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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, Inc. (Nasdaq: SWTX) has announced a clinical trial collaboration with Regeneron Pharmaceuticals, Inc. to evaluate nirogacestat in combination with Regeneron's REGN5458 for treating relapsed multiple myeloma. This partnership marks SpringWorks' eighth collaboration focused on BCMA therapies. Nirogacestat, currently in Phase 3 trials for desmoid tumors, aims to enhance the efficacy of BCMA-targeted therapies by preserving membrane-bound BCMA. Regeneron will lead the clinical study while SpringWorks will provide nirogacestat. The drug has received multiple FDA designations for its potential benefits.
SpringWorks Therapeutics (SWTX) reported no revenue for Q4 and full-year 2021, a decline from $35 million in the previous year. R&D expenses surged to $29.3 million for Q4 and $101.7 million for the year, driven by increased personnel and trial costs. General and Administrative expenses also rose to $26.5 million in Q4, resulting in a net loss of $56.1 million for Q4 and $173.9 million for the year. Despite these losses, cash reserves stood strong at $432.7 million as of December 31, 2021. Upcoming milestones include topline data from the Phase 3 DeFi Trial anticipated in H1 2022.
SpringWorks Therapeutics, focused on rare diseases and cancer treatments, announced its participation in three upcoming investor conferences. The events include the Guggenheim Oncology Conference on February 10, Cowen 42nd Annual Health Care Conference on March 7, and Barclays Global Healthcare Conference on March 16. Webcasts will be available on the company’s website for each conference, with replays offered for a limited time. SpringWorks is advancing 17 development programs and emphasizes a precision medicine approach.
SpringWorks Therapeutics (Nasdaq: SWTX) announced that CEO Saqib Islam will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 8:15 am ET. A video webcast of the event will be available on the company's Investors & Media section of their website, with a replay accessible afterward. SpringWorks focuses on developing medicines for severe rare diseases and cancer, with 17 development programs in progress, including two late-stage clinical trials.
SpringWorks Therapeutics (SWTX) has announced a clinical collaboration with AbbVie to study nirogacestat in combination with ABBV-383 for treating relapsed or refractory multiple myeloma. This marks the seventh BCMA collaboration for SpringWorks. AbbVie will sponsor the Phase 1b study, covering all costs except for nirogacestat manufacturing and certain intellectual property expenses. Nirogacestat has shown promise in preclinical studies by enhancing the effectiveness of BCMA-targeted therapies. The study is set to begin in the first half of 2022.
SpringWorks Therapeutics (Nasdaq: SWTX) has initiated a Phase 1b/2 trial for nirogacestat, a gamma secretase inhibitor, alongside Pfizer's elranatamab for treating relapsed or refractory multiple myeloma. The trial aims to assess safety, tolerability, and preliminary efficacy. Preclinical studies indicate that nirogacestat may enhance BCMA-targeted therapies by increasing BCMA density on myeloma cells. This collaboration with Pfizer also includes a joint development approach, intending to improve treatment options for patients.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced the full enrollment of its Phase 2b ReNeu trial, which evaluates mirdametinib, a MEK inhibitor, for treating NF1-associated plexiform neurofibromas (NF1-PN) in adults and children. Over 50 adults and 50 pediatric patients have been enrolled. The trial will assess the drug's efficacy, safety, and tolerability with a primary endpoint of a ≥ 20% tumor volume reduction. Interim data showed promising results, with 50% of the initial patients responding positively to treatment. The company plans to share further updates at an upcoming R&D Day.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) will participate in a Fireside Chat at the 4th Annual Evercore ISI HealthCONx Conference on November 30, 2021, at 3:30 pm ET. The event will be held virtually, and a video webcast can be accessed through the company’s Investors & Media page. SpringWorks specializes in developing medicines for severe rare diseases and cancer, with 16 development programs and two advanced product candidates in late-stage clinical trials. For further details, visit SpringWorks’ website.
SpringWorks Therapeutics (SWTX) reported significant advancements in its oncology pipeline, including progression to randomized Phase 2 studies for nirogacestat in patients with relapsed multiple myeloma. The company also expanded its oncology portfolio with the in-licensing of next-generation EGFR inhibitors, initiated a Phase 1/2 study for mirdametinib in breast cancer, and secured new patents extending protection until 2041. Financially, R&D expenses rose to $22.9 million and G&A expenses increased to $18 million, contributing to a net loss of $41 million for Q3 2021.
SpringWorks Therapeutics (SWTX) has announced the initiation of a randomized Phase 2 cohort expansion study exploring the combination of BLENREP (0.95 mg/kg Q3W) with nirogacestat in patients with relapsed/refractory multiple myeloma. This follows positive preliminary data from earlier trials. Additionally, two new sub-studies are planned to assess this combination with standard therapies. The company continues to focus on nirogacestat’s potential as a cornerstone therapy, collaborating closely with GlaxoSmithKline amidst ongoing evaluations in various clinical studies.
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