Regulatory setbacks piled up over the holiday window as Outlook Therapeutics received a third complete response letter (CRL) from FDA for its bevacizumab biosimilar ONS‑5010, triggering a steep share price fall, and both Sanofi and Corcept faced unexpected FDA rejections on separate applications. Investors reacted sharply to the signals of persistent regulatory scrutiny and unmet evidentiary thresholds. Analysts warned that multiple CRLs and rejections increase financing pressure for smaller developers and could compress windows for commercial opportunity when competitors advance. Companies will need to reassess development plans, data packages and regulatory engagement strategies in response to the latest decisions. Clarification: a CRL is FDA’s communication that an application cannot be approved in its current form and typically lists deficiencies or requests additional data.