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) will release its first quarter 2022 financial results on May 9, 2022, after U.S. market close. A conference call and audio webcast will follow at 4:30 p.m. ET to discuss the results and business updates. Interested parties can access the webcast on the company's website. Syndax's pipeline includes promising cancer therapies such as SNDX-5613, a Menin–MLL inhibitor, axatilimab, a CSF-1 receptor blocker, and entinostat, a class I HDAC inhibitor.
Syndax Pharmaceuticals announced an inducement award for its new Chief Medical Officer, Dr. Catherine Madigan, granting her the option to purchase 180,000 shares of common stock at an exercise price of $16.06, equal to the closing stock price on March 1, 2022. This option will vest over four years, with a quarter vesting after one year and the remainder vesting monthly after that. The award, approved by Syndax's Board of Directors, complies with NASDAQ Listing Rule 5635(c)(4). Syndax is developing a pipeline of innovative cancer therapies including SNDX-5613 and axatilimab.
Syndax Pharmaceuticals reported strong fourth-quarter results for 2021. The company recorded a net profit of $96.2 million, or $1.81 per share, compared to a loss of $20.4 million in the same period last year. License revenue surged to $126.6 million due to a collaboration with Incyte. Syndax outlined significant progress in its clinical pipeline, expecting topline data from pivotal trials in 2023. Cash and equivalents stood at $439.9 million, providing ample runway for ongoing research and development.
Syndax Pharmaceuticals (SNDX) appointed Kate Madigan, M.D., as Chief Medical Officer, effective immediately. Dr. Madigan brings over 20 years of clinical hematology expertise and will lead the clinical development strategy at Syndax. She succeeds Michael Meyers, M.D., Ph.D., who will transition to a consulting role. Under her leadership, Syndax expects to advance its pipeline, which includes SNDX-5613 and axatilimab, with pivotal FDA filings anticipated next year, positioning the company to impact underserved cancer treatment areas.
Syndax Pharmaceuticals announced participation in two investor conferences: a panel at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 10:30 a.m. ET, and a presentation at the Barclays Global Healthcare Conference on March 16, 2022, at 3:50 p.m. ET. Both events will be available via live webcast on www.syndax.com, along with replays. Syndax is advancing an innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. These events aim to engage investors and communicate the company’s progress in developing cancer treatments.
Soligenix, a late-stage biopharmaceutical company focused on rare diseases, will present at the BIO CEO & Investor Conference from February 14-17, 2022. The presentation, available on-demand from February 11, will be led by CEO Christopher J. Schaber, PhD. Attendees can also schedule one-on-one meetings with management during the conference. Soligenix is advancing potential treatments like HyBryte™ for cutaneous T-cell lymphoma and RiVax® for ricin toxin exposure. For more details, visit the conference website.
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.