
MRNA
Moderna develops vaccines and other pharmaceutical products using mRNA technology, with a pipeline spanning infectious diseases, oncology, and other therapeutic areas at various stages of clinical development. The company manufactures its own products and relies on third-party manufacturers, while facing typical biotech risks including regulatory approval timelines, clinical trial uncertainties, manufacturing complexities, and competitive market pressures. Moderna has transitioned from a development-stage company to a commercial organization with marketed products, though it continues to advance multiple product candidates through clinical testing.
Pipeline
Catalyst Calendar
“The Company has completed submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe and expects potential approvals to begin in 2026.”
“The Company's mRNA-1083 filing is under review with the European Medicines Agency (EMA). Moderna submitted for approval to Health Canada in 2025. The Company is awaiting further guidance from the U.S. FDA on refiling.”
“Moderna's ongoing Phase 3 study of mRNA-1403 is enrolling a second Northern Hemisphere season (2025-2026) for additional case accruals, which will inform the timing of the Phase 3 readout. The Company expects an interim analysis in 2026.”
“The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.”
“Moderna's mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, with a registrational study expected to begin in 2026.”
“Moderna's ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with data expected in 2026, subject to case accruals.”
“Moderna's ongoing Phase 3 safety and efficacy study of mRNA-1403 is fully enrolled in a second Northern Hemisphere season (2025-2026) with a data readout expected in 2026, subject to case accruals.”
“The meeting will be held on June 18, 2026, from 8:30 a.m. to 4:00 p.m. Eastern Time.”
“A Phase 2, Observer-Blind, Placebo-Controlled Proof-of-Concept Trial to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Patients Who Have Undergone Allogeneic Hematopoietic Cell Transplantation (HCT) — primary completion 2026-08-01”
“The U.S. FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for mRNA-1010 of August 5, 2026.”
“A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age — primary completion 2026-09-22”
“Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to those ongoing regulatory reviews.”
“A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age — primary completion 2027-02-15”
“Targeting approval in 2028, early data are promising for future mRNA-4359 development options”
“Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors — primary completion 2032-02-18”
“The pivotal Phase 3 study of mRNA-1647 is fully enrolled and has now accrued sufficient cases for evaluation of the primary endpoint of the study, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. Moderna is updating its analysis plan to incorporate additional secondary endpoints. The Company remains blinded and anticipates a Phase 3 final analysis in 2025.”
“Moderna recently shared interim data from the Phase 1/2 study of its investigational therapeutic for MMA (mRNA-3705) at ICIEM 2025.”
“The Company's PA candidate is in a registrational study and target enrollment has been reached.”
“a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled.”
“In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled.”
“Moderna expects to complete submissions for approval of mRNA-1010 in the U.S., EU, Canada and Australia by January 2026.”
“The Company expects to complete submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe by January 2026.”
“Announces full enrollment of Phase 2 intismeran autogene trial in muscle invasive bladder cancer”
“Announces Norovirus Phase 3 trial fully enrolled with a data readout expected in 2026”
“The Company recently announced an upcoming oral presentation on June 1 at 8 a.m. to 11 a.m. CT at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting highlighting positive five-year Phase 2b adjuvant melanoma data, which showed a sustained benefit with intismeran in combination with KEYTRUDA, reducing the risk of recurrence or death by 49% compared to KEYTRUDA alone.”