Welcome to our dedicated page for Syndax Pharmaceuticals news (Ticker: SNDX), a resource for investors and traders seeking the latest updates and insights on Syndax Pharmaceuticals stock.
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) is a commercial-stage biopharmaceutical company whose news flow centers on cancer drug development, regulatory milestones, and commercialization updates. The company’s announcements emphasize progress with its two FDA-approved therapies: Revuforj® (revumenib), an oral menin inhibitor for specific relapsed or refractory acute leukemias, and Niktimvo™ (axatilimab-csfr), a CSF-1 receptor-blocking antibody for chronic graft-versus-host disease after at least two prior systemic therapies.
News for SNDX often covers quarterly and annual financial results, product revenue trends for Revuforj and Niktimvo, and guidance on research and development as well as selling, general and administrative expenses. Investors can follow updates on clinical trial milestones, such as Phase 2 and Phase 3 studies of revumenib in newly diagnosed and relapsed or refractory NPM1-mutated and KMT2A-rearranged AML, and trials of axatilimab in chronic GVHD and idiopathic pulmonary fibrosis.
Press releases also highlight regulatory events, including FDA approvals and label expansions, inclusion of revumenib in clinical practice guidelines, and special designations such as Orphan Drug, Fast Track, and Breakthrough Therapy. Scientific and medical conference activity is another recurring theme, with multiple abstracts and oral presentations at meetings like the American Society of Hematology and appearances at investor conferences and healthcare forums.
In addition, Syndax issues news on collaborations and access initiatives, such as its agreement with the World Orphan Drug Alliance to launch a multi-regional Managed Access Program for Revuforj outside the United States. For investors and observers tracking SNDX, the news stream provides insight into commercial performance, pipeline evolution, partnership activity, and the company’s stated path toward profitability.
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.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on innovative cancer therapies, has announced its participation in two upcoming investor conferences in May 2025. CEO Michael A. Metzger and the management team will present at:
- The Bank of America Merrill Lynch Vegas Health Care Conference on May 15, 2025, at 12:20 p.m. ET
- The TD Cowen 6th Annual Oncology Innovation Summit on May 28, 2025, at 10:30 a.m. ET
Both presentations will be available via webcast on the company's website at www.syndax.com.
FAQ
What is the current stock price of Syndax Pharmaceuticals (SNDX)?
What is the market cap of Syndax Pharmaceuticals (SNDX)?
