Outlook Therapeutics received a third FDA complete response letter for ONS‑5010, its bevacizumab formulation for wet age‑related macular degeneration; the company’s stock plunged after the agency’s action, reflecting a materially diminished commercial outlook. The CRL compounds regulatory and capital risks for small specialty biotechs seeking reformulations of established biologics, and analysts flagged limited runway and the competitive landscape as drivers of the negative market reaction. Management will need a clear regulatory or financing plan to sustain operations.
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