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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) is a dynamic, mission-driven biopharmaceutical company dedicated to creating transformative medicines for underserved patient populations facing severe rare diseases and cancer. Initially conceived by Pfizer, SpringWorks exemplifies a novel model of collaboration by connecting scientists, biopharmaceutical partners, patient groups, funders, and philanthropists to propel cutting-edge science into clinical reality. Founded in 2017, the company's name reflects its proactive approach to drug development, focusing on addressing unmet medical needs promptly.
SpringWorks employs a precision medicine approach to acquiring, developing, and commercializing life-changing therapies. The company's portfolio includes a range of small molecule targeted oncology product candidates, with a focus on debilitating conditions such as desmoid tumors, neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), hereditary xerocytosis, and post-traumatic stress disorder. Among its significant achievements, SpringWorks recently launched OGSIVEO™ (nirogacestat), the first U.S. Food and Drug Administration (FDA)-approved therapy for adults with progressing desmoid tumors.
In December 2023, SpringWorks successfully priced an underwritten public offering, raising approximately $275 million to further its development initiatives. This financial boost supports ongoing and future clinical trials, such as the Phase 2 trial evaluating nirogacestat in recurrent ovarian granulosa cell tumors and multiple BCMA-directed therapies in collaboration with industry leaders.
SpringWorks' strategic collaborations extend to both industry and academia, enhancing its ability to deliver innovative treatment options. The company’s precision medicine strategy has facilitated rapid advancements in clinical trials for rare tumor types and genetically defined cancers. For instance, the Phase 2b ReNeu trial for mirdametinib, an investigational MEK inhibitor for NF1-PN, has shown promising results and is soon to be submitted for FDA approval.
The company’s approach to clinical development is underscored by its diversified oncology pipeline. This includes efforts to address highly prevalent, genetically defined cancers and solid tumors. SpringWorks continues to expand its reach with ongoing trials and upcoming regulatory submissions, aiming to bring more life-altering therapies to patients.
SpringWorks remains focused on its mission to improve the lives of patients with severe and rare diseases while demonstrating robust operational excellence and strategic growth. For more detailed and updated information, please visit www.springworkstx.com and follow SpringWorks on X, LinkedIn, and YouTube.
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.
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.
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