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 reported significant advancements in its clinical trials and a financial update for Q4 and full-year 2022. Key highlights include anticipated topline data from the AUGMENT-101 trial for revumenib expected in Q3 2023 and from the AGAVE-201 trial for axatilimab expected mid-2023. The company is on track to submit two U.S. regulatory filings by the end of 2023. Financially, Syndax reported a net loss of $39.2 million for Q4 2022 and $149.3 million for the full year. The company had cash reserves totaling $481.3 million as of year-end 2022, which supports ongoing R&D activities.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced that it will report its fourth quarter and year-end 2022 financial results on February 28, 2023, after the U.S. market close. The management will conduct a conference call and live audio webcast at 4:30 p.m. ET the same day to discuss these results and provide a business update. Investors can access the webcast through the company's website and a replay will be available 24 hours after the call for 90 days. Syndax is focused on developing cancer therapies, with its pipeline including revumenib and axatilimab, which are in pivotal trials.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced participation in several upcoming investor conferences. Key events include a fireside chat at the Citi 2023 Virtual Oncology Leadership Summit on February 21, a session at Cowen's 43rd Annual Healthcare Conference on March 6, a panel discussion on leukemia at the same conference on March 8, and another fireside chat at Barclays Global Healthcare Conference on March 15. Live webcasts of these discussions will be accessible via the Company’s investor website, where replays will also be available for a limited time. Syndax is focused on developing innovative cancer therapies, with key candidates currently in pivotal trials.
Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) announced that CEO Michael A. Metzger will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 10:30 a.m. PT. The presentation can be accessed via a live webcast on the company’s Investor section of its website, with a replay available for a limited time. Syndax is focused on developing innovative cancer therapies, including revumenib (SNDX-5613) and axatilimab, both currently in pivotal trials.
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.
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?
