Syndax Pharmaceuticals

FDA approves Revuforj® (revumenib), the first menin inhibitor for treating R/R acute leukemia with KMT2A translocation in adult and pediatric patients. Based on AUGMENT-101 trial data, Revuforj showed 21% CR+CRh rate and 6.4-month median duration of remission. Syndax to launch Revuforj in November, with 25 mg tablets available in Q1-Q2 2025.

FDA approved revumenib, a menin inhibitor, for treating relapsed/refractory acute leukemia with KMT2A translocation in patients aged one and older. Supported by AUGMENT-101 trial data, it offers durable responses, enabling curative treatments like stem cell transplantation, despite common adverse events.

CareMax files for Chapter 11 bankruptcy in Texas with $693 million in debts. Bangladesh faces a severe dengue crisis with over 400 deaths. California reports its first clade I mpox case, while Oregon records its first human bird flu case. The UK combats bird flu with poultry culling and protection zones. Eyenovia halts an eye drug study and cuts staff, contrasting with Syndax Pharmaceuticals' FDA approval for a blood cancer drug.

J.P. Morgan analyst Anupam Rama maintains bullish stance on SNDX stock, citing FDA early approval of Revuforj for acute leukemias and favorable pricing strategy. Goldman Sachs also maintains Buy rating with $31.00 price target. SNDX stock dropped 27.85% over six months.

FDA approves Revuforj® (revumenib), the first menin inhibitor for R/R acute leukemia with KMT2A translocation in adult and pediatric patients. Efficacy based on AUGMENT-101 trial showing 21% CR+CRh rate. Safety profile includes common adverse reactions like hemorrhage and nausea.

The FDA approved revumenib for relapsed or refractory acute leukemia with a KMT2A translocation, based on the AUGMENT-101 trial. The drug showed a CR+CRh rate of 21.2% and was generally well-tolerated, with data to be presented at the 2024 ASH Annual Meeting.

Revumenib achieved a 23% CR/CRh rate in relapsed/refractory NPM1-mutated AML, with 64% of responders showing negative MRD status. Syndax plans to file a supplemental NDA for NPM1-mutated AML in H1 2025, following potential FDA approval for KMT2A-rearranged leukemia.

The FDA approved revumenib (Revuforj) for relapsed/refractory acute leukemia with KMT2A translocation, based on AUGMENT-101 trial results showing 21.2% complete response rate and median response duration of 6.4 months. 40% of responders proceeded to allogeneic stem cell transplant.

FDA approves Revuforj (revumenib), the first menin inhibitor for R/R acute leukemia with KMT2A translocation in adult and pediatric patients. Efficacy based on AUGMENT-101 trial data showing 21% CR+CRh rate. Safety evaluated in 135 patients, with common adverse reactions including hemorrhage and nausea.