GLOBE NEWSWIRE) -- Aqu
Read more →AQSTAquestive Therapeutics to Participate in Piper Sandler 33rd Annual Virtual Healthcare Conference
WARREN, N.J., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2021 Financial Results, Provides Business Update and Improves Full Year Guidance Libervant (diazepam) Buccal Film continues to progress through the FDA review process in advan
Aquestive Therapeutics Reports Third Quarter 2021 Financial Results, Provides Business Update and Improves Full Year Guidance Libervant (diazepam) Buccal Film continues to progress through the FDA review process in advance of PDUFA goal date of December 23, 2021 AQST-109 top li
Read more →AQST▲ +7.9%on this news
Document Aquestive Therapeutics Reports Positive Topline Data from Phase 1 Pharmacokinetic Trial of AQST-109 (epinephrine prodrug sublingual film) Supporting its Development as an Oral Alternative to Epinephrine Autoinje
Aquestive Therapeutics Reports Positive Topline Data from Phase 1 Pharmacokinetic Trial of AQST-109 (epinephrine prodrug sublingual film) Supporting its Development as an Oral Alternative to Epinephrine Autoinjectors for the Emergency Treatment of Allergic Reactions -First and o
Read more →AQST▲ +7.9%on this news
Aquestive Therapeutics Reports Positive Topline Data from Phase 1 Pharmacokinetic Trial of AQST-109 (epinephrine prodrug sublingual film) Supporting its Development as an Oral Alternative to Epinephrine Autoinjectors for the Emergency Treatment of Allergic Reactions
First and only orally delivered epinephrine product candidate AQST-109 demonstrates clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of allergic reactions Median time to peak concentration (Tmax) of 15 minutes or less achieve
Read more →AQSTAquestive Therapeutics to Report Third Quarter 2021 Financial Results and Recent Business Highlights on November 2 and Host Conference Call on November 3 at 8:00 a.m. ET
WARREN, N.J., Oct. 14, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTAquestive Therapeutics Reaches Agreement to Extend Principal Payments Due Under Credit Facility to March 30, 2023 and Receives Bridge Waiver of Principal Debt Payment in Advance of Concluding Formal Agreement
WARREN, N.J., Oct. 06, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it has r
Read more →AQSTDocument Aquestive Therapeutics Reaches Agreement to Extend Principal Payments Due Under Credit Facility to
Aquestive Therapeutics Reaches Agreement to Extend Principal Payments Due Under Credit Facility to March 30, 2023 and Receives Bridge Waiver of Principal Debt Payment in Advance of Concluding Formal Agreement WARREN, N.J., October 6, 2021 -- Aquestive Therapeutics, Inc. (NASDAQ
Read more →AQSTAquestive Therapeutics to Participate in Three Investor Conferences in September
WARREN, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the man
Read more →AQSTDocument Aquestive Therapeutics Negotiates Six Month Extension to
Aquestive Therapeutics Negotiates Six Month Extension to June 30, 2022 for Additional Libervant Related Capital Under Current Debt Agreement Provides access to $30 million in capital contingent on FDA approval and U.S. market access for Libervant WARREN, N.J., August 9, 2021 --
Read more →AQSTAquestive Therapeutics Negotiates Six Month Extension to June 30, 2022 for Additional Libervant™ Related Capital Under Current Debt Agreement
Provides access to $30 million in capital contingent on FDA approval and U.S. market access for Libervant WARREN, N.J., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiate
Read more →AQSTAquestive Therapeutics to Participate in 12th Annual Wedbush PacGrow Healthcare Virtual Conference
WARREN, N.J., Aug. 06, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2021 Financial Results, Provides Business Update and Raises Full Year Revenue Guidance Libervant TM NDA resubmission accepted, PDUFA goal date of
Aquestive Therapeutics Reports Second Quarter 2021 Financial Results, Provides Business Update and Raises Full Year Revenue Guidance LibervantTM NDA resubmission accepted, PDUFA goal date of December 23, 2021 On track to report top-line data from Phase 1 study for AQST-109 epin
