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.
On April 17, 2023, SpringWorks Therapeutics (NASDAQ: SWTX) and partners presented updated clinical data for BGB-3245, a selective RAF dimer inhibitor, at the AACR Annual Meeting 2023. This Phase 1a/1b study focuses on patients with advanced solid tumors bearing MAPK pathway aberrations. The preliminary results, showcased by Dr. Alison M. Schram, demonstrate a manageable safety profile with an 18% objective response rate and a disease control rate of 79%. Patients exhibited an average of three prior therapies, indicating potential for BGB-3245 in BRAF V600E and NRAS mutant populations. The study has progressed to Phase 1b dose expansion since October 2022, aiming to confirm these findings in defined patient cohorts.
SpringWorks Therapeutics (SWTX) announced significant results from the Phase 3 DeFi trial of nirogacestat for desmoid tumors. The investigational oral drug showed a 71% reduction in disease progression risk compared to placebo, achieving a median progression-free survival (PFS) not reached versus 15.1 months for placebo. The objective response rate was 41% for nirogacestat versus 8% for placebo. Nirogacestat also improved key patient-reported outcomes, including pain and quality of life. The FDA is reviewing the New Drug Application with a PDUFA action date of August 27, 2023, highlighting the potential to address an unmet need in desmoid tumor treatment.
SpringWorks Therapeutics (Nasdaq: SWTX) announced management's participation in a fireside chat at the Cowen 43rd Annual Health Care Conference on March 7, 2023, at 12:50 p.m. ET. The event will focus on the company's mission to develop life-changing medicines for patients with severe rare diseases and cancer. Interested parties can access the live webcast through the Investors & Media section on their website, with a replay available afterward. SpringWorks is known for its targeted oncology pipeline and innovative partnerships aimed at advancing clinical development in rare and genetically defined cancers.
SpringWorks Therapeutics received FDA acceptance for its NDA for nirogacestat for treating adults with desmoid tumors and was granted Priority Review, with a PDUFA date set for August 27, 2023. The company expects topline data from the Phase 2b ReNeu trial for mirdametinib in patients with NF1-associated plexiform neurofibromas in the second half of 2023 and anticipates an NDA submission in early 2024. SpringWorks ended 2022 with $597.0 million in cash and equivalents, supporting its operations into 2026.
SpringWorks Therapeutics (Nasdaq: SWTX) recently announced that the FDA has accepted its New Drug Application (NDA) for nirogacestat, a gamma secretase inhibitor aimed at treating adults with desmoid tumors. The NDA has received Priority Review status, with a PDUFA action date set for August 27, 2023. This designation is reserved for drugs that promise significant treatment advancements for serious conditions. The NDA’s review is based on positive results from the Phase 3 DeFi trial, which evaluated nirogacestat's efficacy and safety in desmoid tumor patients. Currently, there are no FDA-approved therapies for this condition.
SpringWorks Therapeutics (Nasdaq: SWTX) presented its achievements from 2022 and key goals for 2023 at the J.P. Morgan Healthcare Conference. The company highlighted positive Phase 3 data for nirogacestat in desmoid tumors and the submission of an NDA to the FDA for the same treatment, which is currently under review. Financially, SpringWorks reported over $650 million in cash and equivalents, ensuring a runway into 2026. Upcoming milestones include potential FDA approval for nirogacestat and planned NDA submissions for mirdametinib.
SpringWorks Therapeutics (Nasdaq: SWTX) announced that CEO Saqib Islam will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 7:30 a.m. PT. Interested parties can access the live webcast through the company's Investors & Media section. A replay will also be available for a limited time post-event.
SpringWorks is focused on developing medicines for severe rare diseases and cancer, featuring a robust oncology pipeline and strategic partnerships to enhance patient solutions.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has submitted a New Drug Application (NDA) to the FDA for nirogacestat, aimed at treating adults with desmoid tumors. The NDA is under the FDA's Real-Time Oncology Review program and includes data from the Phase 3 DeFi trial, which assessed efficacy and safety. Nirogacestat has received Fast Track, Breakthrough Therapy, and Orphan Drug designations due to its potential impact on a serious unmet medical need. SpringWorks emphasizes its commitment to expediting access to this therapy for patients with desmoid tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) will participate in a fireside chat at the Evercore ISI 5th Annual HealthCONx Conference on November 29, 2022, at 4:20 p.m. ET. The event will be held virtually, and investors can access the live webcast on the company's website. A replay will be available for a limited time afterward. SpringWorks focuses on developing life-changing medicines for patients with severe rare diseases and cancer, emphasizing precision medicine and a robust oncology pipeline.
SpringWorks Therapeutics (SWTX) presented positive data from its Phase 3 DeFi trial of nirogacestat at ESMO 2022, showing a 71% reduction in the risk of disease progression for patients with desmoid tumors. The company also expanded its collaboration with GSK for nirogacestat in multiple myeloma and initiated a Phase 2 trial for ovarian granulosa cell tumors. Financially, SpringWorks has over $650 million in cash and equivalents, providing a runway into 2026, despite reporting a net loss of $72.4 million in Q3 2022.