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 (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.
SpringWorks Therapeutics, Inc. (SWTX) will participate in the BofA Securities 2024 Health Care Conference in Las Vegas. Management will engage in a fireside chat on May 14, 2024, at 3:40 p.m. PT / 6:40 p.m. ET. Investors can access the live webcast on the company's website.
SpringWorks Therapeutics reported first quarter 2024 financial results and highlighted recent business updates with $21.0 million in OGSIVEO net product revenue, FDA approval of a Supplemental NDA for OGSIVEO, validation from EMA for MAA of nirogacestat, initiation of rolling submission of NDA for mirdametinib, and Phase 2b ReNeu trial results acceptance at ASCO Annual Meeting.
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