| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA Date example | BLA | — | Subscribe to access the data. | Biologics | Ophthalmologic System | ||
PDUFA Date example | BLA | — | Subscribe to access the data. | Biologics | Ophthalmologic System | ||
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Recent Updates
Recently added Catalysts
Outlook Therapeutics, Inc.$1.55
-0.01 (-0.64%)
D 35Pipeline Score Overvalued Biotech · Clinical
Market Cap
37.46 M
EPS
-
P/E Ratio
-
Value Trade
8.77 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
4.50 M
Total Assets
21.89 M
Total Liabilities
50.89 M
Equity
-28.99 M
D/E Ratio
12,345
32.04 %
Week
6.94 %
1 Month
-29.08 %
3 Month
-83.6 %
6 Month
-99.35 %
5 Year
-99.95 %
All Time
Cash Data
Cash Position
7.75 M
Monthly Burn
4.68 M
Runway
0 mo
Burn Trend
StableSEC Filing
May 15, 2026
Overview
Volume
8.79 M
52 Week Range
0.16 - 3.39
% held by Insiders
17.42 %
% held by Institutions
6.92 %
Enterprise Value
56.90 M
Total Shares
83.08 M
Short %
10.6 %
Float Shares
83.00 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Outlook Therapeutics, Inc.
318Total events
6Upcoming
108Tier-1 (high impact)
2016 – 2027Coverage
Upcoming catalysts 2
TBD
T1PDUFA Date
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TBD
T1PDUFA Date
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Event history 2
TBD
▲FDA Filing AcceptedONS-5010ApprovedRegulatory Filing
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TBD
▲Product LaunchLYTENAVA™ApprovedPost-Market
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Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2026-06-30 | ONS-5010/LYTENAVA | BLA Submission | BLA | — | – | – | – |
2026-06-30 | ONS-5010/LYTENAVA | BLA Submission | BLA | — | – | – | – |
2026-06-30 | ONS-5010/LYTENAVA | BLA Submission | BLA | — | – | – | – |
Drug Pipeline Intelligence
D35
Pipeline Score $24M
Pipeline ValueOvervalued
Valuation Signal1
Drugs Scored0.6x
rNPV / MCap Top 48%
Micro Cap (rank 475 of 912)
Percentile RankOutlook Therapeutics, Inc. faces pipeline headwinds (35/100), with $1.8B risk-adjusted pipeline value, led by ranibizumab in Age-related Macular Degeneration (Phase 3), but cash runway is a concern.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ranibizumab Monoclonal antibody | Age-related Macular Degeneration | Phase 3 | NCT03834753 | 51% | $1.8B | COMPLETED | 289 | - | - | Jul 8, 2021 | - | Mar 19, 2025 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
ONS-5010 | wet AMD | — | 2024-11-27 | -2.257 BCVA letters; 95% confidence interval of (-4.044, -0.470); -3.5 at a 95% confidence interval; +4.2 letter improvement in BCVA in the ONS-5010 arm; +6.3 letter improvement in BCVA in the ranibizumab arm Read More | Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Final efficacy data expected in January 2025 Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J. Read More | |
ONS-5010 | wet AMD | — | 2024-11-27 | -2.257 BCVA letters; 95% confidence interval of (-4.044, -0.470); -3.5 at a 95% confidence interval; +4.2 letter improvement in BCVA in the ONS-5010 arm; +6.3 letter improvement in BCVA in the ranibizumab arm Read More | Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Final efficacy data expected in January 2025 Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J. Read More | |
ONS-5010 | wet AMD | — | 2024-11-27 | -2.257 BCVA letters; 95% confidence interval of (-4.044, -0.470); -3.5 at a 95% confidence interval; +4.2 letter improvement in BCVA in the ONS-5010 arm; +6.3 letter improvement in BCVA in the ranibizumab arm Read More | Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Final efficacy data expected in January 2025 Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J. 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 OTLK
| 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 |
OTLK 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 | |
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-08-21 | 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
OTLK▲ +35.3%on this news· ran to +58% by day 3
Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD
Outlook Therapeutics announced that the FDA has accepted its resubmitted Biologics License Application for ONS-5010/LYTENAVA™ for the treatment of wet AMD. This resubmission is classified as a Class 1 review, with a target action date set for July 29, 2026. If approved, ONS-5010/LYTENAVA™ will be the first FDA-approved ophthalmic formulation of bevacizumab, enhancing treatment options for patients.
Read more →OTLK▲ +15.5%on this news
Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics has resubmitted its Biologics License Application for ONS-5010/LYTENAVA™ to the FDA for treating neovascular age-related macular degeneration. The FDA has determined that substantial evidence of effectiveness exists, eliminating the need for additional trials. The resubmission is classified as Class 1, with a decision expected within 60 days.
Read more →OTLKOutlook Therapeutics Announces Pricing of $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Outlook Therapeutics announced a $5 million registered direct offering priced at $0.5855 per share. The offering involves the sale of 8,539,709 shares to GMS Ventures, the company's largest stockholder. Proceeds will be used for working capital and corporate purposes. The company also plans to amend existing warrants to a lower exercise price.
Read more →OTLK▲ +29.1%on this news· ran to +136% by day 3shared move
Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA (bevacizumab-vikg) Company plans to resubmit BLA to the FDA in June 2026 ISELIN, N.J.
Outlook Therapeutics has successfully won an appeal from the FDA regarding its ONS-5010/LYTENAVA (bevacizumab-vikg) product after a Formal Dispute Resolution process. The FDA now recognizes substantial evidence for the drug's effectiveness in treating neovascular age-related macular degeneration (nAMD). As a result, the company plans to resubmit its Biologics License Application (BLA) in June 2026. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab.
