Syndax: FDA Grants Breakthrough Therapy Designation For Revumenib - Quick Facts

(RTTNews) - Syndax Pharmaceuticals, Inc. (SNDX) announced the FDA has granted Breakthrough Therapy Designation for revumenib for the treatment of adult and pediatric patients with relapsed or refractory acute leukemia harboring a KMT2A rearrangement. Revumenib is the company's highly selective, oral menin inhibitor. The FDA designation is based on phase 1 data from the AUGMENT-101 trial.

Michael Metzger, CEO, said: "Syndax is committed to bringing revumenib to these patients as quickly as possible and we look forward to working collaboratively with the FDA to expedite a potential approval of revumenib."

The company said it remains on track to submit an NDA for revumenib by the end of 2023 with the potential for an expedited approval with a broad indication.

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