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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 received FDA acceptance for its NDA for nirogacestat for treating adults with desmoid tumors and was granted Priority Review, with a PDUFA date set for August 27, 2023. The company expects topline data from the Phase 2b ReNeu trial for mirdametinib in patients with NF1-associated plexiform neurofibromas in the second half of 2023 and anticipates an NDA submission in early 2024. SpringWorks ended 2022 with $597.0 million in cash and equivalents, supporting its operations into 2026.
SpringWorks Therapeutics (Nasdaq: SWTX) recently announced that the FDA has accepted its New Drug Application (NDA) for nirogacestat, a gamma secretase inhibitor aimed at treating adults with desmoid tumors. The NDA has received Priority Review status, with a PDUFA action date set for August 27, 2023. This designation is reserved for drugs that promise significant treatment advancements for serious conditions. The NDA’s review is based on positive results from the Phase 3 DeFi trial, which evaluated nirogacestat's efficacy and safety in desmoid tumor patients. Currently, there are no FDA-approved therapies for this condition.
SpringWorks Therapeutics (Nasdaq: SWTX) presented its achievements from 2022 and key goals for 2023 at the J.P. Morgan Healthcare Conference. The company highlighted positive Phase 3 data for nirogacestat in desmoid tumors and the submission of an NDA to the FDA for the same treatment, which is currently under review. Financially, SpringWorks reported over $650 million in cash and equivalents, ensuring a runway into 2026. Upcoming milestones include potential FDA approval for nirogacestat and planned NDA submissions for mirdametinib.
SpringWorks Therapeutics (Nasdaq: SWTX) announced that CEO Saqib Islam will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 7:30 a.m. PT. Interested parties can access the live webcast through the company's Investors & Media section. A replay will also be available for a limited time post-event.
SpringWorks is focused on developing medicines for severe rare diseases and cancer, featuring a robust oncology pipeline and strategic partnerships to enhance patient solutions.
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) has submitted a New Drug Application (NDA) to the FDA for nirogacestat, aimed at treating adults with desmoid tumors. The NDA is under the FDA's Real-Time Oncology Review program and includes data from the Phase 3 DeFi trial, which assessed efficacy and safety. Nirogacestat has received Fast Track, Breakthrough Therapy, and Orphan Drug designations due to its potential impact on a serious unmet medical need. SpringWorks emphasizes its commitment to expediting access to this therapy for patients with desmoid tumors.
SpringWorks Therapeutics (Nasdaq: SWTX) will participate in a fireside chat at the Evercore ISI 5th Annual HealthCONx Conference on November 29, 2022, at 4:20 p.m. ET. The event will be held virtually, and investors can access the live webcast on the company's website. A replay will be available for a limited time afterward. SpringWorks focuses on developing life-changing medicines for patients with severe rare diseases and cancer, emphasizing precision medicine and a robust oncology pipeline.
SpringWorks Therapeutics (SWTX) presented positive data from its Phase 3 DeFi trial of nirogacestat at ESMO 2022, showing a 71% reduction in the risk of disease progression for patients with desmoid tumors. The company also expanded its collaboration with GSK for nirogacestat in multiple myeloma and initiated a Phase 2 trial for ovarian granulosa cell tumors. Financially, SpringWorks has over $650 million in cash and equivalents, providing a runway into 2026, despite reporting a net loss of $72.4 million in Q3 2022.
Applied BioMath has announced a collaboration with SpringWorks Therapeutics (SWTX) to develop a systems pharmacology model for multiple myeloma. This model will analyze the interactions between nirogacestat, an oral selective small molecule gamma secretase inhibitor, and agents targeting B-cell maturation antigen (BCMA). Todd Shearer, PhD, emphasized the goal of enhancing the understanding of pharmacodynamic interactions to streamline therapy advancements. Applied BioMath aims to leverage its modeling expertise to support drug research and development success.
SpringWorks Therapeutics (SWTX) has initiated a Phase 2 trial for nirogacestat, a gamma secretase inhibitor, targeting recurrent ovarian granulosa cell tumors. As these tumors constitute about 5% of ovarian cancers with no FDA-approved treatments, the trial addresses a significant unmet medical need. The study will enroll 40 patients to evaluate nirogacestat's safety, efficacy, and pharmacokinetics. With a primary endpoint of objective response rate, the trial represents a promising step towards potential regulatory approval for this patient population.
SpringWorks Therapeutics (SWTX) announced positive results from their Phase 3 DeFi trial of nirogacestat, a treatment for progressing desmoid tumors. The trial met its primary endpoint with a 71% reduction in disease progression risk and demonstrated a confirmed objective response rate of 41% for nirogacestat versus 8% for placebo. The company plans to submit a New Drug Application to the FDA in the second half of 2022, utilizing the Real-Time Oncology Review program. Additionally, a manageable safety profile was observed, although some participants experienced treatment-emergent adverse events.
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