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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, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company focused on cancer therapies, announced an inducement stock option grant for its new President, Dr. Neil Gallagher. Effective April 10, 2023, Dr. Gallagher received an award to purchase 250,000 shares at an exercise price of $19.35, the closing stock price on that date. The stock options will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent on Dr. Gallagher's continued employment. This grant was approved by Syndax's Board of Directors in accordance with NASDAQ Listing Rule 5635(c)(4). Syndax's innovative pipeline includes drugs like revumenib and axatilimab, which are in pivotal trials. Further details can be found on their official website.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a biopharmaceutical company focused on cancer therapies, announced on April 3, 2023, the granting of inducement awards to six new employees under its 2023 Inducement Plan. These awards total 121,100 shares of common stock, with an exercise price set at $20.91 per share, reflecting the closing stock price on that date. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent upon the employees’ continued service. Syndax's notable pipeline includes revumenib and axatilimab, both currently in pivotal trials.
Syndax Pharmaceuticals (Nasdaq: SNDX) has appointed Neil Gallagher, M.D., Ph.D., as President and Head of Research and Development, effective April 10, 2023. With over 20 years in oncology drug development, including roles at AbbVie and Novartis, Gallagher aims to enhance the company’s pipeline, notably revumenib and axatilimab, both in pivotal trials. CEO Michael A. Metzger praised Gallagher's experience, particularly in securing drug approvals. The transition follows the prior president's shift to the Board of Directors, indicating a strategy for growth and innovation in targeted oncology.
Syndax Pharmaceuticals (SNDX) announced the publication of Phase 1 data from its AUGMENT-101 trial of revumenib for treating nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2Ar) relapsed/refractory acute leukemia in Nature. The study involved 68 patients, with 60 evaluable for efficacy. Results showed a 53% overall response rate (32/60) and 30% CR/CRh (18/60). Revumenib was well-tolerated, with no treatment-related discontinuations. The company anticipates topline data from the pivotal trial by Q3 2023 and plans to file a New Drug Application by year-end, potentially positioning revumenib as the first approved menin inhibitor.
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) announced on March 6, 2023, the granting of stock options for 15,200 shares to a new employee under their 2023 Inducement Plan. The options have an exercise price of $24.86, closing on March 1, 2023. The vesting schedule includes 25% vesting on the one-year anniversary, with the remaining shares vesting monthly over three years, contingent upon continued employment. Syndax focuses on developing cancer therapies including innovative drugs like revumenib and axatilimab, which are currently in pivotal trials.
Syndax Pharmaceuticals reported significant advancements in its clinical trials and a financial update for Q4 and full-year 2022. Key highlights include anticipated topline data from the AUGMENT-101 trial for revumenib expected in Q3 2023 and from the AGAVE-201 trial for axatilimab expected mid-2023. The company is on track to submit two U.S. regulatory filings by the end of 2023. Financially, Syndax reported a net loss of $39.2 million for Q4 2022 and $149.3 million for the full year. The company had cash reserves totaling $481.3 million as of year-end 2022, which supports ongoing R&D activities.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced that it will report its fourth quarter and year-end 2022 financial results on February 28, 2023, after the U.S. market close. The management will conduct a conference call and live audio webcast at 4:30 p.m. ET the same day to discuss these results and provide a business update. Investors can access the webcast through the company's website and a replay will be available 24 hours after the call for 90 days. Syndax is focused on developing cancer therapies, with its pipeline including revumenib and axatilimab, which are in pivotal trials.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced participation in several upcoming investor conferences. Key events include a fireside chat at the Citi 2023 Virtual Oncology Leadership Summit on February 21, a session at Cowen's 43rd Annual Healthcare Conference on March 6, a panel discussion on leukemia at the same conference on March 8, and another fireside chat at Barclays Global Healthcare Conference on March 15. Live webcasts of these discussions will be accessible via the Company’s investor website, where replays will also be available for a limited time. Syndax is focused on developing innovative cancer therapies, with key candidates currently in pivotal trials.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced that CEO Michael A. Metzger will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 10:30 a.m. PT. The presentation can be accessed via a live webcast on the company’s Investor section of its website, with a replay available for a limited time. Syndax is focused on developing innovative cancer therapies, including revumenib (SNDX-5613) and axatilimab, both currently in pivotal trials.
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