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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.

Overview

Syndax Pharmaceuticals Inc (SNDX) is a commercial-stage biopharmaceutical company that is reimagining cancer care with an innovative pipeline of combination therapies. Focused in the field of oncology and biotechnology, the company is renowned for its specialized approach in developing novel treatments targeted at various cancer indications and immune disorders. By capitalizing on decades of scientific discovery and clinical expertise, Syndax continues to strengthen its position in a competitive landscape through careful research and data-driven development programs.

Innovative Pipeline and Core Product Candidates

The company has built a reputation on its dedication to research and development, with an intriguing pipeline that includes:

  • Revumenib: An oral, small molecule menin inhibitor developed to target acute leukemias, particularly those driven by KMT2A-rearrangements or mutant NPM1. Revumenib is designed to interfere with the menin-KMT2A interaction, an essential pathway in leukemogenesis, and demonstrates significant promise in altering the course of aggressive blood cancers.
  • Axatilimab (Niktimvo): A monoclonal antibody that blocks the colony stimulating factor 1 receptor (CSF-1R) to modulate inflammation and fibrosis. Axatilimab has been positioned as a first-in-class therapy in chronic graft-versus-host disease (GVHD), offering a new therapeutic option for patients who have exhausted multiple lines of systemic treatment.

These candidates are supported by comprehensive clinical programs and regulatory milestone achievements that emphasize both innovation and scientific rigor.

Clinical Development and Regulatory Milestones

Syndax has strategically advanced its product candidates through rigorous clinical trials and development programs designed to meet clear medical needs. The clinical data for revumenib and axatilimab have played a central role in building the company’s credentials. The approach involves:

  • Robust evaluation of efficacy and safety across varied dosing regimens.
  • Strategic collaborations with key clinical and research institutions to enhance trial designs.
  • Adherence to stringent regulatory guidelines which have culminated in FDA approvals and breakthrough designations for specific indications.

The company’s achievements underscore a strong commitment to not only advancing its pipeline but also ensuring that each candidate meets high standards of scientific validity and doctor-patient safety.

Business Model and Strategic Partnerships

Syndax integrates a multifaceted business model that combines active clinical development with innovative funding strategies and commercial readiness. A recent synthetic royalty funding agreement illustrates the strategic infusion of capital that enables the company to maintain its research trajectory while progressing toward profitability. In addition, collaboration with industry peers helps amplify the value proposition of its approved therapies and supports a robust commercial launch infrastructure. This collaborative model provides the framework for continuous research, expansive trials, and wider therapeutic application beyond the initial clinical focus.

Commitment to Research, Expertise, and Market Position

At its core, Syndax Pharmaceuticals is driven by excellence in research and a dedication to transforming patient care through targeted therapies. The company leverages deep scientific expertise to tackle intricate molecular pathways underlying cancer, such as the menin-KMT2A interaction in acute leukemias and the CSF-1R mediated inflammatory cascade in chronic GVHD. This technical focus is supported by:

  • Expert-led clinical trial programs utilizing cutting-edge methodologies.
  • A strong network of academic, clinical, and industry partners who contribute to substantial peer validation and real-world experience.
  • An unwavering commitment to bridging the gap between innovative science and accessible patient treatments.

By establishing itself as a trusted name in the biopharmaceutical community, Syndax remains a key player among companies with a mission centered on improved clinical outcomes and long-term patient benefits.

Key Takeaways for Investors and Analysts

Syndax Pharmaceuticals’ strategic approach is marked by:

  • Robust clinical data supporting its core product candidates.
  • A balanced business model that efficiently integrates clinical innovation with commercial execution.
  • Ongoing validation through regulatory milestones and industry collaborations.
  • An emphasis on addressing significant unmet medical needs in oncology and immunotherapy.

The company’s well-crafted scientific strategy and commitment to data integrity make it a compelling subject of study for investors and industry analysts seeking a deep-dive into advanced cancer therapeutics. Syndax exemplifies thoroughness in clinical research, prudence in financial management, and a forward-thinking approach to redefining standards of patient care in oncology.

Conclusion

In summary, Syndax Pharmaceuticals Inc embodies the convergence of innovative science and strategic commercial execution. Its portfolio of targeted therapies, underpinned by rigorous clinical research and regulatory achievements, positions the company as a noteworthy contender in the biopharmaceutical space. With deep expertise in niche molecular pathways and a commitment to transforming treatment paradigms, Syndax continues to enhance its influence across the oncology landscape, ensuring that meaningful scientific advancements translate into lasting patient benefits.

Rhea-AI Summary
Syndax Pharmaceuticals (SNDX) announced that data from the pivotal trial of revumenib, their oral menin inhibitor, will be featured in a late-breaking presentation at the American Society of Hematology Annual Meeting. The results continue to underscore revumenib's potential as a first- and best-in-class treatment option for patients with KMT2Ar and mNPM1 acute leukemias. The presentation will take place on December 12, 2023, and will feature topline efficacy and safety results from the pivotal AUGMENT-101 Phase 2 Study.
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Syndax Pharmaceuticals (Nasdaq: SNDX) CEO Michael A. Metzger will participate in a fireside chat at the Stifel Healthcare Conference on November 14, 2023, at 4:45 p.m. ET. The event will be live webcasted and accessible from the company's website.
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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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FAQ

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

The current stock price of Syndax Pharmaceuticals (SNDX) is $12.92 as of April 22, 2025.

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

The market cap of Syndax Pharmaceuticals (SNDX) is approximately 974.9M.

What is Syndax Pharmaceuticals Inc?

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing innovative combination therapies for cancer and immune-related conditions.

What are the company’s primary product candidates?

Key candidates include revumenib, an oral menin inhibitor for treating acute leukemias, and axatilimab (marketed as Niktimvo), a monoclonal antibody targeting CSF-1R for chronic graft-versus-host disease.

How does revumenib work?

Revumenib targets the menin-KMT2A interaction, a critical pathway in leukemogenesis, thereby interfering with the progression of acute leukemias such as those characterized by KMT2A rearrangements or mutant NPM1.

What distinguishes axatilimab in treatment?

Axatilimab is designed to block the CSF-1 receptor, reducing inflammation and fibrosis associated with chronic graft-versus-host disease, especially in patients with limited options after multiple therapies.

How does Syndax generate revenue?

The company leverages a multifaceted business model that includes strategic partnerships, innovative funding agreements like synthetic royalty financing, and building a commercial-ready infrastructure for its therapies.

What role do clinical trials play in their strategy?

Clinical trials are central to Syndax’s strategy, aiding in the evaluation of efficacy and safety for its product candidates while supporting regulatory submissions and reinforcing the company's scientific credibility.

How does Syndax ensure scientific expertise and trustworthiness?

Syndax emphasizes rigorous clinical research, partnerships with leading academic and clinical institutions, and adherence to high regulatory standards, thereby showcasing its deep industry expertise and commitment to patient safety.

What makes Syndax unique in a competitive market?

Its focus on addressing key molecular pathways in cancer through specialized therapies, combined with robust clinical data and strategic commercial partnerships, sets Syndax apart as an innovative player in the biopharmaceutical sector.
Syndax Pharmaceuticals Inc

Nasdaq:SNDX

SNDX Rankings

SNDX Stock Data

974.88M
84.96M
1.3%
116.29%
22.32%
Biotechnology
Pharmaceutical Preparations
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