OTLK
Outlook Therapeutics, Inc.Substantial doubt about the company's ability to continue as a going concern.
“As a result, there is substantial doubt about the Company’s ability to continue as a going concern.”View the 10-Q filed May 15, 2026
Press releases and events scraped from the company's investor relations website. Past events open our own call or event page when we host one; otherwise listings link to the original source.
Recent news
| Date | Headline |
|---|---|
| 2026-06-16 |
Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD
Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026 ISELIN, N.J., June 16, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced |
| 2026-06-01 |
Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
ISELIN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced the resubmission |
| 2026-05-28 |
Outlook Therapeutics Announces Pricing of $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
ISELIN, N.J., May 28, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced that it has |
| 2026-05-26 |
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., May 26, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment |
| 2026-05-15 |
Outlook 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; Decision Expected This Month Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe with Commercial Distribution Agreement with Mediconsult AG in Switzerland Launched Real-World |
| 2026-04-23 |
Outlook Therapeutics Announces Closing of $5.0 Million Registered Direct Offering
ISELIN, N.J., April 23, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics” or the “Company”), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the closing of its |
| 2026-04-22 |
Outlook Therapeutics Announces $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
ISELIN, N.J., April 22, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics” or the “Company”), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has entered into |
| 2026-04-21 |
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., April 21, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed its |
| 2026-04-07 |
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
ISELIN, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it submitted a formal dispute resolution request (FDRR) to the |
| 2026-03-25 |
Outlook Therapeutics Announces Closing of $5.0 Million Public Offering
ISELIN, N.J., March 25, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the closing of its previously announced public offering of |