SWTX Announces 2024 Preliminary Results and 2025 Goals

SpringWorks Therapeutics (SWTX) has shared its preliminary net product revenues for the fourth quarter and full-year 2024, highlighting the performance of its sole marketed drug, Ogsiveo (nirogacestat). Ogsiveo is approved for treating adult patients with progressing desmoid tumors who require systemic treatment. The company reported preliminary revenues of $61.5 million in the fourth quarter and $172 million for the full year of 2024. Following the announcement, shares of SWTX were down by 13.9% on January 13.

Looking ahead to 2025, SpringWorks has outlined several expected milestones and pipeline goals. The marketing authorization application for Ogsiveo for treating adult patients with desmoid tumors is currently under review with the European Medicines Agency (EMA), with a potential approval expected in 2025. The company plans to launch Ogsiveo in the EU, starting with Germany in mid-2025. Additionally, several studies on Ogsiveo targeting different cancer indications are ongoing.

SpringWorks also anticipates reporting initial data from a phase II study evaluating nirogacestat as a monotherapy in patients with recurrent ovarian granulosa cell tumors in the first half of 2025. Furthermore, a regulatory filing seeking approval for SpringWorks’ investigational MEK inhibitor, mirdametinib, for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) in pediatric and adult patients is under review in the United States, with a final decision from the FDA expected on February 28, 2025. A marketing authorization application for mirdametinib has also been validated by the European Medicines Agency.

In addition to these developments, SpringWorks is evaluating its investigational, oral, selective pan-TEAD inhibitor, SW-682, in a phase I study for treating patients with Hippo-mutant solid tumors, with the study currently enrolling patients.

Despite these advancements, SpringWorks currently carries a Zacks Rank #4 (Sell), reflecting a cautious outlook from investors.