TLDR
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Syndax scores FDA nod for Revuforj, but stock tumbles despite big milestone.
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Revuforj gets FDA green light for AML, yet SNDX ends the day in the red.
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FDA expands Revuforj use, but Syndax stock faces heavy afternoon selloff.
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Syndax gains key approval for Revuforj, but shares sink on market response.
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Despite FDA win, SNDX stock dips, Revuforj’s expanded use is not enough boost.
Syndax Pharmaceuticals (SNDX) stock dropped 7.83% to close at $13.53, despite announcing an FDA approval for Revuforj. After the close, the price fell further by 1.92% to $13.27 in extended trading.
Syndax Pharmaceuticals, Inc., SNDX
This sharp decline surprised many, as Revuforj gained approval for treating NPM1-mutated AML in both adults and children.
Revuforj Secures Second FDA Nod for Acute Leukemia Treatment
The FDA approved Revuforj for relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation in patients aged one and older. This expands its original label, which included treatment for KMT2A translocated leukemia, to a broader group. Now, Revuforj becomes the only FDA-approved menin inhibitor for both AML types.
The decision followed data from the Phase 2 AUGMENT-101 trial that demonstrated encouraging remission rates among treated patients. The trial showed a 23% complete remission or CRh rate in relapsed/refractory NPM1-mutated AML cases. These results appeared in the journal Blood and were also presented at the 2025 European Hematology Association meeting.
Revuforj’s expanded use could significantly change how physicians approach relapsed NPM1-mutated AML. It provides a targeted option where few satisfactory treatments currently exist. SNDX emphasized the drug’s consistent efficacy and tolerability across patient populations.
Revuforj Gains NCCN Recognition as a Category 2A Option
On September 18, 2025, Revuforj was added to the NCCN Guidelines for AML as a category 2A treatment. It now appears in the guidelines for both NPM1-mutated AML and KMT2A-translocated leukemia. This marks a crucial step in standardizing its clinical use.
The NCCN designation aligns with data from clinical trials and real-world outcomes over the past year. Since its first approval in 2024, Revuforj has treated over 1,000 patients through clinical and commercial channels. SNDX aims to capitalize on this momentum with deeper market penetration.
Revuforj is available through specialty distributors and pharmacies nationwide. Syndax has implemented SyndAccess, a patient support program, to ease access and provide financial assistance. The company continues to support patient needs as usage scales.
Syndax Pharmaceuticals Stock Slides Despite Milestone Approval
Despite the regulatory milestone, SNDX stock experienced heavy selling after 2 PM, signaling market discontent. The drop came unexpectedly, even as the approval strengthens the company’s commercial pipeline. Market participants may have reacted to broader market trends or profit-taking after anticipation of the approval.
The approval did not ease bearish sentiment, as the stock declined further after hours. Some concerns could stem from the modest remission rates in the trial or expected commercialization costs. Still, SNDX) reiterated its commitment to expanding Revuforj’s reach and impact.
Mutations in NPM1 are present in roughly 30% of adult AML patients and correlate with high relapse rates. Patients with relapsed NPM1-mutated AML often have limited options, making new targeted therapies essential. SNDX positions Revuforj as a new standard in this treatment area.
Revuforj’s Future Potential and Syndax’s Clinical Direction
The safety profile of Revuforj remains consistent with past trial results across adult and pediatric patients. The FDA’s review included data from 241 patients, reinforcing confidence in its risk-benefit balance. SNDX aims to extend Revuforj’s indications further in future studies.
The company continues to invest in menin-inhibitor development for additional leukemia subtypes. It is currently leading multiple clinical programs targeting menin-dependent blood cancers. SNDX views this drug class as a central pillar of its long-term strategy.
With the latest approval, Syndax enhances its position as a key player in precision oncology. The company remains focused on clinical innovation and execution. SNDX maintains its long-term vision despite short-term market fluctuations.
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