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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) announced the presentation of data from the Phase 3 DeFi trial assessing nirogacestat for adults with progressing desmoid tumors at the ESMO Congress 2022. The late-breaking oral presentation will occur on September 10, 2022, emphasizing the trial's significance. The company plans to submit a New Drug Application (NDA) by year-end under the FDA’s Real-Time Oncology Review program. This investigational drug has received Orphan Drug Designation and both Fast Track and Breakthrough Therapy Designations.
SpringWorks Therapeutics (SWTX) announced strong progress in its clinical trials, particularly with nirogacestat for desmoid tumors, achieving its primary endpoint in the Phase 3 DeFi trial, demonstrating a 71% risk reduction in disease progression. The company also reported preliminary positive data from the Phase 1/2 study of nirogacestat in combination with low-dose belantamab mafodotin for multiple myeloma. Financially, Q2 2022 saw a net loss of $69.1 million, up from $47.0 million in Q2 2021, with a cash position of $334.5 million. NDA submission for nirogacestat is expected in H2 2022.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) will participate in a fireside chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10th at 10:55 a.m. ET. The event can be accessed via a live webcast on the company’s website, with a replay available afterward. SpringWorks focuses on developing life-changing medicines for severe rare diseases and cancer, boasting a targeted oncology pipeline that includes late-stage clinical trials for rare tumors and genetically defined cancers. For more details, visit SpringWorks’ website.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced the appointment of Carlos Albán to its Board of Directors. Albán, the former Vice Chairman and Chief Commercial Officer at AbbVie, brings over 30 years of experience in global commercial strategy. His leadership is expected to be crucial as SpringWorks transitions to a commercial-stage company. Under Albán's tenure at AbbVie, sales surged from $18 billion in 2013 to over $45 billion in 2020. SpringWorks focuses on developing treatments for severe rare diseases and cancer.
SpringWorks Therapeutics (Nasdaq: SWTX) announced a virtual R&D Day on June 10, 2022, showcasing advancements in their oncology pipeline. Key highlights include the upcoming NDA filing for Nirogacestat in Desmoid Tumors expected in late 2022 and a new Phase 2 study for ovarian granulosa cell tumors. Ongoing collaborations with BCMA therapies and significant focus on Mirdametinib for rare tumors were also discussed. The company aims to provide approved therapies for desmoid tumors by 2023 and anticipates two approvals by 2025.
SpringWorks Therapeutics (Nasdaq: SWTX) will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on June 15, 2022, at 8:40 a.m. PT / 11:40 a.m. ET. The event will be accessible via a live webcast on the company’s Investors & Media page. SpringWorks is focused on developing targeted therapies for severe rare diseases and cancer, with 18 programs in development, including two in late-stage trials. The company aims to enhance patient outcomes through strategic partnerships and innovative clinical approaches.
SpringWorks Therapeutics (SWTX) announced initial clinical data from a Phase 1/2 study of nirogacestat in combination with BLENREP for relapsed or refractory multiple myeloma. Data revealed a promising safety profile, with significant reductions in ocular adverse events compared to single-agent treatment. Additionally, long-term follow-up from a NCI-sponsored Phase 2 study of nirogacestat in desmoid tumors showed no disease progression and median treatment duration of 4.4 years. This data will be presented at the ASCO Annual Meeting, June 3-7, 2022, in Chicago.
SpringWorks Therapeutics (SWTX) announced positive topline results from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor for desmoid tumors. The trial achieved its primary endpoint, showing a 71% reduction in disease progression risk compared to placebo (Hazard Ratio: 0.29; P < 0.001). All key secondary endpoints, including objective response rate and patient-reported outcomes, also showed statistically significant improvement. Nirogacestat was generally well tolerated. The company plans to submit a NDA to the FDA in the second half of 2022.
SpringWorks Therapeutics (Nasdaq: SWTX) will host a virtual R&D Day for investors on June 10, 2022, at 10:00 am ET. The event will feature presentations from the executive leadership team and external experts in the company's development areas, followed by a Q&A session. Interested participants can register here. The webcast will be available on the SpringWorks website after the event.
SpringWorks Therapeutics reported its Q1 2022 financial results, highlighting a net loss of $61.8 million, or $1.26 per share, compared to a loss of $29.8 million, or $0.62 per share, in Q1 2021. R&D expenses surged to $34.1 million, up from $17.4 million, mainly due to increased personnel costs and trial expenses. The company continues to advance its oncology pipeline, with 18 development programs. Key upcoming events include topline data from the Phase 3 DeFi trial expected in Q2 2022 and initial data at the ASCO Annual Meeting.
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