Read more →OTLKOutlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update Completed Formal Dispute Resolution Meeting with FDA regarding Complete Response Letter (CRL) for ONS-5010; Dec
Outlook Therapeutics reported its financial results for Q2 FY 2026, showing a significant reduction in net loss compared to the same period last year. The company continues to advance its commercialization of LYTENAVA in Europe, with plans to expand into Switzerland and other markets. Outlook is also waiting for the FDA's decision regarding the ONS-5010 application, having conducted a formal dispute resolution meeting to clarify its path forward. Overall, the company remains optimistic about its prospects in both European launches and U.S. regulatory approval.
Read more →OTLKOutlook Therapeutics Announces Closing of $5.0 Million Registered Direct Offering
Outlook Therapeutics has successfully closed a $5 million registered direct offering, selling over 16 million shares at $0.31 each. The company also issued unregistered warrants for the same number of shares, which could generate an additional $5 million if exercised. Proceeds will support working capital and corporate initiatives. The company’s product, LYTENAVA™, has received marketing authorization in Europe, enhancing its market position.
Read more →OTLK▼ -13.7%on this newsshared move
Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA (bevacizumab-vikg) Formal decision expected in May 2026 ISELIN, N.J.
Outlook Therapeutics has completed its Federal Dispute Resolution meeting with the FDA regarding ONS-5010/LYTENAVA. This meeting follows a previous Type A meeting related to a Complete Response Letter for the drug. The company is hopeful for constructive feedback from the FDA, which is expected in May 2026. ONS-5010/LYTENAVA aims to enhance the treatment of neovascular age-related macular degeneration, pending regulatory approval.
Read more →OTLK▲ +6.2%on this news· ran to +25% by day 1
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
Outlook Therapeutics has submitted a formal dispute resolution request to the FDA regarding the Complete Response Letter for ONS-5010/LYTENAVA™. The FDA has accepted this request and scheduled a meeting for April 2026. The company believes that the data from clinical trials supports the efficacy and safety of the treatment for neovascular age-related macular degeneration.
Read more →OTLKOutlook Therapeutics Announces Closing of $5.0 Million Public Offering
Outlook Therapeutics has announced the successful closing of a $5 million public offering, which included 20 million shares of common stock and accompanying warrants. The offering is expected to enhance the company's working capital and support its corporate initiatives. The potential additional proceeds from the warrants could amount to another $5 million, although there is no guarantee they will be exercised.
Read more →OTLK▼ -38.1%on this newsshared move
Outlook Therapeutics Announces Pricing of $5.0 Million Public Offering
Outlook Therapeutics has announced the pricing of a public offering, selling 20 million shares at $0.25 each, aiming to raise $5 million. The proceeds will primarily support working capital and corporate purposes. The offering is expected to close on March 25, 2026, pending customary conditions. The company continues to develop LYTENAVA™, an ophthalmic formulation of bevacizumab for retinal diseases.
Read more →OTLK▼ -8.9%on this news· ran to -44% by day 1shared move
Outlook Therapeutics Announces Proposed Public Offering
Outlook Therapeutics has initiated a public offering of its common stock to raise funds for working capital and corporate purposes. The offering is contingent upon market conditions, and the company has engaged H.C. Wainwright & Co. as the exclusive placement agent. Outlook aims to enhance the treatment of retina diseases with its investigational product ONS-5010/LYTENAVA™, which has already received marketing authorization in Europe.
Read more →OTLK▼ -10.7%on this news
Supplemental Risk Factors Except as set forth below, as of
The article outlines serious financial challenges facing OTLK as they report substantial doubt about their ability to continue as a going concern. Despite receiving marketing authorization for ONS-5010/LYTENAVA in Europe, the company lacks sufficient funding to sustain operations and product development efforts. The need for further capital, coupled with a recent Complete Response Letter from the FDA for ONS-5010, suggests a complex path forward. OTLK is actively seeking strategic partnerships to aid in commercialization but faces significant risks ahead.
Read more →OTLKWalnut Street Julia A. Haller, MD Suite 1510 Philadelphia, PA 19107 Ophthalmologist-in-Chief and William Tasman, MD, Endowed Chair Professor and Chair of Ophthalmology Sidney Kimmel Medical College at Thomas Jefferson Un
Julia A. Haller, MD, has announced her resignation from the Board of Directors of Outlook Therapeutics, effective March 10, 2026, due to her new responsibilities as CEO at Wills Eye Hospital. She expressed gratitude for her time on the board and acknowledged the team's efforts to develop new therapies for patients. Haller's departure may have implications for the company's governance and current projects.
Read more →OTLKOutlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA (bevacizumab-vikg) ISELIN, N.J.
Outlook Therapeutics has provided an update following its recent Type A meeting with the FDA regarding the Biologics License Application (BLA) for its product ONS-5010/LYTENAVA. The meeting aimed to address outstanding concerns mentioned in the December 2025 Complete Response Letter, specifically regarding the demonstration of substantial evidence of effectiveness. Outlook Therapeutics remains committed to collaborating with the FDA to establish an efficient path for potential approval. The company plans to continue discussions to clarify regulatory expectations and review available options for advancing ONS-5010 toward U.S. approval.
Read more →OTLK▼ -13.8%on this news
Outlook Therapeutics Reports First Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
Outlook Therapeutics reported a net loss of $23.1 million for Q1 FY 2026, despite significant growth in unit sales of LYTENAVA in Europe. The company plans to expand its product launches into more EU markets and is addressing regulatory feedback from the FDA regarding its investigational product ONS-5010. The financial results reflect challenges, but the company remains optimistic about future growth.
