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.
About Syndax Pharmaceuticals Inc.
Syndax Pharmaceuticals Inc. (Nasdaq: SNDX) is a commercial-stage biopharmaceutical company dedicated to transforming cancer care through the development and commercialization of innovative therapies. Headquartered in Waltham, Massachusetts, Syndax focuses on addressing significant unmet medical needs in oncology and immunology. The company's pioneering approach leverages advanced scientific insights to develop first-in-class treatments that target specific molecular mechanisms driving disease progression.
Core Business and Product Portfolio
Syndax's business model is centered around the research, development, and commercialization of targeted therapies for cancer and related conditions. The company has successfully brought two FDA-approved therapies to market:
- Revuforj® (revumenib): A first-in-class menin inhibitor approved for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A (KMT2A) gene translocation in adult and pediatric patients. Revuforj addresses a critical unmet need in hematologic oncology, offering a novel mechanism of action that disrupts leukemogenic transcriptional pathways.
- Niktimvo™ (axatilimab-csfr): A monoclonal antibody targeting the colony stimulating factor 1 receptor (CSF-1R), approved for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Niktimvo represents a breakthrough in managing inflammation and fibrosis in chronic GVHD patients.
Market Position and Competitive Landscape
Syndax operates in the highly competitive biopharmaceutical industry, which is characterized by rapid innovation, stringent regulatory requirements, and significant R&D investment. The company's strategic focus on niche oncology markets with high unmet needs, such as KMT2A-rearranged leukemia and chronic GVHD, sets it apart from competitors. By targeting specific molecular pathways, Syndax has established itself as a leader in precision medicine.
The co-commercialization agreement with Incyte for Niktimvo further strengthens Syndax's market presence, enabling broader access to international markets. This partnership underscores the company's commitment to leveraging strategic collaborations to maximize the impact of its therapies.
Research and Development
Syndax is deeply committed to advancing its pipeline of innovative therapies. The company is conducting multiple clinical trials to explore additional indications and combination therapies for its existing products. For example, Revuforj is being evaluated in combination with standard-of-care agents for newly diagnosed acute myeloid leukemia (AML) patients, while Niktimvo is undergoing trials for idiopathic pulmonary fibrosis and other fibrotic diseases.
Strategic Vision
Fueled by a mission to reimagine cancer care, Syndax aims to unlock the full potential of its pipeline and expand its therapeutic footprint. The company's robust clinical development programs, coupled with its strategic partnerships and commercialization efforts, position it for sustained growth in the oncology and immunology sectors.
Commitment to Patients
At the heart of Syndax's operations is a commitment to improving patient outcomes. The company offers comprehensive support programs, such as SyndAccess™, to ensure patients have access to its therapies. These initiatives reflect Syndax's dedication to removing barriers to treatment and enhancing the quality of life for patients worldwide.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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