Lucentis (ranibizumab)

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OTLK Stock Crashes 54% as FDA Issues Second CRL for Eye Disease Drug
ZACKSยท 2025-08-29 15:41
Key Takeaways OTLK stock dropped 54.1% after the FDA issued a second CRL for ONS-5010 in wet AMD.The CRL cited insufficient efficacy as ONS-5010 missed the NORSE EIGHT non-inferiority endpoint.OTLK will meet with the FDA for clarity regarding requirements.Shares of Outlook Therapeutics (OTLK) tumbled 54.1% after the FDA issued a second complete response letter (CRL) rejecting its biologics license application (BLA) resubmission for ONS-5010 in wet age-related macular degeneration (wet AMD).The CRL cited a s ...