FDA CRL Holds ITM-11 on Manufacturing Issues

Company: ITM Radiopharma · Event Type: Clinical/Regulatory Signal · Product/Asset: ITM-11 · Subject: Neuroendocrine Tumors · Event Date: August 10, 2026 Summary FDA issued a Complete Response Letter for ITM’s 177Lu-edotreotide NDA in gastroenteropancreatic neuroendocrine tumors. ITM said the letter cited chemistry, manufacturing and controls…