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 promising results from the Phase 1 portion of the AUGMENT-101 trial for SNDX-5613, an oral menin inhibitor targeting MLLr and NPM1c mutant acute leukemias. With a 48% overall response rate among 31 evaluable patients, 67% achieved minimal residual disease negative status. The company identified a recommended Phase 2 dose of 226 mg every 12 hours. The drug was well-tolerated, with no discontinuations due to treatment-related adverse events. The pivotal Phase 2 trial is anticipated to start by Q2 2021.
Syndax Pharmaceuticals will host a conference call on April 20, 2021, at 8:00 a.m. ET to share updated data from the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613. This trial focuses on patients with relapsed or refractory acute leukemias, utilizing SNDX-5613, a selective oral menin inhibitor. The call will feature insights from Dr. Eytan M. Stein from Memorial Sloan Kettering Cancer Center, highlighting the progress in cancer treatment research. The event will be available via live webcast on the Syndax website.
Syndax Pharmaceuticals announced the FDA granted Orphan Drug Designation to axatilimab for idiopathic pulmonary fibrosis (IPF), a severe lung disease affecting about 150,000 patients in the U.S. This designation supports axatilimab's development as a potential treatment for this underserved patient population. The drug targets the CSF-1 receptor, showing promise in clinical trials for conditions like chronic graft versus host disease (cGVHD). Orphan Drug Designation offers incentives like tax credits, fee waivers, and seven years of market exclusivity upon FDA approval.
Syndax Pharmaceuticals has received Orphan Drug Designation from the FDA for axatilimab, designed to treat chronic graft versus host disease (cGVHD). This designation highlights the drug's potential, promising various incentives like tax credits and market exclusivity upon approval. The Phase 2 AGAVE-201 trial is currently ongoing with topline results expected in 2023. Axatilimab is positioned to address unmet needs in cGVHD, affecting approximately 14,000 patients in the U.S., and has previously shown durable responses in early trials.
Syndax Pharmaceuticals announced its Q4 2020 financial results and provided a pipeline update. As of December 31, 2020, the company held $293.1 million in cash and reported a net loss of $20.4 million ($0.44 per share) for the quarter. Research and development expenses for the quarter rose to $15.5 million from $9.5 million, driven by increased clinical activities. The company expects R&D expenses to reach $90 to $100 million in 2021. Key milestones include the Phase 1 data presentation for SNDX-5613 and the initiation of the pivotal Phase 2 AGAVE-201 trial for axatilimab.
Syndax Pharmaceuticals (SNDX) will release its fourth quarter and year-end 2020 financial results on March 8, after U.S. market close. A conference call will follow at 4:30 p.m. ET for a discussion of the results and a business update. Investors can access the live audio webcast via the company's website. The company is known for its innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat.
Syndax Pharmaceuticals, a clinical stage biopharmaceutical firm, will participate in two virtual investor conferences. The first event is a panel at the Cowen 41st Annual Health Care Conference on March 3, 2021, at 11:40 a.m. ET. The second event is a fireside chat at the Barclays Global Healthcare Conference on March 9, 2021, at 3:35 p.m. ET. Interested parties can access a live webcast of the Barclays presentation through the Company's website, where a replay will also be available. Syndax is developing innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat.
Syndax Pharmaceuticals, Inc. (SNDX) has been selected for addition to the NASDAQ Biotechnology Index, effective before market open on December 21, 2020. The NASDAQ Biotechnology Index tracks securities classified as biotechnology or pharmaceutical companies, with specific eligibility criteria such as market capitalization and average daily trading volume. Syndax develops an innovative pipeline of cancer therapies including SNDX-5613, axatilimab, and entinostat.
Syndax Pharmaceuticals announced the closing of its public offering of 6,250,000 shares of common stock at $23.00 each, raising approximately $143.8 million in gross proceeds. This includes the full exercise of the underwriters' option for an additional 815,217 shares. The offering was facilitated by Goldman Sachs, Citigroup, and Cowen, among others, under a previously effective shelf registration statement. The proceeds will support the company's innovative cancer therapy pipeline, which includes candidates like SNDX-5613 and entinostat.
Syndax Pharmaceuticals announced the pricing of an underwritten public offering of 5,434,783 shares of common stock at $23.00 per share, projected to raise approximately $125 million before expenses. The offering is expected to close on December 11, 2020, pending customary closing conditions. Underwriters also have a 30-day option to purchase an additional 815,217 shares. The shares are offered under an effective SEC registration statement. Syndax develops innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat.