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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 (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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