Pharma M&A is running well ahead of last year’s pace, with Lilly and Gilead leading a 2026 deal surge concentrated in oncology and autoimmune assets. Gilead lifted its first-year Yeztugo (lenacapavir) sales forecast to $1 billion after Q1 sales of $166 million, while Novo Nordisk’s oral Wegovy launch continues to gain momentum against Eli Lilly. On the regulatory front, the FDA pushed the PDUFA for Eisai/Biogen’s Leqembi IQLIK (lecanemab-irmb) subcutaneous starting dose by three months to August 24, 2026, and signaled willingness to reassess Pierre Fabre’s twice-rejected Ebvallo (tabelecleucel) for EBV+ PTLD. Capricor sued partner NS Pharma over deramiocel Duchenne muscular dystrophy launch preparations ahead of an August 22, 2026 PDUFA.
What to Watch
- Oral GLP-1 uptake dynamics — Novo’s oral Wegovy momentum will test whether pill formulations can meaningfully expand the obesity market or simply cannibalize existing injectable franchises, with implications for pricing power and competitive positioning against Lilly.
- M&A pipeline targets — With Lilly and Gilead leading a deal resurgence focused on oncology and autoimmune assets, expect heightened competition for late-stage programs in these categories and potential valuation inflation for promising preclinical platforms.
- Mifepristone precedent implications — The Supreme Court decision on FDA authority over mifepristone could set a precedent affecting regulatory predictability across the pharmaceutical sector, particularly for products facing political or social controversy.
