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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, 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.
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.
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