Syndax Pharmaceuticals Inc Stock Price, News & Analysis

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.

Syndax Pharmaceuticals, a clinical stage biopharmaceutical company, announced its participation in three virtual investor conferences. The events include a fireside chat at the Morgan Stanley Global Healthcare Conference on September 9, 2021, a panel at the Citi BioPharma Virtual Conference on September 10, and another fireside chat at the Baird Global Healthcare Conference on September 14. Investors can access a live webcast of the first two events and find replays on the company's website. Syndax is developing innovative cancer therapies, including SNDX-5613 and axatilimab.