Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) in the United Sta
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News
- Outlook Therapeutics Reports Financial Results for Fiscal Year 2025 [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics Reports Financial Results for Fiscal Year 2025GlobeNewswire
- Oncobiologics (NASDAQ:OTLK) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Oncobiologics (NASDAQ:OTLK) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Outlook Therapeutics to Present at the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
OTLK
Earnings
- 8/14/25 - Miss
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Sec Filings
- 12/19/25 - Form 10-K
- 12/19/25 - Form 8-K
- 11/3/25 - Form 8-K
- OTLK's page on the SEC website