Syndax Pharmaceuticals Inc Stock Price, News & Analysis

Syndax Pharmaceuticals plans to offer and sell $150 million of common stock in an underwritten public offering. The company will grant underwriters a 30-day option to purchase up to an additional 15% of shares sold. Goldman Sachs, J.P. Morgan, and Cowen are managing the offering. This move is part of a shelf registration previously filed with the SEC. The proceeds are expected to bolster Syndax's cancer therapy pipeline, which includes pivotal trials for revumenib and axatilimab. However, there are risks regarding market conditions and offering completion.

Syndax Pharmaceuticals has received Breakthrough Therapy Designation from the FDA for revumenib, the first treatment for relapsed or refractory KMT2Ar acute leukemia. This designation is based on Phase 1 data from the AUGMENT-101 trial, which indicated a 27% complete remission rate in patients. The company aims to submit a New Drug Application (NDA) for revumenib by the end of 2023, with potential expedited approval due to the significant unmet need in this patient population. Revumenib targets an estimated 10% of all acute leukemias, crucially impacting infant cases.

Syndax Pharmaceuticals and Incyte announced promising results from the Phase 1/2 trial of axatilimab in patients with chronic graft-versus-host disease (cGVHD), showing an overall response rate (ORR) of 67% and ORR of 82% at 1 mg/kg every two weeks. The treatment demonstrated broad clinical benefits across multiple organ systems, with a 52% reduction in glucocorticoids for responding patients. Furthermore, axatilimab had a favorable safety profile, with 40% experiencing serious adverse events, yet no high-grade toxicities. Topline data from the AGAVE-201 study is expected mid-2023.

Syndax Pharmaceuticals (Nasdaq: SNDX) has appointed Steve Sabus as Chief Commercial Officer, effective December 5, 2022. Sabus, with over 30 years in the biopharmaceutical industry, will lead commercial functions and launch initiatives for the company's key cancer therapies, revumenib and axatilimab. CEO Michael A. Metzger highlighted Sabus's extensive experience in oncology product launches as vital for the company's growth. Sabus previously held senior roles at Turning Point Therapeutics and Astellas Pharma, focusing on oncology commercialization and market expansion.

Syndax Pharmaceuticals (SNDX) reported Q3 2022 financial results and business updates. The Phase 1 AUGMENT-101 trial of revumenib showed a 30% complete response rate and a median response duration of 9.1 months. Enrollment is complete for the AGAVE-201 trial of axatilimab for chronic graft versus host disease (cGVHD). The company is on track for two U.S. regulatory filings by year-end 2023. Financials show a Q3 net loss of $35.4 million, an increase from $20.6 million in the prior year, but reduced R&D guidance to $115-$125 million reflects cost-saving measures.

Syndax Pharmaceuticals (SNDX) announced positive interim results from the Phase 1 portion of the AUGMENT-101 trial for revumenib in patients with relapsed/refractory acute leukemias featuring NPM1 or MLLr mutations. The trial demonstrated a 53% overall response rate and a 30% complete response (CR/CRh) rate, with a median response duration of 9.1 months. Notably, 9 out of 12 patients who underwent stem cell transplants post-treatment remained in remission. Updated data will be presented at the 64th ASH Annual Meeting, with top-line data for a pivotal trial expected in Q3 2023.

Syndax Pharmaceuticals (SNDX) will release its Q3 2022 financial results on November 3 after market close. Management will host a conference call and live audio webcast at 4:30 p.m. ET on the same day to discuss the results and company updates. The Q3 earnings call will be accessible through the company's website. Syndax is focused on innovative cancer therapies, with key assets like revumenib and axatilimab in pivotal trials. Further information can be found on their website.

Syndax Pharmaceuticals (SNDX) reported its Q2 2022 financial results, revealing a net loss of $37.6 million, or $0.62 per share, compared to a loss of $22.9 million, or $0.44 per share, in the previous year. The company has $378.9 million in cash and equivalents as of June 30, 2022. Key developments include the ongoing pivotal trials for revumenib and axatilimab, with topline data expected in the first half of 2023. R&D expenses surged to $29.7 million, attributed to clinical activities for both compounds.

Syndax Pharmaceuticals, a clinical-stage biopharmaceutical company, will report its second quarter 2022 financial results on August 8, after U.S. market close. A subsequent conference call is scheduled for 4:30 p.m. ET to discuss the results and provide updates. The live audio webcast will be accessible on Syndax's website. Key pipeline highlights include revumenib (SNDX-5613) and axatilimab, both in pivotal trials. Replays will be available post-call for 90 days.