| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
Phase 2b interim results example | Phase 2b | — | Subscribe to access the data. | Medical Devices | Immunology | ||
Phase 2b interim results example | Phase 2b | — | Subscribe to access the data. | Medical Devices | Immunology | ||
Phase 2b interim results example | Phase 2b | — | Subscribe to access the data. | Medical Devices | Immunology |
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Recently added Catalysts
ARS Pharmaceuticals, Inc.$7.94
+0.06 (+0.76%)
D 36Pipeline Score Overvalued Pharma · Commercial
Market Cap
788.47 M
EPS
-2.00
P/E Ratio
-
Value Trade
10.61 M
SEC Financials
Q1 2026Dilution Risk
40%Revenue
22.68 M
R&D Expenses
4.34 M
Operating CF
-44.95 M
Total Assets
287.57 M
Total Liabilities
226.26 M
Equity
61.31 M
D/E Ratio
12,345
7.3 %
Week
-0.63 %
1 Month
-15.17 %
3 Month
18.68 %
6 Month
-71.83 %
5 Year
-72.62 %
All Time
Cash Data
Cash Position
200.97 M
Monthly Burn
14.98 M
Runway
11.8 mo
Burn Trend
StableSEC Filing
May 15, 2026
Overview
Volume
1.40 M
52 Week Range
6.66 - 18.90
% held by Insiders
35.05 %
% held by Institutions
74.53 %
Enterprise Value
684.61 M
Total Shares
99.36 M
Short %
44.37 %
Float Shares
48.99 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for ARS Pharmaceuticals, Inc.
314Total events
9Upcoming
116Tier-1 (high impact)
2020 – 2027Coverage
Upcoming catalysts 9
Event history 305
Jul 7, 2026
Jul 1, 2026
▼Quarterly UpdateCorporate
No new commercial formulary additions or coverage decisions for neffy in July 1, 2026 cycle
Jun 2026
◆Timing GuidancePresentation
Definitive update on CVS Caremark formulary approval anticipated
May 15, 2026
▲Enrollment MilestoneneffyApprovedTrial
Interim analysis population fully enrolled in Phase 2b CSU trial
Chronic spontaneous urticaria (CSU)source ↗
Apr 15, 2026
▲Other Regulator MilestoneneffyApprovedEx-US Regulatory
Health Canada approved neffy
Allergic reactions including anaphylaxissource ↗
Q2 2026
▲Product LaunchneffyApprovedPost-Market
Inclusion of carrying case in each prescription carton
Type I allergic reactions including anaphylaxissource ↗
Q2 2026
◆Other Regulator MilestoneneffyApprovedEx-US Regulatory
neffy approval in Canada expected Q2 2026
Anaphylaxissource ↗
Mar 31, 2026
▲EU ApprovalEURneffyApprovedEx-US Regulatory
European Commission granted marketing authorization for EURneffy 1 mg
Anaphylaxis in pediatric patients 4+ years, 15-30 kgsource ↗
Mar 27, 2026
▲FDA ApprovalneffyApprovedFDA Decision
FDA approval to remove age requirement from neffy 1 mg label
Type I allergic reactions including anaphylaxissource ↗
Mar 9, 2026
Drug Pipeline Intelligence
D36
Pipeline Score $134M
Pipeline ValueOvervalued
Valuation Signal3
Drugs Scored0.2x
rNPV / MCap Top 49%
Micro Cap (rank 466 of 911)
Percentile RankARS Pharmaceuticals, Inc. faces pipeline headwinds (36/100), with $605M risk-adjusted pipeline value, led by ARS-1 in Asthma (Phase 2).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ARS-1 Small molecule | Urticaria | Phase 2 | NCT05496465 | 17% | $479M | COMPLETED | 21 | - | - | Feb 29, 2024 | - | Apr 7, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
neffy | chronic spontaneous urticaria | Phase 2 | 2024-02-26 | statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema; as early as 5 minutes post-administration; 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores Read More | ARS Pharmaceuticals announces neffy meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study Read More | |
neffy | chronic spontaneous urticaria | Phase 2 | 2024-02-26 | statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema; as early as 5 minutes post-administration; 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores Read More | ARS Pharmaceuticals announces neffy meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study Read More | |
neffy | chronic spontaneous urticaria | Phase 2 | 2024-02-26 | statistically significant and clinically meaningful improvement in pruritus, hives, body surface area and erythema; as early as 5 minutes post-administration; 1 mg and 2 mg neffy demonstrating statistically significant and clinically meaningful changes from baseline in itch, hives, urticaria and erythema scores Read More | ARS Pharmaceuticals announces neffy meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study 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 SPRY
| 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 |
SPRY 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 | |
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 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
SPRY▲ +0.8%today
ARS Pharmaceuticals Announces CEO Succession
ARS Pharmaceuticals has announced a leadership transition, with co-founder Richard Lowenthal stepping down as CEO effective July 6, 2026. Donn Casale, previously the President, has been appointed as the new CEO and Director. The Board expresses confidence in Casale's ability to drive growth for the neffy franchise and enhance the company's market position.
Read more →SPRY▼ -23.9%on this news
ARS Pharmaceuticals Provides Commercial and Financial Updates
ARS Pharmaceuticals provided updates on its epinephrine nasal spray, neffy, indicating no new coverage decisions from payers for July 2026. The company has lowered its cash-based operating expenses for 2026 and remains on track for cash-flow breakeven by 2027. Additionally, interim data from the Phase 2b trial for chronic spontaneous urticaria is expected in Q4 2026, highlighting potential growth opportunities.
Read more →SPRY▼ -6.5%on this news
ARS Pharmaceuticals Reports First Quarter 2026 Financial Results and Corporate Update
ARS Pharmaceuticals reported a total revenue of $22.7 million for Q1 2026, driven by strong sales of its epinephrine nasal spray, neffy. The company is expanding its sales force and is in the final stages of a proposal to CVS Caremark for formulary inclusion. Additionally, the Phase 2b study for chronic spontaneous urticaria is fully enrolled, with interim results expected in Q4 2026. However, the company also reported a significant net loss of $60.6 million.
Read more →SPRY▼ -7.2%on this newsshared move
ARS Pharmaceuticals Strengthens Leadership Team with Appointment of Industry Veteran Donn Casale as President
ARS Pharmaceuticals has appointed Donn Casale as President, effective June 1, 2026. Casale, a seasoned biopharmaceutical leader, will oversee global operations and drive growth, particularly for the epinephrine nasal spray, neffy. His experience in commercial strategy is expected to enhance patient access and prepare the company for expansion into chronic spontaneous urticaria.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its First Quarter 2026 Financial Results
ARS Pharmaceuticals has announced a conference call and webcast scheduled for May 15, 2026, to discuss its first quarter financial results and business highlights. The event aims to provide insights into the company's performance and future direction. Interested participants can register for dial-in information and access the webcast through the company's website.
