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 strong fourth-quarter results for 2021. The company recorded a net profit of $96.2 million, or $1.81 per share, compared to a loss of $20.4 million in the same period last year. License revenue surged to $126.6 million due to a collaboration with Incyte. Syndax outlined significant progress in its clinical pipeline, expecting topline data from pivotal trials in 2023. Cash and equivalents stood at $439.9 million, providing ample runway for ongoing research and development.
Syndax Pharmaceuticals (SNDX) appointed Kate Madigan, M.D., as Chief Medical Officer, effective immediately. Dr. Madigan brings over 20 years of clinical hematology expertise and will lead the clinical development strategy at Syndax. She succeeds Michael Meyers, M.D., Ph.D., who will transition to a consulting role. Under her leadership, Syndax expects to advance its pipeline, which includes SNDX-5613 and axatilimab, with pivotal FDA filings anticipated next year, positioning the company to impact underserved cancer treatment areas.
Syndax Pharmaceuticals announced participation in two investor conferences: a panel at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 10:30 a.m. ET, and a presentation at the Barclays Global Healthcare Conference on March 16, 2022, at 3:50 p.m. ET. Both events will be available via live webcast on www.syndax.com, along with replays. Syndax is advancing an innovative cancer therapy pipeline, including SNDX-5613, axatilimab, and entinostat. These events aim to engage investors and communicate the company’s progress in developing cancer treatments.
Soligenix, a late-stage biopharmaceutical company focused on rare diseases, will present at the BIO CEO & Investor Conference from February 14-17, 2022. The presentation, available on-demand from February 11, will be led by CEO Christopher J. Schaber, PhD. Attendees can also schedule one-on-one meetings with management during the conference. Soligenix is advancing potential treatments like HyBryte™ for cutaneous T-cell lymphoma and RiVax® for ricin toxin exposure. For more details, visit the conference website.
Syndax Pharmaceuticals has announced a leadership transition, with Michael A. Metzger becoming the new Chief Executive Officer and Briggs W. Morrison transitioning to President and Head of Research and Development, effective February 3, 2022. Both executives will remain on the Board of Directors. This change aims to better align their roles with their expertise as the company prepares for ongoing clinical trials and potential New Drug Applications for their product candidates, SNDX-5613 and axatilimab, expected in 2023.
Syndax Pharmaceuticals announced management will participate in a fireside chat at B. Riley Securities' 2022 Oncology Conference on January 27, 2022, at 12:00 p.m. ET. The event will be accessible via a live webcast on the Investor section of the Company's website, with a replay available for a limited time. Syndax is focused on developing innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat. For detailed information, visit www.syndax.com.
Syndax Pharmaceuticals (Nasdaq: SNDX) announced that CEO Briggs W. Morrison will present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 08:15 a.m. ET. The presentation will be available via live webcast on the Company’s Investor website, with replays accessible for a limited time. Syndax is a clinical stage biopharmaceutical company focusing on innovative cancer therapies, including SNDX-5613, axatilimab, and entinostat.
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.
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?
