Efficacy

• The FDA has raised concerns regarding the efficacy of Capricor Therapeutics' treatment for Duchenne muscular dystrophy ahead of an upcoming advisory committee hearing. • The agency's skepticism contradicts claims made by Capricor regarding the clinical benefits of the rare disease drug. • This development is critical as it may influence the FDA's final decision on whether to grant regulatory approval for the therapy.

• Eisai and Biogen announced positive top-line results from CLARITY AD trial extension on April 7, 2026, with lecanemab reducing cognitive decline by 27% over 18 months in 1,795 US patients. • Drug cleared 59% more amyloid plaques vs. placebo, with ARIA side effects in 12.6% of participants; full data at June AD/PD conference. • Approval could expand to mild cases, addressing 6.7 million US Alzheimer's sufferers; analysts predict $2.4 billion annual sales.

An FDA advisory committee has recommended the development of next year's flu vaccine, as new data from the CDC indicates the current 2025-2026 flu vaccine provides moderate protection against hospitalization for vaccinated individuals despite concerns about late-emerging H3N2 strains. The committee reviewed winter flu shot effectiveness reports published in the CDC's online MMWR journal, which showed moderate protective efficacy against severe outcomes requiring hospitalization. The timing of vaccine selection remains critical as late-emerging H3N2 variants can significantly undermine vaccine effectiveness, a concern flagged by the committee during this year's review. Current guidance continues to emphasize vaccination for those at high risk of severe illness, particularly elderly and immunocompromised populations.