Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration [Yahoo! Finance]
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: Yahoo! Finance
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 it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). “We remain committed to bringing an ophthalmic bevacizumab to market in the United States and providing retina patients suffering from wet AMD with a much needed treatment option that has the potential to address the problems associated with unapproved repackaged bevacizumab. Our team has worked diligently to address the FDA's requests and we believe this resubmission provides the necessary evidence to support approval of the ONS-5010 BLA in
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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
OTLK
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