Read more →AQSTAquestive Therapeutics to Report Second Quarter 2021 Financial Results and Recent Business Highlights on August 3 and Host Conference Call on August 4 at 8:00 a.m. ET
WARREN, N.J., July 21, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTDocument Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film Prescription Drug User Fee Act (PDUFA) Target Goal Date set for
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021 If approved by the FDA for U.S. market access, Libervant would be th
Read more →AQST▲ +7.8%on this newsshared move
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant™ (diazepam) Buccal Film
Prescription Drug User Fee Act (PDUFA) Target Goal Date set for December 23, 2021 If approved by the FDA for U.S. market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) --
Read more →AQSTAquestive Therapeutics Resubmits New Drug Application for Libervant™ (diazepam) Buccal Film
Anticipates FDA PDUFA goal date in late 2021 If approved by the FDA for US market access, Libervant would be the first orally delivered diazepam product for the management of seizure clusters WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:
Read more →AQSTDocument Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film Anticipates FDA PDUFA goal date in late 2021 If approved by the FDA for US market access, Libervant would be the first o
Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film Anticipates FDA PDUFA goal date in late 2021 If approved by the FDA for US market access, Libervant would be the first orally delivered diazepam product for the management of seizure clus
Read more →AQSTAquestive Therapeutics Announces Leadership Transition of Chief Financial Officer
WARREN, N.J., June 21, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that A. Ernes
Read more →AQSTAquestive Therapeutics to Participate in JMP Securities and BMO Capital Market Investor Conferences
WARREN, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQSTAquestive Therapeutics to Participate in 2021 RBC Capital Markets Global Healthcare Conference
WARREN, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the manag
Read more →AQSTAquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update On track to refile Libervant (diazepam) Buccal Film New Drug Application (NDA) by end of second quarter 2021 Initiated firs
Aquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update Warren, N.J., May 4, 2021 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patie
Read more →AQSTAquestive Therapeutics, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm
Investors with a $4,600 or more in losses are are encouraged to contact the firm before April 30, 2021; click here to submit trade information LOS ANGELES, April 28, 2021 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises investors that a class action lawsuit has been filed on beh
Read more →AQSTAquestive Therapeutics to Report First Quarter 2021 Financial Results and Recent Business Highlights on May 4 and Host Conference Call on May 5 at 8:00 a.m. ET
WARREN, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTAnaphylaxis and EpinephrineR&D Day
Anaphylaxis and EpinephrineR&D Day March 25, 2021 Forward Looking Statement This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "in
Read more →AQSTAquestive Therapeutics Successfully Demonstrates Repeatable and Predictable Oral Sublingual Film Administration of Epinephrine
Provides in-depth scientific and clinical data in R&D event today at 9:00 am ET Outlines data from two completed Phase 1 pharmacokinetic (PK) trials for AQST-108 (dipivefrin) sublingual film Articulates development strategy for second prodrug candidate, AQST-109 sublingual film
Read more →AQSTAquestive Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update Libervant (diazepam) Buccal Film New Drug Application (NDA) resubmission expected end of second quarter 2021
Aquestive Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update Warren, N.J., March 9, 2021 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products t
Read more →AQSTAquestive Therapeutics to Host Investor & Analyst Virtual Epinephrine Drug Delivery R&D Event on March 25 at 9:00 a.m. ET
