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) reported Q3 2022 financial results and business updates. The Phase 1 AUGMENT-101 trial of revumenib showed a 30% complete response rate and a median response duration of 9.1 months. Enrollment is complete for the AGAVE-201 trial of axatilimab for chronic graft versus host disease (cGVHD). The company is on track for two U.S. regulatory filings by year-end 2023. Financials show a Q3 net loss of $35.4 million, an increase from $20.6 million in the prior year, but reduced R&D guidance to $115-$125 million reflects cost-saving measures.
Syndax Pharmaceuticals (SNDX) announced positive interim results from the Phase 1 portion of the AUGMENT-101 trial for revumenib in patients with relapsed/refractory acute leukemias featuring NPM1 or MLLr mutations. The trial demonstrated a 53% overall response rate and a 30% complete response (CR/CRh) rate, with a median response duration of 9.1 months. Notably, 9 out of 12 patients who underwent stem cell transplants post-treatment remained in remission. Updated data will be presented at the 64th ASH Annual Meeting, with top-line data for a pivotal trial expected in Q3 2023.
Syndax Pharmaceuticals (SNDX) will release its Q3 2022 financial results on November 3 after market close. Management will host a conference call and live audio webcast at 4:30 p.m. ET on the same day to discuss the results and company updates. The Q3 earnings call will be accessible through the company's website. Syndax is focused on innovative cancer therapies, with key assets like revumenib and axatilimab in pivotal trials. Further information can be found on their website.
Syndax Pharmaceuticals (SNDX) reported its Q2 2022 financial results, revealing a net loss of $37.6 million, or $0.62 per share, compared to a loss of $22.9 million, or $0.44 per share, in the previous year. The company has $378.9 million in cash and equivalents as of June 30, 2022. Key developments include the ongoing pivotal trials for revumenib and axatilimab, with topline data expected in the first half of 2023. R&D expenses surged to $29.7 million, attributed to clinical activities for both compounds.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will report its second quarter 2022 financial results on August 8, after U.S. market close. A subsequent conference call is scheduled for 4:30 p.m. ET to discuss the results and provide updates. The live audio webcast will be accessible on Syndax's website. Key pipeline highlights include revumenib (SNDX-5613) and axatilimab, both in pivotal trials. Replays will be available post-call for 90 days.
Syndax Pharmaceuticals announced the hiring of Chief Financial Officer Keith A. Goldan, who received an inducement award to purchase 230,000 shares at an exercise price of $15.60. This stock option will vest over four years, with 25% vesting after the first year and the remainder vesting monthly. The award was approved in compliance with NASDAQ Listing Rule 5635(c)(4). Syndax is focused on developing innovative cancer therapies, including revumenib and axatilimab, which are currently in pivotal trials.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the appointment of Keith A. Goldan as Chief Financial Officer. Goldan, with nearly 30 years of experience in the pharmaceutical sector, previously served as CFO at Optinose, assisting in the launch of XHANCE. CEO Michael A. Metzger emphasized Goldan's expertise as crucial for the company's growth. The press release also highlighted upcoming pivotal readouts for revumenib and axatilimab, both targeting significant cancer treatment needs. Additionally, Sharon Klahre was appointed Vice President of Investor Relations.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced participation in two investor conferences. Management will engage in a virtual fireside chat at Cowen's 3rd Annual Oncology Innovation Summit on June 2, 2022, at 12:30 p.m. ET. Additionally, they will partake in a fireside chat at Goldman Sachs' 43rd Annual Global Healthcare Conference on June 14, 2022, at 6:20 p.m. ET in Rancho Palos Verdes, CA. Live webcasts of both events will be accessible on their website, along with a limited-time replay.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical firm focused on cancer therapies, announced CEO Michael A. Metzger's participation in a targeted oncology panel at Citi's Biopharma Virtual Co-Panel Day on May 18, 2022, at 1:30 p.m. ET. The event will highlight the company's innovative drug pipeline, including revumenib and axatilimab, which are currently in pivotal trials. A live webcast of the panel will be available on their website, along with a replay for limited access.
Syndax Pharmaceuticals (SNDX) reported its Q1 2022 financial results, revealing a net loss of $37.2 million or $0.63 per share, up from a loss of $27.7 million or $0.54 per share in Q1 2021. Research and development expenses rose to $30 million from $21.9 million due to increased clinical activities. The company is advancing its pivotal trials for revumenib (SNDX-5613) and axatilimab, with topline data expected in 1H23 and two FDA filings planned for 2023. As of March 31, 2022, Syndax had $397.9 million in cash and equivalents.