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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), a clinical-stage biopharmaceutical company, announced the grant of inducement awards to eight new employees. These awards, totaling options to purchase up to 124,000 shares of common stock, were granted under the Company's 2023 Inducement Plan on July 1, 2024. According to the vesting schedule, 25% of the shares will vest after one year, with the remaining shares vesting monthly over the next 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals announced updated positive data from two combination trials of revumenib in patients with acute leukemias at the EHA 2024 Congress.
In the BEAT AML trial, a 96% composite complete remission (CRc) rate was observed in newly diagnosed AML patients treated with revumenib in combination with venetoclax and azacitidine. The AUGMENT-102 trial showed a 52% CRc rate in relapsed/refractory acute leukemia patients treated with revumenib and fludarabine-cytarabine.
Both trials demonstrated strong efficacy and an acceptable safety profile. No new safety signals were observed, and most adverse events were manageable. These results support revumenib's potential as a promising treatment in various settings of acute leukemia, and further trials are planned.
Syndax Pharmaceuticals announced the advancement into Phase 1b of its Phase 1/2 trial of revumenib for relapsed or refractory metastatic MSS colorectal cancer (CRC). This decision follows a favorable safety profile observed in Phase 1a, as reviewed by the Independent Data Monitoring Committee (IDMC). In Phase 1a, 19 patients were treated across three dose levels, with revumenib being well-tolerated and no Grade 3 or higher treatment-related adverse events reported. Preliminary efficacy showed that 33% of patients had stable disease at 16 weeks. The trial will proceed with a 276 mg TID dosage in Phase 1b.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. CEO Michael A. Metzger will join a fireside chat on June 12, 2024, at 8:40 a.m. ET. The event will be webcast live on the company's website, with a replay available for a time.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company, announced on June 3, 2024, that it granted inducement awards to purchase up to 499,200 shares of common stock to fifty-three new employees. These awards were given under the Company's 2023 Inducement Plan on June 1, 2024. The stock options will vest over four years, with 25% vesting on the one-year anniversary of the vesting commencement date and the remaining shares vesting monthly thereafter over 36 months. The vesting is contingent upon the employee's continued service with Syndax.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company focused on cancer therapies, has appointed Aleksandra Rizo, M.D., Ph.D., to its Board of Directors effective May 15, 2024. Dr. Rizo, who has extensive experience in clinical development and commercialization of hematology drugs, will replace Dr. Briggs Morrison. Dr. Rizo currently serves as President and CEO of Vividion and has previously held leadership roles at Geron and Celgene Syndax is transitioning to a commercial-stage organization with the potential launch of two new treatments, Revumenib and Axatilimab, in 2024. Dr. Rizo will contribute her expertise as Syndax aims for long-term success in clinical and corporate development.
Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will participate in a fireside chat at the Bank of America Securities 2024 Health Care Conference on May 16, 2024. The event will be live webcasted on the company's website, with a replay available for a time.
Syndax Pharmaceuticals reported its first-quarter financial results for 2024, highlighting the NDA filing for revumenib and BLA filing for axatilimab with Priority Reviews. The Company anticipates significant milestones with pivotal data from the AUGMENT-101 trial and potential approvals in the third quarter. The CEO emphasized the value-creating potential of launching innovative therapies into multi-billion-dollar markets. Syndax continues to focus on building a strong team for successful commercialization.
Syndax Pharmaceuticals granted inducement awards to six new employees to purchase up to 100,600 shares of common stock under the 2023 Inducement Plan. The stock options will vest over four years, with gradual vesting conditions tied to the employees' continued service relationship.
Syndax Pharmaceuticals (Nasdaq: SNDX) will announce its first quarter 2024 financial results and provide a business update on May 8, 2024. The company will host a conference call and webcast to discuss the financial results and business progress.
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