Syndax Pharma Says FDA Extended Drug Approval Decision Date For Revumenib By 3 Months

(RTTNews) - Syndax Pharmaceuticals, Inc. (SNDX) Monday said the Food and Drug Administration or FDA has extended the drug approval decision date for revumenib by three months for the treatment of patients with KMT2A-rearranged acute leukemia. Syndax shares were down more than 14 percent in pre-market to $20.95.

On July 26, the FDA notified the company that it requires more time to review the requested supplemental information provided to it.

"The submission of additional information to the FDA was determined to constitute a Major Amendment to the NDA and resulted in a standard three-month extension to the original PDUFA action date of September 26, 2024," Syndax said in a statement.

No additional trials or manufacturing information have been requested by the regulator, the company added.

Syndax stock had closed at $24.49, down 0.57 percent on Friday. It has traded in the range of $11.22 - $25.34 in the last 1 year.