Read more →OTLK▲ +11.5%on this newsshared move
Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter
Outlook Therapeutics has submitted a Type A meeting request to the FDA following a Complete Response Letter regarding its Biologics License Application for ONS-5010, aimed at treating wet AMD. The CRL pointed out a deficiency in evidence of effectiveness, which the company disputes based on previous discussions with the FDA. Outlook remains optimistic about the clinical data supporting ONS-5010 and plans to work closely with the FDA to address the concerns raised.
Read more →OTLK▼ -15.3%on this news· ran to -72% by day 3
Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD FDA issues Complete Response Letter (CRL) for resubmitted O
Outlook Therapeutics announced that the U.S. FDA has issued a Complete Response Letter (CRL) regarding the ONS-5010/LYTENAVA application for the treatment of wet AMD, indicating that the application cannot be approved in its current form. The FDA's decision stems from the need for additional confirmatory evidence of efficacy, though specifics were not provided. Despite this setback, Outlook Therapeutics intends to explore all possible avenues for approval in the U.S. and continues its expansion efforts in European markets, where the drug has already received authorization.
Read more →OTLK▲ +8.8%on this news· ran to -64% by day 3shared move
Outlook Therapeutics Announces New Employment Inducement Grants - December 26, 2025
Outlook Therapeutics announced the granting of stock options to two new employees as an inducement for joining the company. This grant, totaling 150,000 shares at an exercise price of $2.01, aligns with NASDAQ regulations. The company continues to focus on its product, LYTENAVA™, which has received marketing authorization in Europe for treating wet AMD.
Read more →OTLK▼ -8.5%on this news
Outlook Therapeutics Reports Financial Results for Fiscal Year 2025
Outlook Therapeutics reported a net loss of $62.4 million for fiscal year 2025, an improvement from the previous year's loss. The company achieved initial revenue from LYTENAVA™ sales in Germany and the UK, with plans for further market expansion. Outlook is preparing for a potential FDA approval and continues to focus on commercial activities in Europe.
Read more →OTLK▲ +14.8%on this news· ran to +49% by day 3
Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics announced that the FDA has accepted the resubmission of its Biologics License Application for ONS-5010, an investigational treatment for wet AMD. The FDA's acknowledgment marks a significant milestone, with a review period set for 60 days. If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab.
Read more →OTLKOutlook Therapeutics Re-Submits Biologics License Application for ONS-5010
Outlook Therapeutics has re-submitted its Biologics License Application for ONS-5010 to the FDA after a Type A meeting. This investigational treatment aims to optimize bevacizumab for wet AMD and could be branded as LYTENAVA™. The company is also focusing on commercial efforts in Europe while preparing for potential U.S. approval.
Read more →OTLK▲ +9.3%on this news
Outlook Therapeutics Provides Update on Type A Meeting with FDA
Outlook Therapeutics has completed a Type A Meeting with the FDA to discuss the complete response letter concerning its BLA resubmission for ONS-5010, an investigational treatment for wet AMD. The company plans to resubmit the BLA by the end of 2025 after reviewing FDA feedback. The CEO expressed commitment to delivering an effective treatment for patients.
Read more →OTLKOutlook Therapeutics to Present at the 2025 EURETINA Innovation Spotlight (EIS)
Outlook Therapeutics, Inc. announced its participation in the EURETINA Innovation Spotlight at the 25th EURETINA Congress in Paris on September 3, 2025. CEO Bob Jahr will present on optimizing retinal disease treatment. The company is focused on its product LYTENAVA™ (bevacizumab-vikg), which has received marketing authorization in Europe and is investigational in the U.S.
Read more →OTLKOutlook Therapeutics Requests Type A Meeting with FDA
Outlook Therapeutics has requested a Type A Meeting with the FDA to discuss the Complete Response Letter regarding its BLA resubmission for ONS-5010, an investigational treatment for wet AMD. The FDA acknowledged the success of the NORSE TWO trial but requested further confirmatory evidence of efficacy. The meeting aims to clarify the FDA's requirements to address the identified deficiencies.
Read more →OTLK▼ -54.1%on this newsshared move
Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
Outlook Therapeutics announced that the FDA issued a complete response letter regarding its BLA for ONS-5010/LYTENAVA™ for wet AMD, citing insufficient evidence of effectiveness. Despite this setback, the company plans to meet with the FDA for further guidance and continues to expand its market presence in Europe, where the product has received authorization. The FDA noted no other deficiencies in the application.
Read more →OTLK▲ +14.1%on this news
Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2025 and Provides Corporate Update
Outlook Therapeutics reported a net loss of $20.2 million for Q3 FY2025, with initial revenue from LYTENAVA™ sales in Germany and the UK. The company is preparing for potential FDA approval of ONS-5010, which could enhance treatment options for wet AMD. A strategic collaboration with Cencora aims to support the global launch of LYTENAVA™.
Read more →OTLKOutlook Therapeutics to Present at the 8th Annual Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase
Outlook Therapeutics, Inc. will present at the 8th Annual Ophthalmology Innovation Summit on July 29, 2025. CEO Bob Jahr will showcase their advancements in retinal disease treatments. The company is known for its investigational product, ONS-5010/LYTENAVA™, which aims to enhance the standard of care for bevacizumab. This product has already received marketing authorization in Europe.
Read more →OTLKOutlook Therapeutics Participates in the Virtual Investor “What’s Your Story” Summer Spotlight On-Demand Conference
Outlook Therapeutics, Inc. participated in the Virtual Investor 'What’s Your Story' Summer Spotlight On-Demand Conference, featuring insights from newly appointed CEO Bob Jahr. He discussed his journey to the company and expressed optimism about its future. The on-demand video is available for viewing on the company's website and the virtual investor platform.
