1. Syndax's Revuforj® wins Best New Drug at the 2025 Scrip Awards. 2. Revuforj treats relapsed leukemia and received FDA approvals in 2024 and 2025. 3. CEO highlights Syndax’s commitment to menin inhibition and patient care. 4. Multiple clinical trials for Revuforj are ongoing across various patient groups. 5. Revuforj has potential risks like differentiation syndrome and QTc prolongation.
FAQ
Why Bullish?
The recognition at the Scrip Awards boosts Revuforj's visibility and credibility. Historical data shows similar awards often lead to short-term stock price increases.
How important is it?
The article highlights critical approvals and accolades for Revuforj, directly impacting SNDX's market position and investor interest.
Why Short Term?
Immediate interest in Revuforj may drive stock price up quickly, depending on market reactions. Past award winners in the biopharma sector like Amgen have seen a quick price appreciation post-award.
Revuforj® (revumenib) Recognized as Best New Drug at the Scrip Awards 2025
NEW YORK, Dec. 12, 2025 – Syndax Pharmaceuticals (Nasdaq: SNDX), an innovative biopharmaceutical company dedicated to advancing cancer therapies, has announced that its drug Revuforj® (revumenib) has been awarded the title of Best New Drug at the esteemed Scrip Awards 2025, held by Citeline. This recognition highlights the drug’s significance in pharmaceutical development, representing a major advancement in therapeutic options for patients.
About Revuforj® (revumenib)
Revuforj is a first-in-class menin inhibitor, recently receiving approval from the FDA in November 2024 for patients aged one year and older with relapsed or refractory (R/R) acute leukemia characterized by a KMT2A translocation. In October 2025, Revuforj gained further FDA approval for its use in treating R/R acute myeloid leukemia (AML) associated with a nucleophosmin 1 (NPM1) mutation, marking a significant milestone for adult and pediatric patients lacking satisfactory alternative treatments.
Significance of the Scrip Award
“It is an honor to receive this prestigious award from Scrip in recognition of the groundbreaking science behind Revuforj and the tremendous promise it holds for patients with menin-dependent acute leukemia,” stated Michael A. Metzger, Chief Executive Officer of Syndax Pharmaceuticals. He emphasized that this award, following the recent approval for a second patient population, underscores Syndax’s commitment to leadership in menin inhibition and devotion to patient care.
The Scrip Awards are among the most respected accolades within the biopharmaceutical sector, celebrating innovations and breakthroughs that shape the global landscape of medicine.
Clinical Profile of Revuforj
Revuforj (revumenib) is specifically designed as an oral menin inhibitor, with dual FDA approval for:
- R/R acute leukemia with a KMT2A translocation.
- R/R acute myeloid leukemia (AML) with a susceptible NPM1 mutation.
Ongoing and planned clinical trials are exploring the efficacy of Revuforj in combination with standard care therapies for newly diagnosed patients with NPM1m or KMT2Ar AML.
Regulatory Designations
Revuforj has received several regulatory recognitions, including:
- Orphan Drug Designation from the U.S. FDA for treating AML, ALL, and acute leukemias of ambiguous lineage (ALAL).
- Fast Track designation from the U.S. FDA for adult and pediatric patients with R/R acute leukemias harboring KMT2A rearrangement or NPM1 mutation.
- Breakthrough Therapy Designation by the U.S. FDA for adult and pediatric patients suffering from R/R acute leukemia with KMT2A rearrangement.
Important Safety Information
WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION, and TORSADES DE POINTESRevuforj usage may lead to differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, renal dysfunction, and hypotension. Immediate corticosteroid therapy is indicated if differentiation syndrome is suspected.
QTc prolongation and Torsades de Pointes have been observed in patients treated with Revuforj. Pre-treatment correction of hypokalemia and hypomagnesemia is essential, and patients should not be initiated on Revuforj with a QTcF > 450 msec. Monitoring of the QTc interval is advised throughout treatment.
Conclusion
The accolades and advancements surrounding Revuforj (SNDX) exemplify Syndax Pharmaceuticals' commitment to transforming cancer treatment pathways. With ongoing developments and a focus on patient health and safety, Revuforj is poised to make a substantial impact in the fight against acute leukemias.