Upcoming Pivotal Phase III Readouts
Top-line data for Phase III SENTRY (myelofibrosis) expected in March 2026 and Phase III EXPORT EC042 (endometrial cancer) expected mid-2026 — both positioned as potential practice‑changing events and primary near‑term value drivers for the company.
Compelling Early Clinical Signals
Phase I combination data reported an SVR35 of ~79% versus ~33% with ruxolitinib historical data; absolute TSS improvement of 18.5 points (week 24) versus 11–14 reported with ruxolitinib in prior trials; early blinded SENTRY safety signals suggest lower rates of grade 3+ anemia and manageable non‑heme toxicities.
Commercial Performance and 2026 Revenue Guidance
Q4 2025 U.S. XPOVIO net product revenue of $32.1M (up 9.6% YoY) and full‑year 2025 U.S. XPOVIO net product revenue of $114.9M (up 1.9% YoY). Total revenue Q4 $34.1M (up 11.8% YoY) and full‑year total revenue $146.1M (slight increase vs 2024). 2026 guidance: U.S. XPOVIO net product revenue $115M–$130M; total revenue $130M–$150M.
Disciplined Operating Cost Reductions
Research & development expense decreased 17% Q4 and 12% for full‑year 2025 (Q4 R&D $27.7M; FY R&D $125.6M). Selling, general & administrative expenses decreased 16% in Q4 and 9% for the full year (Q4 SG&A $22.8M; FY SG&A $105.2M), reflecting cost reduction initiatives and prioritization of late‑stage programs.
Large Addressable Myelofibrosis Opportunity & Commercial Readiness
Company cites ~20,000 prevalent U.S. myelofibrosis patients and ~6,000 new diagnoses annually, focusing on ~4,000 newly diagnosed intermediate‑to‑high risk patients (platelets >100k). Market research indicates 75% physician intent to use a combination regimen; management estimates peak U.S. revenue potential approaching $1 billion.
Dose Optimization and Improved Tolerability Strategy
Selinexor dose refined to 60 mg weekly for myelofibrosis (higher exposure and efficacy vs 40 mg in Phase I) with mandated dual antiemetics in early cycles; company emphasizes lower dosing/optimized supportive care in MF vs higher doses historically used in multiple myeloma to improve tolerability and adoption.