WARREN, N.J., March 05, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTAQUESTIVE THERAPEUTICS, INC. CLASS ACTION ALERT: Wolf Haldenstein Adler Freeman & Herz LLP notifies investors that a securities class action lawsuit has been filed in the United States District Court for the District of New Jersey
NEW YORK, March 04, 2021 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a federal securities class action lawsuit has been filed against Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") (NASDAQ: AQST) in United States District Court for t
Read more →AQSTAquestive Therapeutics Reaffirms Near-Term NDA Resubmission for Libervant (diazepam) Buccal Film Following FDA Feedback Reaffirms plans to resubmit its New Drug Application (NDA) around the end of second quarter 2021 Rec
Aquestive Therapeutics Reaffirms Near-Term NDA Resubmission for Libervant (diazepam) Buccal Film Following FDA Feedback Warren, NJ, February 25, 2021 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated
Read more →AQSTAquestive Therapeutics to Announce Fourth Quarter and Year End 2020 Financial Results and Recent Business Highlights on March 9 and Host Conference Call on March 10 at 8:00 a.m. ET
WARREN, N.J., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTAquestive Therapeutics Strengthens Board of Directors with Appointments of Julie Krop, M.D., and Marco Taglietti, M.D., and Announces Resignation of Douglas K. Bratton from Board of Directors Warren, NJ
Aquestive Therapeutics Strengthens Board of Directors with Appointments of Julie Krop, M.D., and Marco Taglietti, M.D., and Announces Resignation of Douglas K. Bratton from Board of Directors Warren, NJ, February 9, 2021 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmac
Read more →AQSTAquestive Therapeutics Appoints Mark Lepore, MD, as Chief Medical Officer for Allergy
New hire helps lead Aquestive’s continued focus on its epinephrine program Provides update on Libervant™ (diazepam) Buccal Film WARREN, N.J., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commer
Read more →AQSTMITSUBISHI TANABE PHARMA AMERICA AND AQUESTIVE THERAPEUTICS ANNOUNCE U.S. LICENSING AND SUPPLY DEAL FOR RILUZOLE ORAL FILM FOR ALS TREATMENT JERSEY CITY, N.J. and WARREN, N.J.
MITSUBISHI TANABE PHARMA AMERICA AND AQUESTIVE THERAPEUTICS ANNOUNCE U.S. LICENSING AND SUPPLY DEAL FOR RILUZOLE ORAL FILM FOR ALS TREATMENT JERSEY CITY, N.J. and WARREN, N.J., January 21, 2021 - Mitsubishi Tanabe Pharma America, Inc. (MTPA) and Aquestive Therapeutics, Inc. (N
Read more →AQSTJanuary 2021 Aquestive TherapeuticsCorporate Presentation Forward Looking Statement 2 This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Word
January 2021 Aquestive TherapeuticsCorporate Presentation Forward Looking Statement 2 This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "esti
Read more →AQSTAquestive Therapeutics Provides Business Update Resubmitted revised dosing regimen for Libervant to FDA in December 2020, as committed Multiple clinical trials demonstrate that AQST-108 can consistently deliver epinephri
Aquestive Therapeutics Provides Business Update Warren, NJ, January 7, 2021 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve therapeutic problem
Read more →AQSTAquestive Therapeutics to Present at Two Upcoming Investor Conferences
WARREN, N.J., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQSTAquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer Warren, NJ
Aquestive Therapeutics Announces Departure of Chief Financial Officer and Appointment of Interim Chief Financial Officer Warren, NJ, December 16, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiate
Read more →AQSTAquestive Therapeutics to Present at Piper Sandler 32nd Annual Virtual Healthcare Conference
WARREN, N.J., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that the mana
Read more →AQSTAquestive Therapeutics Receives First Milestone Payment from KYNMOBI Monetization Receives first milestone payment of $10 million, bringing total fourth quarter proceeds to $50 million Warren, NJ
Aquestive Therapeutics Receives First Milestone Payment from KYNMOBI Monetization Warren, NJ, November 23, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet
Read more →AQSTAquestive Therapeutics Completes FDA Type A Meeting on Libervant FDA confirms issues identified in FDA Complete Response Letter (CRL) of
