Moderna stock surges as FDA reverses course, agrees to review new flu shot

Core Viewpoint - Moderna's stock experienced a significant increase of over 6% following the FDA's decision to review its flu vaccine, reversing a previous rejection of the review request [1][3]. Group 1: FDA Review and Regulatory Pathway - The FDA initially declined to review Moderna's flu vaccine, citing dissatisfaction with the company's trials, which is a critical step for market approval [2]. - Moderna proposed a regulatory pathway targeting specific age groups, seeking full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older [4]. - The company expressed appreciation for the FDA's engagement and looks forward to making the flu vaccine available later this year for seniors [4]. Group 2: Financial Performance and Market Reaction - Shares of Moderna fell approximately 2% after the publication of the FDA's "refusal-to-file" letter [3]. - The company reported a smaller-than-expected adjusted loss of $2.11 per share and revenue of $678 million, outperforming analysts' estimates of a loss of $2.64 per share and revenue of $623.9 million [5]. - Moderna's stock surged by about 15% after announcing positive clinical results for a skin cancer vaccine developed in partnership with Merck [6]. Group 3: Market Position and Competitors - Moderna's shares have increased over 55% since the beginning of 2026, contrasting with smaller gains for competitors like Pfizer, BioNTech, and AstraZeneca [4].