FDA, Revuforj

FDA approves Syndax’s Revuforj to treat leukaemia
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation. Revuforj is now the first and only menin inhibitor approved for treating patients aged one year and older.
Syndax gets FDA okay for first-in-class leukaemia drug
Revuforj is Syndax's second first-in-class approval for 2024, coming after the company and partner Incyte got a green light from the FDA for anti-CSF-1R antibody Niktimvo (axatilimab) as a third-line or later treatment for chronic graft-versus-host disease (GVHD) in August.
Syndax Pharmaceuticals Gains ‘Buy’ Rating Amidst Revuforj’s FDA Approval and Promising Market Prospects
Edward White, an analyst from H.C. Wainwright, reiterated the Buy rating on Syndax Pharmaceuticals (SNDX – Research Report). The associated
Syndax earns its 2nd drug approval in 2024 with Revuforj
The US Food and Drug Administration (FDA) has approved Syndax Pharmaceuticals’ Revuforj (revumenib). Revuforj is the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.
US FDA approves Syndax's blood cancer drug
The U.S. Food and Drug Administration on Friday approved Syndax Pharmaceuticals' drug for the treatment of adult and pediatric patients with a type of blood cancer, sending the company's shares up 3% in after-hours trading.
Syndax's Revuforj Garners FDA Approval for Refractory KMT2A-Altered Acute Leukemia
In the AUGMENT-101 trial, 21 percent of patients achieved complete remission plus complete remission with partial hematological recovery on the drug.
Syndax Pharmaceuticals Gains Buy Rating Boost from Revuforj’s Early Approval and Strategic Launch Plan
Syndax Pharmaceuticals (SNDX – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst yesterday. Analyst Kelly
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Syndax ⁠scores FDA approval for Revuforj after it disappointed in another acute leukemia indication
The U.S. patient population for Revuforj in its approved indication is roughly 2,000 according to Syndax. KMT2A leukemias ...
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Syndax secures FDA OK for new kind of leukemia drug
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain ...
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Syndax wins U.S. approval for leukemia treatment
The Food and Drug Administration approved on Friday a new drug developed by Syndax Pharmaceuticals to treat patients with a ...
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FDA Approves First and Only Drug for Rare Leukemia
Syndax Pharmaceuticals recently announced the FDA approval of Revuforj (revumenib) for the treatment of relapsed or refractory acute leukemia in adult and pediatric patients one year and older. It ...
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Syndax confirms FDA approval of Revuforj for acute leukemia
Syndax (SNDX) Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of relapsed or refractory acute leukemia with a lysine ...