Aquestive Therapeutics Completes FDA Type A Meeting on Libervant Warren, NJ, November 18, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients' unmet needs and solve
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update Sympazan (clobazam) continues to meet key performance metrics and market penetration FDA Type A meeting for Libervant (diaz
Aquestive Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update Warren, N.J., November 4, 2020 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address
Read more →AQSTAquestive Therapeutics Signs Royalty Monetization Agreement with Marathon Asset Management for up to $125 Million
Receives $40 million of proceeds at closing, with potential $25 million of additional proceeds by mid-2022 Reduces outstanding debt to $51.5 million WARREN, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on
Read more →AQSTAquestive Therapeutics to Announce Third Quarter Financial Results and Recent Business Highlights on November 4 and Host Conference Call on November 5 at 8:00 a.m. ET
WARREN, N.J., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTAquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Complete Response Letter cites exposure levels (Cmax) in certain weight groups No
Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Warren, NJ, September 25, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializ
Read more →AQSTAquestive Therapeutics Initiates Phase 1 Pharmacokinetic Trial of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) In Development for Treatment of Allergic Reactions Including Anaphylaxis
First healthy volunteer dosed in a Phase 1 study of AQST-108 for the treatment of allergic reactions including anaphylaxis Pharmacokinetic and pharmacodynamics data expected in fourth quarter 2020 WARREN, N.J., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NAS
Read more →AQSTAquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Treatment of Allergic Reactions Including Anaphylaxis Finalizing preparations for
Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Treatment of Allergic Reactions Including Anaphylaxis Warren, NJ, August 10, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmace
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Approaches Generated 59% year-over-year revenue growth for
Aquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Warren, N.J., August 4, 2020 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on develo
Read more →AQSTAquestive Therapeutics to Present at 2020 Wedbush PacGrow Healthcare Virtual Conference
WARREN, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that managemen
Read more →AQSTAquestive Therapeutics to Announce Second Quarter Financial Results and Recent Business Highlights on Aug 4 and Host Conference Call on Aug 5 at 8:00 a.m. ET
WARREN, N.J., July 15, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that it will
Read more →AQSTThe Fly Interview Q&A Keith Kendall, President and CEO of Aquestive Therapeutics 1. Last month, the company said it plans to advance its strategy to monetize the anticipated royalties associated with Sunovion Pharmaceuti
The Fly Interview Q&A Keith Kendall, President and CEO of Aquestive Therapeutics As expected, Sunovion's KynmobiTM product was approved by the FDA on May 21. Sunovion has announced its intention to launch the product in the US in September of 2020. Sunovion licensed Aquestive T
Read more →AQSTAquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment Expects to initiate its planned pharmacokinetic (PK
Aquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment Warren, NJ, June 29, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on
Read more →AQSTAquestive Therapeutics to Present at BMO Capital Markets 2020 Prescriptions for Success Healthcare Conference
WARREN, N.J., June 16, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that managemen
Read more →AQSTAquestive Therapeutics to Hold Virtual-Only Annual Meeting of Stockholders
WARREN, N.J., June 04, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that due to t
Read more →AQSTAquestive Therapeutics Advances Royalty Monetization Plan as Sunovion Pharmaceuticals' Apomorphine Sublingual Film Therapy Receives FDA Approval Warren, N.J.
