Drug News: November 2025

Covering key developments between 1 November 2025 and 30 November 2025.

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European Medicines Agency (EMA)

November’s CHMP meeting delivered ten positive opinions for new medicines and four indication extensions, with a continued focus on rare diseases, endocrine/metabolic disorders, vaccines and oncology. (Source: EMA CHMP November 2025 highlights)

1. Dawnzera (donidalorsen) — Otsuka — hereditary angioedema (HAE), a subcutaneous antisense therapy to prevent HAE attacks in patients ≥12 years, EMA communication.
   
2. Waskyra (etuvetidigene autotemcel) — Fondazione Telethon — in Wiskott-Aldrich syndrome. It’s the first EU-authorised gene therapy for this life-threatening immunodeficiency.
   
3. Inluriyo (imlunestrant) — Lilly — ESR1-mutated ER+/HER2- breast cancer, EMA communication.
   
4. Teizeild (teplizumab) — Sanofi — stage 2 type 1 diabetes. This is first treatment to delay the onset of stage 3 T1D, EMA communication.
   
5. VacPertagen — BioNet Europe — pertussis booster in individuals of 12 years and older, EMA communication.
   
6. PRAC — November 2025 meeting No new major safety referrals, EMA communication.

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US Food and Drug Administration (FDA)

November was strong for first-in-disease approvals, particularly in rare disease, RNA therapeutics and targeted oncology.

1. Kygevvi — UCB — TK2 deficiency: the first-ever approved treatment for TK2d, FDA communication.
   
2. Komzifti (ziftomenib) — Kura/Kyowa Kirin in acute / refractory acute myeloid leukemia, FDA communication.
   
3. Redemplo (plozasiran) — Arrowhead — FCS Approved to reduce triglycerides in familial chylomicronemia syndrome, FDA communication.
   
4. Hyrnuo (sevabertinib) — Bayer — HER2-mutated NSCLC, FDA communication.
   
5. Voyxact (sibeprenlimab-szsi) — Otsuka — Accelerated approval in nephropathy, FDA communication.
   
6. Imfinzi (durvalumab) + FLOT — AstraZeneca — peri-operative regimen with maintenance in resectable gastric/GEJ cancer**, FDA communication.
   

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New data from clinical trials (Phase 2, Phase 3)

1. Doravirine/Islatravir (DOR/ISL) — Merck — HIV: Non-inferior to triple therapy at Week 48; first non-INSTI 2-drug STR, Press Release.
   
2. Semaglutide (EVOKE) — Novo Nordisk — Alzheimer’s (Phase 3)Failed primary cognitive endpoint; development direction under review, Press Release.
   
3. Mitapivat — Agios — Sickle cell disease (RISE UP Phase 3) Mixed outcome: met Hb improvement; did not reduce VOC crises, Press Release.
   
4. Atacicept — Vera — IgA nephropathy (ORIGIN Phase 3): Statistically significant proteinuria reduction + supportive eGFR trend, Press Release.
   
5. Zanidatamab — Zymeworks/BeiGene/Jazz — HER2+ gastric (Phase 3): Met PFS and OS endpoints in first-line HER2-positive gastric/GEJ cancer, Zymeworks website.

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Development Program Updates — November 2025

• Milvexian (BMS/J&J) — ACS: Phase 3 Librexia ACS stopped early for futility.
  
• MannKind — Inhaled clofazimine (ICoN-1) Change: Phase 3 discontinued after strategic review.
  
• Prelude Therapeutics — portfolio re-prioritisation: Option deal with Incyte for selective JAK2V617F inhibitors; other assets paused, Press Release.

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Dealmaking & Financing

Totals for November 2025 (publicly announced):

• M&A headline value: ~USD 22–23B (≈CHF 20–21B)
• Key financings highlighted below: ~USD 620–650M combined

M&A & Licensing

1. Merck → Cidara Therapeutics
   Value: USD ~9.2B cash
   Focus: Long-acting antiviral CD388 for influenza prevention, Press Release.
   
2. Pfizer → Metsera
   Value: Up to USD 10B (cash + milestones)
   Focus: Obesity/metabolic pipeline (injectable + oral incretins), Press Release.
   
3. Johnson & Johnson → Halda Therapeutics
   Value: ~USD 3.05B
   Focus: Induced-proximity degraders (RiPTAC platform), Press Release.
   
4. Prelude ↔ Incyte — option
   Structure: Exclusive option for mutant-selective JAK2 inhibitors Press Release.
   

Financings

1. Braveheart Bio — Series A — USD 185M
   Focus: Hypertrophic cardiomyopathy therapy Press Release.
   
2. AAVantgarde Bio — Series B — USD 141M
   Focus: AAV gene therapies in inherited retinal disease Press Release.
   
3. Solve Therapeutics — USD 120M
   Focus: Best-in-class next-generation ADCs, Press Release.
   
4. Aspen Neuroscience — Series C — USD 115M
   Focus: Autologous iPSC cell therapy for Parkinson’s disease, Press Release.
   
5. AI Proteins — Series A — USD 41.5M
   Focus: De novo protein therapeutics (AI-enabled design), Press Release.
   
6. AEON Biopharma — PIPE + note exchange — up to USD 22M
   Focus: Botulinum neurotoxin in neurology (ABP-450),Press Release.

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Health Economia Advisory (HE Advisory) is an independent advisory firm supporting biotech and pharma investors and leadership teams with evidence-based insights across development, regulatory and market-access strategy.
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