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 plans to offer shares of its common stock in an underwritten public offering, subject to market conditions. The offering includes a potential 30-day option for underwriters to purchase an additional 15% of shares. Goldman Sachs, Citigroup, and Cowen are the joint book-running managers, with BTIG as the lead manager. This public offering is part of a "shelf" registration statement previously approved by the SEC. There is no guarantee regarding the completion, size, or terms of the offering.
Syndax Pharmaceuticals (SNDX) announced promising results from its Phase 1 trial of axatilimab, an anti-CSF-1R monoclonal antibody for chronic graft versus host disease (cGVHD). Findings will be presented at the ASH Annual Meeting. The trial included 15 patients, with approximately 60% showing responses despite previous therapies. Axatilimab demonstrated durable efficacy across multiple organs, and 67% of patients achieved meaningful symptom improvements. Syndax plans to initiate the pivotal AGAVE-201 trial by year-end 2020, aiming for topline data in 2023.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced a conference call on December 6, 2020, at 2:00 p.m. E.T. to discuss axatilimab, its monoclonal antibody for chronic graft versus host disease (cGVHD). This event follows an oral presentation of updated Phase 1 trial data at the ASH Annual Meeting. Featuring experts Mukta Arora and Geoffrey Hill, the call will cover the ASH presentation summary and case studies, exploring axatilimab's role in cGVHD treatment.
Details for the call and webcast are available on Syndax's website.
Syndax Pharmaceuticals (Nasdaq: SNDX) will present at the Stifel 2020 Virtual Healthcare Conference on November 18, 2020, at 1:20 p.m. ET. CEO Briggs W. Morrison will discuss the company's innovative cancer therapies pipeline, which includes SNDX-5613, axatilimab, and entinostat. A live webcast of the presentation can be accessed through the Investor section of Syndax's website, where a replay will also be available.
Syndax Pharmaceuticals announced updated data from its Phase 1 trial of axatilimab for chronic graft versus host disease (cGVHD). During an oral presentation at the 62nd American Society of Hematology Annual Meeting on December 6, 2020, findings revealed objective responses in 7 of 12 patients with refractory disease. The treatment demonstrated a strong safety profile, with no severe adverse events. Syndax plans to initiate a pivotal trial for axatilimab by the end of 2020, furthering its commitment to address the unmet needs in cGVHD.
Syndax Pharmaceuticals (SNDX) reported its Q3 2020 financial results, highlighting progress in its cancer therapy pipeline. The company is advancing the Phase 1 AUGMENT-101 trial for SNDX-5613, showing promising initial results in patients with MLL-r and NPM1 mutant acute leukemias. Additionally, after discussions with the FDA, Syndax plans to initiate a pivotal trial for axatilimab by year's end, targeting chronic graft versus host disease (cGVHD). Financially, Syndax reported a net loss of $20.4 million, with cash reserves of $170.2 million as of September 30, 2020.
Syndax Pharmaceuticals announced it will release its third quarter 2020 financial results on November 2, 2020, 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. Investors can access the live event via the company's website. Syndax develops innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat, aiming to improve treatment options. For more details, visit www.syndax.com.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced participation in three upcoming virtual investor conferences. The events include the Citi 15th Annual BioPharma Virtual Conference on September 9, 2020, a panel at 11:40 a.m. ET, the Baird 2020 Virtual Global Healthcare Conference on September 10, 2020, with a fireside chat at 4:20 p.m. ET, and the Morgan Stanley 18th Annual Global Virtual Healthcare Conference on September 14, 2020, with a fireside chat at 2:15 p.m. ET. Live webcasts will be available on the company’s website, with a replay following the events.
Syndax Pharmaceuticals (SNDX) reported its Q2 2020 financial results, revealing a net loss of $17.1 million, or $0.42 per share, compared to $14.9 million, or $0.47 per share, in Q2 2019. The company is focused on advancing its pipeline, particularly SNDX-5613, for which the FDA approved key changes to its AUGMENT-101 trial, now targeting pediatric and specific leukemia patients. Research and development expenses decreased to $10.9 million in Q2 2020. Syndax projects operating expenses of $40 to $45 million for the second half of 2020, emphasizing continuous commitment to improving cancer treatments.
Syndax Pharmaceuticals (Nasdaq:SNDX) announced participation in the BTIG Biotechnology Conference on August 10, 2020, at 12:00 p.m. ET. The company's management team will engage in a virtual fireside chat, and a live webcast will be available on its investor website, with a replay accessible temporarily. Syndax is focused on developing innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat. For further details, visit www.syndax.com.