Outlook Therapeutics Provides Regulatory Update on U.S. Food and Drug Administration Review of ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
ISELIN, N.J., Aug. 28, 2025 (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 the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its biologics license application (BLA) resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).
Related Questions
How will the FDA's complete response letter affect Outlook Therapeutics' short‑term stock volatility and trading volume?
What are the specific FDA concerns in the CRL, and what timeline and cost are required for additional data or studies to address them?
How does this regulatory setback compare to recent outcomes for other biotech firms with AMD therapies, and what impact might it have on OTLK's valuation relative to its peers?