Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
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 U.S. Food and Drug Administration (FDA) as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration. The FDA has accepted the FDRR and has granted a meeting with the deciding official to be conducted in April 2026. Subsequent to receiving the CRL in December 2025, Outlook Therapeutics has engaged with the FDA on multiple occasions, including a formal Type A meeting on March 2, 2026, which led to the submission of the FDRR and associated meeting. “We look forward to our discussions with the
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News
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OTLK
Earnings
- 2/17/26 - Miss
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Sec Filings
- 3/25/26 - Form 8-K
- 3/25/26 - Form 424B5
- 3/23/26 - Form 424B5
- OTLK's page on the SEC website