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 (SNDX) announced new data from secondary analysis of the AGAVE-201 trial for Niktimvo™ (axatilimab-csfr) in chronic graft-versus-host disease to be presented at the ASH Annual Meeting. The pivotal trial met its primary endpoint with a 75% overall response rate at the approved dose of 0.3 mg/kg. More than half of responders showed clinical response by day 56, with an estimated 60% maintaining response at 12 months. Organ-specific responses ranged from 1.2 to 3.7 months, with GI tract, liver, and joints responding faster than lung, mouth, eye, and skin manifestations.
Syndax Pharmaceuticals (SNDX) presented positive data for revumenib, their oral menin inhibitor, at the ASH Annual Meeting. Key highlights include:
- 64% Overall Response Rate (62/97) in patients with R/R KMT2Ar acute leukemia in Phase 2 AUGMENT-101 pivotal cohort
- 88% Overall Response Rate (23/26) in SAVE trial testing revumenib combination therapy in R/R AML
The FDA has granted Priority Review for revumenib's New Drug Application with a PDUFA date of December 26, 2024. The company also completed enrollment for the final AUGMENT-101 pivotal trial cohort in R/R mNPM1 AML patients, with topline data expected in Q4 2024.
Syndax Pharmaceuticals (SNDX) has secured a $350 million synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo™. Under the agreement, Syndax will provide a 13.8% royalty on U.S. net sales until reaching a 2.35x multiple. The funding is expected to support the upcoming product launches and development of Niktimvo and revumenib, with proforma cash approaching $800 million as of June 30. The deal aims to fund Syndax through profitability while maintaining participation in Niktimvo's profits and future growth potential. Niktimvo is positioned as a first-in-class treatment for chronic graft-versus-host disease (GVHD).
Syndax Pharmaceuticals (Nasdaq: SNDX) announced the granting of inducement awards to four new employees on November 1, 2024. The awards consist of stock options to purchase up to 78,700 shares of common stock under the Company's 2023 Inducement Plan. The options will vest over four years, with 25% vesting after one year and the remaining vesting monthly over the following 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (SNDX) announced its participation in four major healthcare investor conferences in November 2024. The company's CEO Michael A. Metzger and management team will attend: Guggenheim's Inaugural Healthcare Innovation Conference in Boston (Nov 13), UBS Global Healthcare Conference in Ranchos Palos Verdes (Nov 14), Stifel 2024 Healthcare Conference in New York (Nov 18), and Jefferies London Healthcare Conference (Nov 20-21). Live webcasts of the fireside chats will be available on the company's website.
Syndax Pharmaceuticals (SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, has scheduled its third quarter 2024 financial results announcement and business update for November 5, 2024. The company will host a conference call and live audio webcast at 4:30 p.m. ET on the same day. Management will discuss financial results and provide business updates during the call, which will be accessible via phone or webcast. A replay will be available on the company's website for 90 days following the call.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, has announced the granting of inducement awards under its 2023 Inducement Plan. On October 1, 2024, the company granted stock options to five new employees, allowing them to purchase up to 62,700 shares of common stock.
The stock options have a four-year vesting schedule. Specifically, 25% of the underlying shares will vest on the one-year anniversary of the vesting commencement date. Following that, 1/48th of the underlying shares will vest monthly over the next 36 months. These vesting terms are subject to the employee's continued service relationship with Syndax throughout the applicable vesting dates.
Incyte and Syndax Pharmaceuticals announced the publication of pivotal Phase 2 AGAVE-201 trial results for Niktimvo™ (axatilimab-csfr) in The New England Journal of Medicine. The trial met its primary endpoint across all dose cohorts, with 74% of patients achieving a complete or partial response within the first six months of treatment at the 0.3 mg/kg every 2 weeks dose. Niktimvo has been approved by the U.S. FDA for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. It has also been added to the latest NCCN Guidelines® for chronic GVHD treatment. The drug showed rapid, durable responses in all organs studied and patient subgroups, with 60% of patients reporting clinically meaningful symptom burden reduction.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, has announced the granting of an inducement award under its 2023 Inducement Plan. On September 1, 2024, the company granted stock options to purchase up to 60,000 shares of common stock to a new employee. The stock options have a four-year vesting schedule, with 25% of the shares vesting after one year and the remaining shares vesting monthly over the subsequent 36 months. This vesting is contingent on the employee's continued service with Syndax.
Foundation Medicine has partnered with Syndax Pharmaceuticals to develop a companion diagnostic for identifying acute myeloid leukemia (AML) patients with NPM1 mutations. This collaboration aims to support regulatory approval for an assay based on the FoundationOne®Heme platform. NPM1 mutations occur in about 30% of newly diagnosed AML cases, with no currently approved targeted treatments. The partnership focuses on advancing Syndax's menin inhibitor, revumenib, as a potential targeted therapy for NPM1-mutated AML.
If approved, this assay could become the first next-generation sequencing companion diagnostic for detecting genomic alterations in hematologic neoplasms. Foundation Medicine, a leader in companion diagnostic approvals, sees this collaboration as a critical step in expanding precision medicine options for blood cancer patients.