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The Fast Track Ends; The Lawsuits Continue

Nathan Brinkman

Moderna completed the fourth quarter with a balance sheet still fortified by pandemic-era cash generation, but continues with a business model still fully exposed to the volatility of a post-COVID commercial environment. Q4 results reflect a company in transition, from a pandemic-driven revenue engine to a late-stage development and launch organization attempting to build a multi-product mRNA franchise. COVID vaccine sales continue to normalize amid weaker booster uptake and seasonal variability, while operating discipline and pipeline execution are increasingly central to the equity story.

At the same time, regulatory uncertainty has become a meaningful overhang. Shifting global vaccination recommendations, evolving strain-selection timelines, potential changes in U.S. public health policy, and heightened scrutiny on updated vaccine approvals should introduce significant variability in new product registrations. Upcoming programs will require regulatory alignment on immuno-bridging endpoints, correlates of protection, and post-marketing commitments.  These will materially influence launch timing and commercial ramp of the Moderna pipeline.

Even though Moderna received a refusal to file letter from the FDA for mRNA-1010 (seasonal flu vaccine), they are still guiding to a 10% revenue increase for FY2026, surprising the market.  As I write this, MRNA is up almost 10% after the release of the Q4 financials.

What’s next for Moderna, let’s have a look.