SpringWorks Therapeutics Inc

Latest Results (08.10.2025):

SpringWorks Therapeutics Inc reported its first quarter of 2024 with notable achievements in product revenue and regulatory progress. The company demonstrated strong performance in the launch of OGSIVEO® and made significant strides in advancing its pipeline, underscoring its commitment to addressing severe rare diseases and cancer.

OGSIVEO® Revenue

In the first quarter of 2024, SpringWorks achieved $21.0 million in net product revenue from OGSIVEO® (nirogacestat), marking a successful start to its market launch.

Regulatory Approvals

The company received validation from the European Medicines Agency (EMA) for the Marketing Authorization Application (MAA) of nirogacestat for treating adults with desmoid tumors. Additionally, SpringWorks obtained FDA approval for a Supplemental New Drug Application (NDA) for OGSIVEO in new blister packaging, enhancing patient convenience.

NDA Submission for Mirdametinib

SpringWorks initiated the rolling submission of an NDA to the FDA for mirdametinib, targeting the treatment of children and adults with NF1-PN. The NDA submission is expected to be completed in the second quarter of 2024, with plans to file an MAA with the EMA in the latter half of the year.

Research and Development Progress

The company advanced its R&D efforts with the acceptance of Phase 2b ReNeu trial results for oral presentation at the 2024 ASCO Annual Meeting. SpringWorks also continues to expand its pipeline with ongoing trials for brimarafenib and mirdametinib, aiming to address additional unmet medical needs.

Financial Performance

For the first quarter of 2024, SpringWorks reported a net loss of $87.4 million, or $1.18 per share, compared to a net loss of $73.4 million for the same period in 2023. The increase in expenses was primarily due to higher selling, general, and administrative (SG&A) costs related to the OGSIVEO launch and increased research and development (R&D) expenditures.