SpringWorks Therapeutics (SWTX) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key product and pipeline updates

• OGSIVEO is the first and only FDA-approved treatment for desmoid tumors, rapidly becoming the systemic standard of care for adults, generating $172M in net revenue in its first full year, and showing strong real-world efficacy and physician adoption.

• Mirdametinib, targeting NF1-PN, is under priority FDA review with a PDUFA date set for February 28, 2025, and EU MAA review ongoing, with launch preparations and physician education underway.

• OGSIVEO European launch will begin in Germany in mid-2025, expanding sequentially to other major markets as reimbursement is secured, with commercial infrastructure and access programs already established.

• Both OGSIVEO and mirdametinib have durable U.S. patent protection into 2043, supporting long-term growth.

• Diversified pipeline includes late- and early-stage programs targeting solid tumors and hematological cancers, with multiple regulatory submissions and data readouts expected in 2025.

Market opportunity and physician sentiment

• The desmoid tumor patient pool is larger than previously estimated, with ~11,000 unique patients identified via ICD-10 codes, and over 90% expected to seek treatment.

• Mirdametinib targets a fragmented NF1-PN treatment landscape, with ~40,000 U.S. patients and no approved adult options; market research shows high physician enthusiasm and likelihood to prescribe.

• Majority of physicians expect to increase OGSIVEO use, with 90% likely to prescribe it as frontline therapy, and mirdametinib is anticipated to become standard of care for NF1-PN.

• The adult NF1-PN market is three times larger than pediatric, representing a significant greenfield opportunity.

• Global expansion and robust adoption across centers of excellence and community settings are expected to drive further growth.

Clinical data and pipeline progress

• Long-term phase III data for OGSIVEO show sustained tumor reduction and symptom improvement over three years, with no new safety signals.

• Mirdametinib's pivotal ReNeu trial demonstrated significant tumor reduction and quality-of-life improvements in both adults and children.

• Pipeline includes phase II studies for nirogacestat in ovarian granulosa cell tumors and multiple BCMA combination trials in multiple myeloma.

• Additional programs include brimarafenib (RAF dimer inhibitor), SW-682 (TEAD inhibitor), and SW-3431 in early-stage trials, plus a new in-licensed PP2A activator for uterine cancer.

• Key 2025 milestones: mirdametinib FDA decision, European Commission decisions for both lead products, and initial data from ovarian granulosa cell tumor study.