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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 company, announced its participation in three virtual investor conferences. The events include a fireside chat at the Morgan Stanley Global Healthcare Conference on September 9, 2021, a panel at the Citi BioPharma Virtual Conference on September 10, and another fireside chat at the Baird Global Healthcare Conference on September 14. Investors can access a live webcast of the first two events and find replays on the company's website. Syndax is developing innovative cancer therapies, including SNDX-5613 and axatilimab.
Syndax Pharmaceuticals (SNDX) reported Q2 2021 financial results, highlighting significant progress in their cancer therapy pipeline. As of June 30, 2021, the company had $253.1 million in cash and equivalents. Research and development expenses rose to $16.9 million, up from $10.9 million year-over-year. Syndax reported a net loss of $22.9 million, or $0.44 per share, compared to a loss of $17.1 million, or $0.42 per share, in Q2 2020. Looking ahead, the company expects R&D expenses to reach $25-$30 million in Q3.
Syndax Pharmaceuticals will release its second quarter 2021 financial results on August 9 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. The company is focused on developing cancer therapies, including SNDX-5613, axatilimab, and entinostat. Investors can access the live webcast and slides on the Syndax website.
Syndax Pharmaceuticals has announced that the FDA granted Fast Track Designation to its oral menin inhibitor, SNDX-5613, for treating relapsed or refractory acute leukemias with specific mutations. This designation aims to expedite the drug's development and review process, highlighting SNDX-5613's potential to improve patient outcomes in an area with high unmet medical need. Currently under evaluation in the AUGMENT-101 clinical trial, SNDX-5613 has shown preclinical promise with significant tumor growth inhibition.
Syndax Pharmaceuticals, Inc. (SNDX) announced its participation in the Goldman Sachs 42nd Annual Global Healthcare Conference scheduled for June 10, 2021, at 2:10 p.m. ET. Management will present details about the company’s innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. The live presentation will be accessible through the Investor section of Syndax's website, with a replay available for a limited time afterward.
Syndax Pharmaceuticals announced its participation in the Cowen 2nd Annual Virtual Oncology Innovation Summit on May 20, 2021, at 12:00 p.m. ET. The management team will present details about their innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. A live webcast of the presentation can be accessed through the Company's website, with a replay available for a limited time thereafter.
Syndax Pharmaceuticals (SNDX) reported its Q1 2021 financial results, highlighting positive interim Phase 1 data from the AUGMENT-101 trial for SNDX-5613 in treating acute leukemias, with a 23% complete response rate among patients. The company has identified a recommended Phase 2 dose and plans to initiate this pivotal trial soon. Additionally, Syndax completed enrollment of 23 patients in the Phase 2 expansion of axatilimab for chronic graft versus host disease (cGVHD), with updates expected later this year. The financial overview shows a net loss of $27.7 million and increased R&D expenses.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will release its first quarter 2021 financial results on May 11, 2021, after market close. Management will hold a conference call at 4:30 p.m. ET on the same day to discuss the results and provide business updates. Key pipeline products include SNDX-5613, axatilimab, and entinostat, focused on cancer therapies. Investors can access the call via the company's website or through designated dial-in numbers. A replay will also be available post-event.
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.
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