Moderna Inc. saw its stock price climb approximately 5% in extended trading Friday, reaching $42.23, after the biotech firm surpassed Wall Street's fourth-quarter revenue expectations and maintained its financial guidance for 2026.
Earnings and Outlook
The company reported quarterly revenue of $678 million, though it posted a loss of $2.11 per share. CEO Stéphane Bancel highlighted that annual operating expenses were reduced by about $2.2 billion for 2025. Looking ahead, Bancel stated the company is positioned to deliver up to 10% revenue growth in 2026, driven by its next-generation COVID vaccine and new international agreements.
Regulatory Setback and Strategy
Investor optimism was tempered by a regulatory development. Moderna disclosed it received a refusal-to-file letter from the U.S. Food and Drug Administration for its mRNA-1010 seasonal influenza vaccine. The company has requested a Type A meeting with the agency to determine the next steps.
This U.S. hurdle contrasts with progress elsewhere, as regulators in the European Union, Canada, and Australia have agreed to review the flu shot filing, with potential approvals commencing in 2026. Moderna's combined flu and COVID vaccine, mRNA-1083, is also under review in those regions.
Broader Pipeline and Challenges
Moderna is navigating a pivotal transition, aiming to counter declining COVID-related sales with new products in respiratory vaccines and oncology. The company pointed to key 2026 milestones, including Phase 3 data for a norovirus vaccine and its personalized cancer vaccine developed with Merck.
However, the path forward carries uncertainty. A prolonged U.S. regulatory process for its flu and combo vaccines could pressure near-term revenue. The company also anticipates its year-end cash and investments in 2026 will dip below the 2025 closing level, weighed down by ongoing research and development spending.
Markets will be closed Monday for the Presidents' Day holiday. Trading resumes Tuesday, with investors awaiting updates on the FDA meeting schedule and international regulatory reviews.
