STAMFORD, Conn. - SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a biopharmaceutical company, announced today its key achievements from the past year and outlined its objectives for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference. The company's notable 2023 milestones include the FDA approval of OGSIVEO™ (nirogacestat) for treating adult patients with progressing desmoid tumors, a rare condition.
The approval was based on the Phase 3 DeFi trial results, which were published in the New England Journal of Medicine and presented at medical conferences. These results showed significant improvements in pain and functionality for patients treated with OGSIVEO. SpringWorks also completed a Phase 2 trial for nirogacestat in ovarian granulosa cell tumor patients and is exploring its use in multiple myeloma in collaboration with industry leaders.
In addition, SpringWorks presented promising data from the ReNeu trial of mirdametinib, an investigational MEK inhibitor, for treating neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The trial showed favorable response rates in both pediatric and adult patients.
The company's emerging pipeline includes brimarafenib, a RAF dimer inhibitor, which has moved into the Phase 1b cohort expansion study. SpringWorks also initiated a combination study of brimarafenib and mirdametinib and has plans to begin a trial combining brimarafenib with panitumumab for colorectal and pancreatic cancers.
SpringWorks strengthened its financial position with an upsized public offering, raising approximately $316.25M and reporting over $700M in cash, cash equivalents, and marketable securities as of September 30, 2023.
Looking forward to 2024, SpringWorks plans to submit a Marketing Authorisation Application for nirogacestat in the EU and an NDA for mirdametinib in the US for NF1-PN treatment. The company also expects to report initial data from its Phase 2 trial of nirogacestat and present additional data on its RAF dimer inhibitor programs.
Saqib Islam, CEO of SpringWorks, expressed confidence in the company's progress and its mission to improve the lives of patients with severe diseases. The information for this article is based on a press release statement from SpringWorks Therapeutics.
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