Outlook bleaker after latest Lytenava blow
Shares in Outlook Therapeutics (Nasdaq: OTLK), a US biopharma focused on enhancing the standard of care for Avastin (bevacizumab) for the treatment of retina diseases, closed 49% lower Thursday after the company announced a new setback.
It was revealed that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to the company’s biologics license application (BLA) resubmission for Lytenava/ONS-5010 (bevacizumab-vikg), indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration (wet AMD).
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