Read more →OTLKOutlook Therapeutics Appoints Biopharmaceutical Industry and Commercial Leader Bob Jahr as Chief Executive Officer
Outlook Therapeutics has appointed Bob Jahr as its new Chief Executive Officer, bringing over 20 years of biopharmaceutical experience. Jahr's leadership is anticipated to drive the company's growth as it prepares for a commercial launch of its product in Europe and seeks FDA approval in the U.S. He replaces Lawrence A. Kenyon, who will remain as CFO.
Read more →OTLKOutlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2025 and Provides Corporate Update LYTENAVA (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingd
Outlook Therapeutics has provided a financial update for the second quarter of fiscal year 2025, indicating progress toward commercializing LYTENAVA (bevacizumab gamma) in Germany and the United Kingdom by Q2 CY2025. The company also highlighted a PDUFA goal date of August 27, 2025, for FDA approval of ONS-5010, which could bolster their position in the ophthalmic market. However, the reported net loss of $46.4 million raises concerns about the company's financial health, despite a decrease from the previous year's loss.
Read more →OTLKOutlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2025 and Provides Corporate Update ONS-5010 / LYTENAVA (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet tar
Outlook Therapeutics reported financial results for Q1 FY 2025, highlighting the recent regulatory approvals for LYTENAVA in the EU and UK. The company plans to launch this approved ophthalmic formulation of bevacizumab for wet AMD and expects to generate revenue during 2025. However, the recent NORSE EIGHT trial did not meet its primary endpoint, and the company reported a significant adjusted net loss despite the revenue prospects. Overall, Outlook Therapeutics is optimistic about its future trajectory amid ongoing regulatory efforts.
Read more →OTLK▲ +18.2%on this news
Reports Financial Results for Fiscal Year 2024 and Provides Corporate Update
Outlook Therapeutics reported its fiscal year 2024 financial results and provided key updates regarding its product, LYTENAVA, approved in the EU and UK for treating wet AMD. The company received a positive recommendation from NICE, paving the way for an anticipated commercial launch in 2025. Despite a net loss reported for the year, Outlook Therapeutics is preparing for upcoming regulatory resubmissions in early 2025 while remaining optimistic about LYTENAVA's potential impact in the market. However, regulatory hurdles in the U.S. and performance in clinical trials present ongoing challenges for the company.
Read more →OTLK▼ -65.2%on this news
Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Final efficacy data expected in January 2025 Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J.
Outlook Therapeutics announced preliminary topline results of its NORSE EIGHT clinical trial for the treatment of wet AMD using ONS-5010. While the drug did not meet the non-inferiority endpoint set by the FDA, preliminary data indicated an improvement in vision and a favorable safety profile. The company plans to analyze further data and resubmit its Biologics License Application (BLA) in early 2025. Additionally, there are ongoing efforts for a launch in Europe in the same timeframe.
Read more →OTLK▼ -5.3%on this news
Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update Received European Union (EU) and United Kingdom (UK) Marketing Authorization for LYTENAVA (bevacizumab gamma
Outlook Therapeutics reported its financial results for the third quarter of fiscal year 2024, highlighting key milestones including the receipt of EU and UK marketing authorization for LYTENAVA, the first ophthalmic formulation of bevacizumab for wet AMD. The company is on track to complete enrollment in the NORSE EIGHT clinical trial by Q3 CY2024, with results expected in Q4 CY2024 and a BLA resubmission planned for Q1 CY2025. Despite achieving growth in revenue, Outlook reported a net loss attributable to common stockholders for the quarter, raising concerns over financial stability amidst regulatory challenges.
Read more →OTLKOutlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update Positive opinion received from Committee for Medicinal Products for Human Use (CHMP) of the European Medici
Outlook Therapeutics, Inc. has reported its financial results for the second quarter of fiscal year 2024, revealing a substantial net loss, primarily attributed to warrant-related expenses and liabilities. The company is advancing toward regulatory approval for ONS-5010, an ophthalmic formulation of bevacizumab, with a positive opinion from the CHMP in the EU. Outlook is executing trials and plans to resubmit a BLA to the FDA by the end of 2024, aiming for a commercial launch in 2025. The next steps include further clinical trial enrollment and addressing regulatory feedback.
Read more →OTLKOutlook Therapeutics Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD UK submission for national MAA review follows recently received positive opinion from Comm
Outlook Therapeutics announced the submission of a Marketing Authorization Application (MAA) for ONS-5010 to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for wet age-related macular degeneration (AMD). This submission follows a favorable opinion from the European Medicines Agency's CHMP. If approved, ONS-5010 will be the first authorized ophthalmic formulation of bevacizumab, offering a significant advancement in treatment options. The MAA is supported by results from three completed clinical trials as Outlook Therapeutics aims for authorization in multiple markets.
Read more →OTLK▲ +5.1%on this news· ran to +21% by day 1
Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update NORSE EIGHT underway with first subject dosed and additional clinical sites beginning enrollment Continue to
Outlook Therapeutics, Inc. reported financial results for the first quarter of fiscal year 2024, highlighting significant progress with the ongoing NORSE EIGHT trial for its investigational product ONS-5010. The company received FDA agreement on the trial protocol, allowing for a non-inferiority study against ranibizumab, and has begun enrolling subjects. Outlook also announced a potential financing of up to $172 million to support its regulatory efforts and commercial launch preparations. Despite a net loss of $11.2 million in the quarter, the company views progress favorably as it aims for regulatory approval.
