Moderna rises 14% to highest intraday level since November 2024.

Moderna rises 14% to highest intraday level since November 2024.

Moderna Stock Surges 14% to Highest Intraday Level Since November 2024

Moderna Inc. (NASDAQ: MRNA) shares rose 14% in recent trading, reaching an intraday high not seen since November 2024, as positive developments surrounding its regulatory and clinical pipelines fueled investor optimism. The biotech company’s stock has gained 57% over the past month, closing at $54, well above the average analyst price target of $37.

The recent rally followed a pivotal regulatory update: The U.S. Food and Drug Administration (FDA) reversed its earlier refusal to file (RTF) decision for Moderna’s mRNA-1010 seasonal flu vaccine, agreeing to review the application after a “Type A” meeting. The agency set a Prescription Drug User Fee Act (PDUFA) decision date of August 5, 2026, with Moderna proposing a revised approval pathway targeting adults aged 50–64 for full approval and those 65+ for accelerated approval, contingent on post-marketing studies according to regulatory filings. CEO Stéphane Bancel praised the FDA’s “constructive” engagement, emphasizing the potential to bring a first-of-its-kind mRNA-based flu vaccine to market ahead of the 2026–27 flu season.

Analysts highlighted the significance of the FDA’s reversal, with Jefferies projecting $750 million in combined U.S. sales for the flu vaccine and a potential COVID/flu combination product by 2030. The development also spurred price target increases from multiple firms, including a 25% increase to $35 at Evercore ISI and a 14% raise to $41 at Goldman Sachs.

Additional momentum came from a favorable European patent ruling against rival Arbutus Biopharma, though Bloomberg Intelligence noted the outcome had limited relevance to pending U.S. patent proceedings. Meanwhile, positive Phase III data for Moderna’s cancer vaccine candidate, mRNA-4157, and expectations for success in an adjuvant melanoma trial further bolstered sentiment.

Despite the gains, Moderna’s stock remains far below its 2021 peak of $484.47, reflecting broader market skepticism about sustaining high margins post-pandemic. However, the company’s focus on expanding its mRNA platform—seven new products in development—has reinvigorated investor confidence.

While other vaccine developers like BioNTech and Novavax saw modest gains, Moderna’s rally was uniquely tied to its regulatory progress and pipeline advancements. With a PDUFA decision looming and ongoing clinical trials, the stock’s trajectory will likely remain sensitive to near-term developments.