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Syndax Pharmaceuticals, Inc. (symbol: SNDX) is a clinical-stage biopharmaceutical company headquartered in Waltham, Massachusetts. Dedicated to the development of combination therapies, the company primarily focuses on innovative treatments for various cancer indications.
Syndax's pipeline is rich with promising drugs aimed at improving the lives of cancer patients. The company's leading candidates include entinostat, an agent that targets both cancer cells and immune regulatory cells, and revumenib, a selective inhibitor of the menin-KMT2A binding interaction. This agent is particularly geared towards addressing acute leukemias such as KMT2A-rearranged (KMT2Ar) and NPM1-mutant acute myeloid leukemia (AML). Another notable product in development is axatilimab, a monoclonal antibody designed to enhance the immune response against tumors through CSF-1R inhibition.
Syndax operates primarily within the United States and has achieved several milestones. Recently, the company completed enrollment in the pivotal AUGMENT-101 trial for revumenib targeting relapsed/refractory mutant nucleophosmin (mNPM1) AML. The trial aims to evaluate revumenib's safety, tolerability, and efficacy, with topline data expected by the end of 2024. Positive results from this trial could support new drug applications in early 2025.
Revumenib has achieved several regulatory designations, including Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA, reflecting its potential to address unmet clinical needs in leukemias. Syndax has also reported encouraging outcomes from its studies, including high response rates and favorable safety profiles in both adult and pediatric populations suffering from acute leukemia.
Financially, Syndax maintains a robust position to advance its clinical programs. The company regularly updates stakeholders through earnings calls and investor presentations, with a recent update scheduled for May 2024. Syndax's progress is further bolstered by strategic partnerships and collaborations that support its mission to innovate and deliver significant value to patients and shareholders alike.
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.
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.
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