FDA Shifts to One Pivotal Trial and Moderna Flu Shot Back Under FDA Review – This Week in Biotech #90

Moderna in 2026: What the Wins and Losses Are Telling Us

Subscribe to Biotech Blueprint for free at biotechblueprint.com [biotechblueprint.com] In the latest joint podcast episode by Biotech Blueprint × Biotech Capital Compass, we zoom in on Moderna and where the company stands in 2026. We work through the Q1 earnings beat, the unprecedented FDA refusal-to-file on mRNA-1010, the CMV Phase 3 failure, the Vertex cystic fibrosis wind down, and the individualized neoantigen therapy (INT) program that has moved to the center of the pipeline. The short companion piece below picks up one thread from the conversation, which is the pattern across Moderna’s wins and losses, and what it suggests about where the platform actually works.

FDA Shifts to One Pivotal Trial and Moderna Flu Shot Back Under FDA Review – This Week in Biotech #90

Subscribe to Biotech Blueprint for free at biotechblueprint.com.

Hims Launches Compounded GLP-1 Pill, CVS Forces Biosimilars – This Week in Biotech #88

Compounded semaglutide draws FDA scrutiny as Novo Nordisk guides 2026 lower and Eli Lilly leans into a $50 Medicare copay (Jan 30-Feb 5, 2026). Follow Biotech Blueprint at biotechblueprint.com [biotechblueprint.com].

Regenxbio FDA Hold, Sanofi Vaccine Demand Softness, and CMS Negotiation Expansion – This Week in Biotech #87

FDA pauses two AAV programs, Sanofi reports US vaccine uptake slipping, and CMS widens negotiations to more blockbuster drugs (Jan 23-29, 2026). Subscribe to Biotech Blueprint at biotechblueprint.com [biotechblueprint.com].

Moderna Merck V940 Shows Five Year Melanoma Durability, Biopharma Deal Activity Picks Up

This Week in Biotech #86. Subscribe to Biotech Blueprint for free at biotechblueprint.com [biotechblueprint.com]. KEYNOTE-942 durability, plus GSK’s $2.2B RAPT food allergy deal, BMS partners with Janux, Corcept's overall survival win, and Corvus posts Phase 1 eczema data (Jan 16-22, 2026).