Aquestive Therapeutics Advances Royalty Monetization Plan as Sunovion Pharmaceuticals' Apomorphine Sublingual Film Therapy Receives FDA Approval Warren, N.J., May 21, 2020 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercial
Read more →AQSTAquestive Therapeutics to Present at 2020 RBC Capital Markets Global Healthcare Conference
WARREN, N.J., May 07, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that management
Read more →AQSTAquestive Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update: AQST-108 and Libervant Remain On Track Continues to manufacture and deliver therapies and advance R&D efforts during COVID
Aquestive Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update: AQST-108 and Libervant Remain On Track Warren, N.J., May 5, 2020 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing di
Read more →AQSTAquestive Therapeutics to Announce First Quarter Financial Results and Recent Business Highlights on May 5 and Host Investment Community Conference Call on May 6
WARREN, N.J., April 21, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that it will
Read more →AQSTAquestive Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights Expects to submit IND application for AQST-108 (epinephrine) in second quarter 2020 and commence pharmacok
Aquestive Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights Warren, N.J., March 11, 2020 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products
Read more →AQSTAquestive Therapeutics to Announce Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights on March 12, 2020
WARREN, N.J., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today announced that
Read more →AQSTAquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant (diazepam) Buccal Film FDA Acceptance of Libervant (diazepam) Buccal Film NDA for Managemen
Aquestive Therapeutics Announces U.S. Food and Drug Administration Filing Acceptance of New Drug Application (NDA) for Libervant (diazepam) Buccal Film Warren, NJ, February 10, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on deve
Read more →AQSTAquestive Therapeutics Announces FDA Confirmed 505(b)(2) Pathway for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment Pre-IND Meeting on AQST-108 Completed FDA Confirmed AQ
Aquestive Therapeutics Announces FDA Confirmed 505(b)(2) Pathway for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment Warren, NJ, February 6, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company
Read more →AQSTAquestive Therapeutics Receives FDA Response to Citizen's Petition Warren, NJ
Aquestive Therapeutics Receives FDA Response to Citizen's Petition Warren, NJ, January 12, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients' unmet needs an
Read more →AQSTAquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance
Anticipates full year 2019 preliminary unaudited total revenues to be approximately $52 million, exceeding previously provided full year revenue guidance Anticipates fourth quarter 2019 preliminary unaudited total revenues to be approximately $16 million Expects preliminary una
Read more →AQSTAquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance Anticipates full year 2019 preliminary unaudited total revenue
Aquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance Warren, NJ, January 10, 2020 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused o
Read more →AQSTAquestive Therapeutics Announces Pricing of Public Offering of Common Stock
WARREN, N.J., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (Nasdaq:AQST) (“Aquestive”), a specialty pharmaceutical company focused on developing and commercializing differentiated products to meet patients’ unmet needs and solve therapeutic problems, today annou
Read more →AQSTAquestive Therapeutics Announces Proposed Public Offering of Common Stock Warren, NJ
Aquestive Therapeutics Announces Proposed Public Offering of Common Stock Warren, NJ, December 10, 2019 - Aquestive Therapeutics, Inc. (Nasdaq: AQST) ("Aquestive"), a specialty pharmaceutical company focused on developing and commercializing differentiated products based on its
Read more →AQSTInvestor and Analyst Update on LIBERVANT
Investor and Analyst Update on LIBERVANT December 9, 2019 Forward Looking Statement 2 Certain statements in this presentation and associated oral statements made by management may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Re
Read more →AQSTAquestive Therapeutics to Host Investor & Analyst Libervant™ (diazepam) Buccal Film Update Forum at American Epilepsy Society 2019 Annual Meeting
WARREN, N.J., Dec. 04, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that it
Read more →AQSTAquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Warren, N.J.
Aquestive Therapeutics Completes Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Libervant (diazepam) Buccal Film for Management of Seizure Clusters Warren, N.J., December 2, 2019 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a spe
Read more →AQSTAquestive Therapeutics Announces Poster Presentations of Data on Libervant™ (diazepam) Buccal Film at American Epilepsy Society 2019 Annual Meeting
Company to Host Scientific Exhibit on Monday, December 9 from 8:00 am ET to 11:00 am ET Company to Host Investor & Analyst Libervant Update Forum and Webcast on Monday, December 9 at 4:00 pm ET WARREN, N.J., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ
Read more →AQSTUnreliable Absorption With Rectal Administration of Diazepam Gary Slatko 1 , Stephen Wargacki 1 , David J. Wyatt 2 , Allen H. Heller 3 1 Aquestive Therapeutics, Warren, NJ; 2 Syneos Health Clinical Solutions Early Phase,
Unreliable Absorption With Rectal Administration of Diazepam Gary Slatko1, Stephen Wargacki1, David J. Wyatt2, Allen H. Heller3 1Aquestive Therapeutics, Warren, NJ; 2Syneos Health Clinical Solutions Early Phase, Miami, FL; 3Pharma Study Design, LLC, Woodbridge, CT Rationale:
Read more →AQSTAquestive Therapeutics Receives FDA Approval for Exservan (riluzole) Oral Film WARREN, N.J.
