Crescent Biopharma's Investigational New Drug Application for CR-002 to Treat Solid Tumors Cleared by FDA

MT newswire2026/10/05 12:27

08:27 AM EDT, 10/05/2026 (MT Newswires) -- Crescent Biopharma (CBIO) said Monday that the US Food and Drug Administration cleared its Investigational New Drug application for CR-002, a potential treatment for advanced solid tumors. The clearance enables the oncology company to initiate the global phase 1/2 APOLLO trial, which is expected to enroll about 200 patients with advanced cancers, including non-small cell lung cancer, head and neck squamous cell carcinoma, and selected gastrointestinal and gynecological tumors. Initial clinical data are expected in the second half of 2027, including safety, pharmacokinetic and preliminary antitumor-activity results across multiple tumor types. Shares were up 1.5% premarket.

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