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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, 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.

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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.

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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.

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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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Syndax Pharmaceuticals (SNDX) CEO to participate in fireside chat at Stifel 2024 Virtual Targeted Oncology Forum. The event will be held on April 17, 2024, at 11:00 a.m. ET. Investors can access the live webcast on the company's website.
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Syndax Pharmaceuticals (SNDX) presents positive data from the pivotal AUGMENT-101 trial in pediatric patients with relapsed/refractory acute leukemia at the ASPHO Conference. The data highlights impressive activity and consistency with the adult population, showcasing a complete remission rate of 23% and an overall response rate of 46%. The safety profile of revumenib remains favorable, with no treatment-related discontinuations or dose reductions.
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Syndax Pharmaceuticals (SNDX) grants inducement awards to new employees, offering up to 164,200 shares of common stock under the 2023 Inducement Plan.
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Syndax Pharmaceuticals completes enrollment in pivotal trial for revumenib in mutant nucleophosmin acute myeloid leukemia, with topline data expected in 4Q24 potentially supporting sNDA filing in 1H25.
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Syndax Pharmaceuticals (SNDX) receives Priority Review from the FDA for revumenib NDA, targeting adult and pediatric relapsed or refractory KMT2Ar acute leukemia. PDUFA action date set for September 26, 2024, under the RTOR program.
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Syndax Pharmaceuticals appoints Steven Closter as Chief Commercial Officer, bringing over 30 years of experience to lead commercial strategy. Company aims for two potential first- and best-in-class product launches in 2024.
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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