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.
Syndax Pharmaceuticals, Inc. (symbol: SNDX) is a clinical-stage biopharmaceutical company headquartered in Waltham, Massachusetts. Dedicated to the development of combination therapies, the company primarily focuses on innovative treatments for various cancer indications.
Syndax's pipeline is rich with promising drugs aimed at improving the lives of cancer patients. The company's leading candidates include entinostat, an agent that targets both cancer cells and immune regulatory cells, and revumenib, a selective inhibitor of the menin-KMT2A binding interaction. This agent is particularly geared towards addressing acute leukemias such as KMT2A-rearranged (KMT2Ar) and NPM1-mutant acute myeloid leukemia (AML). Another notable product in development is axatilimab, a monoclonal antibody designed to enhance the immune response against tumors through CSF-1R inhibition.
Syndax operates primarily within the United States and has achieved several milestones. Recently, the company completed enrollment in the pivotal AUGMENT-101 trial for revumenib targeting relapsed/refractory mutant nucleophosmin (mNPM1) AML. The trial aims to evaluate revumenib's safety, tolerability, and efficacy, with topline data expected by the end of 2024. Positive results from this trial could support new drug applications in early 2025.
Revumenib has achieved several regulatory designations, including Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA, reflecting its potential to address unmet clinical needs in leukemias. Syndax has also reported encouraging outcomes from its studies, including high response rates and favorable safety profiles in both adult and pediatric populations suffering from acute leukemia.
Financially, Syndax maintains a robust position to advance its clinical programs. The company regularly updates stakeholders through earnings calls and investor presentations, with a recent update scheduled for May 2024. Syndax's progress is further bolstered by strategic partnerships and collaborations that support its mission to innovate and deliver significant value to patients and shareholders alike.
Syndax Pharmaceuticals announced the successful closing of its public offering of 7,840,909 shares at a price of $22.00 per share, totaling $172.5 million in gross proceeds. The offering included the full exercise of an underwriters' option for an additional 1,022,727 shares. Syndax now has 68,100,918 shares outstanding. The shares were issued under a previously effective 'shelf' registration statement with the SEC. Major underwriters included Goldman Sachs, J.P. Morgan, and Cowen.
Syndax Pharmaceuticals (SNDX) presented positive data from the Phase 1 AUGMENT-101 trial for its oral menin inhibitor, revumenib, during the ASH Annual Meeting. The trial showed a 30% CR/CRh rate in the efficacy evaluable population and a 53% overall response rate among 60 patients. Notably, 75% of patients who underwent stem cell transplants remained in remission. Revumenib has been granted Breakthrough Therapy Designation for treating relapsed/refractory acute leukemia. The company aims to report top-line Phase 2 data by Q3 2023 and submit a New Drug Application by the end of 2023.
Syndax Pharmaceuticals announced the hiring of Steve M. Sabus as Chief Commercial Officer on December 5, 2022. As part of this appointment, Sabus received an inducement award to purchase up to 220,000 shares of common stock at an exercise price of $25.44, the closing price on his hiring date. The award will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter, contingent on his continued employment. This award was approved by Syndax's Board of Directors in line with NASDAQ Listing Rule 5635(c)(4).
Syndax Pharmaceuticals has priced an underwritten public offering of 6,818,182 shares of its common stock at $22.00 per share. The total gross proceeds from this offering are expected to reach approximately $150 million, excluding underwriting discounts and expenses. Additionally, underwriters have a 30-day option to purchase up to 1,022,727 additional shares. This offering is set to close on December 9, 2022, pending customary conditions. The shares are being offered under an effective registration statement with the SEC.
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.
FAQ
What is the current stock price of Syndax Pharmaceuticals (SNDX)?
What is the market cap of Syndax Pharmaceuticals (SNDX)?
What does Syndax Pharmaceuticals, Inc. specialize in?
What are Syndax's key product candidates?
Where is Syndax Pharmaceuticals located?
What recent milestones has Syndax Pharmaceuticals achieved?
What is the significance of revumenib?
Has revumenib received any special designations?
How does Syndax Pharmaceuticals maintain its financial health?
What upcoming events is Syndax participating in?
Where can I find more information about Syndax's clinical trials?
How can I contact Syndax Pharmaceuticals?
