Moderna provides update on pipeline progress

The company said, “Highlights from Moderna’s (MRNA) approved vaccines and prioritized portfolio include: Seasonal Vaccines: Spikevax: Approved in 40 countries. mNEXSPIKE: Approved in the U.S. and Canada. The Company has filed and is targeting 2026 approvals in Australia, the EU, Japan and Taiwan. mRESVIA: Approved in 40 countries for adults aged 60 and older, and in 31 of those countries for adults 18-59 at increased risk for RSV disease. mRNA-1010: Moderna expects to complete submissions for approval of mRNA-1010 in the U.S., EU, Canada and Australia by January 2026. mRNA-1083: The Company’s mRNA-1083 filing is under review with the European Medicines Agency Moderna submitted for approval to Health Canada in 2025. The Company is awaiting further guidance from the U.S. FDA on refiling. mRNA-1403: The ongoing Phase 3 study has not accrued sufficient cases and is enrolling a second Northern Hemisphere season for additional case accruals, which will inform the timing of the Phase 3 readout. Moderna expects an interim analysis in 2026. Oncology Therapeutics: mRNA-4157 : Advancing in collaboration with Merck, with eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. mRNA-4359: Designed to elicit T-cell immune responses against tumor and immunosuppressive cells, the Phase 1/2 study is ongoing with the Phase 2 portion including cohorts in first-line metastatic melanoma and first-line metastatic NSCLC. Rare Disease Therapeutics: mRNA-3927: Reached target enrollment in a registrational study. mRNA-3705: Selected for the U.S. FDA’s START program, with a registrational study expected to begin in 2026. Programs Discontinued: Based on the Company’s strategic prioritization, four programs in its pipeline are discontinued: mRNA-1647: The Company is discontinuing its congenital Cytomegalovirus clinical development program. Moderna will continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients. mRNA-1608: The Company’s herpes simplex virus clinical development program will not advance to Phase 3. mRNA-1468: The Company’s Varicella-Zoster virus clinical development program will not advance to Phase 3. mRNA-3745: The Company’s Glycogen Storage Disease Type 1a clinical development program will not advance to Phase 2.”