New York, Feb 13, 2026, 5:27 PM ET — Trading after the bell.
- Moderna climbed roughly 5% in after-hours action following its fourth-quarter numbers and 2026 guidance.
- After the FDA issued a refusal-to-file on its flu shot, the company is now requesting a Type A meeting with the agency.
- Investors are juggling U.S. regulatory unknowns with expectations for international expansion and key 2026 pipeline updates.
Moderna jumped roughly 5% to $42.23 in late Friday trading. The vaccine maker managed to beat Wall Street’s revenue expectations and stuck with its 2026 growth targets, despite dealing with an FDA setback on its flu shot.
Moderna is at a turning point, needing to offset shrinking COVID-era sales with fresh bets on respiratory vaccines and cancer treatments. So far, the company has pinned its hopes on a flu shot and a combined flu/COVID vaccine for quick revenue, but the regulatory process in the U.S. has grown shakier.
That cloud of uncertainty comes as Moderna pushes to rebalance its sales overseas, locking in more long-term government contracts outside the U.S. The company figures the U.S. will contribute about half its total revenue this year—down from around 62% last year, according to Reuters.
Moderna turned in $678 million in fourth-quarter revenue, posting a loss of $2.11 per share. CEO Stéphane Bancel said annual operating expenses were slashed by roughly $2.2 billion for 2025. Heading into 2026, Bancel expects the company is “poised to deliver up to 10 percent revenue growth,” citing momentum from its next-generation COVID vaccine and new international deals. https://www.sec.gov/Archives/edgar/data/16…
Moderna disclosed it got a refusal-to-file letter from the U.S. Food and Drug Administration for its mRNA-1010 seasonal flu vaccine. The company has asked for a Type A meeting with the agency to clarify next steps.
The company reported that regulators in the European Union, Canada, and Australia have agreed to review its flu filing, opening the door for potential approvals starting in 2026. Moderna added that mRNA-1083, its combined flu and COVID vaccine, is being reviewed in Europe and Canada as well. In the U.S., it’s still waiting on additional direction from the FDA regarding another attempt at filing.
Bancel cautioned analysts that “sustained regulatory uncertainty threatens U.S. leadership in innovative medicines,” Reuters reported. The article also highlighted FDA vaccine official Vinay Prasad’s view that the flu trial should have included a higher-dose comparator, typically used for older adults. Moderna countered, saying the FDA had already signed off on the trial design when it kicked off. https://www.reuters.com/business/healthcar…
Outside its respiratory vaccine lineup, Moderna pointed to a handful of 2026 targets. The company’s Phase 3 norovirus vaccine trial has finished enrolling patients, with results on track for 2026. For the personalized cancer vaccine it’s developing with Merck, Moderna is also anticipating Phase 3 adjuvant melanoma data that same year, plus additional readouts still to come.
The road ahead looks bumpy. If the U.S. rollout of flu and combo shots drags on, Moderna could see a squeeze on near-term revenue. And even by its own guidance, the company expects year-end cash and investments in 2026 to fall below the 2025 close, with ongoing R&D spending weighing on the balance sheet.
U.S. markets are off for Presidents’ Day on Monday. Come Tuesday, Moderna will face its next test when the full session opens—traders are keyed in on any updates around the FDA Type A meeting schedule, plus hints of movement in foreign regulatory reviews.
