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SpringWorks Therapeutics, Inc. - SWTX STOCK NEWS

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. (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.

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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 appoints Tai-An Lin, Ph.D. as Chief Scientific Officer
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SpringWorks Therapeutics, Inc. (SWTX) Reports Positive Phase 3 DeFi Data and Updates on Clinical Trials
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SpringWorks Therapeutics announced that the FDA has extended the PDUFA date for the NDA of nirogacestat by three months to November 27, 2023. The extension is due to the FDA's request for additional time to review data provided by SpringWorks. No additional data or studies have been requested at this time.
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FAQ

What is the current stock price of SpringWorks Therapeutics (SWTX)?

The current stock price of SpringWorks Therapeutics (SWTX) is $35.59 as of December 20, 2024.

What is the market cap of SpringWorks Therapeutics (SWTX)?

The market cap of SpringWorks Therapeutics (SWTX) is approximately 2.6B.

What is SpringWorks Therapeutics, Inc.?

SpringWorks Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines for severe rare diseases and cancer.

What is the company's latest product?

SpringWorks recently launched OGSIVEO™ (nirogacestat), the first FDA-approved therapy for adults with progressing desmoid tumors.

What is SpringWorks' approach to drug development?

SpringWorks employs a precision medicine approach, focusing on innovative treatments for underserved patient populations with severe diseases.

What are some of the key diseases SpringWorks is targeting?

SpringWorks is targeting diseases such as desmoid tumors, neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), hereditary xerocytosis, and post-traumatic stress disorder.

What recent financial achievement did SpringWorks make?

In December 2023, SpringWorks raised approximately $275 million through a public offering to support its development initiatives.

What is the focus of SpringWorks' strategic collaborations?

SpringWorks collaborates with industry and academia to enhance its ability to deliver innovative treatment options and accelerate clinical advancements.

What clinical trials is SpringWorks currently advancing?

SpringWorks is advancing several clinical trials, including trials for nirogacestat in recurrent ovarian granulosa cell tumors and mirdametinib for NF1-PN.

How does SpringWorks plan to expand its treatment offerings?

SpringWorks plans to expand by progressing its diversified oncology pipeline and submitting new drug applications for emerging therapies.

Where can I find more information about SpringWorks?

For more information, visit www.springworkstx.com and follow SpringWorks on X, LinkedIn, and YouTube.

Who can I contact for investor relations information?

For investor relations information, you can contact Kim Diamond, Vice President of Communications and Investor Relations, at kdiamond@springworkstx.com.

SpringWorks Therapeutics, Inc.

Nasdaq:SWTX

SWTX Rankings

SWTX Stock Data

2.57B
70.75M
1.92%
116.49%
16.52%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
STAMFORD