Read more →SPRY▼ -5.7%on this news
ARS Pharmaceuticals Receives FDA Approval to Remove Age Requirement From neffy® 1 mg (epinephrine nasal spray) Label
ARS Pharmaceuticals has received FDA approval to update the neffy® 1 mg (epinephrine nasal spray) label, removing the age requirement for use. Now, all individuals weighing 33 lbs. or more can utilize this needle-free treatment for allergic reactions, including anaphylaxis. The update aims to ease the administration of emergency treatment for families with young children.
Read more →SPRYARS Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Updates on neffy® (epinephrine nasal spray) Commercialization
ARS Pharmaceuticals reported strong financial results for 2025, with $72.2 million in U.S. net product revenue from neffy, its epinephrine nasal spray. The company is focusing on expanding market share and securing payor access while managing significant operational costs. Despite a net loss of $171.3 million, ARS Pharma maintains a robust cash position to support its growth strategy.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its Fourth Quarter and Full Year 2025 Financial Results and Participation at Upcoming Conferences
ARS Pharmaceuticals has announced a conference call and webcast scheduled for March 9, 2026, to discuss its fourth quarter and full year 2025 financial results. The company is also participating in several upcoming investor conferences. ARS Pharma is known for its epinephrine nasal spray, neffy®, aimed at treating allergic reactions, including anaphylaxis.
Read more →SPRYARS Pharmaceuticals to Showcase Scientific Innovation and Robust Clinical Data on neffy® (epinephrine nasal spray) at 2026 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting
ARS Pharmaceuticals is set to present five posters and additional reports on neffy, an epinephrine nasal spray, at the 2026 AAAAI Annual Scientific Meeting. The presentations will cover clinical advancements, usability, and health-economic analyses, highlighting neffy's potential advantages over traditional injectable epinephrine. The company emphasizes the importance of providing a reliable and intuitive option for patients at risk of anaphylaxis.
Read more →SPRYEURneffy® 1 mg (adrenaline nasal spray) Recommended for Approval in the EU for Emergency Treatment of Type 1 Allergic Reactions, including Anaphylaxis in Children Weighing ≥15 kg to <30 kg
ARS Pharmaceuticals announced that the European Medicines Agency's CHMP has recommended approval for EURneffy® 1 mg, a needle-free adrenaline nasal spray for emergency treatment of anaphylaxis in children weighing 15 kg to less than 30 kg. This marks a significant advancement in providing a practical treatment option for younger children at risk of severe allergic reactions. The product is expected to be authorized by the European Commission, expanding access across EU member states.
Read more →SPRYCalifornia K-12 Schools Now Eligible for neffyinSchools Program, Offering Needle-Free Epinephrine at No Cost for Emergency Use
California has joined 23 other states in the neffyinSchools program, allowing K-12 schools to receive free needle-free epinephrine for emergency use. This initiative aims to empower school staff to respond effectively to allergic reactions, which can lead to anaphylaxis. The program has expanded significantly since its launch, now covering 24 states and over 8,000 schools nationwide.
Read more →SPRYneffy® (epinephrine nasal spray) Approved in China as the First and Only Community Use Epinephrine Product for the Treatment of Allergic Reactions (anaphylaxis)
ARS Pharmaceuticals' neffy® (epinephrine nasal spray) has received approval from China's National Medical Products Administration for the emergency treatment of anaphylaxis in adults and children over 30 kg. This marks the first community-use epinephrine product available in China, addressing a significant gap in treatment options. The product is expected to be available by spring 2026, with plans for additional dosage approvals in the future.
Read more →SPRYARS Pharmaceuticals to Participate in Piper Sandler 37th Annual Healthcare Conference
ARS Pharmaceuticals will participate in the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025. CEO Richard Lowenthal and CCO Eric Karas will engage in a fireside chat on December 3. The event will provide a platform for investor meetings and includes a live webcast of the discussion.
Read more →SPRYARS Pharmaceuticals Reports Third Quarter 2025 Financial Results and Highlights for neffy® (epinephrine nasal spray)
ARS Pharmaceuticals reported a strong financial performance for Q3 2025, achieving $32.5 million in revenue, primarily driven by the successful launch of neffy®, an epinephrine nasal spray. The company is enhancing its commercial strategy through direct-to-consumer initiatives and real-world evidence to boost prescriber confidence. A conference call is scheduled to discuss these results and future plans.
Read more →SPRYARS Pharma Launches Get neffy® on Us for Patients with Severe Allergic Reactions to Improve Access to neffy (epinephrine nasal spray)
ARS Pharmaceuticals has launched the 'Getneffy on Us' program, which allows eligible patients to access the needle-free epinephrine spray, neffy, through a hassle-free virtual visit with a healthcare provider. This initiative aims to improve accessibility for those with severe allergies, particularly in light of the limited availability of allergists. The program offers a $0 co-pay for eligible patients with commercial insurance, making it easier for them to obtain this critical medication.
Read more →SPRYUPDATE -- ARS Pharma to Present Real-World Data on Intranasal Epinephrine at 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
ARS Pharmaceuticals will present real-world data on its intranasal epinephrine product, neffy®, at the 2025 ACAAI Annual Scientific Meeting. The presentations will include a late-breaking oral presentation and six posters, showcasing the effectiveness of neffy® in treating anaphylaxis. Experts emphasize the reliability and convenience of this needle-free treatment option for patients experiencing severe allergic reactions.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its Third Quarter 2025 Financial Results
ARS Pharmaceuticals has announced a conference call and webcast scheduled for November 10, 2025, to discuss its third quarter financial results and business highlights. The event will provide insights into the company's performance and future strategies. Interested participants can register for dial-in information and access the webcast through the company's website.
Read more →SPRYARS Pharma to Present Real-World Data on Intranasal Epinephrine at 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
ARS Pharma is set to present significant findings regarding its intranasal epinephrine product, neffy, at the upcoming 2025 ACAAI Annual Scientific Meeting. The late-breaking oral presentation and six poster presentations will showcase real-world data highlighting the effectiveness of neffy in treating anaphylaxis. Key findings reveal that approximately 90% of patients treated with a single dose of neffy experienced successful outcomes. This evidence supports the efficacy and convenience of needle-free epinephrine administration, appealing to both clinicians and caregivers.
Read more →SPRY▲ +7.6%on this news
ARS Pharmaceuticals Receives Favorable Decision from European Patent Office on Patent Related to neffy® (epinephrine nasal spray)
ARS Pharmaceuticals announced that the European Patent Office upheld its patent for neffy®, an epinephrine nasal spray. This decision reinforces the validity of the patent across over 30 European countries, extending coverage until at least 2039. The company also successfully defended a related U.S. patent earlier this year, enhancing its confidence in its patent portfolio.
Read more →SPRYARS Pharmaceuticals Secures Up to $250 Million Loan Facility with RA Capital Management and OMERS Life Sciences to Accelerate U.S. Commercialization of neffy®
ARS Pharmaceuticals has secured a loan facility of up to $250 million with RA Capital Management and OMERS Life Sciences to accelerate the commercialization of neffy, a needle-free epinephrine nasal spray. The initial $100 million will primarily fund marketing and medical affairs initiatives. Consumer interest is strong, with a significant percentage of patients likely to consider neffy if recommended by healthcare providers. This funding aims to enhance market share and support the company's growth strategy.
