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Syndax Pharmaceuticals, Inc. - SNDX STOCK NEWS

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.

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Syndax Pharmaceuticals has granted inducement awards to ten new employees, allowing them to purchase up to 169,600 shares of common stock. The stock options will vest over four years, with 25% vesting after one year and the rest vesting monthly over 36 months.
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Syndax Pharmaceuticals reports positive data from Phase 1 trial of revumenib, demonstrating a 36% CR/CRh rate in patients with mNPM1 AML. Registrational filings for revumenib and axatilimab on track for completion in 2023. Revumenib pivotal monotherapy results and combination data to be presented at ASH Annual Meeting. Syndax expects to launch two blockbuster therapies in 2024.
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Syndax Pharmaceuticals will present updated data from multiple trials of revumenib, its oral menin inhibitor, at the 65th American Society of Hematology Annual Meeting. The Phase 2 portion of the AUGMENT-101 trial met its primary endpoint with a CR/CRh rate of 23% in KMT2Ar AML and ALL cohorts. Syndax plans to submit an NDA for revumenib for the treatment of R/R KMT2Ar acute leukemia by year-end. The Phase 1/2 SAVE study showed a 100% overall response rate in R/R AML patients treated with revumenib, venetoclax, and decitabine/cedazuridine. Revumenib maintenance therapy post-HSCT demonstrated durable MRD negative responses in patients.
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Syndax Pharmaceuticals announced that results from the AGAVE-201 trial of axatilimab in patients with chronic graft-versus-host disease (cGVHD) will be presented at the ASH Annual Meeting. The trial met the primary endpoint, with all three dose cohorts showing positive results. The overall response rate at the 0.3 mg/kg dose was 74%, and 60% of patients were still responding at one year. Syndax and Incyte plan to submit a BLA filing by year-end 2023.
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Syndax Pharmaceuticals will report its Q3 2023 financial results and provide a business update on November 2. A conference call and webcast will be held to discuss the results.
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Syndax Pharmaceuticals plans to submit a New Drug Application (NDA) for revumenib in relapsed or refractory KMT2Ar acute leukemia, including AML and ALL, under the FDA's RTOR program. The FDA's inclusion in the RTOR program follows the Breakthrough Therapy Designation for the same indication and recent positive topline data from the AUGMENT-101 pivotal trial. Syndax expects to complete the NDA submission by year-end 2023.
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Syndax Pharmaceuticals grants inducement awards to new employees
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Syndax Pharmaceuticals announces positive results from the AUGMENT-101 trial of revumenib in KMT2Ar acute leukemia, meeting its primary endpoint with a CR/CRh rate of 23% (p-value = 0.0036). Syndax plans to submit FDA filings for revumenib and axatilimab by the end of 2023. Safety profile is favorable with only 6% discontinuing due to treatment-related adverse events. Syndax is funded into the second half of 2025. Revumenib shows potential as a first- and best-in-class agent.
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Syndax Pharmaceuticals will share topline results from the AUGMENT-101 trial in relapsed/refractory KMT2Ar acute leukemia on October 2, 2023.
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Syndax Pharmaceuticals grants inducement awards to new employees
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FAQ

What is the current stock price of Syndax Pharmaceuticals (SNDX)?

The current stock price of Syndax Pharmaceuticals (SNDX) is $13.08 as of December 20, 2024.

What is the market cap of Syndax Pharmaceuticals (SNDX)?

The market cap of Syndax Pharmaceuticals (SNDX) is approximately 1.1B.

What does Syndax Pharmaceuticals, Inc. specialize in?

Syndax Pharmaceuticals specializes in developing combination therapies for various cancer indications, focusing on innovative treatments for acute leukemias and other cancers.

What are Syndax's key product candidates?

Key product candidates include entinostat, revumenib, and axatilimab, targeting cancer cells, immune regulatory cells, and enhancing immune responses against tumors.

Where is Syndax Pharmaceuticals located?

Syndax Pharmaceuticals is headquartered at 35 Gatehouse Dr., Building D, Floor 3, Waltham, MA 02451, USA.

What recent milestones has Syndax Pharmaceuticals achieved?

Syndax recently completed enrollment in the pivotal AUGMENT-101 trial for revumenib targeting relapsed/refractory mutant nucleophosmin (mNPM1) AML and expects topline data by the end of 2024.

What is the significance of revumenib?

Revumenib is a selective inhibitor of the menin-KMT2A binding interaction, showing promise in treating acute leukemias such as KMT2A-rearranged and NPM1-mutant AML.

Has revumenib received any special designations?

Yes, revumenib has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, highlighting its potential to address significant unmet medical needs.

How does Syndax Pharmaceuticals maintain its financial health?

Syndax maintains a robust financial position by regularly updating stakeholders, engaging in strategic partnerships, and advancing its clinical programs efficiently.

What upcoming events is Syndax participating in?

Syndax's CEO will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on April 17, 2024, at 11:00 a.m. ET.

Where can I find more information about Syndax's clinical trials?

Detailed information about Syndax's clinical trials is available on the company's website and in their investor presentations and press releases.

How can I contact Syndax Pharmaceuticals?

You can contact Syndax Pharmaceuticals through Sharon Klahre at sklahre@syndax.com or by calling 781.684.9827.

Syndax Pharmaceuticals, Inc.

Nasdaq:SNDX

SNDX Rankings

SNDX Stock Data

1.10B
81.86M
0.81%
107.42%
12.42%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
WALTHAM