Welcome to our dedicated page for Syndax Pharmaceuticals news (Ticker: SNDX), a resource for investors and traders seeking the latest updates and insights on Syndax Pharmaceuticals stock.
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 focused on developing cancer therapies, has announced the granting of inducement awards to nine new employees. The awards, issued on August 1, 2024, consist of stock options to purchase up to 104,600 shares of common stock under the Company's 2023 Inducement Plan.
The stock options have a four-year vesting schedule, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date. The remaining shares will vest monthly at a rate of 1/48th over the following 36 months, contingent on the employee's continued service with Syndax.
Syndax Pharmaceuticals (Nasdaq: SNDX) reported Q2 2024 financial results and provided a clinical update. Key highlights include:
1. Axatilimab BLA for refractory chronic GVHD under Priority Review with PDUFA date of August 28, 2024.
2. Revumenib NDA for R/R KMT2Ar acute leukemia under RTOR review with PDUFA date extended to December 26, 2024.
3. Pivotal AUGMENT-101 topline data for mNPM1 AML expected in Q4 2024.
4. Q2 2024 net loss of $68.1 million ($0.80 per share).
5. Cash position of $454.6 million as of June 30, 2024.
6. Full-year 2024 R&D expenses expected to be $240-$260 million, with total operating expenses of $355-$375 million.
7. Sufficient capital to fund operations through 2026.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced that the FDA has extended the PDUFA action date for the New Drug Application (NDA) of revumenib to December 26, 2024. This three-month extension from the original date of September 26, 2024, allows the FDA additional time to review supplemental information provided by Syndax in response to their requests. The submission was deemed a Major Amendment to the NDA.
Revumenib is being developed for the treatment of adults and pediatric patients with relapsed or refractory KMT2Ar acute leukemia. Upon approval, it would be the first drug indicated for this specific condition. The NDA has been granted Priority Review and is being reviewed under the FDA's Real-Time Oncology Review program. Revumenib has also received Breakthrough Therapy, Fast Track, and Orphan Drug designations.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, has announced it will release its second quarter 2024 financial results on August 1, 2024. The company will host 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 through the Events & Presentations page on Syndax's website or join the conference call using the provided dial-in numbers. For those unable to attend, a replay will be available on the company's website for 90 days following the call.
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.
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