Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
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 Federal Dispute Resolution meeting with the Office of New Drugs at the U.S. Food and Drug Administration (FDA). The meeting was conducted as part of the Company’s ongoing efforts to seek alignment with the FDA regarding the regulatory pathway for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) and as a follow-up to its recent Type A meeting with the Division of Ophthalmology and Office of Specialty Medicine regarding the December 30, 2025 Complete Response Letter (CRL) for the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration. “We appreciate the opportunity to engage in constructive dialogue with the FDA through the FDR process,” said Bob Jahr, Chief Executive O
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News
- Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDAGlobeNewswire
- Outlook Therapeutics Announces Closing of $5.0 Million Public OfferingGlobeNewswire
- Outlook Therapeutics Announces Pricing of $5.0 Million Public OfferingGlobeNewswire
- Outlook Therapeutics Announces Proposed Public Offering [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics launches public offering; shares down [Seeking Alpha]Seeking Alpha
OTLK
Earnings
- 2/17/26 - Miss
OTLK
Sec Filings
- 4/7/26 - Form 8-K
- 3/25/26 - Form 8-K
- 3/25/26 - Form 424B5
- OTLK's page on the SEC website