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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) has initiated a Phase 1/2 clinical trial for mirdametinib, a MEK inhibitor targeting low-grade glioma (LGG) in pediatric patients. Sponsored by St. Jude Children’s Research Hospital, the trial aims to assess the safety and efficacy of mirdametinib in children and young adults aged 2 to 24. With over 250 previous subjects treated, mirdametinib shows promise in addressing the unmet medical needs of pediatric LGG, which lacks FDA-approved therapies. The study will enroll up to 130 patients, offering hope for improved outcomes in this challenging condition.
SpringWorks Therapeutics (Nasdaq: SWTX) announced encouraging interim data from the Phase 2b ReNeu trial of mirdametinib, an investigational MEK inhibitor for NF1-associated plexiform neurofibromas (NF1-PN). Presented at the 2021 Children’s Tumor Foundation NF Conference, the update showed that 50% of the first 20 adult patients achieved a ≥20% reduction in tumor volume, with 80% remaining on treatment after 12 months. Mirdametinib was generally well tolerated, with adverse events primarily at Grade 1 or 2 levels. The trial aims to complete enrollment in late 2021.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a clinical trial collaboration with Seagen Inc. to evaluate nirogacestat, a gamma secretase inhibitor, combined with Seagen's SEA-BCMA monoclonal antibody for treating multiple myeloma. Nirogacestat aims to enhance BCMA-targeted therapies by increasing membrane-bound BCMA. Seagen will conduct the Phase 1 study, with costs covered, and a joint committee will oversee it. SpringWorks is also conducting a Phase 3 trial for nirogacestat as a monotherapy for desmoid tumors and has received FDA orphan drug designation.
SpringWorks Therapeutics, a clinical-stage biopharmaceutical company specializing in rare diseases and cancer treatments, announced participation in a Fireside Chat at the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021. The event is scheduled for 3:00 PM ET. Interested parties can access the live webcast via the company’s Investors & Media section. A recording will be available afterward. SpringWorks is advancing clinical trials for targeted oncology therapies and has formed partnerships to enhance its portfolio.
SpringWorks Therapeutics (Nasdaq: SWTX) announced its participation in a Fireside Chat at the Cowen 2nd Annual Oncology Innovation Summit on May 21, 2021, at 10:00 AM ET. The event aims to highlight the company’s efforts in developing medicines for rare diseases and cancer. Interested parties can access the live webcast through the company’s website, with a replay available afterward. SpringWorks is known for its precision medicine approach and is advancing clinical trials for targeted oncology product candidates.
SpringWorks Therapeutics (Nasdaq: SWTX) announced the appointment of Mike Burgess, M.B.Ch.B., Ph.D. as Head of Research and Development, effective immediately. Dr. Burgess brings over 20 years of R&D leadership in oncology, most recently as President of R&D at Turnstone Biologics. He succeeds Stephen Squinto, Ph.D., who will remain on the Board of Directors. This leadership change is strategic as SpringWorks aims to enhance its oncology pipeline and develop life-changing therapies for cancer patients.
SpringWorks Therapeutics reported first-quarter financial results, highlighting significant advancements in its clinical programs. The mirdametinib trial in NF1-associated plexiform neurofibromas showed a 50% objective response rate among the first 20 adult patients. Additionally, the company has achieved key milestones in its nirogacestat studies for multiple myeloma, expanding its oncology pipeline with an exclusive license for TEAD inhibitors. Financially, R&D expenses rose to $17.4 million, and G&A expenses increased to $12.4 million, resulting in a net loss of $29.8 million for the quarter.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has announced an exclusive licensing agreement with KU Leuven and VIB for novel small molecule inhibitors targeting the TEA Domain (TEAD) family, aimed at treating biomarker-defined solid tumors linked to the Hippo pathway. An upfront payment of $11 million will be made, along with potential future milestones totaling $285 million. The company plans to nominate a development candidate in 2022 and commence IND-enabling studies. This strategic advancement is expected to enhance SpringWorks' portfolio of targeted therapies for cancer patients.
SpringWorks Therapeutics (Nasdaq: SWTX) announced the initiation of a Phase 1b clinical trial for nirogacestat, a novel gamma secretase inhibitor, combined with teclistamab, an investigational bispecific antibody. This trial targets patients with relapsed or refractory multiple myeloma, aiming to evaluate safety and efficacy. Nirogacestat has shown promise in preclinical studies by enhancing the effectiveness of BCMA-targeted therapies. The trial is part of a collaboration with Janssen Research, which covers trial costs, excluding nirogacestat supply. SpringWorks also continues its Phase 3 study for nirogacestat as a standalone treatment for desmoid tumors.
SpringWorks Therapeutics (SWTX) announced the appointment of Bhavesh Ashar as Chief Commercial Officer, effective immediately. With over 20 years of experience in oncology, Ashar previously held senior roles at Bayer and Sanofi Genzyme. His leadership is expected to enhance commercial operations as the company advances its targeted oncology portfolio, including two registrational trials for nirogacestat and mirdametinib. The company aims to report data from these trials later this year, signaling potential growth in addressing severe rare diseases and cancers.
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