Hyrnuo (sevabertinib) : Kinase inhibitor approved 19-Nov-2025 for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. NDA #219947. Bayer Healthcare Pharms https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972
Komzifti (ziftomenib): Priority approval granted 13-Nov-2025 to treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options. NDA #220305. Kura Oncology, Inc. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305
Redemplo (plozasiran): Approved 18-Nov-2025 for familial chylomicronemia syndrome. RNA interference therapeutic to reduce triglycerides. NDA #219947. Arrowhead Pharmaceuticals, Inc. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219947/
Kygevvi (doxecitine and doxribtimine) - Approved 03-Nov-2025. for treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. NDA #219792. UCB Inc. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219792
Daratumumab and hyaluronidase-fihj: Approved 06-Nov-2025 for high-risk smoldering multiple myeloma
M&A Deals
Major Acquisitions:
Merck acquires Cidara Therapeutics: $9.2 billion (announced November 14). CD388, a long-acting antiviral for influenza prevention currently in Phase 3. First participant dosed September 2025, targeting 6,000 enrollment FDA. CD388 provided 76% protection from symptomatic influenza over 24 weeks in mid-stage trial. Not a vaccine, works regardless of immune status. Received FDA Breakthrough Designation in October 2025. Expected close Q1 2026. https://www.merck.com/news/
Johnson & Johnson acquires Halda Therapeutics: $3.05 billion in cash (announced November 17). HLD-0915 oral therapy for metastatic castration-resistant prostate cancer using proprietary RIPTAC platform. First-in-class RIPTAC (Regulated Induced Proximity Targeting Chimera) designed to overcome treatment resistance. Phase 1/2 data showed 59% achieved PSA50 response in heavily pretreated patient. J&J's second major deal this year after $14.6B Intra-Cellular acquisition. https://www.jnj.com/media-center/press-releases/
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Johnson & Johnson acquires Intra-Cellular Therapies: $14.6 billion, acquiring Caplyta for schizophrenia and bipolar depression (Source)
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Novartis acquires Avidity Biosciences: Approximately $12 billion acquisition for RNA-based therapies
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Merck & Co. acquires Verona Pharma - $10 billion for Ohtuvayre (ensifentrine), a COPD treatment approved in June 2024. https://www.merck.com/news
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Thermo Fisher acquires Clario - Up to $9.4 billion for clinical-trial endpoint and data-analytics capabilities
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Sanofi acquires Blueprint Medicines - $9.5 billion for rare disease portfolio including Ayvakit/Ayvakyt
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Endo and Mallinckrodt merger: $6.7 billion specialty pharma deal scheduled to close in 2025
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Novo Nordisk acquires Akero Therapeutics - Up to $5.2 billion (October 9) for efruxifermin, a fibroblast growth factor 21 analog for compensated cirrhosis
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Merck KGaA acquires SpringWorks Therapeutics: $3.9 billion for rare cancer therapies including Ogsiveo for desmoid tumors
AztraZeneca acquires eSoBiotec: AstraZeneca closed near $1 billion acquisition of eSoBiotec for next-generation cell therapy manufacturing. Novartis' $12 billion Avidity deal signals confidence in RNA-based precision delivery
Pfizer acquires Metsera: Pfizer sealed $10 billion acquisition of Metsera after bidding war with Novo Nordisk. Eli Lilly inked $1.3 million deal with Superliminal for AI/ML-generated obesity medications. These acquisitions highlight the continued growth of the obesity and GLP-1 space.
Clinical Trial Setbacks
Sarepta Therapeutics - Duchenne muscular dystrophy confirmatory trials failed (November 4). Long-delayed trials for two drugs showed no patient benefit. Stock and outlook downgraded.
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Intellia Therapeutics - Clinical hold imposed by FDA on October 29 for ATTR amyloidosis trials; patient death reported November 6 in MAGNITUDE trial. Stock plunged over 20% in one week (Source)
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Novartis discontinues ianalumab for hidradenitis suppurativa - Phase IIb proof-of-concept trial failed to meet target criteria despite showing efficacy vs placebo
Context: Clinical trial complexity continues to increase with 90% of drug candidates failing in clinical development, primarily due to lack of efficacy (40-50%) and unmanageable toxicity (30%) https://www.biopharmadive.com/topic/clinical-trials/
Technological Breakthroughs
CRISPR Gene Editing Advances:
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CRISPR Cholesterol Trial Success - Cleveland Clinic's CTX310 Phase 1 trial showed safe reduction of LDL cholesterol and triglycerides within two weeks, with effects lasting at least 60 days. Results presented at American Heart Association's Scientific Sessions on November 8, 2025 (Source)
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Retron-Based Gene Editing - University of Texas at Austin researchers developed a more efficient gene-editing approach using retrons, achieving 30% efficiency vs. previous 1.5%. Successfully corrected 30% of target cells, with potential for multiple mutations simultaneously (Published October 25, 2025)
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CRISPR-GPT AI Tool - Stanford Medicine developed an AI copilot for gene-editing design, automating experimental design and predicting off-target edits. Trained on 11 years of CRISPR research data (Announced September 2025)
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Personalized CRISPR for Rare Disease - Penn Medicine and Children's Hospital of Philadelphia created bespoke base-editing treatment for infant "KJ" with ultra-rare metabolic disease in just 6 months (May 2025 breakthrough)
Other Innovations:
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Queen Mary University of London launched Europe's largest organ-on-a-chip facility in February 2025, funded by NC3Rs to reduce animal testing
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Self-amplifying RNA technology - Researchers developing mRNA therapies requiring smaller doses, valuable for resource-limited settings
Notable Clinical Trials
- Long COVID Treatment Trial: Scripps Research launches LoCITT trial (October 30, 2025) - First fully remote trial testing tirzepatide (GLP-1 drug) for Long COVID. Recruiting 1,000 participants nationwide for 12-month study. Anecdotal reports show 60-90% of patients experienced symptom reduction. Trial details: https://longcovid.scripps.edu/
AstraZeneca's FASENRA (benralizumab) - NATRON Phase III trial showed statistically significant delay in hypereosinophilic syndrome flares, presented at ACAAI 2025
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Kardigan's ataciguat - Positive Phase 2 data slowed progression of calcific aortic valve stenosis, presented at American Heart Association 2025
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Ionis Pharmaceuticals' olezarsen - Phase 3 CORE studies achieved up to 72% placebo-adjusted mean reduction in triglycerides at 6 months for severe hypertriglyceridemia
Market Insights
AI Integration: 60% of executives plan to increase generative AI investments. AI-backed companies report 20-30% improvements in clinical trial success rates and 50% shorter trial durations. https://www.oncologynewscentral.com/drugs/info/oncology-drugs-fast-tracked-by-the-fda-in-october-2025
Market Growth: Global biotech market estimated at USD 1.744 trillion in 2025, projected to reach over USD 5 trillion by 2034.
Q3 2025 M&A Activity: Deal value surged 36.7% to $43.2 billion, though deal volume declined 21.9% to 107 transactions. Oncology led with 32 deals. October M&A Surge: 13 company acquisitions announced since early October—the most active dealmaking stretch in several years. https://www.labiotech.eu/recent-biotech-deals/
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Regulatory Challenges: 72% of life sciences executives cite regulatory compliance as a top challenge. Some companies bypassing U.S. trials in favor of EU/Australian pathways
- Why so many M&As? Patent cliff threatens $300 billion revenue loss by 2028, driving M&A activity. $300 billion revenue loss threatened by 2028, with 190 drugs losing patents by 2030.