Aquestive Therapeutics Receives FDA Approval for Exservan (riluzole) Oral Film WARREN, N.J., November 25, 2019 -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeuti
Read more →AQSTAquestive Therapeutics Licenses Riluzole Oral Film to Zambon for Development and Commercialization in the EU for Patients with ALS Warren, NJ
Aquestive Therapeutics Licenses Riluzole Oral Film to Zambon for Development and Commercialization in the EU for Patients with ALS Warren, NJ, November 13, 2019 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercial
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2019 Financial Results and Raises 2019 Guidance Increased full year 2019 revenue and earnings guidance Expected to complete its rolling New Drug Application (NDA) submission f
Aquestive Therapeutics Reports Third Quarter 2019 Financial Results and Raises 2019 Guidance Warren, NJ, November 5, 2019 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet
Read more →AQSTAquestive Therapeutics Reaffirms Full Year 2019 Revenue Guidance and Will Announce Third Quarter 2019 Financial Results and Recent Business Highlights on
Aquestive Therapeutics Reaffirms Full Year 2019 Revenue Guidance and Will Announce Third Quarter 2019 Financial Results and Recent Business Highlights on November 6, 2019 WARREN, N.J., October 15, 2019 -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical co
Read more →AQSTAquestive Therapeutics Announces Successful Completion of Phase 1 Trial for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) - Represents Significant Proof-of-Concept Milestone for Sublingual Epinep
Aquestive Therapeutics Announces Successful Completion of Phase 1 Trial for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) - Represents Significant Proof-of-Concept Milestone for Sublingual Epinephrine Pipeline Product - WARREN, N.J., September 30, 2019
Read more →AQSTAquestive Therapeutics to Attend Two Upcoming Investor Conferences
WARREN, N.J., Aug. 26, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that th
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2019 Financial Results and Recent Business Highlights Reported positive topline data from single dose crossover pharmacokinetic (PK) trial for Libervant (diazepam) Buccal Fil
Aquestive Therapeutics Reports Second Quarter 2019 Financial Results and Recent Business Highlights Warren, NJ, August 6, 2019 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that
Read more →AQSTAquestive Therapeutics Announces Positive Topline Results from Libervant™ (Diazepam) Buccal Film Single Dose Crossover Study
The study confirms the dosing algorithm developed for Libervant (diazepam) buccal film, a potentially first in class oral treatment for breakthrough or cluster seizures Libervant adult rolling New Drug Application (NDA) submission expected to be completed in the fourth quarter o
Read more →AQSTAquestive Therapeutics to Present at 2019 Wedbush PacGrow Healthcare Conference
WARREN, N.J., July 29, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced that ma
Read more →AQSTAquestive Therapeutics Completes $70 Million Debt Refinancing Warren, NJ
Aquestive Therapeutics Completes $70 Million Debt Refinancing Warren, NJ, July 15, 2019 - Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive"), a specialty pharmaceutical company focused on developing and commercializing differentiated products based on its proprietary Phar
Read more →AQSTAquestive Therapeutics Reports First Quarter 2019 Financial Results and Recent Business Highlights U.S. launch of Sympazan (clobazam) Oral Film progressing to plan Rolling NDA submission for Libervant TM (diazepam) Bucca
Aquestive Therapeutics Reports First Quarter 2019 Financial Results and Recent Business Highlights Warren, NJ, May 8, 2019 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that m
Read more →AQSTAquestive Therapeutics, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Recent Business Highlights Secured U.S. Food and Drug Administration (FDA) approval and launched the first proprietary commerci
Aquestive Therapeutics, Inc. Reports Fourth Quarter and Full Year 2018 Financial Results and Recent Business Highlights Warren, NJ, March 14, 2019 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differe
Read more →AQSTSunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)
Sunovion Pharmaceuticals received a Complete Response Letter from the FDA for its apomorphine sublingual film application, which aims to treat OFF episodes in Parkinson's disease. The FDA requires additional information but no new clinical studies.
