Moderna issues letter to shareholders (31.56 +0.70)
- "Beginning in 2026, we expect a cadence of oncology readouts as we work toward a multi-indication oncology franchise. With nine clinical readouts anticipated over the next several years, we believe oncology represents a major long-term value driver for Moderna. We are proud to demonstrate the role our mRNA-based therapies could play in transforming the lives of those affected by cancer.
- Three of the nine expected clinical readouts are Phase 3 programs for intismeran. We are encouraged by the momentum behind intismeran and look forward to the five-year Phase 2b melanoma data in early 2026 and the Phase 3 data, potentially in 2026. If the data are positive, we would then work to prepare for a potential launch, together with our partner Merck, of this important medicine as early as in 2027.
- Our early-stage oncology programs continue to mature in parallel, including our wholly owned mRNA-4359 program. This product has shown an encouraging clinical signal in Stage 4 lung and skin cancer patients, where approved immune-therapy treatments did not work. Targeting approval in 2028, early data are promising for future mRNA-4359 development options, and we are encouraged by the potential to address such a high unmet need for many patients.
- By 2028, we also expect to launch our first rare disease program in PA, supported by data expected in 2026. These milestones position us to diversify our revenue base as oncology and rare disease therapeutics begin contributing meaningfully in the latter half of the decade. Moving forward, we will continue to look at innovative ways to use mRNA technology across oncology."