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. (SWTX) is a clinical-stage biopharmaceutical company pioneering targeted therapies for rare diseases and oncology. This news hub provides investors and healthcare professionals with essential updates on therapeutic advancements, regulatory milestones, and strategic collaborations.
Access authoritative information on SWTX's precision medicine pipeline, including FDA communications, clinical trial developments, and partnership announcements. Our curated collection features:
• Regulatory updates on approved therapies and review timelines
• Clinical trial progress across rare disease and oncology programs
• Research collaborations with academic institutions and industry leaders
• Scientific presentations at major medical symposiums
Bookmark this page for real-time access to verified SWTX developments. For comprehensive analysis of the company's therapeutic pipeline and market position, visit regularly for the latest updates directly from primary sources.
SpringWorks Therapeutics (SWTX) has received FDA approval for GOMEKLI™ (mirdametinib), the first medicine approved for both adults and children with NF1-PN (neurofibromatosis type 1 with plexiform neurofibromas). The approval is based on the Phase 2b ReNeu trial results, which showed significant efficacy with a 41% objective response rate in adults and 52% in children.
The trial demonstrated deep and durable tumor volume reductions, with median best percentage changes of -41% in adults and -42% in children. The responses were long-lasting, with approximately 90% of patients maintaining responses for at least 12 months. GOMEKLI showed a manageable safety profile, with common side effects including rash, diarrhea, and nausea.
SpringWorks received a rare pediatric disease priority review voucher from the FDA. The drug is expected to be available in the US within two weeks through specialty pharmacies.
SpringWorks Therapeutics (SWTX) has announced it will host a conference call and webcast on Thursday, February 20, 2025, at 8:30 a.m. ET to discuss its fourth quarter and full year 2024 financial results along with recent business updates. The commercial-stage biopharmaceutical company, which focuses on severe rare diseases and cancer, will provide access to the live webcast with accompanying slides. Participants wishing to join the conference call need to pre-register to receive dial-in details. A replay of the webcast will be temporarily available on the company's investor relations website.
SpringWorks Therapeutics (SWTX) reported preliminary Q4 and full-year 2024 results, with OGSIVEO® achieving $61.5 million in Q4 and $172.0 million in full-year U.S. net product revenues. The company ended 2024 with $461.9 million in cash, cash equivalents, and marketable securities, expecting to fund operations through profitability anticipated in H1 2026.
Long-term follow-up data from the Phase 3 DeFi trial showed improved outcomes with nirogacestat, including further tumor size reductions and increased response rates. The company secured a global license from Rappta Therapeutics for SW-3431, a PP2A molecular glue, for $13 million upfront.
Key 2025 priorities include continuing OGSIVEO's U.S. launch, securing EU approval, launching mirdametinib for NF1-PN treatment (PDUFA: February 28, 2025), and advancing pipeline programs including SW-682 and SW-3431.
SpringWorks Therapeutics (SWTX), a commercial-stage biopharmaceutical company specializing in severe rare diseases and cancer, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Chief Executive Officer Saqib Islam will deliver a presentation on Monday, January 13, 2025, at 11:15 a.m. PT.
The presentation will be accessible via live webcast through the Events & Presentations page in the Investors & Media section of SpringWorks' website. Interested parties can view a replay of the presentation for a time following the conference through the company's website at ir.springworkstx.com.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Tuesday, December 3, 2024, at 12:30 p.m. ET in Coral Gables, Florida.
The event will be accessible via live webcast through the Events & Presentations page on SpringWorks' investor website. A replay will be available for a time after the conference. SpringWorks is a commercial-stage biopharmaceutical company specializing in severe rare diseases and cancer treatments.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced its participation in the upcoming Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, November 19, 2024, at 10:30 a.m. ET in London, UK. The event will be accessible via live webcast through the Events & Presentations page on SpringWorks' investor website. A replay will be available for a time after the conference.
SpringWorks Therapeutics (SWTX) reported Q3 2024 financial results with $49.3 million in OGSIVEO® net product revenue, a 23% increase from Q2. The company posted a net loss of $53.5 million ($0.72 per share). Long-term follow-up data from Phase 3 DeFi trial showed improved tumor reduction and safety profile. The FDA granted Priority Review for mirdametinib NDA with PDUFA date of February 28, 2025. With $498.1 million in cash and equivalents, SpringWorks expects to achieve profitability by first half of 2026.
SpringWorks Therapeutics (SWTX) announced positive data from its pivotal Phase 2b ReNeu trial of mirdametinib for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The trial demonstrated deep and sustained tumor volume reductions, with 62% of adults and 52% of children achieving deep response (>50% reduction). Quality of life improvements were clinically meaningful and sustained. Additionally, promising results from a Phase 1/2 study in pediatric low-grade glioma showed a 63% objective response rate. The FDA granted Priority Review for mirdametinib's New Drug Application with a decision date of February 28, 2025.
SpringWorks Therapeutics announced the publication of pivotal Phase 2b ReNeu trial results for mirdametinib in the Journal of Clinical Oncology. The trial evaluated the MEK inhibitor in adults and children with NF1-PN, demonstrating significant confirmed objective response rates of 41% in adults and 52% in children. The study showed deep and durable tumor volume reductions, with median best percentage changes of -41% in adults and -42% in children. Patients experienced early and sustained improvements in pain and quality of life. The treatment was generally well-tolerated, with mostly Grade 1 or 2 adverse events. The FDA's PDUFA action date is set for February 28, 2025.
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.
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