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

Key product updates and launches

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

• Mirdametinib, targeting NF1-PN, is under FDA Priority Review with a PDUFA date of February 28, 2025, and EU MAA review ongoing, with launch preparations and high physician intent to prescribe upon approval.

• OGSIVEO's European launch will begin in Germany in mid-2025, expanding as reimbursement negotiations conclude, supported by established infrastructure and access programs.

• The pipeline includes late- and early-stage programs such as nirogacestat (phase II in ovarian granulosa cell tumors), multiple BCMA combination studies in multiple myeloma, mirdametinib in pediatric low-grade glioma, and brimarafenib in MAPK pathway-mutant cancers.

• Profitability is expected in the first half of 2026, supported by a strong balance sheet and durable IP protection for lead programs.

Market opportunity and physician adoption

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

• OGSIVEO is firmly established as the standard of care in centers of excellence and is seeing increased adoption among community physicians, addressing a previously unmet need.

• Long-term data and real-world experience support sustained efficacy, safety, and transformative benefits of OGSIVEO, encouraging prolonged use.

• Updated treatment guidelines now favor systemic therapy over surgery, broadening the eligible patient base for OGSIVEO.

• Mirdametinib is expected to address a fragmented NF1-PN market, with ~40,000 U.S. patients (75% adults) and high unmet need, especially among adults with no approved therapies; market research shows high physician enthusiasm.

Pipeline and R&D progress

• Positive phase I data for mirdametinib in low-grade glioma showed responses in ~80% of patients; phase II is ongoing.

• Brimarafenib, a next-gen RAF dimer inhibitor, is advancing in monotherapy and combination trials for MAPK pathway-mutant cancers.

• A new in-licensed preclinical asset, SW-3431, targets biomarker-defined uterine cancer and is expected to enter the clinic next year.

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

• Additional data disclosures, regulatory submissions, and new trial initiations are planned across the portfolio, with a focus on underserved patient populations.