Read more →SPRYneffy® (epinephrine nasal spray) Approved in Japan as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)
ARS Pharmaceuticals has received approval for neffy®, an epinephrine nasal spray, in Japan. This marks the first needle-free treatment for anaphylaxis available in the country. The product is expected to be available by Q4 2025, providing a new option for patients who may hesitate to use injectable epinephrine. The approval aims to address the significant need for effective allergy management in Japan.
Read more →SPRY▲ +6.3%on this news
Real-World Evidence Supports Clinical Effectiveness of neffy® (epinephrine nasal spray) in Patients Experiencing Anaphylaxis
ARS Pharmaceuticals has published findings supporting the effectiveness of neffy, an epinephrine nasal spray, in treating anaphylaxis. Nearly 90% of patients were successfully treated with a single dose during routine clinical practice. This data aligns with historical success rates of epinephrine injections, reinforcing the potential interchangeability of neffy with traditional methods.
Read more →SPRYARS Pharmaceuticals to Participate in Upcoming Investor Conferences
ARS Pharmaceuticals, Inc. will participate in two upcoming investor conferences: the Cantor Global Healthcare Conference on September 3, 2025, and the Stifel Immunology and Inflammation Summit on September 15, 2025. Key executives Richard Lowenthal and Eric Karas will present at these events. Live webcasts will be available for both presentations.
Read more →SPRY▼ -5%on this news· ran to -16% by day 3
ARS Pharmaceuticals Reports Second Quarter 2025 Financial Results and Highlights Accelerating Growth for neffy (epinephrine nasal spray) $15.7 million in revenue, including $12.8 million in neffy U.S. net product revenue
ARS Pharmaceuticals announced its financial results for the second quarter of 2025, reporting a total revenue of $15.7 million, including $12.8 million from neffy, its epinephrine nasal spray. The company has secured 93% commercial coverage and anticipates further growth from a national direct-to-consumer campaign and a pediatric co-promote partnership. Significant milestones include the launch of EURneffy in Germany and its approval in the U.K., expanding the global footprint of ARS's products. However, despite positive revenue growth, the company faced a net loss of $44.9 million during the quarter, highlighting the steep marketing and operational costs involved.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its Second Quarter 2025 Financial Results
ARS Pharmaceuticals announced it will host a conference call and webcast on August 13, 2025, to discuss its financial results for the second quarter of 2025. The company specializes in developing treatments for allergic reactions, particularly through its product, neffy®, an epinephrine nasal spray. Interested participants can register for dial-in information and access the webcast on the company’s website. A replay of the event will also be made available for 30 days after the call.
Read more →SPRY▼ -9.4%on this news
ARS Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Progress in U.S. Commercial Launch of neffy (epinephrine nasal spray) $7.8 million in total neffy U.S. net product revenue in first quarter
ARS Pharmaceuticals reported its first quarter 2025 financial results, showcasing progress in the U.S. commercial launch of neffy, its needle-free epinephrine nasal spray. The product generated $7.8 million in net revenue, with over 5,000 prescriptions issued. Despite these positive developments, the company recorded a net loss of $33.9 million, primarily due to high selling, general, and administrative expenses. The launch strategy includes comprehensive marketing campaigns and collaborations with healthcare providers to increase awareness and accessibility.
Read more →SPRYARS Pharmaceuticals’ neffy (epinephrine nasal spray) 1 mg is Now Available in the United States for Type I Allergic Reactions, including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms
ARS Pharmaceuticals has announced that neffy, an epinephrine nasal spray, is now available in the U.S. for the emergency treatment of Type I allergic reactions, including anaphylaxis, specifically targeting pediatric patients aged 4 years and older who weigh between 15 to 30 kilograms. The product was approved by the FDA in March 2025 and addresses the need for a needle-free option, which can help alleviate parental concerns about administering treatments. The company has implemented supportive programs aimed at making neffy more accessible and affordable for families, particularly with back-to-school preparations approaching.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its First Quarter 2025 Financial Results
ARS Pharmaceuticals, Inc. has announced a conference call and webcast scheduled for May 14, 2025, to discuss its first quarter financial results and business highlights. The call reflects the company's dedication to engaging with stakeholders and providing updates on their performance. ARS Pharma focuses on empowering patients at risk of allergic reactions leading to anaphylaxis, with their product neffy® aimed at emergency treatment. The company is transparent about its operations, inviting participation from interested parties.
Read more →SPRY▲ +22.8%on this news
ARS Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates $7.3 million in total neffy (epinephrine nasal spray) U.S. net product revenue in 2024 since launch in late Se
ARS Pharmaceuticals reported its financial results for Q4 and full year 2024, highlighting $7.3 million in revenue from the neffy nasal spray. The company secured FDA approval for neffy 1 mg, enabling it to serve 2 million children at risk for severe allergies. With significant cash reserves of $314 million, ARS is poised to advance its commercialization strategies and investments in 2025. The company anticipates continued growth through expanding market access and a strong marketing campaign planned for mid-2025.
Read more →SPRYARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions, Including Anaphylaxis, in Pediatric Patients Weighing 15 to < 30 Kilograms
ARS Pharmaceuticals has received FDA approval for neffy 1 mg, a needle-free epinephrine nasal spray designed for children aged 4 and weighing between 15 to 30 kilograms. This medication aims to address the long-standing fear of using needle-based auto-injectors, which often delays critical treatment during allergic emergencies. The approval is backed by clinical trials showing consistency with traditional epinephrine injections. neffy is expected to enhance access and encourage timely administration of epinephrine among pediatric patients with allergies.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcast for its Fourth Quarter and Full Year 2024 Financial Results and Participation at Upcoming Conferences
ARS Pharmaceuticals, Inc. announced that it will host a conference call and webcast on March 20, 2025, to discuss its fourth quarter and full year 2024 financial results. The company is focused on empowering at-risk patients against anaphylaxis and will also participate in multiple investor conferences, including the Leerink Partners Global Healthcare Conference and the Roth Conference. These events serve as platforms to convey financial performance and future business strategies.
Read more →SPRYARS Pharmaceuticals Announces OptumRx, Cigna Healthcare and Navitus Health Systems Add neffy (Epinephrine Nasal Spray) to National Formularies, Further Expanding Coverage for Patients
ARS Pharmaceuticals has successfully added its nasal spray, neffy, to the National Formularies of Cigna Healthcare, Navitus Health Systems, and OptumRx, significantly increasing patient access to this treatment for Type I allergic reactions. This integration is expected to provide improved affordability and accessibility, allowing millions of patients to benefit from neffy's availability without prior authorizations. The company continues to work towards expanding its coverage further by negotiating with more health plans, notably UnitedHealthcare. The epinephrine nasal spray represents a critical advancement in allergic reaction management, especially for those averse to traditional injectable options.
