Last week, the U.S. Food and Drug Administration (FDA) declined to review Moderna’s mRNA-based flu vaccine. The decision came in a refuse-to-file letter signed by Vinay Prasad, Director of the Center for Biologics Evaluation and Research. Prasad stated that Moderna’s comparator group “does not reflect the best-available standard of care.” In response, Moderna argued that the Center had previously considered a standard-dose flu shot to be an “acceptable” comparator. The Department of Health and Human Services (HHS) supported Prasad’s position, noting that Moderna did not “follow very clear FDA guidance from 2024.”
This development affects Moderna’s plans to break even financially, impacting not only its investigational flu vaccine but also its combined flu-COVID shot and other products in its pipeline. The situation underscores ongoing regulatory uncertainty within the industry as of 2026, while other countries continue to advance new types of therapies.
Regulatory challenges were also seen with Disc Medicine. The FDA rejected Disc's rare disease drug bitopertin. Although Disc aims to proceed with a Phase 3 trial in hopes of refiling, some analysts have raised concerns because the study was designed under previous FDA leadership. There are additional questions regarding the Commissioner’s National Priority Voucher program, since bitopertin had received such a voucher.
In contrast, Compass Pathways released data from two Phase 3 trials of its psilocybin-based therapy COMP360. Stifel analysts noted that these results showed strong durability and “clearly met the Street’s bar for success.” Compass Pathways intends to complete a rolling new drug application before year-end.
The Centers for Disease Control and Prevention (CDC) is currently without a permanent leader following the departure of acting director Jim O’Neill, who took over after Susan Monarez was removed last summer.
Separately, Paul Hudson was removed as CEO of Sanofi last week. He will be succeeded by Belén Garijo from Merck KGaA, making her only the second woman to lead a major pharmaceutical company.
