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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.
Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes, with U.S. launch expected in early February. Niktimvo is the first FDA-approved treatment targeting CSF-1R for chronic graft-versus-host disease (GVHD) in patients who failed at least two prior systemic therapies.
The approval was based on the AGAVE-201 trial results, where 75% of patients receiving 0.3 mg/kg every two weeks achieved response at six months. The approved dose is 0.3 mg/kg (max 35 mg) via intravenous infusion every two weeks for patients weighing at least 40 kg.
Notable adverse reactions occurred in 44% of patients, with 10% discontinuing treatment. The most common side effects included increased AST, infections, and decreased phosphate levels. The treatment has been added to NCCN Guidelines as a category 2A recommendation.
Syndax Pharmaceuticals (SNDX) highlighted its achievements and 2025 milestones, featuring two major FDA approvals in 2024: Revuforj® for R/R acute leukemia with KMT2A translocation and Niktimvo™ for chronic GVHD treatment. Both drugs were added to NCCN Clinical Practice Guidelines.
Key developments include positive results from the AUGMENT-101 trial for Revuforj, with plans to submit an sNDA for R/R mNPM1 AML in 1H25. The company secured a $350 million royalty funding agreement with Royalty Pharma for Niktimvo's U.S. sales.
2025 milestones include launching Niktimvo in Q1, maximizing Revuforj adoption, and initiating multiple frontline trials. The company expects its current financial position to support operations through profitability.
Syndax Pharmaceuticals (NASDAQ: SNDX), a commercial-stage biopharmaceutical company focused on cancer therapies, announced that CEO Michael A. Metzger will present at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Tuesday, January 14, 2025, at 10:30 a.m. PT/ 1:30 p.m. ET. Interested parties can access a live webcast of the fireside chat through the Investor section of Syndax's website, where a replay will also be available temporarily.
Syndax Pharmaceuticals (SNDX) announced the granting of inducement awards to five new employees on January 1, 2025. The awards consist of stock options to purchase up to 123,100 shares of common stock under the Company's 2023 Inducement Plan. The vesting schedule spans four years, with 25% of shares vesting after the first year and the remaining 1/48th vesting monthly over the subsequent 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (SNDX) announced additional positive data from two clinical trials for Revuforj® (revumenib): the AUGMENT-101 trial in relapsed/refractory mNPM1 AML and the BEAT AML frontline combination trial. Key highlights include:
In the AUGMENT-101 trial's Phase 2 cohort, the protocol-defined efficacy population showed 23% CR+CRh rate and 47% ORR. In the expanded analysis of 77 evaluable patients, 26% achieved CR+CRh and 48% achieved overall response.
The BEAT AML trial, combining revumenib with venetoclax/azacitidine in newly diagnosed patients, demonstrated remarkable results with 100% ORR (37/37) and 95% CRc (35/37). The safety profile remained consistent with previous data, showing manageable differentiation syndrome and QTc prolongation events.
Syndax Pharmaceuticals (SNDX) presented positive data from multiple trials of Revuforj® (revumenib) at the 66th ASH Annual Meeting. Key highlights include:
- SAVE trial: 82% overall response rate (27/33 patients) and 48% CR/CRh rate (16/33 patients) in combination with venetoclax and decitabine/cedazuridine in R/R AML
- AUGMENT-101 trial: 64% overall response rate (62/97 patients) and 23% CR/CRh rate (22/97 patients) in R/R KMT2Ar acute leukemia patients, with high MRD negativity rates
- INTERCEPT trial: 54% (6/11) of evaluable mNPM1 patients showed MRD reduction, with 36% (4/11) achieving MRD negativity
The drug demonstrated rapid responses, durability, and favorable tolerability across trials.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced the granting of inducement awards to two new employees under its 2023 Inducement Plan. The awards consist of stock options to purchase up to 23,900 shares of common stock. The options have a four-year vesting schedule, with 25% vesting after one year and the remaining shares vesting monthly over the following 36 months at a rate of 1/48th per month, contingent on continued employment with Syndax.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced that CEO Michael A. Metzger will participate in a panel discussion focused on novel mechanisms in oncology at the Citi 2024 Global Healthcare Conference. The panel is scheduled for Thursday, December 5, 2024, at 11:00 a.m. ET. A live webcast will be available on the company's website investor section, with a replay option available for a time.
Syndax Pharmaceuticals (SNDX) has received FDA approval for Revuforj® (revumenib), the first menin inhibitor for treating relapsed or refractory acute leukemia with KMT2A translocation in patients aged one year and older. The approval is based on the AUGMENT-101 trial results, where 21% of patients achieved complete remission plus CR with partial hematological recovery. The median duration of response was 6.4 months, and 23% of patients underwent stem cell transplantation following treatment. The drug will be available in the US through specialty distributors in November 2024, with 25mg tablets expected in early 2025.
Syndax Pharmaceuticals (SNDX) announced positive topline results from the AUGMENT-101 trial of revumenib in relapsed/refractory mNPM1 AML patients. The trial met its primary endpoint with a 23% complete remission rate (p-value = 0.0014) and achieved a 47% overall response rate in a heavily pre-treated population. The safety profile was favorable, with only 5% of patients discontinuing due to treatment-related adverse events. The company plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025, following anticipated FDA approval for KMT2Ar acute leukemia in Q4 2024.
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