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 cancer therapies, has announced inducement grants under NASDAQ Listing Rule 5635(c)(4). The company granted stock options to purchase up to 50,000 shares of common stock to four new employees under its 2023 Inducement Plan.
The stock options feature a four-year vesting schedule, with 25% of shares vesting after the first year and the remaining shares vesting monthly at 1/48th over the subsequent 36 months. Continued employment with Syndax is required through applicable vesting dates.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has announced its upcoming participation in the Stifel 2025 Virtual Targeted Oncology Forum. CEO Michael A. Metzger and other management team members will engage in a fireside chat scheduled for Wednesday, April 9, 2025, at 10:30 a.m. ET. The event will be accessible via live webcast through the company's website investor section, with a replay option available for a time.
Syndax Pharmaceuticals (NASDAQ: SNDX) has announced the granting of inducement awards under its 2023 Inducement Plan. The company, which focuses on developing cancer therapies, issued stock options to purchase up to 282,000 shares of common stock to 12 new employees on March 1, 2025.
The stock options feature a four-year vesting schedule, with 25% of shares vesting after the first year, followed by monthly vesting of 1/48th of the underlying shares over the subsequent 36 months. Continued employment with Syndax is required through the applicable vesting dates.
Syndax Pharmaceuticals (SNDX) reported Q4 and full year 2024 results, highlighting strong initial performance of two newly launched products. Revuforj generated $7.7 million in net product revenue in its first five weeks of launch, while Niktimvo was launched in partnership with Incyte in late January 2025.
The company reported Q4 2024 financial results with a net loss of $94.2 million ($1.10 per share). R&D expenses increased to $65.5 million, while SG&A expenses rose to $37.7 million. For full year 2024, net loss was $318.8 million ($3.72 per share).
Key developments include positive pivotal data from AUGMENT-101 trial, with plans to submit sNDA for Revuforj in R/R mNPM1 AML in Q2 2025. The company maintains a strong financial position with $692.4 million in cash and investments, which is expected to fund operations until profitability.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company focused on developing cancer therapies, has announced its participation in two major investor conferences in March 2025. The company's CEO Michael A. Metzger and management team members will attend the TD Cowen 45th Annual Health Care Conference in Boston on March 4, featuring a fireside chat at 3:10 p.m. ET, and the Barclays 27th Annual Global Healthcare Conference in Miami Beach on March 13, with a fireside chat scheduled for 8:30 a.m. ET.
Live webcasts of both presentations will be available on Syndax's website in the Investor section at www.syndax.com, where replays will also be accessible for a time.
Syndax Pharmaceuticals (SNDX) has scheduled its fourth quarter and full year 2024 financial results announcement and business update for Monday, March 3, 2025. The company will host a conference call and live audio webcast at 8:00 a.m. ET on the same day.
Investors and interested parties can access the webcast through the Events & Presentations page in the Investors section of Syndax's website. Alternative access is available via phone using the conference ID: Syndax4Q24, with domestic dial-in number 800-590-8290 and international dial-in number 240-690-8800.
A replay of the conference call will be available on the company's website approximately 24 hours after the event and will remain accessible for 90 days.
Syndax Pharmaceuticals (SNDX) has announced the granting of inducement awards under its 2023 Inducement Plan. The company granted stock options to purchase up to 124,000 shares of common stock to six new employees on February 1, 2025. These stock options follow a four-year vesting schedule, with 25% of shares vesting after the first year, followed by monthly vesting of 1/48th of the underlying shares over the subsequent 36 months. The vesting is contingent upon continued employment with Syndax.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has announced its participation in two upcoming investor conferences in February 2025. CEO Michael A. Metzger and the management team will attend:
1. The Guggenheim SMID Cap Biotech Conference in New York, featuring a fireside chat on February 6, 2025, at 10:30 a.m. ET
2. Citi's 2025 Virtual Oncology Leadership Summit, with a fireside chat scheduled for February 19, 2025, at 9:00 a.m. ET
Both presentations will be available via webcast on the company's website investor section, with replays accessible for a time.
Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes, with U.S. launch expected in early February. Niktimvo is the first FDA-approved treatment targeting CSF-1R for chronic graft-versus-host disease (GVHD) in patients who failed at least two prior systemic therapies.
The approval was based on the AGAVE-201 trial results, where 75% of patients receiving 0.3 mg/kg every two weeks achieved response at six months. The approved dose is 0.3 mg/kg (max 35 mg) via intravenous infusion every two weeks for patients weighing at least 40 kg.
Notable adverse reactions occurred in 44% of patients, with 10% discontinuing treatment. The most common side effects included increased AST, infections, and decreased phosphate levels. The treatment has been added to NCCN Guidelines as a category 2A recommendation.
Syndax Pharmaceuticals (SNDX) highlighted its achievements and 2025 milestones, featuring two major FDA approvals in 2024: Revuforj® for R/R acute leukemia with KMT2A translocation and Niktimvo™ for chronic GVHD treatment. Both drugs were added to NCCN Clinical Practice Guidelines.
Key developments include positive results from the AUGMENT-101 trial for Revuforj, with plans to submit an sNDA for R/R mNPM1 AML in 1H25. The company secured a $350 million royalty funding agreement with Royalty Pharma for Niktimvo's U.S. sales.
2025 milestones include launching Niktimvo in Q1, maximizing Revuforj adoption, and initiating multiple frontline trials. The company expects its current financial position to support operations through profitability.