FDA Extends Camizestrant PDUFA After AdCom Votes 3–6 Against

Daily Biopharma Digest — May 27, 2026

• FDA extended the PDUFA date for AstraZeneca’s camizestrant after an April 2026 AdCom voted 3–6 against approval; EMA’s CHMP issued a positive opinion May 22, 2026.
• Eli Lilly unveiled $3.83 billion in vaccine acquisitions — Curevo ($1.5B), Vaccine Company, Inc. ($1.55B), and LimmaTech Biologics (up to $780M).
• Apogee secured up to $1.3 billion in non-dilutive royalty financing from Blackstone Life Sciences to advance zumilokibart into Phase 3 atopic dermatitis (Phase 2 APEX: 65.9% EASI-75 vs. 23.4% placebo).
• CordenPharma expanded GLP-1 production via a peptide CDMO acquisition, adding US and China sites.

What to Watch

• Lilly’s Vaccine Strategy — The $3.83 billion bet marks Lilly’s first major return to vaccines in seven years; watch Curevo’s Phase 2 shingles readouts and Phase 3 timing for the lead Curevo asset.
• FDA vs. EMA on Camizestrant — The transatlantic split (FDA AdCom 3–6 against; EMA CHMP positive opinion May 22) could set the tone for ctDNA-defined endpoints in HR+/HER2- breast cancer SERDs.
• Eczema Market Competition — Apogee’s Phase 3 advancement intensifies the atopic dermatitis landscape versus Dupixent and Ebglyss.
• GLP-1 Manufacturing Arms Race — CordenPharma’s peptide CDMO deal highlights supply chain bottlenecks, with capacity critical through 2027 and beyond.