Outlook Therapeutics Provides Update on Type A Meeting with FDA [Yahoo! Finance]
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: Yahoo! Finance
ISELIN, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency's feedback and meeting minutes. “We had a productive discussion with the FDA. Based on our meeting, and pending receipt of the agency's written minutes, we plan to resubmit the BLA later this year. We remain committed to providing patients, physicians and payors in the U.S. with a s
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News
- 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
- Oncobiologics (NASDAQ:OTLK) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMDGlobeNewswire
- Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010GlobeNewswire
OTLK
Earnings
- 8/14/25 - Miss
OTLK
Sec Filings
- 11/3/25 - Form 8-K
- 10/21/25 - Form SCHEDULE
- 10/3/25 - Form 4
- OTLK's page on the SEC website