SpringWorks Therapeutics, Inc. - SWTX STOCK NEWS

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.

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.