Syndax Pharmaceuticals Inc Stock Price, News & Analysis

Syndax Pharmaceuticals announced that the European Commission has granted Orphan Drug Designation to SNDX-5613, a selective oral menin inhibitor, for treating acute myeloid leukemia (AML). This designation supports SNDX-5613's role as a potential best-in-class treatment for patients with NPM1 and MLLr acute leukemias. The Orphan Drug Designation allows for benefits like ten years of market exclusivity and protocol assistance. SNDX-5613 is currently in the AUGMENT-101 Phase 1/2 clinical trial for relapsed/refractory acute leukemias, having also received Fast Track designation from the FDA.

Syndax Pharmaceuticals announced the closing of a public offering of 3,802,144 shares of common stock, including 645,000 shares from underwriters' options, and pre-funded warrants for 1,142,856 shares. The offering price was $17.50 per share, generating gross proceeds of approximately $86.5 million before expenses. The shares were offered under an effective SEC registration statement, with Goldman Sachs and Cowen serving as joint book-running managers. This capital raise is aimed at advancing Syndax's pipeline of cancer therapies, including SNDX-5613 and axatilimab.

Syndax Pharmaceuticals announced a public offering of 3,157,144 shares of common stock at $17.50 per share, with pre-funded warrants for 1,142,856 shares priced at $17.4999 each. The offering will raise approximately $75.3 million, before expenses, and is expected to close on December 20, 2021. The underwriters have a 30-day option to purchase an additional 645,000 shares. Goldman Sachs and Cowen are joint book-running managers for the offering, which is being conducted under a 'shelf' registration statement filed with the SEC.

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.