Read more →OTLK▲ +30.5%on this news
Outlook Therapeutics Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010 Obtained clarit
Outlook Therapeutics announced the receipt of an FDA agreement under Special Protocol Assessment for their NORSE EIGHT trial evaluating ONS-5010, an investigational treatment for neovascular age-related macular degeneration. The company also announced a private placement to raise up to $172 million for advancing ONS-5010's development. Following the trial's success, the company aims to address previous deficiencies noted by the FDA and resubmit its Biologics License Application by the end of 2024. Additionally, stockholder approvals will be sought for the private placement.
Read more →OTLKOutlook Therapeutics Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first c
Outlook Therapeutics has reported its financial results for fiscal year 2023, highlighting a net loss of $59 million and an anticipated FDA response on its NORSE EIGHT trial protocol by February 2024. The company reiterated its commitment to ONS-5010, an investigational ophthalmic formulation of bevacizumab. Significant milestones include the expected commencement of the NORSE EIGHT clinical trial and a decision regarding its European Marketing Authorization Application in the first half of 2024. Outlook also aims to resubmit the Biologics License Application by the end of 2024.
Read more →OTLK▼ -46.2%on this news
Outlook Therapeutics Provides Update on Type A Meetings with
Outlook Therapeutics has provided an update regarding their Type A Meetings with the FDA concerning their investigational drug, ONS-5010, aimed at treating wet AMD. The FDA has requested an additional clinical trial for the drug's approval, but Outlook has reached an agreement in principle on a clinical trial design that may lead to a BLA resubmission by the end of 2024. Outlook believes these efforts will support eventual approval and is confident in meeting the FDA's requirements. The company aims to be the first to bring an FDA-approved ophthalmic formulation of bevacizumab to market.
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Outlook Therapeutics Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for fu
Outlook Therapeutics has announced that the FDA has issued a Complete Response Letter (CRL) concerning its Biologics License Application (BLA) for ONS-5010, an investigational formulation of bevacizumab for the treatment of wet AMD. The agency highlighted concerns surrounding CMC issues, unresolved observations from manufacturing inspections, and a lack of substantial evidence despite previous trial successes. The company plans to engage with the FDA to clarify these issues and determine steps towards potential resubmission of the BLA.
Read more →OTLKOutlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones Prescription Drug User Fee Act (PDUFA) goal date of
Outlook Therapeutics, Inc. has reported its financial results for the third quarter of fiscal year 2023, highlighting its pre-launch activities for ONS-5010. The company aims to receive FDA approval for this drug, offering a new treatment option for wet AMD. The reported net loss for the quarter was $20.7 million, but the company maintains sufficient cash to fund operations through anticipated regulatory milestones. Positive clinical trial results bolster the potential of ONS-5010 to transform the company into a commercial-stage entity with a strong market presence.
Read more →OTLKOutlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update U pcoming Prescription Drug User Fee Act (PDUFA) goal date of
Outlook Therapeutics reported its financial results for the second quarter of fiscal year 2023 and provided updates on its drug development efforts. The company is awaiting a PDUFA goal date of August 29, 2023, for ONS-5010, an investigational ophthalmic formulation of bevacizumab for wet AMD. Pre-launch commercial activities are ongoing as they prepare for potential FDA approval. Additionally, Outlook Therapeutics is exploring collaborations and partnerships to bolster market access for ONS-5010, which they believe could set a new standard of care in retinal treatments.
Read more →OTLKOutlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA)
Outlook Therapeutics, Inc. reported its financial results for the first quarter of fiscal year 2023, highlighting ongoing preparations for the potential commercialization of ONS-5010, an ophthalmic formulation of bevacizumab. The company has advanced its BLA submission to the FDA, with a review date set for August 29, 2023. In addition to securing FDA filing, Outlook has formed strategic partnerships for manufacturing and distribution. However, the company continues to experience financial losses, reporting a net loss of $18.7 million in the recent quarter, similar to the previous year.
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Outlook Therapeutics Reports Financial Results for Fiscal Year 2022 and Provides Corporate Update Attained U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of
Outlook Therapeutics Reports Financial Results for Fiscal Year 2022 and Provides Corporate Update ISELIN, N.J., December 29, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulatio
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Outlook Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules ISELIN, N.J.
Outlook Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules N.J., December 23, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formul
Read more →OTLKOutlook Therapeutics Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD Decision for potential approval expected from European Commission
Outlook Therapeutics Announces Validation of Marketing Authorization Application by the European Medicines Agency for ONS-5010 as a Treatment for Wet AMD N.J., December 22, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and lau
Read more →OTLKOutlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones Planned re-submission of ONS-5010 / LYTENAVA (bevacizumab-vikg) Biologics License Appl
Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones N.J., August 10, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FD
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Outlook Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet
Therapeutics Provides Update on Biologics License Application (BLA) Submission for ONS-5010 as a Treatment for Wet AMD N.J., May 31, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved
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Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update ONS-5010 / LYTENAVA (bevacizumab-vikg) Biologics License Application (BLA) submitted to U.S. Food and Drug
Outlook Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2022 and Provides Corporate Update N.J., May 13, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved opht
Read more →OTLKOutlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2022 and Provides Corporate Update Outlook Therapeutics remains on track to submit new U.S. FDA Biologics License Application (BLA) for first o
Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2022 and Provides Corporate Update ISELIN, N.J., February 14, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthal
Read more →OTLKOutlook Therapeutics Reports Financial Results for Fiscal Year 2021 and Provides Corporate Update Positive clinical data reported for ONS-5010 / LYTENAVA (bevacizumab-vikg) in 2021 from multiple clinical trials, includin
Outlook Therapeutics Reports Financial Results for Fiscal Year 2021 and Provides Corporate Update N.J., December 22, 2021 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bev
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Outlook Therapeutics Announces $10 Million Bought Deal Offering of Common Stock ISELIN, N.J.
