Welcome to our dedicated page for Springworks Therapeutics news (Ticker: SWTX), a resource for investors and traders seeking the latest updates and insights on Springworks Therapeutics stock.
SpringWorks Therapeutics, Inc. (former Nasdaq: SWTX) generates a steady flow of news as a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer. Company announcements emphasize its approved medicines OGSIVEO (nirogacestat) for adults with desmoid tumors and GOMEKLI / EZMEKLY (mirdametinib) for adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), as well as its broader pipeline of targeted therapy product candidates for rare tumors and hematological cancers.
News items for SWTX commonly cover clinical and regulatory milestones. For nirogacestat, SpringWorks has reported pivotal and long-term data from the Phase 3 DeFi trial in desmoid tumors, including publications in peer-reviewed journals and analyses of progression-free survival, objective response rates, tumor size reductions and patient-reported outcomes. For mirdametinib, the company has highlighted results from the Phase 2b ReNeu trial in NF1-PN, describing objective response rates, durable tumor volume reductions and improvements in pain and quality of life in both adult and pediatric patients.
Regulatory developments are another frequent theme. SpringWorks has issued releases on FDA approvals of OGSIVEO and GOMEKLI, Orphan Drug designations, and European Commission decisions granting marketing authorization for OGSIVEO and conditional authorization for EZMEKLY. The company also reports on opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and anticipated timelines for European regulatory decisions.
Corporate and transaction news is also prominent. In 2025, SpringWorks and Merck KGaA, Darmstadt, Germany announced a definitive agreement for Merck KGaA, Darmstadt, Germany to acquire SpringWorks, followed by updates on shareholder votes, expected closing timing and the completion of the merger. Financial updates, such as quarterly and annual results, product revenue figures for OGSIVEO, cash position, and pipeline progress, are provided through earnings releases.
Investors and observers following SWTX-related news can use this page to review historical announcements on clinical trial readouts, regulatory approvals, safety information, strategic transactions and pipeline developments associated with SpringWorks Therapeutics.
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.
SpringWorks Therapeutics (Nasdaq: SWTX) announced encouraging interim data from the Phase 2b ReNeu trial of mirdametinib, an investigational MEK inhibitor for NF1-associated plexiform neurofibromas (NF1-PN). Presented at the 2021 Children’s Tumor Foundation NF Conference, the update showed that 50% of the first 20 adult patients achieved a ≥20% reduction in tumor volume, with 80% remaining on treatment after 12 months. Mirdametinib was generally well tolerated, with adverse events primarily at Grade 1 or 2 levels. The trial aims to complete enrollment in late 2021.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a clinical trial collaboration with Seagen Inc. to evaluate nirogacestat, a gamma secretase inhibitor, combined with Seagen's SEA-BCMA monoclonal antibody for treating multiple myeloma. Nirogacestat aims to enhance BCMA-targeted therapies by increasing membrane-bound BCMA. Seagen will conduct the Phase 1 study, with costs covered, and a joint committee will oversee it. SpringWorks is also conducting a Phase 3 trial for nirogacestat as a monotherapy for desmoid tumors and has received FDA orphan drug designation.
SpringWorks Therapeutics, a clinical-stage biopharmaceutical company specializing in rare diseases and cancer treatments, announced participation in a Fireside Chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021. The event is scheduled for 3:00 PM ET. Interested parties can access the live webcast via the company’s Investors & Media section. A recording will be available afterward. SpringWorks is advancing clinical trials for targeted oncology therapies and has formed partnerships to enhance its portfolio.
SpringWorks Therapeutics (Nasdaq: SWTX) announced its participation in a Fireside Chat at the Cowen 2nd Annual Oncology Innovation Summit on May 21, 2021, at 10:00 AM ET. The event aims to highlight the company’s efforts in developing medicines for rare diseases and cancer. Interested parties can access the live webcast through the company’s website, with a replay available afterward. SpringWorks is known for its precision medicine approach and is advancing clinical trials for targeted oncology product candidates.