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 presented long-term efficacy and safety data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid tumors. With a median treatment duration of 33.6 months, the data showed further tumor size reductions, increased objective response rate (ORR) of 45.7% (34.3% partial responses, 11.4% complete responses), and sustained improvement in patient symptoms. The median best reduction in tumor size improved from -32.3% at year one to -75.8% for patients completing four years of treatment. Most adverse events were Grade 1 or 2, with decreasing severity over time.
SpringWorks Therapeutics (Nasdaq: SWTX), a commercial-stage biopharmaceutical company specializing in rare diseases and cancer treatments, has announced its participation in Guggenheim's Inaugural Healthcare Innovation Conference. The company's management will engage in a fireside chat on Wednesday, November 13, 2024, at 1:00 p.m. ET in Boston, Massachusetts. A live webcast will be available on the company's investor relations website, with a replay accessible for a time after the event.
SpringWorks Therapeutics (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focusing on severe rare diseases and cancer, has announced its plans to report third quarter 2024 financial results on Tuesday, November 12, 2024. The company will host a live conference call and webcast at 8:30 a.m. ET to discuss the financial results and provide recent business updates.
Interested parties can join the live webcast and view the accompanying slides by clicking on the provided link. To participate in the conference call by phone, pre-registration is required through another provided link. Registered participants will receive a dial-in number and conference code for access. A replay of the webcast will be available for a time on the company's Investors & Media section of their website.
SpringWorks Therapeutics (Nasdaq: SWTX) announced that the FDA has accepted its New Drug Application (NDA) for mirdametinib, granting it Priority Review for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in adults and children. The PDUFA target action date is set for February 28, 2025. Additionally, the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for mirdametinib.
Mirdametinib has the potential to be the first approved therapy for adult patients and a best-in-class therapy for children with NF1-PN. The FDA has previously granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for mirdametinib. The submissions include data from the pivotal Phase 2b ReNeu trial, which demonstrated robust objective response rates, durable responses, and improvements in pain and quality of life.
SpringWorks Therapeutics (Nasdaq: SWTX) reported Q2 2024 financial results and business highlights. Key points include:
1. $40.2 million in OGSIVEO® (nirogacestat) net product revenue.
2. Completed NDA submission to FDA for mirdametinib for NF1-PN treatment.
3. Presented Phase 2b ReNeu trial results and Phase 3 DeFi trial analyses at 2024 ASCO Annual Meeting.
4. Initiated Phase 1a trial of SW-682 for Hippo mutant solid tumors.
5. Q2 net loss of $39.9 million ($0.54 per share), compared to $77.9 million ($1.25 per share) in Q2 2023.
6. Cash, cash equivalents, and marketable securities of $521.9 million as of June 30, 2024.
SpringWorks Therapeutics (Nasdaq: SWTX), a commercial-stage biopharmaceutical company, has appointed Dr. Martin Mackay to its Board of Directors. Dr. Mackay brings over 30 years of pharmaceutical and biotech R&D experience, having held leadership roles at Pfizer, AstraZeneca, and Alexion. He is currently the Executive Chairman of Rallybio, a clinical-stage biotech company focused on rare diseases.
CEO Saqib Islam praised Dr. Mackay's expertise in rare diseases and R&D leadership, stating it will be valuable as SpringWorks advances its pipeline. Dr. Mackay expressed enthusiasm for joining the board, citing SpringWorks' potential to make a significant impact in therapeutic areas with tremendous potential.
SpringWorks Therapeutics (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focusing on severe rare diseases and cancer, has announced its upcoming second quarter 2024 financial results report. The company will host a live conference call and webcast on Wednesday, August 7, 2024, at 8:30 a.m. ET to present the results and discuss recent business updates. Interested parties can join the webcast to view the presentation slides or pre-register for the conference call to participate by phone. A replay of the webcast will be available for a time on the company's investor relations website.
SpringWorks Therapeutics has submitted a New Drug Application (NDA) to the FDA for mirdametinib, a MEK inhibitor aimed at treating neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in both children and adults. This submission follows the pivotal Phase 2b ReNeu trial, which demonstrated significant objective response rates, improved pain and quality of life, and a manageable safety profile. The FDA has granted mirdametinib Orphan Drug, Fast Track, and Rare Pediatric Disease designations. SpringWorks also plans to seek regulatory approval in the EU later this year.
SpringWorks Therapeutics, a commercial-stage biopharmaceutical company (Nasdaq: SWTX), will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, in Miami, Florida. The company's management will engage in a fireside chat at 2:00 p.m. ET. A live webcast of the event will be accessible via the company's Investors & Media section on their website, with a replay available shortly after the event concludes.
SpringWorks Therapeutics will present four abstracts at the 2024 ASCO Annual Meeting from May 31 to June 4, 2024. Key highlights include data from the Phase 2b ReNeu trial of mirdametinib for NF1-PN patients, showing significant tumor volume reductions and improved quality of life for both adults and children. Additionally, three analyses from the Phase 3 DeFi trial of nirogacestat for desmoid tumors will be presented, demonstrating consistent safety and efficacy. The ReNeu trial reported a 41% confirmed ORR in adults and 52% in children, with deep and durable tumor volume reductions. In the DeFi trial, nirogacestat showed improvements in progression-free survival and overall response rate in high-risk desmoid tumor patients.