SpringWorks Therapeutics Anticipates Key Milestones for OGSIVEO and Mirdametinib in 2025
Key Insights
SpringWorks Therapeutics projects OGSIVEO revenue to reach $61.5 million for Q4 and aims for EU regulatory approval in mid-2025, starting with Germany.
The company anticipates FDA approval for mirdametinib in NF1-associated plexiform neurofibromas (search) by February 28, 2025, with EU approval and launch also planned for 2025.
Initial data from a Phase 2 trial of nirogacestat (OGSIVEO) in ovarian granulosa cell tumors (search) is expected in the first half of 2025.
SpringWorks Therapeutics is poised for a transformative year in 2025, with key milestones anticipated for its lead drugs, OGSIVEO (nirogacestat) and mirdametinib. The company expects continued growth in OGSIVEO sales, projecting $61.5 million in revenue for the fourth quarter of 2024 and $172 million for the full year. This momentum is expected to continue with expansion into the European market. Saqib Islam, Chief Executive Officer of SpringWorks, stated the company is energized by the opportunity to continue delivering on its commitments to the patient communities it serves.
OGSIVEO (Nirogacestat) Expansion and Further Studies
Following FDA approval for adult patients with progressing desmoid tumors (search) requiring systemic treatment, SpringWorks is focused on securing regulatory approval for OGSIVEO in the European Union. The company anticipates launching OGSIVEO in individual EU countries, beginning with Germany, by mid-2025, pending reimbursement authorization. Additionally, long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors is slated for publication in a peer-reviewed journal by the end of 2025.
SpringWorks also plans to report initial data from a Phase 2 trial evaluating nirogacestat as a monotherapy in patients with ovarian granulosa cell tumors (search) in the first half of 2025. The company will continue supporting industry and academic collaborations evaluating nirogacestat as part of B-cell maturation antigen (BCMA (search)) combination therapy regimens in multiple myeloma (search) patients.
Mirdametinib for NF1-Associated Plexiform Neurofibromas
The FDA's decision on mirdametinib for adults and children with NF1-associated plexiform neurofibromas (search) (NF1-PN) is expected by February 28, 2025 (PDUFA date). SpringWorks anticipates a U.S. launch following approval. The company is also pursuing regulatory approval in the EU for mirdametinib in NF1-PN, with initial launch planned for 2025.
Advancing the Emerging Pipeline
SpringWorks' pipeline includes several emerging oncology programs. MapKure is expected to present additional data from the brimarafenib monotherapy trial in the second half of 2025. Patient enrollment continues in the Phase 1 trial of SW-682 in Hippo-mutant solid tumors (search). SpringWorks plans to file an Investigational New Drug (IND) application for SW-3431 by the end of 2025. These programs reflect SpringWorks' commitment to developing precision medicine approaches for severe rare diseases and cancer.