Syndax Pharmaceuticals

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Syndax Pharmaceuticals' drug Revuforj, a menin inhibitor, received FDA approval for treating acute leukemia with KMT2A translocation, offering a new treatment option for patients with poor prognoses. The drug, priced at $39,500/month, showed promising results in a Phase 1/2 study, with 21.2% achieving complete remission. Revuforj carries a black box warning for differentiation syndrome risk.

The FDA approved revumenib for treating advanced acute leukemia in patients with relapsed or refractory disease and a KMT2A gene translocation, based on AUGMENT-101 trial data showing a 21.2% CR+CRh rate and median CR+CRh duration of 6.4 months.

Syndax Pharmaceuticals received FDA approval for Revuforj, a menin inhibitor drug for relapsed or refractory acute leukemia with KMT2A gene mutations. The drug, priced at $475,000 per year, showed a 21% complete remission rate in trials and carries a black box warning for differentiation syndrome. Syndax plans to launch two doses in November, with a lower dose available next year.

Syndax Pharmaceuticals' price target increased by H.C. Wainwright to $51.00 following FDA approval of Revuforj for acute leukemia. The drug, a breakthrough menin inhibitor, showed a 21% complete response rate in trials. Despite stock volatility, Syndax holds more cash than debt, though it remains unprofitable.

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FDA approves Syndax Pharmaceuticals' Revuforj, a menin inhibitor pill for treating relapsed or refractory leukemias with KMT2A genetic rearrangement, affecting about 10% of cases.

FDA approves Syndax’s Revuforj as the first menin inhibitor for relapsed or refractory acute leukaemia, based on Phase 1/2 AUGMENT-101 trial data showing 21% CR/CRh rate. Revuforj, available in 110mg and 160mg tablets, is also being evaluated for AML with NPM1 mutations and has received orphan drug, breakthrough therapy, and fast track designations.

FDA approves Syndax Pharmaceuticals' Revuforj (revumenib) for treating relapsed or refractory acute leukaemia with KMT2A translocation, making it the first and only menin inhibitor for patients aged one year and older. The approval was expedited through the FDA’s Real Time Oncology Review programme, based on the Phase I/II AUGMENT-101 trial results, which showed 21% of patients achieved complete remission with partial haematological recovery.