STOCK TITAN

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 plans to offer and sell shares of its common stock through an underwritten public offering. The offering may include pre-funded warrants and a 30-day option for underwriters to purchase an additional 15% of the shares. Goldman Sachs is the book-running manager for this offering, which is conducted under an effective shelf registration statement with the SEC. The proceeds from the offering will be used to support the development of Syndax's innovative cancer therapies, including SNDX-5613 and axatilimab.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1%
Tags
-
Rhea-AI Summary

Syndax Pharmaceuticals announced updated data from the Phase 1 portion of the AUGMENT-101 trial for SNDX-5613, a selective oral menin inhibitor, focused on relapsed/refractory acute leukemias with NPM1 mutations or MLL rearrangements. The trial's positive results were presented at the ASH Annual Meeting on December 13, 2021. Key outcomes included a 55% overall response rate and a 31% MRD negative rate among evaluable patients. The FDA indicated that the ongoing Phase 2 trial may support regulatory filings for various leukemia indications, marking a significant step for the company's development strategy.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
9.56%
Tags
-
Rhea-AI Summary

Syndax Pharmaceuticals reported encouraging results from its Phase 1/2 trial of axatilimab for chronic graft-versus-host disease (cGVHD) during the 63rd ASH Annual Meeting on December 11, 2021. Axatilimab, a monoclonal antibody targeting CSF-1R, showed a 68% overall response rate in patients with refractory cGVHD, and 53% reported meaningful symptom improvement. The drug was well-tolerated, with no significant adverse effects. Ongoing enrollment in the pivotal Phase 2 AGAVE-201 trial aims to further assess axatilimab’s efficacy, with topline data anticipated in 2023.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
Tags
none
Rhea-AI Summary

Syndax Pharmaceuticals (Nasdaq: SNDX) announced the expiration of the Hart-Scott-Rodino antitrust waiting period, leading to the closure of its collaboration and license agreement with Incyte for the development of axatilimab, an anti-CSF-1R monoclonal antibody. Incyte paid Syndax $117 million as an upfront license fee and invested $35 million in equity. Axatilimab is being evaluated in the global Phase 2 AGAVE-201 trial, targeting chronic graft-versus-host disease, and has received Orphan Drug Designation from the FDA for both cGVHD and idiopathic pulmonary fibrosis.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-5.43%
Tags
none
-
Rhea-AI Summary

Syndax Pharmaceuticals (SNDX) announced its third quarter 2021 financial results, reporting a net loss of $20.6 million or $0.40 per share. R&D expenses surged to $25.6 million, up from $14.4 million in Q3 2020. The Phase 2 portion of the AUGMENT-101 trial for SNDX-5613 is now enrolling patients, with the potential for regulatory filings confirmed by the FDA. Additionally, an oral presentation of updated Phase 1 data for SNDX-5613 is scheduled at the 63rd ASH Annual Meeting. Cash reserves stand at $229.7 million, reflecting ongoing investment in clinical trials.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.29%
Tags
-
Rhea-AI Summary

Syndax Pharmaceuticals, Inc. (SNDX) will release its third quarter 2021 financial results on November 15, after U.S. market close. A conference call and live audio webcast will occur at 4:30 p.m. ET on the same day to discuss these results and provide a business update. The details for accessing the call are provided, including dial-in numbers and a link for the webcast. Syndax is focused on innovative cancer therapies, with a pipeline that includes SNDX-5613, axatilimab, and entinostat.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.57%
Tags
Rhea-AI Summary

Syndax Pharmaceuticals (Nasdaq: SNDX) announced that updated data for its cancer therapies, SNDX-5613 and axatilimab, will be presented at the 63rd ASH Annual Meeting from December 11-14, 2021. SNDX-5613, a selective oral menin inhibitor, showed a 44% composite complete response rate in patients with MLLr and NPM1c mutations. Axatilimab demonstrated a 66% overall response rate in chronic graft-versus-host disease patients. Both programs highlight Syndax's commitment to developing innovative cancer treatments.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-16.4%
Tags
conferences
-
Rhea-AI Summary

Flare Therapeutics has expanded its leadership team with the appointments of Daphne Karydas as COO and CFO, and Michaela Bowden as SVP of Biology and Translation. Karydas, with over 20 years in biopharma, previously served as CFO for Syndax Pharmaceuticals (SNDX). Bowden, holding a PhD, brings extensive experience from Bristol Myers Squibb. The company aims to enhance its precision oncology pipeline by leveraging their expertise in developing small molecule medicines targeting transcription factors.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.05%
Tags
management
-
Rhea-AI Summary

Syndax Pharmaceuticals and Incyte announced a global collaboration to develop axatilimab, an anti-CSF-1R monoclonal antibody, focusing on chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Syndax will receive $117 million upfront and $35 million in equity investment, along with potential milestone payments of up to $450 million. The companies will share profits in the U.S. 50:50, with Syndax receiving double-digit royalties internationally. Ongoing trials for axatilimab aim to provide innovative treatments for patients with severe conditions, with topline data expected in 2023.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
5.11%
Tags
none
Rhea-AI Summary

Syndax Pharmaceuticals has expanded its Board of Directors to nine members by appointing Dr. Martin H. Huber, M.D., effective immediately. Dr. Huber brings over 20 years of experience in drug development, currently serving as President of R&D at Xilio Therapeutics. The company's leadership expressed confidence in Dr. Huber's expertise, highlighting its potential to enhance Syndax's innovative cancer therapy pipeline, including drug candidates like SNDX-5613 and axatilimab. This strategic appointment aims to strengthen the company's ability to serve underserved cancer patients.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-0.26%
Tags
management

FAQ

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

The current stock price of Syndax Pharmaceuticals (SNDX) is $12.01 as of April 1, 2025.

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

The market cap of Syndax Pharmaceuticals (SNDX) is approximately 1.0B.

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

1.04B
84.91M
1.3%
116.29%
22.32%
Biotechnology
Pharmaceutical Preparations
Link
United States
WALTHAM