RLAY - Relay down 13% after disclosing registrational path for bile duct cancer candidate

Relay Therapeutics (NASDAQ:RLAY) will forge ahead with a single arm trial design for RLY-4008 for cholangiocarcinoma ("CCA"), also known as bile duct cancer. The company said it will examine FGFRi-naïve FGFR2-fusion CCA at 70 mg once daily in the hopes of an accelerated approval in a mid-stage trial. In the future, additional cohorts will be added to an NDA submission, including frontline, FGFRi-experienced and FGFR2 mutation and amplification patients. Interim data shared with the U.S. FDA includes safety on 115 patients, with 58 patients treated with the once-daily dosing. Also, 13 were FGFRi-naïve FGFR2-fusion CCA patients treated once daily schedule ranging from 20 mg to 70 mg. An efficacy analysis FDA showed partial responses in eight out of thirteen (62%) FGFRi-naïve FGFR2-fusion CCA patients from the 200 mg to 70 mg cohorts.

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Relay down 13% after disclosing registrational path for bile duct cancer candidate