Read more →SPRYARS Pharmaceuticals to Showcase Innovation and Present Data on neffy (epinephrine nasal spray) at 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Scientific Meeting
ARS Pharmaceuticals will present data on neffy, its epinephrine nasal spray, at the 2025 AAAAI Annual Scientific Meeting. The presentations will cover various efficacy studies, including a comparative analysis of anaphylaxis treatments and pharmacokinetics. Notably, neffy has been shown to quickly alleviate symptoms, making it a promising needle-free option for managing allergic reactions. The company aims to advance the scientific understanding of intranasal epinephrine and engage with the allergy community during the event.
Read more →SPRYARS Pharmaceuticals to Participate in the Oppenheimer 35th Annual Healthcare Conference
ARS Pharmaceuticals, Inc. announced its participation in the virtual Oppenheimer 35th Annual Healthcare Conference. CEO Richard Lowenthal and CCO Eric Karas will engage in a fireside chat on February 12, 2025, aimed at boosting investor relations. The event will also include one-on-one meetings with investors, enhancing the company's visibility and commitment to addressing severe allergies. Additionally, ARS Pharmaceuticals is known for its epinephrine nasal spray, neffy®, which is aimed at treating anaphylaxis.
Read more →SPRY▲ +7.2%on this news
ARS Pharmaceuticals Launches neffyinSchools Program Providing Free Life-Saving Needle-Free Epinephrine For Emergency Use to Eligible K-12 Schools
ARS Pharmaceuticals has initiated the neffyinSchools program, offering eligible K-12 schools free cartons of neffy (epinephrine nasal spray) to aid in emergency situations involving allergic reactions. This initiative lets participating schools receive two cartons of epinephrine, facilitating quick response to anaphylaxis without any cost to the institutions. It underscores the importance of accessible emergency medication in schools where allergic reactions can sometimes occur unexpectedly among students. The program reflects a commitment to enhancing student safety during school hours.
Read more →SPRY▲ +5.7%on this news· ran to +19% by day 3shared move
ARS Pharmaceuticals Announces Preliminary Fourth Quarter 2024 Financial Results and 2025 Objectives for neffy (epinephrine nasal spray) Preliminary fourth quarter neffy net product revenue of approximately $6.5 million P
ARS Pharmaceuticals reported preliminary financial results for Q4 2024, indicating approximately $6.5 million in net product revenue for its intranasal epinephrine spray, neffy. The company holds $314 million in cash reserves, supporting operations for three years. Going into 2025, ARS plans to enhance sales through targeted marketing and educational initiatives. Despite strong early sales, final financial results remain unaudited, with potential side effects of neffy noted as risks.
Read more →SPRYARS Pharmaceuticals Announces Preliminary Fourth Quarter 2024 Financial Results and 2025 Objectives for neffy (epinephrine nasal spray)
ARS Pharmaceuticals announced preliminary financial results for neffy, reporting approximately $6.5 million in net product revenue for the fourth quarter of 2024. With a cash reserve of $314 million, the company is well-positioned to sustain operations for at least the next three years. The company plans to enhance neffy's market presence in 2025 with various initiatives aimed at increasing awareness and prescriber engagement. Additionally, ARS Pharma is preparing for a presentation at the upcoming J.P. Morgan Healthcare Conference.
Read more →SPRYARS Pharmaceuticals Announces neffy (Epinephrine Nasal Spray) is available on Express Scripts Commercial National Formularies
ARS Pharmaceuticals has announced that seuffy, its epinephrine nasal spray, has been added to Express Scripts' Commercial National Formularies, effective November 22, 2024. This inclusion improves access to a needle-free option for treating Type I allergic reactions, including anaphylaxis, for millions of insured patients. neffy is notable as the first new delivery method for epinephrine in over 35 years, addressing prevalent barriers such as fear of needles. ARS Pharma's efforts reflect a commitment to enhancing patient care and reducing obstacles in allergy treatment.
Read more →SPRY▼ -6.8%on this newsshared move
ARS Pharmaceuticals to Participate in the 43rd Annual J.P. Morgan Healthcare Conference
ARS Pharmaceuticals, Inc. has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference from January 13-16, 2025. CEO Richard Lowenthal will present on January 15, 2025, at 7:30 a.m. PT, and company management will engage in one-on-one meetings with investors. A webcast of the presentation will be accessible live and will also be archived for later viewing for 90 days.
Read more →SPRYARS Pharmaceuticals Announces Filings for Approval of neffy in China, Japan and Australia
ARS Pharmaceuticals announced that its partners in China, Japan, and Australia have filed for approval of neffy, an epinephrine nasal spray designed for emergency treatment of anaphylaxis. The product was recently approved in the U.S. and shows positive results from clinical studies conducted in Japan and China, indicating its effectiveness. ARS Pharma retains U.S. rights for neffy and aims to make it available globally, recognizing the significance of its needle-free delivery system in emergency situations. However, potential risks and the reliance on licensing partnerships for wider market access remain as challenges.
Read more →SPRY▲ +6%on this news
ARS Pharmaceuticals Announces Planned Launch of neffyinSchools Program to Provide Life-Saving Needle Free Epinephrine to Eligible K-12 Schools at No Cost
ARS Pharmaceuticals announced the launch of its neffyinSchools Program, set to begin in January 2025, which will provide eligible K-12 schools in the U.S. with free cartons of neffy, a needle-free epinephrine nasal spray for emergency use against anaphylaxis. The program aims to ensure that schools can act quickly in life-threatening allergic reactions, particularly given that many reactions occur without prior diagnoses. Schools are encouraged to check state laws regarding epinephrine use to ensure compliance. More information about the program and application instructions will be available following its official launch.
Read more →SPRY▼ -15.2%on this news
ARS Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Updates Commercial launch of neffy (epinephrine nasal spray) underway in the United States Supplemental NDA for neffy 1mg dose grante
ARS Pharmaceuticals reported a successful launch for neffy (epinephrine nasal spray) in the U.S. during Q3 2024, driven by recent FDA approvals. The company is positioned to benefit from its partnership with ALK-Abell, which secured an upfront payment of $145 million. While the firm's cash reserves of approximately $349.6 million strengthen its position, they reported a net loss of $19.1 million, highlighting initial low sales following the product launch. The FDA has also given priority review status to a supplemental NDA for a 1 mg dosage of neffy, signaling positive growth potential in the near term.
Read more →SPRYARS Pharmaceuticals Announces Exclusive Agreement with Global Allergy Leader ALK to Commercialize neffy in Europe, Canada and Other Geographies Outside the United States
ARS Pharmaceuticals has entered an exclusive agreement with ALK to commercialize neffy, its needle-free epinephrine nasal spray, in Europe, Canada, and other regions outside the U.S. Under the agreement, ARS will receive an upfront payment of $145 million, with the potential for additional milestone payments and royalties. This partnership allows ARS Pharma to concentrate on its U.S. market launch while leveraging ALK’s extensive global network in the allergy market. ARS Pharma retains U.S. rights to neffy and aims to file for Canadian approval by the end of 2024.
