Syndax Reports FDA Priority Review Of NDA For Revumenib For Treatment Of Relapsed/Refractory KMT2Ar Acute Leukemia
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Syndax Pharmaceuticals has announced that the FDA has granted priority review to its New Drug Application (NDA) for Revumenib, aimed at treating relapsed/refractory KMT2Ar acute leukemia. The Prescription Drug User Fee Act (PDUFA) action date is set for September 26, 2024. The NDA is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program.

March 26, 2024 | 8:09 pm
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Syndax Pharmaceuticals' Revumenib has been granted priority review by the FDA for the treatment of relapsed/refractory KMT2Ar acute leukemia, with a PDUFA action date set for September 26, 2024.
The FDA's decision to grant priority review to Syndax Pharmaceuticals' Revumenib is a significant positive development for the company. This status not only highlights the potential of Revumenib as a treatment option but also accelerates the review process, potentially leading to an earlier market entry. Given the specific focus on relapsed/refractory KMT2Ar acute leukemia, a condition with limited treatment options, this news could significantly impact Syndax's market position and investor sentiment in the short term.
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