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Syndax Pharmaceuticals reports developments as a commercial-stage biopharmaceutical company advancing cancer therapies. Company updates center on Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 receptor.
Recurring news includes quarterly financial results, product revenue for Revuforj and Niktimvo, collaboration revenue from Niktimvo commercialization with Incyte, clinical data presentations in acute leukemia, chronic graft-versus-host disease and related indications, FDA-related product updates, investor conference activity and inducement equity grants under Nasdaq listing rules.
Syndax Pharmaceuticals (NASDAQ:SNDX) reported strong Q2 2025 financial results, highlighting significant growth in its commercial portfolio. Revuforj generated $28.6M in net revenue, up 43% from Q1, while Niktimvo achieved $36.2M in net revenue in its first full quarter, contributing $9.4M in collaboration revenue to Syndax.
Key developments include FDA Priority Review for Revuforj's sNDA in R/R mNPM1 AML with a PDUFA date of October 25, 2025. The company maintains a strong financial position with $517.9M in cash and expects to reach profitability with stable operating expenses. Clinical data showed promising results, including a 48% overall response rate in R/R mNPM1 AML patients.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on innovative cancer therapies, has scheduled its second quarter 2025 financial results announcement and business update for August 4, 2025.
The company will host a conference call and live audio webcast at 4:30 p.m. ET on the same day. Investors can access the event through the company's website or by dialing 800-590-8290 (domestic) or 240-690-8800 (international). A replay will be available on Syndax's website for 90 days after the call.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has granted inducement awards to 14 new employees. The awards consist of options to purchase up to 228,400 shares of common stock under the Company's 2023 Inducement Plan.
The stock options feature a four-year vesting schedule, with 25% vesting after one year and the remaining shares vesting monthly at a rate of 1/48th over the subsequent 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (NASDAQ:SNDX) announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to treat relapsed or refractory mutant NPM1 acute myeloid leukemia.
The FDA has set a PDUFA target action date of October 25, 2025. The sNDA is being reviewed under the FDA's Real-Time Oncology Review program. If approved, Revuforj would become the first and only menin inhibitor approved for both R/R mNPM1 AML and R/R KMT2Ar acute leukemia. The drug received initial FDA approval in 2024 for R/R acute leukemia with KMT2A translocation.
The sNDA submission is supported by positive pivotal data from the AUGMENT-101 trial, with results published in Blood and presented at the EHA Annual Congress Meeting.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on innovative cancer therapies, has announced its participation in two major upcoming investor conferences in June 2025. CEO Michael A. Metzger and the management team will engage in fireside chats at the Jefferies Global Healthcare Conference on June 5 at 1:25 p.m. ET and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11 at 2:00 p.m. ET. Both presentations will be available via live webcast on the company's website investor section, with replays accessible for a limited time.
For Revuforj: Updated results from the BEAT AML trial combining revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients, data from 77 patients with R/R mNPM1 AML in the AUGMENT-101 trial, and outcomes in patients with R/R NUP98r acute leukemias.
For Niktimvo: Data highlighting responses in different organs and subgroups of chronic GVHD patients from the AGAVE-201 trial. The company recently submitted a supplemental NDA for revumenib in R/R mNPM1 AML in April 2025.
Syndax Pharmaceuticals (NASDAQ: SNDX) has appointed Dr. Nicholas Botwood as Head of Research and Development and Chief Medical Officer. Dr. Botwood brings over 25 years of industry experience, most recently serving as Head of Worldwide Medical Oncology at Bristol Myers Squibb. He succeeds Dr. Neil Gallagher, who is departing the company.
Dr. Botwood's extensive background includes senior roles at BMS from 2015-2025, where he oversaw medical activities in oncology, including new asset launches and commercial strategy. Previously, he held leadership positions at AstraZeneca from 2003-2015. His appointment comes as Syndax continues to expand its oncology portfolio, including the recent submission of Revuforj supplemental New Drug Application for relapsed or refractory mNPM1 acute myeloid leukemia.