Read more →SPRYARS Pharmaceuticals Announces Conference Call and Webcasts for its Third Quarter 2024 Financial Results and Presentations at Upcoming Conferences
ARS Pharmaceuticals, Inc. will host a conference call and webcast on November 13, 2024, to discuss its third quarter 2024 financial results. The company is also set to participate in several investor conferences throughout November, including Guggenheim’s Healthcare Innovation Conference and the Stifel Healthcare Conference. ARS Pharmaceuticals is dedicated to assisting at-risk patients with their epinephrine nasal spray, neffy®, for treating severe allergic reactions. The company encourages participation in its upcoming events through its website.
Read more →SPRYARS Pharmaceuticals Showcases Intranasal Epinephrine Data at 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
ARS Pharmaceuticals is presenting seven abstracts at the 2024 ACAAI Annual Scientific Meeting in Boston, highlighting advancements in intranasal epinephrine research. This work underscores the potential advantages of neffy®, an intranasal epinephrine product that offers a needle-free alternative for emergency treatment of anaphylaxis. The studies encompass various aspects such as cardiovascular safety and real-world administration data in pediatric patients, aiming to enhance clinical understanding and treatment options for severe allergic reactions.
Read more →SPRYARS Pharmaceuticals Announces U.S. Availability of neffy (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
ARS Pharmaceuticals has announced the U.S. availability of neffy (epinephrine nasal spray), the first needle-free treatment for Type I allergic reactions, including anaphylaxis. Approved by the FDA, neffy is now accessible to adults and children weighing 30 kg and above through a prescription. The company is also implementing a co-pay savings program to make it financially accessible for eligible patients. Further, ARS plans to expand neffy's availability in Europe and is looking to introduce a pediatric formulation.
Read more →SPRYARS Pharmaceuticals to Participate in the 2024 Cantor Global Healthcare Conference
ARS Pharmaceuticals, Inc. announced its participation in the 2024 Cantor Global Healthcare Conference, scheduled for September 17-19 in New York City. Key executives Richard Lowenthal and Eric Karas will take part in a fireside chat and one-on-one meetings with investors. The participation underscores the company's commitment to enhancing awareness about severe allergic reactions and their treatment options, particularly through their product neffy® (EU trade name EURneffy). A live webcast of the chat will be available, with a replay accessible for 90 days via their website.
Read more →SPRYARS Pharmaceuticals Submits sNDA to FDA for neffy 1 mg Dose for Pediatric Patients with Type I Allergic Reactions Who Weigh 15 to 30 kg (33-66 lbs.)
ARS Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) to the FDA for neffy 1 mg, a needle-free epinephrine treatment aimed at pediatric patients weighing 15 to 30 kg. If approved, it will become the first option of its kind for younger children, who often fear needles. This submission follows the previous FDA approval of neffy 2 mg for older patients. The company emphasizes the urgency for innovative treatments in light of the high incidence of severe allergic reactions among children.
Read more →SPRYARS Pharmaceuticals Launches Pre-Ordering Services for neffy to Help Patients Access the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
ARS Pharmaceuticals has launched pre-ordering services for neffy, a needle-free epinephrine nasal spray for Type I allergic reactions, including anaphylaxis. Expected to be available by late September, neffy offers significant advantages over traditional auto-injectors, including ease of use and accessibility. Patients can obtain prescriptions through existing healthcare providers or virtual consultations. ARS Pharmaceuticals has implemented patient assistance programs aimed at reducing costs, such as a co-pay program and support for those uninsured. The introduction of neffy is anticipated to enhance emergency treatment for allergy patients.
Read more →SPRYARS Update neffy Approval
ARS Pharma's neffy has been approved for the emergency treatment of Type I allergic reactions, including anaphylaxis, for patients weighing over 30 kg. The company plans to file a supplemental regulatory application for a lower dose suitable for pediatric patients in Q3 2024. While neffy offers a needle-free delivery system expected to improve patient compliance, there are concerns over potential safety issues and market acceptance. The product's commercial rollout will include post-marketing studies in alignment with FDA guidelines.
Read more →SPRY▲ +10%on this news· ran to +31% by day 3shared move
ARS Pharmaceuticals Receives FDA Approval of neffy (epinephrine nasal spray), the First and Only Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis
ARS Pharmaceuticals has received FDA approval for neffy, an epinephrine nasal spray, marking the first new delivery method for treating severe allergic reactions in over 35 years. This needle-free treatment aims to address an unmet medical need for patients prone to anaphylaxis, improving administration speed and reducing anxiety. ARS Pharma is also launching patient assistance programs to ensure accessibility, pledging to keep costs low for those in need. The approval highlights the importance of effective and convenient treatment options for allergy sufferers.
Read more →SPRYARS Pharmaceuticals to Participate in the 2024 Wedbush PacGrow Healthcare Conference
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced its participation in the 2024 Wedbush PacGrow Healthcare Conference scheduled for August 13-14, 2024, in New York City. The company's management will meet with investors on August 14, 2024. ARS focuses on protecting patients at risk of severe allergic reactions by developing neffy, an intranasal epinephrine product aimed at preventing life-threatening anaphylaxis caused by various allergens.
Read more →SPRYARS Pharmaceuticals Provides Business Highlights and Reports Second Quarter 2024 Financial Results neffy (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize label
ARS Pharmaceuticals reported its second quarter 2024 financial results, emphasizing the progress of its opioid nasal spray, neffy, which is currently under review by the FDA with a PDUFA date set for October 2024. The company also received a favorable recommendation from the EMA, anticipating marketing authorization for its European variant, EURneffy, by the third quarter of 2024. With $218.7 million available in cash and equivalents, ARS is well-positioned for a potential U.S. launch if received positively by FDA, alongside plans for clinical expansion into the treatment of urticaria.
Read more →SPRY▲ +5.7%on this news
ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
ARS Pharmaceuticals announced a positive recommendation from the CHMP for EURneffy, an adrenaline nasal spray intended for emergency treatment of anaphylaxis in the EU. This marks a significant step as EURneffy would be the first needle-free adrenaline option available, potentially increasing patient compliance and improving treatment outcomes. The recommendation is based on extensive clinical data and will be submitted for formal approval to the EC, with expectations for market access by Q4 2024. A similar application is currently under FDA review in the U.S., with a PDUFA date set for October 2024.
Read more →SPRY▲ +5.7%on this news
Forward-looking statements Statements in this presentation that are not purely historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-loo
ARS Pharma presented forward-looking statements about neffy, its innovative, needle-free solution for Type I allergic reactions. The U.S. FDA is reviewing neffy's data package with a PDUFA date set for October 2, 2024. The company anticipates significant market potential, supported by a positive opinion from the European Medicines Agency. However, regulatory delays and the necessity of supporting clinical results remain substantial risks.
Read more →SPRYForward Looking Statements Statements in this presentation that are not purely historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-loo
ARS Pharma's corporate presentation discusses forward-looking statements regarding the anticipated regulatory review and launch of neffy, a potential needle-free treatment for Type I allergic reactions. The company believes neffy could disrupt the epinephrine injectable market with its unique delivery method. However, the approval process is fraught with uncertainty, including delays and potential issues arising from clinical trial results. ARS Pharma's financial health appears strong with significant funds available for development and commercialization efforts.
