The stock climbed 6.7% to $46.89 before the opening bell, extending a 22% rally over the past 12 months. The FDA’s decision to move forward with the review follows a period of friction; the agency had previously issued a refusal-to-file letter, forcing the company to overhaul its regulatory strategy and meet with officials to find a viable path forward.

A Strategic Regulatory Pivot

Moderna’s amended application introduces a bifurcated approach to gain market entry. The company is seeking full approval for adults aged 50 to 64 while pursuing an accelerated approval pathway for those 65 and older. CEO Stephane Bancel characterized the FDA’s engagement as "constructive" following a critical Type A meeting that paved the way for the current submission.

The expansion of the mRNA-1010 program extends beyond the United States. The vaccine has already been accepted for review in Europe, Canada, and Australia, with Moderna expecting additional filings and potential approvals throughout 2026. This push into seasonal respiratory markets is a cornerstone of the company’s efforts to diversify its portfolio as demand for COVID-19 products continues to stabilize.