Outlook Therapeutics Announces $10 Million Bought Deal Offering of Common Stock ISELIN, N.J., November 23, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("Outlook Therapeutics"), a late clinical-stage biopharmaceutical company working to develop the first
Read more →OTLK▼ -5.1%on this news· ran to -16% by day 3
Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update Reported positive, statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE
Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update N.J., August 13, 2021 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic for
Read more →OTLK▲ +6.6%on this news
Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD In NORSE TWO, ONS-5010 achieved statistically sig
Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA (bevacizumab-vikg) for the Treatment of Wet AMD N.J., August 3, 2021 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to
Read more →OTLKOutlook Therapeutics, Inc. Logo Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer
Outlook Therapeutics, Inc. Logo Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer Experienced executive with a track-record of successful eye care product launches Appointment reflects Outlook Therapeutics' dedication to transition
Read more →OTLKOutlook Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Corporate Update Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3
Outlook Therapeutics Reports Financial Results for Second Quarter of Fiscal Year 2021 and Provides Corporate Update N.J., May 14, 2021 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthal
Read more →OTLKOutlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2021 and Provides Corporate Update Topline data from pivotal Phase 3 safety and efficacy study (NORSE TWO) on target to report in Q3 2021 Topli
Outlook Therapeutics Reports Financial Results for First Quarter Fiscal Year 2021 and Provides Corporate Update JUNCTION, N.J., February 16, 2021 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-appro
Read more →OTLKOutlook Therapeutics Announces $10.0 Million Bought Deal Offering of Common Stock
Outlook Therapeutics Announces $10.0 Million Bought Deal Offering of Common Stock MONMOUTH JUNCTION, N.J., January 28, 2021 (GLOBE NEWSWIRE)- Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("Outlook Therapeutics"), a late clinical-stage biopharmaceutical company working to develop
Read more →OTLKOutlook Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update All planned clinical trials for ONS-5010 / LYTENAVA (bevacizumab-vikg) wet AMD BLA now fully enrolled or completed Pivotal
Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update JUNCTION, N.J., December 23, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulat
Read more →OTLKOutlook Therapeutics Secures $10 Million in Additional Working Capital
Therapeutics Secures $10 Million in Additional Working Capital JUNCTION, N.J., November 5, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for
Read more →OTLKOutlook Therapeutics Provides Update on Progress Towards First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration
Outlook Therapeutics Provides Update on Progress Towards First Approved Ophthalmic Formulation of Bevacizumab-vikg for Advanced Macular Degeneration MONMOUTH JUNCTION, N.J., September 30, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a late clinical-stage biopharmaceutica
Read more →OTLKOutlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA (bevacizumab-vikg) from NORSE 1 ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment
Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA (bevacizumab-vikg) from NORSE JUNCTION, N.J., August 26, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA
Read more →OTLKOutlook Therapeutics Reports Financial Results for the Third Quarter of Fiscal Year 2020 and Provides Corporate Update Successfully completed NORSE 2 enrollment in July 2020 NORSE 1 topline results to be reported in Augu
Outlook Therapeutics Reports Financial Results for the Third Quarter of Fiscal Year 2020 and Provides Corporate Update JUNCTION, N.J., August 14, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-
Read more →OTLKOutlook Therapeutics Announces $11.2
Outlook Therapeutics Announces $11.2 Million Financings Priced At-The-Market Under Nasdaq Rules JUNCTION, N.J., June 23, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("the Company"), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved
Read more →OTLKOutlook Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA (bevacizumab-vikg) Lead product candidate ONS-5010 / LYTENAVA TM (bevacizumab-vikg) has potential to be first FDA-approved ophthalmic formulation of be
Therapeutics Provides Clinical Update on ONS-5010 / LYTENAVA MONMOUTH JUNCTION, N.J., June 17, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bev
Read more →OTLKOutlook Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA (bevacizumab-vikg) Strategic investment at a premium enhances Company's ongoing development activities of O
Therapeutics Announces $16.0 Million Private Placement to Advance the Development of ONS-5010 / LYTENAVA (bevacizumab-vikg) MONMOUTH JUNCTION, N.J., May 26, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working
Read more →OTLKOutlook Therapeutics Reports Financial Results for the Second Quarter of Fiscal Year 2020 and Provides Corporate Update Company remains on track to report topline data results from NORSE 1, its first registration clinica
Outlook Therapeutics Reports Financial Results for the Second Quarter of Fiscal Year 2020 and Provides Corporate Update MONMOUTH JUNCTION, N.J., May 15, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the Company), a late clinical-stage biopharmaceutical company working to d
Read more →OTLKOutlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2 Company reports no anticipated COVID-19 impact on NORSE 1, its first registration clinical trial evaluating ONS-5010, an
Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2 CRANBURY, N.J., April 14, 2020 (GLOBE NEWSWIRE) - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company working to develop
Read more →OTLKOutlook Therapeutics Announces $10.2 Million Financings Priced At-The-Market CRANBURY, N.J.
Outlook Therapeutics Announces $10.2 Million Financings Priced At-The-Market February 24, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of beva
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports Financial Results for the First Quarter of Fiscal Year 2020 - - - First clinical trial results from the Phase 3 development program for ONS-5010 expected in six m
Outlook Therapeutics Provides Business Update and Reports Financial Results for the First Quarter of Fiscal Year 2020 First clinical trial results from the Phase 3 development program for ONS-5010 expected CRANBURY, N.J., February 14, 2020 - Outlook Therapeutics, Inc. (Nasd
Read more →OTLKOutlook Therapeutics Announces Agreements to Streamline Capital Structure and Regain 100% Ownership of Any Future Net Profits for ONS-5010 CRANBURY, N.J.
Therapeutics Announces Agreements to Streamline Capital Structure and Regain 100% Ownership of Any Future Net Profits for ONS-5010 CRANBURY, N.J., January 28, 2020 - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company wor
Read more →OTLKOutlook Therapeutics Announces Warrant Amendment and Restructuring of Senior Secured Notes in Separate Transactions CRANBURY, N.J.
Outlook Therapeutics Announces Warrant Restructuring of Senior Secured Notes in Separate Transactions CRANBURY, N.J., December 23, 2019 - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company working to develop the first F
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports Financial Results for Fiscal Year 2019 Topline results from the NORSE 1 study of ONS-5010 expected to be announced in the third quarter of calendar 2020 Enrollmen
Outlook Therapeutics Provides Business and Reports Financial Results for Fiscal CRANBURY, N.J., December 19, 2019 - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic
Read more →OTLKOutlook Therapeutics, Inc. 2015 Equity Incentive Plan Adopted by the Board of Directors
Outlook Therapeutics, Inc. 2015 Equity Incentive Plan Adopted by the Board of Directors: December 4, 2015 Approved by the Stockholders: December 7, 2015 Effective Date: December 4, 2015 Amended by the Board of Directors: August 7, 2018 Approved by the Stockholders: Septembe
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports Financial Results for Third Quarter of Fiscal 2019 CRANBURY, N.J.
Outlook Therapeutics Provides Business and Reports Financial Results for Third Quarter of Fiscal 2019 CRANBURY, N.J., August 14, 2019 - Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the "Company") today reported business highlights and financial results for its third quarter en
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports Second Quarter Financial Results for Fiscal 2019 CRANBURY, N.J.
Outlook Therapeutics Provides Business and Reports Second Quarter Financial Results for Fiscal 2019 CRANBURY, N.J., May 15, 2019 - Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") today reported business highlights and financial results for its second fiscal quarter
Read more →OTLKOutlook Therapeutics Announces FDA Acceptance of IND for ONS-5010 Enrollment of U.S. patients in the ONS-5010-002 Phase 3 clinical trial expected to be initiated in calendar Q2 2019 CRANBURY, N.J.
Outlook Therapeutics Announces FDA Acceptance Enrollment of U.S. patients in the ONS-5010-002 Phase 3 clinical trial expected to be initiated in calendar Q2 2019 CRANBURY, N.J., April 1, 2019 - Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") announced today the U.S.
Read more →OTLKOutlook Therapeutics Regains Compliance With All Nasdaq Listing Requirements CRANBURY, N.J.
Outlook Therapeutics Regains Compliance With All Nasdaq Listing Requirements CRANBURY, N.J., March 5, 2019 - Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") announced today that the Company received formal notice from The Nasdaq Stock Market LLC that the Company has
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports First Quarter Financial Results for Fiscal 2019 CRANBURY, N.J.
Outlook Therapeutics Provides Business and Reports First Quarter Financial Results CRANBURY, N.J., February 14, 2019 - Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") today reported financial results and business highlights for its first fiscal quarter ended December
Read more →OTLKOutlook Therapeutics Announces Exercise Price Reduction and Term Extension of Series A Warrants CRANBURY, N.J.
Outlook Therapeutics Announces Exercise Price Reduction and Term Extension of Series A Warrants CRANBURY, N.J., January 22, 2019 - Outlook Therapeutics, Inc. (Nasdaq: OTLK, OTLKW) (the "Company") today announced that its publicly traded Series A warrants (Nasdaq: OTLKW) have
Read more →OTLKOutlook Therapeutics Provides Business Update and Reports Financial Results for Fiscal Year 2018 CRANBURY, N.J.
Outlook Therapeutics Provides Business Update and Reports Financial Results for Fiscal CRANBURY, N.J., December 18, 2018 - Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") today reported financial results and business highlights for its fiscal year ended September 30,
Read more →OTLKOncobiologics Changes Name to Outlook Therapeutics Announces Next Steps in Executing ONS-5010 Clinical and Regulatory Strategy Company changes name to Outlook Therapeutics, Inc.; ticker symbol to "OTLK" Jeff Evanson join
Changes Name to Outlook Therapeutics Announces Next Steps in Executing ONS-5010 Clinical and Regulatory Strategy Company changes name to Outlook Therapeutics, Inc.; ticker symbol to "OTLK" Jeff Evanson joins team as Chief Commercial Officer Terry Dagnon joins team as Chie
Read more →OTLKOncobiologics Advances ONS-5010 into wet AMD Clinical Trial - - - Receives commitment for $20 million in proceeds from equity private placement - - - Restructures and extends maturity on $13.5 million of outstanding seni
Oncobiologics Advances ONS-5010 into wet AMD Clinical Trial Receives commitment for $20 million in proceeds from equity private placement Restructures and extends maturity on $13.5 million of outstanding senior secured notes CRANBURY, N.J., November 6, 2018 (GLOBE NEWSWIRE)
Read more →OTLKOncobiologics, Inc. 2015 Equity Incentive Plan Adopted by the Board of Directors
2015 Equity Incentive Plan Adopted by the Board of Directors: December 4, 2015 Approved by the Stockholders: December 7, 2015 Effective Date: December 4, 2015 Amended by the Board of Directors: August 7, 2018 Approved by the Stockholders: September 21, 2018 (a) Eligible Awa
Read more →OTLKOncobiologics Provides Business Update and Reports Third Quarter Financial Results for Fiscal 2018 Cranbury, NJ
Provides Business Update and Reports Third Quarter Financial Results for Fiscal 2018 Cranbury, NJ - August 14, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today reported financial results and business highlights for its three and nine months ended June 30, 2018. "We continue to m
Read more →OTLKOncobiologics Appoints Lawrence A. Kenyon as President and
Oncobiologics Appoints Lawrence A. Kenyon as President and CEO CRANBURY, N.J., August 2, 2018 - Oncobiologics, Inc. (NASDAQ:ONS) today announced that Lawrence A. Kenyon, its Chief Financial Officer (CFO) and Corporate Secretary, has been appointed to the role of President and
Read more →OTLKOncobiologics Completes Exchange of Series A Convertible Preferred Stock for Newly Created Series A-1 Convertible Preferred Stock CRANBURY, N.J.
Oncobiologics Completes Exchange of Series A Convertible Preferred Stock for Newly Created Series A-1 Convertible Preferred Stock CRANBURY, N.J., July 19, 2018 - Oncobiologics, Inc. (Nasdaq: ONS) today announced that, on July 18, 2018, the Company completed the exchange of an
Read more →OTLKOncobiologics Regains Compliance with Applicable Nasdaq Listing Requirements CRANBURY, N.J.
Oncobiologics Regains Compliance with Applicable Nasdaq Listing Requirements CRANBURY, N.J., July 11, 2018 - Oncobiologics, Inc. (Nasdaq:ONS) today announced that, on July 10, 2018, the Company received formal notice from The Nasdaq Stock Market LLC that the Company has evide
Read more →OTLKOncobiologics Announces Randy Thurman as Executive Chairman of the Board of Directors and Lawrence A. Kenyon as Interim
Oncobiologics Announces Randy Thurman as Executive Chairman of the Board of Directors and Lawrence A. Kenyon as Interim CEO CRANBURY, N.J., June 18, 2018 - Oncobiologics, Inc. (NASDAQ:ONS) today announced that Pankaj Mohan, Ph.D., its Chairman and Chief Executive Officer (CEO
Read more →OTLKOncobiologics Reports Second Quarter Financial Results for Fiscal 2018 Cranbury, NJ
Reports Second Quarter Financial Results for Fiscal 2018 Cranbury, NJ - May 15, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today reported financial results and business highlights for its three and six months ended March 31, 2018. Oncobiologics' Chairman and Chief Executive Offi
Read more →OTLKOncobiologics Appoints Randy Thurman to Board of Directors Cranbury, NJ
Appoints Randy Thurman to Board of Directors - April 17, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today announced the appointment of Randy Thurman to its board of directors, effective April 13, 2018. At the same time, Oncobiologics also announced the resignation of Scott Canute
Read more →OTLKOncobiologics Appoints Dr. Joerg Windisch to Board of Directors Cranbury, NJ
Appoints Dr. Joerg Windisch to Board of Directors - March 27, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today announced the appointment of Joerg Windisch, Ph.D. to its board of directors, effective March 23, 2018. In addition, Oncobiologics announced the resignation of Yezan Had
Read more →OTLKOncobiologics Reports First Quarter Fiscal Year 2018 Results Cranbury, NJ
Reports First Quarter Fiscal Year 2018 Results - February 14, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today reported financial results and business highlights for its first fiscal quarter ended December 31, 2017. Oncobiologics had a net loss attributable to common stockholders
Read more →OTLKOncobiologics Announces Term Extension of Series A Warrants Cranbury, NJ
Oncobiologics Announces Term Extension of Series A Warrants Cranbury, NJ - February 9, 2018 - Oncobiologics, Inc. (NASDAQ: ONS; ONSIW; ONSIZ) announced today an extension to the term for exercise of its publicly traded Series A warrants (NASDAQ: ONSIW). The Series A warrants
Read more →OTLKOncobiologics Announces Closing of Strategic Partnership Deal with GMS Tenshi Holdings Cranbury, NJ
Oncobiologics Announces Closing of Strategic with GMS Tenshi Holdings Cranbury, NJ - October 31, 2017 - Oncobiologics, Inc. (NASDAQ:ONS), today announced that it closed the sale of the remaining securities to GMS Tenshi Holdings Pte. Limited ("GMS Tenshi") in the previously a
Read more →OTLKOncobiologics announces strategic partnership with GMS Tenshi Holdings Pte. Limited -Up to $50 million in combination of equity, warrants and license fees- Cranbury, NJ
Oncobiologics announces strategic partnership GMS Tenshi Holdings Pte. Limited -Up to $50 million in combination of equity, warrants and license fees- Cranbury, NJ - September 8, 2017 - Oncobiologics, Inc. (NASDAQ: ONS) today announced that it entered into a Purchase Agreeme
Read more →OTLKOncobiologics Secures Additional Funding Cranbury, NJ
Oncobiologics Secures Additional Funding Cranbury, NJ - April 17, 2017 - Oncobiologics, Inc. (NASDAQ: ONS), a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex monoclonal antibody (mAb) biosimilar therapeutic
Read more →OTLKOncobiologics Issues $8.35 Million of Senior Secured Notes and Warrants to Acquire 1.9 Million Shares as part of Aggregate $10.0 Million Note and 2.3 Million Warrant Offering Cranbury, NJ
Oncobiologics Issues $8.35 Million of Senior Secured Notes and Warrants to Acquire 1.9 Million Shares as part of Aggregate $10.0 Million Note and 2.3 Million Cranbury, NJ - December 23, 2016 - Oncobiologics, Inc. (NASDAQ: ONS), a clinical-stage biopharmaceutical company focus
Read more →OTLKOncobiologics Announces Separation of
Oncobiologics Announces Separation of Units; Trading of Common Stock and Warrants Cranbury, NJ - June 10, 2016 - Oncobiologics, Inc. (NASDAQ: ONSIU), a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex monoc
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