Moderna Expected to Post Lower 4Q Sales as Vaccine Regulatory Path Looks Uncertain -- Earnings Preview

PROFIT: The pharmaceutical company is expected to report a loss of $1.02 billion, or $2.54 a share, according to analysts polled by FactSet. That compares with a loss of $1.12 billion, or $2.91 a share, a year earlier.

HHS’s side of the Moderna spat

The federal government on Wednesday told its side of the story amid a disagreement with Moderna after the FDA decided to refuse reviewing the drugmaker’s flu vaccine application.
STAT

FDA’s rejection of Moderna threatens to stifle broader vaccine industry

Experts say the FDA "moved the goalposts" on Moderna, creating "a destructive precedent that will undermine the future of vaccine development" in the U.S.

Moderna stock sinks on vaccine rejection. Company is 'desperately seeking clarification.'

The vaccine maker says the Food and Drug Administration has refused to review its application to sell a new seasonal flu vaccine.
24/7 Wall St.

Biotech Turnaround: How Moderna Went From Revenue Collapse to YTD Rally Leader

Moderna Inc (NASDAQ:MRNA) has delivered a 37% gain year-to-date, dramatically outpacing the biotech sector’s 0.4% YTD return. In fact, Moderna has the 12th-best gains in the entire S&P 500 so far in 2026!

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech company said the FDA won’t review its flu vaccine, in the latest hit to mRNA development.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna