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 and Incyte announced a global collaboration to develop axatilimab, an anti-CSF-1R monoclonal antibody, focusing on chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Syndax will receive $117 million upfront and $35 million in equity investment, along with potential milestone payments of up to $450 million. The companies will share profits in the U.S. 50:50, with Syndax receiving double-digit royalties internationally. Ongoing trials for axatilimab aim to provide innovative treatments for patients with severe conditions, with topline data expected in 2023.
Syndax Pharmaceuticals has expanded its Board of Directors to nine members by appointing Dr. Martin H. Huber, M.D., effective immediately. Dr. Huber brings over 20 years of experience in drug development, currently serving as President of R&D at Xilio Therapeutics. The company's leadership expressed confidence in Dr. Huber's expertise, highlighting its potential to enhance Syndax's innovative cancer therapy pipeline, including drug candidates like SNDX-5613 and axatilimab. This strategic appointment aims to strengthen the company's ability to serve underserved cancer patients.
Syndax Pharmaceuticals, a clinical stage biopharmaceutical company, announced its participation in three virtual investor conferences. The events include a fireside chat at the Morgan Stanley Global Healthcare Conference on September 9, 2021, a panel at the Citi BioPharma Virtual Conference on September 10, and another fireside chat at the Baird Global Healthcare Conference on September 14. Investors can access a live webcast of the first two events and find replays on the company's website. Syndax is developing innovative cancer therapies, including SNDX-5613 and axatilimab.
Syndax Pharmaceuticals (SNDX) reported Q2 2021 financial results, highlighting significant progress in their cancer therapy pipeline. As of June 30, 2021, the company had $253.1 million in cash and equivalents. Research and development expenses rose to $16.9 million, up from $10.9 million year-over-year. Syndax reported a net loss of $22.9 million, or $0.44 per share, compared to a loss of $17.1 million, or $0.42 per share, in Q2 2020. Looking ahead, the company expects R&D expenses to reach $25-$30 million in Q3.
Syndax Pharmaceuticals will release its second quarter 2021 financial results on August 9 after U.S. market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. The company is focused on developing cancer therapies, including SNDX-5613, axatilimab, and entinostat. Investors can access the live webcast and slides on the Syndax website.
Syndax Pharmaceuticals has announced that the FDA granted Fast Track Designation to its oral menin inhibitor, SNDX-5613, for treating relapsed or refractory acute leukemias with specific mutations. This designation aims to expedite the drug's development and review process, highlighting SNDX-5613's potential to improve patient outcomes in an area with high unmet medical need. Currently under evaluation in the AUGMENT-101 clinical trial, SNDX-5613 has shown preclinical promise with significant tumor growth inhibition.
Syndax Pharmaceuticals, Inc. (SNDX) announced its participation in the Goldman Sachs 42nd Annual Global Healthcare Conference scheduled for June 10, 2021, at 2:10 p.m. ET. Management will present details about the company’s innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. The live presentation will be accessible through the Investor section of Syndax's website, with a replay available for a limited time afterward.
Syndax Pharmaceuticals announced its participation in the Cowen 2nd Annual Virtual Oncology Innovation Summit on May 20, 2021, at 12:00 p.m. ET. The management team will present details about their innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. A live webcast of the presentation can be accessed through the Company's website, with a replay available for a limited time thereafter.
Syndax Pharmaceuticals (SNDX) reported its Q1 2021 financial results, highlighting positive interim Phase 1 data from the AUGMENT-101 trial for SNDX-5613 in treating acute leukemias, with a 23% complete response rate among patients. The company has identified a recommended Phase 2 dose and plans to initiate this pivotal trial soon. Additionally, Syndax completed enrollment of 23 patients in the Phase 2 expansion of axatilimab for chronic graft versus host disease (cGVHD), with updates expected later this year. The financial overview shows a net loss of $27.7 million and increased R&D expenses.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will release its first quarter 2021 financial results on May 11, 2021, after market close. Management will hold a conference call at 4:30 p.m. ET on the same day to discuss the results and provide business updates. Key pipeline products include SNDX-5613, axatilimab, and entinostat, focused on cancer therapies. Investors can access the call via the company's website or through designated dial-in numbers. A replay will also be available post-event.