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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) presented its 2023 accomplishments and 2024 key milestones at the 42nd Annual J.P. Morgan Healthcare Conference, highlighting FDA approval for OGSIVEO, positive data from the Phase 3 DeFi trial of nirogacestat, and positive topline data from the Phase 2b ReNeu trial evaluating mirdametinib.
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SpringWorks Therapeutics, Inc. (SWTX) to present at 42nd Annual J.P. Morgan Healthcare Conference
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SpringWorks Therapeutics, Inc. (SWTX) closed an underwritten public offering of 10,905,171 shares of its common stock at a public offering price of $29.00 per share, grossing approximately $316.25 million. The offering was managed by Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC. The company's focus on severe rare diseases and cancer is evident from its strategic financial moves.
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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has announced the pricing of an underwritten public offering of 9,482,758 shares of its common stock at a public offering price of $29.00 per share. The gross proceeds from the offering are expected to be approximately $275.0 million.
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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has commenced an underwritten public offering of $250.0 million of shares of its common stock, with an additional option for underwriters to purchase up to $37.5 million more. The joint book-running managers for the offering are Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC, and Guggenheim Securities, LLC. The offering is subject to market and other conditions, and the company has filed an automatic shelf registration statement on Form S-3ASR with the SEC.
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SpringWorks Therapeutics, Inc. (SWTX) to participate in fireside chat at the 6th Annual Evercore ISI HealthCONx Conference
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SpringWorks Therapeutics, Inc. (SWTX) receives FDA approval for OGSIVEO (nirogacestat) as a first FDA-approved therapy for adult patients with progressing desmoid tumors. The approval is based on positive data from Phase 3 DeFi trial, showing significant improvement in progression-free survival and objective response rate, with improvements in pain, physical functioning, and overall quality of life. The FDA approval marks a significant therapeutic advance for patients, making OGSIVEO a potential new standard of care for desmoid tumors.
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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced positive topline results from the pivotal Phase 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The trial confirmed an objective response rate of 52% in pediatric patients and 41% in adult patients. Mirdametinib treatment resulted in deep and durable responses and significant improvements in patient-reported outcome measures. The treatment was generally well tolerated with low rates of adverse events. Additional data will be presented at a medical conference, and NDA submission to the U.S. FDA is planned in the first half of 2024.
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SpringWorks Therapeutics reports Q3 2023 financial results and provides business update. PDUFA target action date for nirogacestat NDA remains set for November 27, 2023. Phase 2b ReNeu trial of mirdametinib on track to report topline data in Q4 2023. Phase 3 DeFi data shows significant improvements in functional status in desmoid tumor patients treated with nirogacestat. First patient dosed in Phase 1b study of nirogacestat in combination with linvoseltamab in multiple myeloma patients.
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SpringWorks Therapeutics announced additional data from the Phase 3 DeFi trial, demonstrating the impact of nirogacestat on physical and role functioning in adults with desmoid tumors. The data showed statistically significant and clinically meaningful improvements in patient-reported outcomes, including pain and both physical and role functioning. Nirogacestat met its primary endpoint of significantly improving progression-free survival compared to placebo. The most frequently reported treatment-emergent adverse events were diarrhea, ovarian dysfunction, nausea, fatigue, hypophosphatemia, and maculopapular rash.
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SpringWorks Therapeutics, Inc.
Nasdaq:SWTX
SWTX Rankings
SWTX Stock Data
3.07B
68.01M
2.69%
107.54%
14.39%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
STAMFORD
About SWTX
springworks therapeutics is a mission-driven medicines company dedicated to developing innovative potential new treatments for unserved and underserved patient communities. originally conceived by pfizer, springworks presents a groundbreaking new model for collaboration rooted in connecting scientists, biopharmaceutical partners, patient groups, funders and philanthropists to advance and deliver transformative science to patients. through our partnerships, we remain focused on providing innovative treatments an additional avenue for development, with our launch pipeline focused on advancing potential programs for four diseases, all of which currently have no cure, including desmoid tumor, neurofibromatosis, hereditary xerocytosis and post-traumatic stress disorder. our name is a reflection of our approach to drug development: we’re springing into action to deliver treatments to people who are in great need and without alternatives.