Telix Pharmaceuticals received a complete response letter (CRL) from FDA regarding its Zircaix renal cancer imaging agent, citing chemistry and manufacturing issues that will require additional data and remediation prior to resubmission. Likewise, Outlook Therapeutics faced a CRL over its Lytenava wet age-related macular degeneration drug, as FDA requested more efficacy evidence before approval. Both decisions have significantly impacted stock prices and development timelines for the respective companies.