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 has announced a leadership transition, with Michael A. Metzger becoming the new Chief Executive Officer and Briggs W. Morrison transitioning to President and Head of Research and Development, effective February 3, 2022. Both executives will remain on the Board of Directors. This change aims to better align their roles with their expertise as the company prepares for ongoing clinical trials and potential New Drug Applications for their product candidates, SNDX-5613 and axatilimab, expected in 2023.
Syndax Pharmaceuticals announced management will participate in a fireside chat at B. Riley Securities' 2022 Oncology Conference on January 27, 2022, at 12:00 p.m. ET. The event will be accessible via a live webcast on the Investor section of the Company's website, with a replay available for a limited time. Syndax is focused on developing innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat. For detailed information, visit www.syndax.com.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced that CEO Briggs W. Morrison will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 08:15 a.m. ET. The presentation will be available via live webcast on the Company’s Investor website, with replays accessible for a limited time. Syndax is a clinical stage biopharmaceutical company focusing on innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat.
Syndax Pharmaceuticals announced that the European Commission has granted Orphan Drug Designation to SNDX-5613, a selective oral menin inhibitor, for treating acute myeloid leukemia (AML). This designation supports SNDX-5613's role as a potential best-in-class treatment for patients with NPM1 and MLLr acute leukemias. The Orphan Drug Designation allows for benefits like ten years of market exclusivity and protocol assistance. SNDX-5613 is currently in the AUGMENT-101 Phase 1/2 clinical trial for relapsed/refractory acute leukemias, having also received Fast Track designation from the FDA.
Syndax Pharmaceuticals announced the closing of a public offering of 3,802,144 shares of common stock, including 645,000 shares from underwriters' options, and pre-funded warrants for 1,142,856 shares. The offering price was $17.50 per share, generating gross proceeds of approximately $86.5 million before expenses. The shares were offered under an effective SEC registration statement, with Goldman Sachs and Cowen serving as joint book-running managers. This capital raise is aimed at advancing Syndax's pipeline of cancer therapies, including SNDX-5613 and axatilimab.
Syndax Pharmaceuticals announced a public offering of 3,157,144 shares of common stock at $17.50 per share, with pre-funded warrants for 1,142,856 shares priced at $17.4999 each. The offering will raise approximately $75.3 million, before expenses, and is expected to close on December 20, 2021. The underwriters have a 30-day option to purchase an additional 645,000 shares. Goldman Sachs and Cowen are joint book-running managers for the offering, which is being conducted under a 'shelf' registration statement filed with the SEC.
Syndax Pharmaceuticals plans to offer and sell shares of its common stock through an underwritten public offering. The offering may include pre-funded warrants and a 30-day option for underwriters to purchase an additional 15% of the shares. Goldman Sachs is the book-running manager for this offering, which is conducted under an effective shelf registration statement with the SEC. The proceeds from the offering will be used to support the development of Syndax's innovative cancer therapies, including SNDX-5613 and axatilimab.
Syndax Pharmaceuticals announced updated data from the Phase 1 portion of the AUGMENT-101 trial for SNDX-5613, a selective oral menin inhibitor, focused on relapsed/refractory acute leukemias with NPM1 mutations or MLL rearrangements. The trial's positive results were presented at the ASH Annual Meeting on December 13, 2021. Key outcomes included a 55% overall response rate and a 31% MRD negative rate among evaluable patients. The FDA indicated that the ongoing Phase 2 trial may support regulatory filings for various leukemia indications, marking a significant step for the company's development strategy.
Syndax Pharmaceuticals reported encouraging results from its Phase 1/2 trial of axatilimab for chronic graft-versus-host disease (cGVHD) during the 63rd ASH Annual Meeting on December 11, 2021. Axatilimab, a monoclonal antibody targeting CSF-1R, showed a 68% overall response rate in patients with refractory cGVHD, and 53% reported meaningful symptom improvement. The drug was well-tolerated, with no significant adverse effects. Ongoing enrollment in the pivotal Phase 2 AGAVE-201 trial aims to further assess axatilimab’s efficacy, with topline data anticipated in 2023.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced the expiration of the Hart-Scott-Rodino antitrust waiting period, leading to the closure of its collaboration and license agreement with Incyte for the development of axatilimab, an anti-CSF-1R monoclonal antibody. Incyte paid Syndax $117 million as an upfront license fee and invested $35 million in equity. Axatilimab is being evaluated in the global Phase 2 AGAVE-201 trial, targeting chronic graft-versus-host disease, and has received Orphan Drug Designation from the FDA for both cGVHD and idiopathic pulmonary fibrosis.