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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 (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.
Syndax Pharmaceuticals announced it will release its third quarter 2020 financial results on November 2, 2020, after U.S. market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. Investors can access the live event via the company's website. Syndax develops innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat, aiming to improve treatment options. For more details, visit www.syndax.com.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced participation in three upcoming virtual investor conferences. The events include the Citi 15th Annual BioPharma Virtual Conference on September 9, 2020, a panel at 11:40 a.m. ET, the Baird 2020 Virtual Global Healthcare Conference on September 10, 2020, with a fireside chat at 4:20 p.m. ET, and the Morgan Stanley 18th Annual Global Virtual Healthcare Conference on September 14, 2020, with a fireside chat at 2:15 p.m. ET. Live webcasts will be available on the company’s website, with a replay following the events.
Syndax Pharmaceuticals (SNDX) reported its Q2 2020 financial results, revealing a net loss of $17.1 million, or $0.42 per share, compared to $14.9 million, or $0.47 per share, in Q2 2019. The company is focused on advancing its pipeline, particularly SNDX-5613, for which the FDA approved key changes to its AUGMENT-101 trial, now targeting pediatric and specific leukemia patients. Research and development expenses decreased to $10.9 million in Q2 2020. Syndax projects operating expenses of $40 to $45 million for the second half of 2020, emphasizing continuous commitment to improving cancer treatments.
Syndax Pharmaceuticals (Nasdaq:SNDX) announced participation in the BTIG Biotechnology Conference on August 10, 2020, at 12:00 p.m. ET. The company's management team will engage in a virtual fireside chat, and a live webcast will be available on its investor website, with a replay accessible temporarily. Syndax is focused on developing innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat. For further details, visit www.syndax.com.
Syndax Pharmaceuticals will release its Q2 2020 financial results on August 6, 2020, after U.S. market close. The management team will hold a conference call and live audio webcast at 4:30 p.m. ET on the same day to discuss the results and provide a business update. Investors can access the webcast on the company's website. Syndax is developing a pipeline of cancer therapies, including drug candidates SNDX-5613, axatilimab, and entinostat.
Syndax Pharmaceuticals has appointed Daphne Karydas as Chief Financial Officer, effective July 13, 2020. Karydas has nearly 20 years of experience in the biopharmaceutical sector, serving most recently at Allergan. She replaces Richard P. Shea, who is retiring. CEO Briggs W. Morrison expressed confidence in Karydas’ ability to drive long-term growth as the company advances key drug programs, including SNDX-5613 and axatilimab, with critical readouts expected in Q4 2020. Karydas aims to leverage her expertise to improve patient outcomes in cancer care.
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