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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) is a dynamic, mission-driven biopharmaceutical company dedicated to creating transformative medicines for underserved patient populations facing severe rare diseases and cancer. Initially conceived by Pfizer, SpringWorks exemplifies a novel model of collaboration by connecting scientists, biopharmaceutical partners, patient groups, funders, and philanthropists to propel cutting-edge science into clinical reality. Founded in 2017, the company's name reflects its proactive approach to drug development, focusing on addressing unmet medical needs promptly.
SpringWorks employs a precision medicine approach to acquiring, developing, and commercializing life-changing therapies. The company's portfolio includes a range of small molecule targeted oncology product candidates, with a focus on debilitating conditions such as desmoid tumors, neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), hereditary xerocytosis, and post-traumatic stress disorder. Among its significant achievements, SpringWorks recently launched OGSIVEO™ (nirogacestat), the first U.S. Food and Drug Administration (FDA)-approved therapy for adults with progressing desmoid tumors.
In December 2023, SpringWorks successfully priced an underwritten public offering, raising approximately $275 million to further its development initiatives. This financial boost supports ongoing and future clinical trials, such as the Phase 2 trial evaluating nirogacestat in recurrent ovarian granulosa cell tumors and multiple BCMA-directed therapies in collaboration with industry leaders.
SpringWorks' strategic collaborations extend to both industry and academia, enhancing its ability to deliver innovative treatment options. The company’s precision medicine strategy has facilitated rapid advancements in clinical trials for rare tumor types and genetically defined cancers. For instance, the Phase 2b ReNeu trial for mirdametinib, an investigational MEK inhibitor for NF1-PN, has shown promising results and is soon to be submitted for FDA approval.
The company’s approach to clinical development is underscored by its diversified oncology pipeline. This includes efforts to address highly prevalent, genetically defined cancers and solid tumors. SpringWorks continues to expand its reach with ongoing trials and upcoming regulatory submissions, aiming to bring more life-altering therapies to patients.
SpringWorks remains focused on its mission to improve the lives of patients with severe and rare diseases while demonstrating robust operational excellence and strategic growth. For more detailed and updated information, please visit www.springworkstx.com and follow SpringWorks on X, LinkedIn, and YouTube.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a licensing agreement with Dana-Farber Cancer Institute for novel small molecule inhibitors targeting EGFR mutations in lung cancer. This portfolio, developed at Stanford Medicine, aims to address resistance mutations, notably the C797S mutation. SpringWorks will provide an upfront payment and may owe future milestones and royalties. Additionally, they entered a multi-year Sponsored Research Agreement to support ongoing research at Stanford and Dana-Farber. The company's strategy focuses on precision medicine and targeted therapies for solid tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) announced its participation in the H.C. Wainwright 23rd Annual Global Investment Conference. The management presentation will be available on-demand starting September 13, 2021, at 7:00 am ET. Interested parties can access the webcast via the 'Events & Presentations' section on the company’s website. SpringWorks is focused on developing medicines for severe rare diseases and cancers, with a portfolio that includes 15 development programs and two lead candidates in late-stage clinical trials.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a sponsored research collaboration with Dana-Farber Cancer Institute to further investigate nirogacestat in combination with anti-B-cell maturation antigen (BCMA) therapies for multiple myeloma. Dr. Constantine Mitsiades will lead the research, utilizing preclinical models to explore nirogacestat's mechanism of action. SpringWorks retains an option to exclusively license any new intellectual property from this collaboration. Nirogacestat is currently in Phase 3 clinical development for desmoid tumors and has shown promise in enhancing BCMA-targeted therapies.
SpringWorks Therapeutics (SWTX) announced significant advancements in its clinical development programs, including collaborations to evaluate nirogacestat with BCMA therapies for patients with multiple myeloma. The company also secured a new U.S. patent for mirdametinib, extending its protection until 2041. Q2 2021 financials indicated an increase in R&D expenses to $32.1 million and a net loss of $47.0 million. The company holds a strong cash position with $507.5 million as of June 30, 2021, and expects important data readouts in the second half of the year.
SpringWorks Therapeutics (Nasdaq: SWTX) announced participation in the 12th Annual Wedbush PacGrow Healthcare Conference on August 11, 2021, at 9:45 AM ET. The management will engage in a Fireside Chat discussing the company's innovative approach to developing medicines for severe rare diseases and cancer. Interested parties can access the live webcast through the Investors & Media section of the company's website. SpringWorks is advancing 15 development programs, focusing on targeted oncology and has entered into multiple strategic partnerships to enhance its portfolio.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced a platform study evaluating mirdametinib, an investigational MEK inhibitor, for patients with ER+ metastatic breast cancer and advanced solid tumors with MAPK-activating mutations. The trial, backed by Memorial Sloan Kettering Cancer Center, aims to recruit patients in Q3 2021. Mirdametinib will be assessed in combination with fulvestrant for ER+ mBC and as a standalone treatment for tumors driven by MEK1 or MEK2 mutations. The study seeks to address treatment resistance and improve outcomes in these patient populations.
SpringWorks Therapeutics (Nasdaq: SWTX) announced the appointment of James Cassidy, M.D., Ph.D., as its new Chief Medical Officer, succeeding Jens Renstrup, M.D., MBA. Dr. Cassidy brings over 30 years of oncology experience, including significant roles at Regeneron, Celgene, and Bristol-Myers Squibb. His leadership is expected to enhance SpringWorks' targeted oncology focus. The company continues to advance its differentiated portfolio, with ongoing clinical trials for rare tumors and genetically defined cancers.
SpringWorks Therapeutics (Nasdaq: SWTX) announced the issuance of U.S. Patent No. 11,066,358 for mirdametinib, which is under development for multiple oncology indications, including NF1-associated plexiform neurofibromas (NF1-PN). This patent, expiring in 2041 and assigned to Pfizer, enhances patent protection for the compound. CEO Saqib Islam emphasized the importance of this patent in their strategy to expand intellectual property for targeted oncology treatments. Mirdametinib is currently in clinical trials for various cancer types, with over 250 subjects having been treated.
Precision BioSciences (DTIL) and SpringWorks Therapeutics (SWTX) announced that the first patient has been dosed in their Phase 1/2a trial combining PBCAR269A, an allogeneic CAR T cell therapy targeting BCMA, with nirogacestat, a gamma secretase inhibitor, for treating relapsed/refractory multiple myeloma.
Precision is also gearing up to share interim results from monotherapy studies and plans to progress PBCAR269B into clinical trials in 2022, highlighting their commitment to developing innovative therapies.
SpringWorks Therapeutics (Nasdaq: SWTX) has initiated a Phase 1/2 clinical trial for mirdametinib, a MEK inhibitor targeting low-grade glioma (LGG) in pediatric patients. Sponsored by St. Jude Children’s Research Hospital, the trial aims to assess the safety and efficacy of mirdametinib in children and young adults aged 2 to 24. With over 250 previous subjects treated, mirdametinib shows promise in addressing the unmet medical needs of pediatric LGG, which lacks FDA-approved therapies. The study will enroll up to 130 patients, offering hope for improved outcomes in this challenging condition.
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