Read more →SPRYARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results neffy (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated r
ARS Pharmaceuticals reported positive developments regarding its drug neffy, an epinephrine nasal spray, as the FDA's review of its New Drug Application (NDA) continues. The company expects the review process to complete by early October 2024 and is preparing for a U.S. launch in the latter half of the year, contingent on approval. Furthermore, ARS Pharma is collaborating with CSL Seqirus for the drug's commercialization in Australia and New Zealand. Financially, the company is well-positioned with over $223 million in cash reserves, ensuring sufficient funding for ongoing operations and planned expansion into new markets.
Read more →SPRYARS Pharmaceuticals Submits Response for neffy (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
ARS Pharmaceuticals, Inc. has submitted its Day 180 response to the CHMP for its Marketing Authorization Application for neffy® (epinephrine nasal spray), following prior feedback from the agency. The company has also established a licensing agreement with CSL Seqirus for commercialization in Australia and New Zealand. ARS expects a CHMP opinion in Q2 2024, although risks regarding potential new issues and regulatory approval remain.
Read more →SPRYARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy (Epinephrine Nasal Spray)
ARS Pharmaceuticals has submitted a response to the FDA regarding its New Drug Application for neffy, an epinephrine nasal spray intended for treating Type I allergic reactions. This follows the FDA's Complete Response Letter, which requested additional testing and studies. The company has successfully completed the required pharmacokinetic and pharmacodynamic studies, as well as nitrosamine testing showing no measurable levels. The FDA review period will now commence, with a target action date anticipated for October 2, 2024, pending any further issues that may arise.
Read more →SPRYARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results Preparing to submit response to the FDA's CRL for neffy (epinephrine nasal spray) in Type 1 allergic reactions
ARS Pharmaceuticals provided a business update along with its financial results for the fourth quarter and full year 2023. The company is preparing to submit a response to the FDA's Complete Response Letter for its nasal spray, neffy, aimed at treating Type 1 allergic reactions. Neffy's clinical trials have shown promising results, including a 100% response rate in pediatric anaphylaxis patients. With a robust cash position, ARS plans to advance its development efforts and is also exploring outpatient studies for treating chronic spontaneous urticaria patients later in 2024.
Read more →SPRYARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy Investor Day
ARS Pharmaceuticals hosted an Investor Day to present updates on neffy, a nasal spray for treating severe allergic reactions. The event highlighted the significant unmet need in the epinephrine market, as many patients do not utilize existing treatments effectively. There is a strong potential for neffy to improve compliance due to its needle-free design and ease of use. The company plans to respond to an FDA Complete Response Letter and is optimistic about submitting for approval in early Q2 2024.
Read more →SPRYneffy Investor Day
ARS Pharma's Investor Day highlighted the anticipated NDA filing for neffy, a new no-injection treatment for Type I allergic reactions, slated for early Q2 2024. If approved, a product launch is expected in the second half of 2024, with ARS projecting a significant market opportunity driven by consumer demand. While the presentation expressed optimism about the therapeutic potential of neffy, it also acknowledged various regulatory and market uncertainties that could affect its approval process. Overall, the future remains contingent on the results of forthcoming clinical studies and regulatory evaluations.
Read more →SPRYARS Pharmaceuticals to Participate in the Leerink Partners Global Biopharma Conference 2024
ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) announced its participation in the Leerink Partners Global Biopharma Conference 2024 scheduled for March 11-13 in Miami. Co-Founder and CEO Richard Lowenthal, along with Chief Commercial Officer Eric Karas, will partake in a fireside chat on March 13. Additionally, the company is set to hold one-on-one meetings with investors to discuss their developments, including the neffy® intranasal epinephrine product for severe allergic reactions.
Read more →SPRYARS Pharmaceuticals announces neffy meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study
ARS Pharmaceuticals reported positive results for their investigational drug, neffy, in a Phase 2 clinical trial for chronic spontaneous urticaria. The study showed that neffy significantly improved symptoms like pruritus and hives as early as five minutes post-administration. With a pivotal study planned for 2025 and an outpatient study set for 2024, neffy could offer a novel treatment option for patients who do not respond to current therapies. Data will be presented at the 2024 AAAAI conference in Washington, D.C.
Read more →SPRYARS Pharmaceuticals to Host Virtual neffy Investor Day on March 7, 2024
ARS Pharmaceuticals, Inc. will host a virtual investor day on March 7, 2024, focusing on its product neffy® (epinephrine nasal spray). The event will feature presentations from the company's management and notable allergists. Participants will have the opportunity to engage in a live Q&A session after the presentations. This initiative highlights ARS Pharma's commitment to at-risk patients and caregivers managing severe allergic reactions.
Read more →SPRYARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter
ARS Pharmaceuticals announced positive topline results from its repeat dosing study of neffy (epinephrine nasal spray) under nasal allergen challenge conditions. The results indicated a robust pharmacokinetic and pharmacodynamic profile that may surpass that of intramuscular injection, potentially addressing the FDA's concerns outlined in their Complete Response Letter. The company is preparing to submit these findings in response to the FDA, with an eye toward approval as early as the second quarter of 2024.
Read more →SPRYARS Pharmaceuticals to Present Positive Clinical Efficacy Data for neffy (epinephrine nasal spray) at 2024 AAAAI Annual Meeting
ARS Pharmaceuticals announced the presentation of encouraging clinical efficacy data for its epinephrine nasal spray, neffy, at the 2024 AAAAI Annual Meeting. The findings include a 100% response rate to neffy in pediatric patients experiencing anaphylaxis, showing a median resolution time of 16 minutes. Additional presentations will cover the drug's effectiveness in chronic urticaria and its pharmacokinetic profile compared to injection products. With the NDA re-submission expected in mid-2024, the company aims for launch if approved.
Read more →SPRYARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates Company is on track with ongoing repeat-dose study under allergen-induced allergic rhinitis conditions requested by U.S. FDA
ARS Pharmaceuticals reported its third quarter 2023 financial results, highlighting that they are in progress with their repeat-dose study for neffy as requested by the FDA, with topline data expected in Q1 2024. The company anticipates resubmission of New Drug Application for neffy in H1 2024 and is well-capitalized with $241.9 million in cash for the upcoming FDA launch, if approved. Despite the challenges posed by the FDA's revised study requirements, ARS Pharma has received positive feedback and support from the medical community regarding neffy's potential benefits.
Read more →SPRYARS Pharmaceuticals Announces Presentation of Clinical Data Supporting neffy (epinephrine nasal spray) for the Treatment of Allergic Reactions (Type I) including Anaphylaxis
ARS Pharmaceuticals has announced that clinical data supporting their intranasal epinephrine product, neffy, will be presented at the 2023 American College of Allergy, Asthma and Immunology Annual Scientific Meeting. The data includes insights from a study involving over 600 subjects, highlighting neffy's effectiveness across various patient demographics, including those with upper respiratory infections and pediatrics. Notably, neffy's pharmacokinetics are not affected by BMI or body weight, unlike traditional epinephrine injection methods. The presentation aims to showcase the potential advantages of this new treatment option for severe allergic reactions.
