Outlook Therapeutics received a third complete response letter (CRL) from the FDA for ONS‑5010, its bevacizumab biosimilar candidate for wet age‑related macular degeneration, triggering a steep share selloff. The company’s stock plunged after the regulatory setback, and analysts warned the repeated CRLs may exhaust the company’s remaining runway. FDA CRLs at this stage typically reflect unresolved CMC, clinical or comparability issues; repeated refusals complicate prospects for re‑filing without new data or manufacturing remediation. Investors and potential partners will scrutinize Outlook’s capital needs and strategic options as the company weighs whether to pursue a fourth submission, restructure, or seek asset sales.
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