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 extended its review of Eisai/Biogen's Leqembi IQLIK subcutaneous starting dose by three months and signaled willingness to reassess Pierre Fabre's twice-rejected Ebvallo, while Capricor sued partner NS Pharma over Duchenne therapy launch preparations.
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Lilly and Gilead drive M&A resurgence with focus on oncology and autoimmune assets
Deal volume in 2026 is substantially outpacing last year's activity, with Eli Lilly and Gilead Sciences leading the charge through acquisitions targeting cancer and autoimmune disease drugs, BioPharma Dive reports. Lilly's recent moves include Centessa Pharmaceuticals (~$7.8B, narcolepsy), Orna Therapeutics (up to $2.4B, in vivo cell therapy for autoimmune disease), and Ajax Therapeutics (~$2.3B, JAK inhibitors for myelofibrosis); Gilead's include Arcellx (~$7.8B, multiple myeloma CAR-T), Tubulis (up to $5B, ADCs in oncology), and Ouro Therapeutics (up to $2.18B, autoimmune). This signals renewed confidence in external innovation as a growth lever, particularly as patent cliffs loom for multiple blockbusters across the industry.
Gilead raises Yeztugo (lenacapavir) first-year guidance to $1B on unprecedented launch momentum
Gilead Sciences has increased its 2026 revenue forecast for twice-yearly long-acting PrEP injectable Yeztugo (lenacapavir) from $800 million to $1 billion after Q1 sales of $166 million — what the company describes as an "unprecedented launch trajectory," according to Fierce Pharma. The upward revision reflects strong early adoption, with the product leading the long-acting injectable segment in switch patients and gaining momentum among treatment-naïve individuals. Worth watching because sustained uptake at this pace could position Yeztugo as a cornerstone PrEP franchise and validate the long-acting injectable category for prevention indications.
Novo Nordisk's oral Wegovy launch gains traction in obesity market rivalry with Lilly
Novo Nordisk CEO Mike Doustdar championed a "record-breaking start" for the company's oral formulation of Wegovy in the U.S. market, Pharmaceutical Technology reports. The pill version provides financial fuel in Novo's intensifying competition with Eli Lilly for dominance in the obesity treatment space. This move suggests oral GLP-1 formulations may capture share from patients hesitant about injectables, potentially expanding the addressable market while defending Novo's leadership position.
Former FDA leadership and pharma industry weigh in on Supreme Court mifepristone case
Former FDA leaders and pharmaceutical industry stakeholders have filed amicus briefs in the ongoing Supreme Court case concerning mifepristone regulation, with STAT reporting that the "fundamental question is: Who gets to regulate mifepristone?" The briefs underscore concerns about undermining FDA authority and the precedent such a decision could set for other approved medications. This signals that industry views judicial interference in drug regulation as a threat to the predictability and scientific integrity of the approval process.
FDA extends Leqembi IQLIK subcutaneous review by three months to August 24, 2026; Pierre Fabre Ebvallo reassessment continues
The FDA pushed the PDUFA date for Eisai/Biogen's once-weekly subcutaneous starting dose of Leqembi IQLIK (lecanemab-irmb) for early Alzheimer's disease from May 24, 2026 to August 24, 2026 after deeming additional sponsor information a "major amendment" — the agency has not raised approvability concerns, per an Eisai/Biogen release. Separately, the FDA continues its reassessment of Pierre Fabre's twice-rejected Ebvallo (tabelecleucel) for EBV+ PTLD following a Type A meeting, BioPharma Dive reports. Worth watching because the IQLIK delay extends launch timing for a key Alzheimer's franchise expansion at a moment when subcutaneous administration is central to broader uptake.
Capricor sues NS Pharma over deramiocel U.S. distribution agreement ahead of August 22 PDUFA
On May 7, 2026, Capricor Therapeutics filed suit in the Superior Court of New Jersey against Nippon Shinyaku and its U.S. subsidiary NS Pharma, alleging a "pricing flaw" that could block Medicare, Medicaid and commercial-payer access — and inadequate launch preparation — for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy now under FDA Priority Review with a PDUFA date of August 22, 2026 following a July 2025 Complete Response Letter, Endpoints News reports, with case detail in a Capricor press release. Capricor is seeking to rescind the deal. This signals potential friction in trans-Pacific partnerships when commercial expectations diverge, particularly for rare disease assets where pricing and launch execution are make-or-break factors.
EMA safety committee completes May agenda covering risk management and signal assessments
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded its May 4-7 meeting, addressing safety signals and risk management responsibilities across its portfolio of approved medicines, according to an agency announcement. The routine meeting underscores the ongoing post-approval surveillance infrastructure in Europe. This signals that regulators continue to prioritize lifecycle safety monitoring even as approval timelines compress for novel therapeutics.
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.
Market Snapshot
- GLP-1 franchise expansion: Both Novo Nordisk and Eli Lilly are racing to expand their obesity franchises through new formulations and indications, with oral versions potentially addressing the estimated 60-70% of eligible patients who remain untreated due to injection aversion.
- M&A volume acceleration: Deal activity in 2026 is substantially outpacing 2025 levels, driven by large-cap pharma seeking to offset looming patent expirations and bolster pipelines in high-value therapeutic areas like oncology and immunology.
- Rare disease partnership risks: The Capricor-Nippon Shinyaku dispute highlights the commercial complexities in rare disease partnerships, where pricing strategies and launch execution disagreements can derail programs even after regulatory milestones are achieved.