Moderna (NASDAQ:MRNA) is preparing to seek U.S. approval of its individualized cancer treatment intismeran by year-end, with executives aiming for a 2027 launch alongside partner Merck if regulators approve the therapy.
At an investor event in Marlborough, Massachusetts, company leaders highlighted a positive phase III melanoma trial, outlined manufacturing plans for the personalized treatment and said they expect to increase overall investment in 2027.
President Stephen Hoge said Moderna controls the timing of its submission but that a launch also depends on the Food and Drug Administration’s review and subsequent reimbursement arrangements. Merck will partner with Moderna on U.S. commercialization and lead efforts outside the country, he said.
Melanoma trial and expansion plans
In the phase III INTerpath-001 trial, intismeran combined with Merck’s pembrolizumab reduced the risk of melanoma recurrence or death by 42% compared with pembrolizumab and placebo, Chief Development Officer David Berman said. The study enrolled patients with stage II and III melanoma following surgery.
Berman said the combination also improved distant metastasis-free survival. Overall survival data remained immature, although there was a trend favoring the intismeran group.
Severe and serious adverse event rates were generally similar between the groups, while discontinuations were slightly higher with the combination, Berman said. He said eight deaths classified as adverse events occurred in the intismeran arm, five before patients were eligible to receive the treatment. The three occurring after treatment began were judged unrelated to either drug, he said.
Moderna and Merck are studying intismeran in several other cancers, including lung, kidney and bladder cancer. Berman said the companies expect data from a muscle-invasive bladder cancer study next year. He said the potential for intismeran to work in other tumors, or as a standalone treatment, remains to be tested.
Manufacturing and spending
Chief Operating Officer Juan Andres said the Marlborough facility began producing batches in August 2025 and is intended to be the commercial site for intismeran. Each batch is made for an individual patient, using information from tumor and blood samples to design the treatment.
The company is targeting approximately six weeks from sample collection to treatment delivery and expects to shorten that period over time, Andres said. The median time to first dose in the phase III trial was about 64 days, according to Berman.
Andres said the site could eventually supply tens of thousands of patients, with capacity added in stages. Moderna has made approximately 5,000 batches for clinical trial patients across its operations, he said.
Chief Financial Officer Jamey Mock said Moderna expects approximately $4 billion in companywide investment in 2027, up from $3.8 billion in 2026, followed by a planning range of $4 billion to $4.5 billion in coming years. The increase includes additional investment in intismeran, while spending could change with clinical results.
Mock said the company now expects 2026 revenue growth of 15% to 25%, compared with its earlier framework of up to 10%. The midpoint of its revenue range is approximately $2.3 billion. He cautioned analysts against assuming similar annual growth for the infectious disease business and said 2027 guidance would come with fourth-quarter results.
Moderna anticipates ending 2026 with more than $9 billion in liquidity, Mock said. That includes access to an amended financing facility with $900 million in undrawn liquidity through November 2029.
Respiratory vaccine evidence
Rita Das, head of infectious and rare diseases, presented observational studies of Moderna’s respiratory vaccines. In a Veterans Affairs analysis of adults 65 and older, mNEXSPIKE recipients had a 47% lower rate of COVID-19 hospitalization than recipients of Pfizer-BioNTech’s COMIRNATY, she said.
Das cautioned that residual confounding was possible despite matching and statistical adjustments. She also described exploratory findings on cardiovascular hospitalizations but said the observational study could not establish causality for those outcomes.
Hoge said Moderna’s flu vaccine mFLUSIVA had reached more than 25% of U.S. retail pharmacies and recorded 110,000 administered doses. The company hopes the product will contribute meaningfully to revenue in 2027, its first full contracting cycle, he said.
About Moderna (NASDAQ:MRNA)
Moderna, Inc. is a biotechnology company that develops medicines and vaccines using messenger RNA (mRNA) technology. Its platform is designed to instruct cells to produce proteins that can help prevent or treat disease. The company’s commercial products include Spikevax, a vaccine against COVID-19, and mRESVIA, a vaccine against respiratory syncytial virus (RSV). Moderna also researches potential mRNA-based vaccines and treatments for infectious diseases, cancer, and rare diseases. Founded in 2010 as Moderna Therapeutics, the company is headquartered in Cambridge, Massachusetts.