Read more →SPRY▲ +7%on this news
ARS Pharmaceuticals Announces Scheduling of a Type A Meeting with the U.S. FDA for neffy (epinephrine nasal spray)
ARS Pharmaceuticals has announced a Type A meeting with the FDA to discuss the Complete Response Letter for its neffy epinephrine nasal spray. This follows the FDA Advisory Committee's favorable recommendation for neffy in May 2023. Several challenges remain, including the requirement for an additional study. However, the company is determined to address the urgent need for a needle-free treatment for allergic reactions, with the intention to resubmit their NDA in early 2024.
Read more →SPRY▼ -9.1%on this news
Forward looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding: ARS's ability to complete the newly required trial and provide the additional
ARS Pharma's presentation outlines forward-looking statements regarding neffy, a needle-free treatment for Type I allergic reactions. The company anticipates resubmitting the new drug application (NDA) in H1 2024, following additional study requirements from the FDA. Despite the potential for a multi-billion-dollar market, the outcome of the upcoming clinical trials is uncertain, posing risks to the approval process. Nevertheless, the product could significantly transform treatment options for allergy patients by eliminating the need for injections.
Read more →SPRYARS Reports Second Quarter 2023 Financial Results and Provides Business Updates ARS continues engagement with U.S. FDA on final labeling and post-marketing commitments for the neffy new drug application; PDUFA target act
ARS Pharmaceuticals reported its Q2 2023 financial results while highlighting ongoing engagements with the U.S. FDA for its neffy application, targeting a PDUFA date of September 19, 2023. The company is preparing for the U.S. launch of neffy, a needle-free epinephrine nasal spray designed to treat severe allergic reactions. A favorable FDA Advisory Committee vote supports the drug's potential approval, but outcomes are still uncertain. ARS has sufficient funding to sustain operations through at least three years, with commercial preparations already in progress.
Read more →SPRYARS Pharmaceuticals Announces PDUFA Date Extension for neffy (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
ARS Pharmaceuticals announced an extension of the PDUFA date for neffy (Intranasal Epinephrine) by three months, now set for September 19, 2023. The extension follows a positive assessment from the FDA's advisory committee, which indicated the need for additional time to finalize labeling and discuss post-marketing commitments. ARS has responded to all information requests from the FDA and is hopeful for a timely conclusion to labeling discussions. Meanwhile, neffy is also under review for marketing authorization in Europe, with a decision expected in early 2024.
Read more →SPRYForward-looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding the design and potential benefits of neffy; the anticipated Prescription Drug U
ARS Pharma's presentation reveals forward-looking statements about Neffy, a potentially transformative 'no needle, no injection' solution for Type I allergic reactions. The anticipated PDUFA date is set for mid-2023, supported by favorable FDA advisory assessments. The company aims to capture a significant market share while addressing current device limitations of epinephrine injectables. However, regulatory approval risks and market competition pose challenges to its success.
Read more →SPRYARS Pharmaceuticals Highlights Progress and Reports First Quarter 2023 Financial Results FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy for the Treatment of Allergic Reactions (Type I
ARS Pharmaceuticals reported progress on its product neffy, a nasal spray for allergic reactions, and released its first quarter financial results. The FDA Advisory Committee voted in favor of neffy’s benefit-risk profile, which could potentially offer an alternative to traditional epinephrine injections. The company has sufficient cash reserves of $264.5 million to support operations for at least three years. However, it reported a net loss of $15 million in the quarter and highlighted the low compliance rates with autoinjector prescriptions among patients.
Read more →SPRY▲ +77.9%on this newsshared move
FDA Briefing Document NDA/BLA# 214697 Drug name: ARS-1 (intranasal epinephrine) Applicant: ARS Pharmaceuticals Pulmonary-Allergy Drug Advisory Committee Meeting FDA has posted an Addendum to Briefing Document on its webs
The FDA has provided an Addendum to the Briefing Document for NDA 214697 concerning ARS-1, an intranasal epinephrine product by ARS Pharmaceuticals. This document was shared with committee members ahead of the Pulmonary-Allergy Drug Advisory Committee Meeting. Its purpose is to facilitate discussion and insights related to the drug's development and evaluation. The final determination by the FDA will be influenced by the Advisory Committee's input and is subject to further review and considerations.
Read more →SPRY▼ -12.2%on this news· ran to +59% by day 3shared move
ARS Pharmaceuticals Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm
ARS Pharmaceuticals, Inc. is facing an investigation by Block & Leviton for potential securities law violations following a press release revealing FDA concerns over its drug ARS-1 for treating Type 1 allergic reactions. The FDA noted challenges in establishing the drug's efficacy due to insufficient pharmacokinetic and pharmacodynamic data. This uncertainty led to a significant decline in the company's stock price, which fell over 14% on May 9, 2023. Investors who have suffered losses are encouraged to contact Block & Leviton for potential recovery paths.
Read more →SPRY▼ -14.3%on this news· ran to +30% by day 3shared move
ARS Pharmaceuticals Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on neffy for the Treatment of Type I Allergic Reactions Including Anaphylaxis
ARS Pharmaceuticals announced that the FDA has posted briefing documents for an upcoming advisory committee meeting to review the NDA for neffy, a non-injectable epinephrine nasal spray intended for treating Type I allergic reactions, including anaphylaxis. The meeting is scheduled for May 11, 2023, where ARS will present clinical findings from several studies supporting their application. Despite confidence in their clinical data, the company acknowledges potential risks regarding the approval process and meeting timelines.
Read more →SPRYARS Pharmaceuticals Announces FDA Advisory Committee for neffy for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
ARS Pharmaceuticals announced that the FDA will hold an Advisory Committee meeting on May 11, 2023, to review the new drug application for neffy, a potential non-injectable epinephrine nasal spray for allergic reactions, including anaphylaxis. This development indicates that the FDA sees promise in neffy's pharmacokinetics and pharmacodynamics for approval. The company's CEO expressed optimism about the review process, highlighting the need for improved treatment options for patients who struggle with administering injectable epinephrine. However, the outcome of the Advisory Committee remains uncertain and does not guarantee FDA approval.
Read more →SPRYARS Pharmaceuticals Highlights Progress and Reports Fourth Quarter and Full Year 2022 Financial Results New Drug Application and Marketing Authorization Application for neffy Currently Under Review with the FDA and EMA;
ARS Pharmaceuticals reported progress in its drug development, highlighting the ongoing review of its New Drug Application (NDA) and Marketing Authorization Application (MAA) for neffy by the FDA and EMA. The company boasts a solid financial position with $274.4 million in cash, ensuring its operational runway for the next three years. Clinical trials show the product meets essential pharmacokinetic endpoints, and a pivotal target action date is anticipated in mid-2023. However, ARS faces a net loss of $14.4 million in the last quarter, coupled with rising research and development costs.
