Springworks Therapeutics, Inc. Stock Price, News & Analysis

SpringWorks Therapeutics (Nasdaq: SWTX) announced management's participation in a fireside chat at the Cowen 43rd Annual Health Care Conference on March 7, 2023, at 12:50 p.m. ET. The event will focus on the company's mission to develop life-changing medicines for patients with severe rare diseases and cancer. Interested parties can access the live webcast through the Investors & Media section on their website, with a replay available afterward. SpringWorks is known for its targeted oncology pipeline and innovative partnerships aimed at advancing clinical development in rare and genetically defined cancers.

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.