Read more →AQSTAquestive Therapeutics Provides End of Year Business Update, Including Progress of its Proprietary CNS Assets, Financial and Legal Matters Projects full year 2018 revenues over $67 million, exceeding expectations, and pr
Aquestive Therapeutics Provides End of Year Business Update, Including Progress of its Proprietary CNS Assets, Financial and WARREN, N.J., December 20, 2018 -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company pharmaceutical company focused on iden
Read more →AQSTBusiness UpdateDecember 2018 2 Forward Looking Statements Certain statements in this presentation and associated oral statements made by management may constitute "forward-looking statements." Words such as "believes", "
Business UpdateDecember 2018 2 Forward Looking Statements Certain statements in this presentation and associated oral statements made by management may constitute "forward-looking statements." Words such as "believes", "expects", "projects", "future" and similar expressions oft
Read more →AQSTAquestive Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration (FDA) for Tadalafil Oral Film
Aquestive Therapeutics received a complete response letter from the FDA regarding its NDA for tadalafil oral film, requesting additional data. The company remains optimistic about resubmission and potential approval, stating the issues are manageable and do not affect other products.
Read more →AQSTAquestive Therapeutics Reports Third Quarter 2018 Financial Results and Recent Business Highlights Completed adult epilepsy monitoring study demonstrating that Libervant TM provides comparable bioavailability Received FD
Aquestive Therapeutics Reports Third Quarter 2018 Financial Results and Recent Business Highlights Completed adult epilepsy monitoring study demonstrating that LibervantTM provides comparable bioavailability Received FDA approval for SYMAPAZANTM for the adjunctive treatment of
Read more →AQSTAquestive Therapeutics Announces Completion of the Diazepam Buccal Film Adult Epilepsy Monitoring Unit (EMU) Clinical Study with Positive Topline Results Warren, NJ
Aquestive Therapeutics Announces Completion of the Diazepam Buccal Film Adult Epilepsy Monitoring Unit (EMU) Clinical Study with Positive Topline Results Warren, NJ, October 24, 2018 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announ
Read more →AQSTAquestive Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Highlights, Including Tentative Approval for Sympazan TM Warren, NJ
Aquestive Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Highlights, Including Tentative Approval for SympazanTM Warren, NJ, September 4, 2018 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on identifying
Read more →AQSTAquestive Therapeutics Announces Closing of Exercise of Underwriters' Over-Allotment Option in Initial Public Offering Warren, NJ
Aquestive Therapeutics Announces Closing of Exercise of Underwriters' Over-Allotment Option in Initial Public Offering Warren, NJ, August 15, 2018 - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on identifying, developing and commerciali
Read more →AQSTAquestive Therapeutics Names Sandy Costa as Chairman of the Board of Directors Warren, NJ
Aquestive Therapeutics Names Sandy Costa as Chairman of the Board of Directors Warren, NJ, August 13, 2018 - Aquestive Therapeutics, Inc. (NASDAQ:AQST), a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address u
Read more →AQSTAquestive Therapeutics Announces Closing of Initial Public Offering
Aquestive Therapeutics Announces Closing of Initial Public Offering Warren, NJ, July 27, 2018 - Aquestive Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, today a
Read more →AQSTFDA Approves Strativa Pharmaceuticals' Zuplenz® (ondansetron) Oral Soluble Film
The FDA has approved Strativa Pharmaceuticals' Zuplenz® (ondansetron) oral soluble film for preventing nausea and vomiting related to chemotherapy and surgery. This unique formulation is the first oral soluble film approved as a prescription medication, enhancing treatment options for patients who struggle with traditional tablets.
Read more →Competitive Position
How AQST ranks across every disease it competes inCompetitive Position is a premium feature
See how AQST ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trial