Read more →SPRYTHE FIRST NO-NEEDLE, NO-INJECTION SOLUTION for Type I Allergic Reactions Q1 2023 1 Forward looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regard
ARS Pharma has announced neffy, the first no-needle, no-injection solution for Type I allergic reactions, anticipated to disrupt the current epinephrine injectable market. The FDA has accepted the New Drug Application (NDA), with a mid-2023 Prescription Drug User Fee Act (PDUFA) date expected. The potential for neffy to capture a multi-billion-dollar market hinges on its favorable uptake by healthcare providers and consumers, addressing vital safety concerns associated with injection methods. However, uncertainties around regulatory approval and competition from injectables pose risks to its market launch.
Read more →SPRYARS Pharmaceuticals Announces Presentation of Data Supporting neffy (epinephrine nasal spray) and Real-World Burden of Needle Injectors
ARS Pharmaceuticals announced that data supporting neffy, an intranasal epinephrine spray, will be presented at the 2023 AAAAI meeting. This includes findings from clinical trials that show neffy delivers consistent epinephrine levels comparable to injectable alternatives. The data also emphasize the real-world impact of needle-phobia on patients' reluctance to use epinephrine autoinjectors. The FDA is reviewing the New Drug Application for neffy, highlighting its potential as the first non-injectable treatment for severe allergic reactions.
Read more →SPRYARS Pharmaceuticals Reacquires European Marketing Rights to neffy (ARS-1) for the Treatment of Type I Allergic Reactions Including Anaphylaxis
ARS Pharmaceuticals has successfully reacquired the European marketing rights to neffy (ARS-1), an intranasal epinephrine product aimed at treating Type I allergic reactions, including anaphylaxis. This agreement with Recordati will allow ARS to launch neffy in the U.S. if approved. With approximately $275 million in cash, the company is well-positioned for the anticipated regulatory decision from the European Medicines Agency. If neffy is approved, it could provide an important alternative to traditional epinephrine autoinjectors, addressing unmet needs in the allergy treatment market.
Read more →SPRYForward looking statements This presentation contains forward-looking statements which include, but are not limited to, statements regarding the design and potential benefits of neffy; the anticipated Prescription Drug U
ARS Pharma presented forward-looking statements regarding neffy, a new no-needle solution for Type I allergic reactions. The company anticipates a significant market opportunity and plans to launch neffy pending regulatory approval, with an NDA accepted by the FDA and a PDUFA date expected in mid-2023. The company emphasizes the potential of neffy to disrupt the current epinephrine injectable market, citing its ability to address specific limitations of existing treatments. Furthermore, ARS Pharma's solid leadership team is noted for its experience in developing and commercializing nasal spray products.
Read more →SPRY▲ +5.8%on this newsshared move
ARS Pharmaceuticals to Participate in the SVB Securities Virtual Global Biopharma Conference 2023
ARS Pharmaceuticals is set to participate in the SVB Securities Virtual Global Biopharma Conference 2023, with key executives scheduled for a fireside chat. The event is aimed at increasing visibility for the company's mission to assist at-risk patients with severe allergic reactions. The company is currently developing neffy®, an intranasal epinephrine product for treating Type I allergic reactions. The webcast will be available live and archived for 30 days on the company's investor website.
Read more →SPRYARS Pharmaceuticals Closes Merger with Silverback Therapeutics Over $280 Million in Combined Cash and Securities and at least Three Years Operating Runway to Support Launch and Commercialization of neffy in the U.S., if
ARS Pharmaceuticals Closes Merger with Silverback Therapeutics Over $280 Million in Combined Cash and Securities and at least Three Years Operating Runway to Support Launch and Commercialization of neffy in the U.S., if Approved neffy NDA Currently Under FDA Review; PDUFA Anti
Read more →SPRYSilverback Therapeutics, Inc. announces the FDA s acceptance of ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) including Anaphylaxis neffy has potential to be
Silverback Therapeutics, Inc. announces the FDA s acceptance of ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) including Anaphylaxis October 21, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ) today a
Read more →SPRYSilverback Therapeutics and ARS Pharmaceuticals Announce Merger Transaction to support potential commercialization of neffy , ARS s needle-free epinephrine nasal spray Well-funded with at least three years of operating r
Silverback Therapeutics and ARS Pharmaceuticals Announce Merger Transaction to support potential commercialization of neffy , ARS s needle-free epinephrine nasal spray Well-funded with at least three years of operating runway expected Companies to host conference call today,
Read more →SPRYSilverback Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update SEATTLE
Silverback Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update May 12, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemical
Read more →SPRYSilverback Therapeutics Updates Strategic Priorities and Reports Fourth Quarter and Full Year 2021 Financial Results - Strategic realignment to focus resources on SBT8230 for chronic hepatitis B virus (cHBV) and discover
Silverback Therapeutics Updates Strategic Priorities and Reports Fourth Quarter and Full Year 2021 - Strategic realignment to focus resources on SBT8230 for chronic hepatitis B virus (cHBV) and discovery pipeline by discontinuing SBT6050 and SBT6290 clinical oncology programs
Read more →SPRYSilverback Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update SEATTLE
Silverback Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update SEATTLE November 10, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology pl
Read more →SPRYForward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-lo
Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that
Read more →SPRYTitle: Results of an ongoing Phase 1/1b study of SBT6050 as monotherapy and combined with pembrolizumab in patients with advanced HER2-expressing or amplified solid tumors Samuel J. Klempner 1 , Muralidhar Beeram 2 , Dha
Title: Results of an ongoing Phase 1/1b study of SBT6050 as monotherapy and combined with pembrolizumab in patients with advanced HER2-expressing or amplified solid tumors Samuel J. Klempner1, Muralidhar Beeram2, Dhanusha Sabanathan3, Arlene Chan4, Erika Hamilton5, Sherene Loi6
Read more →SPRYSilverback Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update SEATTLE
Silverback Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update SEATTLE August 12, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology pla
Read more →SPRYSilverback Therapeutics Reports First Quarter 2021 Financial Results SEATTLE
Silverback Therapeutics Reports First Quarter 2021 Financial Results SEATTLE May 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically del
Read more →SPRYSilverback Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Updates Initiated SBT6050 clinical development, with pharmacological activity demonstrated in the first dose cohort
Silverback Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Updates Initiated SBT6050 clinical development, with pharmacological activity demonstrated in the first dose cohort Advanced preclinical development of SBT6290 and declare
Read more →SPRYSilverback Therapeutics Announces the Appointment of Dr. Maria Koehler to its Board of Directors SEATTLE
Silverback Therapeutics Announces the Appointment of Dr. Maria Koehler to its Board of Directors SEATTLE March 15, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platfo
Read more →SPRYSilverback Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters Option to Purchase Additional Shares Seattle, WA
Silverback Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters Option to Purchase Additional Shares Seattle, WA, December 8, 2020 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ( Silverback ), a clinical-stage biopharmaceutical company lev
Read more →Competitive Position
How SPRY ranks across every disease it competes inCompetitive Position is a premium feature
See how SPRY ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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