On February 18 2026 the U.S. Food and Drug Administration announced it would review Moderna’s investigational seasonal influenza vaccine, mRNA‑1010, after a prior refusal‑to‑file letter issued on February 10 2026. The decision followed a Type A meeting in which Moderna presented a revised regulatory strategy that seeks full approval for adults aged 50‑64 and accelerated approval for those 65 and older, with a post‑marketing study for the older cohort.
The FDA’s acceptance clears a regulatory hurdle that had delayed the vaccine’s launch by several months. The agency’s Prescription Drug User Fee Act (PDUFA) goal date for a decision is August 5 2026, a timeline that positions the product for availability during the 2026/27 influenza season. The review is expected to enable Moderna to offer a new mRNA‑based flu shot to seniors in time for the upcoming season, potentially adding a new revenue stream to its respiratory portfolio.
The announcement is significant for investors because it removes a key regulatory barrier that could have postponed the vaccine’s market entry, thereby affecting Moderna’s projected sales and cash‑flow generation from its non‑COVID vaccine pipeline. It also signals confidence in the safety and efficacy data presented by Moderna, reinforcing the company’s broader strategy to expand its mRNA platform beyond COVID‑19.
Moderna’s Q4 2025 earnings, released on February 13 2026, provide important context for the regulatory news. The company reported earnings per share of –$2.11, beating the consensus estimate of –$2.60 by $0.49. Revenue for the quarter reached $678 million, surpassing the consensus estimate of $662.84 million by $15.16 million. The earnings beat was largely driven by disciplined cost control, highlighted by a $2.2 billion reduction in operating expenses in 2025, which helped offset the decline in COVID‑19 vaccine sales that contributed to a net loss of $2.8 billion for the full year 2025.
CEO Stéphane Bancel said, “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review.” He added, “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.” Bancel also noted, “In 2025, we sharpened our commercial execution, launched our third product and brought online three international manufacturing sites, while advancing our mRNA pipeline. At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost‑reduction targets.”
The FDA review acceptance opens a new revenue stream for Moderna, diversifying its portfolio beyond the waning COVID‑19 market. The company’s 2026 guidance projects up to 10% revenue growth, primarily driven by international markets, but does not yet include contributions from mRNA‑1010. The new flu vaccine could help offset the decline in COVID vaccine sales and strengthen the company’s respiratory franchise. However, the company still faces headwinds from a competitive flu vaccine landscape and the need to demonstrate efficacy in older adults, which the post‑marketing study will address.
In summary, the FDA’s decision to review mRNA‑1010 removes a significant regulatory obstacle, aligns with Moderna’s strategic shift toward mRNA‑based respiratory vaccines, and provides a potential new revenue source that could help stabilize the company’s financial performance as it navigates a post‑COVID market environment.
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