Syndax Pharmaceuticals Inc Stock Price, News & Analysis

Syndax Pharmaceuticals, Inc. (SNDX) announced its participation in the Goldman Sachs 42nd Annual Global Healthcare Conference scheduled for June 10, 2021, at 2:10 p.m. ET. Management will present details about the company’s innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. The live presentation will be accessible through the Investor section of Syndax's website, with a replay available for a limited time afterward.

Syndax Pharmaceuticals announced its participation in the Cowen 2nd Annual Virtual Oncology Innovation Summit on May 20, 2021, at 12:00 p.m. ET. The management team will present details about their innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. A live webcast of the presentation can be accessed through the Company's website, with a replay available for a limited time thereafter.

Syndax Pharmaceuticals (SNDX) reported its Q1 2021 financial results, highlighting positive interim Phase 1 data from the AUGMENT-101 trial for SNDX-5613 in treating acute leukemias, with a 23% complete response rate among patients. The company has identified a recommended Phase 2 dose and plans to initiate this pivotal trial soon. Additionally, Syndax completed enrollment of 23 patients in the Phase 2 expansion of axatilimab for chronic graft versus host disease (cGVHD), with updates expected later this year. The financial overview shows a net loss of $27.7 million and increased R&D expenses.

Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will release its first quarter 2021 financial results on May 11, 2021, after market close. Management will hold a conference call at 4:30 p.m. ET on the same day to discuss the results and provide business updates. Key pipeline products include SNDX-5613, axatilimab, and entinostat, focused on cancer therapies. Investors can access the call via the company's website or through designated dial-in numbers. A replay will also be available post-event.

Syndax Pharmaceuticals (SNDX) reported promising results from the Phase 1 portion of the AUGMENT-101 trial for SNDX-5613, an oral menin inhibitor targeting MLLr and NPM1c mutant acute leukemias. With a 48% overall response rate among 31 evaluable patients, 67% achieved minimal residual disease negative status. The company identified a recommended Phase 2 dose of 226 mg every 12 hours. The drug was well-tolerated, with no discontinuations due to treatment-related adverse events. The pivotal Phase 2 trial is anticipated to start by Q2 2021.

Syndax Pharmaceuticals will host a conference call on April 20, 2021, at 8:00 a.m. ET to share updated data from the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613. This trial focuses on patients with relapsed or refractory acute leukemias, utilizing SNDX-5613, a selective oral menin inhibitor. The call will feature insights from Dr. Eytan M. Stein from Memorial Sloan Kettering Cancer Center, highlighting the progress in cancer treatment research. The event will be available via live webcast on the Syndax website.

Syndax Pharmaceuticals announced the FDA granted Orphan Drug Designation to axatilimab for idiopathic pulmonary fibrosis (IPF), a severe lung disease affecting about 150,000 patients in the U.S. This designation supports axatilimab's development as a potential treatment for this underserved patient population. The drug targets the CSF-1 receptor, showing promise in clinical trials for conditions like chronic graft versus host disease (cGVHD). Orphan Drug Designation offers incentives like tax credits, fee waivers, and seven years of market exclusivity upon FDA approval.

Syndax Pharmaceuticals has received Orphan Drug Designation from the FDA for axatilimab, designed to treat chronic graft versus host disease (cGVHD). This designation highlights the drug's potential, promising various incentives like tax credits and market exclusivity upon approval. The Phase 2 AGAVE-201 trial is currently ongoing with topline results expected in 2023. Axatilimab is positioned to address unmet needs in cGVHD, affecting approximately 14,000 patients in the U.S., and has previously shown durable responses in early trials.

Syndax Pharmaceuticals announced its Q4 2020 financial results and provided a pipeline update. As of December 31, 2020, the company held $293.1 million in cash and reported a net loss of $20.4 million ($0.44 per share) for the quarter. Research and development expenses for the quarter rose to $15.5 million from $9.5 million, driven by increased clinical activities. The company expects R&D expenses to reach $90 to $100 million in 2021. Key milestones include the Phase 1 data presentation for SNDX-5613 and the initiation of the pivotal Phase 2 AGAVE-201 trial for axatilimab.