The FDA issued a third complete response letter (CRL) to Outlook Therapeutics for ONS‑5010, its bevacizumab biosimilar/formulation aimed at treating wet age‑related macular degeneration. The agency’s third CRL halted the program and prompted an immediate market reaction, sending Outlook’s stock sharply lower. BioWorld and BioCentury coverage indicate the setback leaves the small company with a narrowed runway and raises questions about the viability of pursuing additional regulatory filings without fresh capital or partnering options. Analysts noted competing approvals in Europe and limited time to recover commercial momentum.