IndustryCompany release

Moderna raises 2026 revenue growth guidance to 15–25% after FDA clears mRNA flu vaccine

🇺🇸 Moderna, Inc. (MRNA) · Fri 06 Nov 2026

The company reported third-quarter revenue of $1.3 billion and net income of $162 million, and highlighted US approval of mFLUSIVA alongside mixed pipeline news.

Moderna reported third-quarter 2026 revenue of $1.3 billion and net income of $162 million on 6 November 2026. The company raised its full-year revenue growth guidance to 15–25%, up from a previous outlook of growth of up to 10%.

A key regulatory event was the US Food and Drug Administration's approval in August of mFLUSIVA, Moderna's mRNA-based influenza vaccine. The agency granted full approval for people aged 50 to 64 and accelerated approval for those aged 65 and over.

Moderna also reported approval of its mCOFLU product in Canada. In oncology, it noted positive Phase 3 results in melanoma for intismeran, given with Merck's Keytruda.

Not all news was favourable. An interim analysis of the company's norovirus vaccine candidate did not meet the criteria for early success. Moderna also noted a $950 million payment to settle litigation.

The summary available does not give further detail on the trial data, the terms of the settlement or the drivers behind the third-quarter sales increase of 29%.

What it means for your team

  • Regulatory teams should note the split approval for mFLUSIVA: full approval for ages 50–64 and accelerated approval for 65+, which in general usually carries follow-up confirmatory obligations.
  • Market-access teams may need to plan for a new mRNA flu option, with different evidence bases by age group.
  • The missed early-success criteria for the norovirus vaccine at interim analysis mean that programme's regulatory timeline remains uncertain; the trial may continue.
  • The Canadian mCOFLU approval and positive Phase 3 melanoma data add to Moderna's regulatory pipeline across respiratory and oncology products.

Company's press release (SEC filing): Moderna, Inc. ↗

Article written by VigiEye from the official source (Moderna, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →