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  • Biotech & Pharma Updates | December 16 - 17, 2025

Biotech & Pharma Updates | December 16 - 17, 2025

🧬 Addition Therapeutics emerges from stealth with $100M to develop novel gene therapies for chronic + rare diseases, Merck & Co.'s Keytruda (pembrolizumab) plus Padcev hits Ph3 endpoints in perioperative muscle-invasive bladder cancer treatment, Boehringer Ingelheim + Galux partner on AI-driven precision protein design research using GaluxDesign platform, Alnylam Pharmaceuticals invests $250M to expand RNAi manufacturing facility using new enzymatic ligation technology, Cascade Pharmaceuticals raises $46M Series B for phase III trials and pipeline development, BMS + Harbour BioMed collaborate on multi-specific antibodies - $90M upfront + $1.035B milestones, Johnson & Johnson's Rybrevant Faspro (amivantamab) receives FDA approval as first subcutaneous EGFR-targeted non-small cell lung cancer therapy

All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

China approves Cytokinetics' Myqorzo (aficamten) cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy treatment
Small molecule, cardiovascular, cardiac myosin inhibitor, hypertrophic cardiomyopathy - Read more

Johnson & Johnson's Rybrevant Faspro (amivantamab) receives FDA approval as first subcutaneous EGFR-targeted non-small cell lung cancer therapy
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, EGFR mutation, subcutaneous administration - Read more

THE GOOD
Business Development & Partnerships

Norgine, Vir Biotechnology license hepatitis D combo for Europe, €55M ($64.6M) upfront, €550M ($646M) total
Licensing deal, infectious disease, antibody, milestone payments - Read more

BMS, Harbour BioMed collaborate on multi-specific antibodies, $90M upfront, $1.035B milestones
Research collaboration, antibody, milestone payments, drug discovery - Read more

Boehringer Ingelheim, Galux partner on AI-driven precision protein design research using GaluxDesign platform
Research collaboration, AI/ML, protein design, antibody - Read more

Valink Therapeutics, Nona Biosciences form strategic alliance to accelerate bispecific antibody and ADC discovery
Strategic alliance, oncology, bispecific antibodies, drug discovery, antibody-drug conjugates - Read more

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 More Good News 

THE GOOD
Clinical Trials

ImmunityBio's Anktiva shows 38% three-year disease-free survival in non-muscle-invasive bladder cancer subtype
Protein therapy, cancer, IL-15 receptor agonist, bladder cancer, combination therapy - Read more

Merck & Co.'s Keytruda (pembrolizumab) plus Padcev hits Ph3 endpoints in perioperative muscle-invasive bladder cancer treatment
Antibody, cancer, monoclonal antibody, bladder cancer, PD-1 checkpoint inhibitor, antibody-drug conjugate - Read more

Personalis' NeXT Personal ctDNA test shows early immunotherapy response prediction across advanced solid tumors
Immunotherapy, cancer, immune checkpoint inhibitors, ctDNA biomarker, solid tumors - Read more

Johnson & Johnson's TECVAYLI (teclistamab) plus DARZALEX shows 83% risk reduction in Ph3 relapsed/refractory multiple myeloma trial
Antibody, cancer, bispecific antibody, multiple myeloma, BCMA target, combination therapy - Read more

THE GOOD
Company Launches

Addition Therapeutics emerges from stealth with $100M to develop novel gene therapies for chronic, rare diseases
Gene therapy, rare disease, major transaction, strategic - Read more

THE GOOD
Fundraises

Cascade Pharmaceuticals raises $46M Series B, phase III trials and pipeline development
Metabolic diseases, small molecule, nuclear receptors, clinical-stage - Read more 

T-Curx raises $20M Series A for non-viral CAR-T cancer therapies
CAR-T cell therapy, oncology, non-viral gene transfer, clinical-stage - Read more

Kodiak Sciences raises $160M public offering, precommercial retina focused biotechnology company
Retina therapeutics, precommercial, biotechnology - Read more

THE GOOD
Investments

Alnylam Pharmaceuticals invests $250M to expand RNAi manufacturing facility using new enzymatic ligation technology
RNAi therapeutics, cardiovascular, operational, major transaction - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Vistagen's fasedienol (PH94B) fails Ph3 trial for social anxiety disorder despite previous positive results
Small molecule, anxiety disorders, intranasal therapy, social anxiety disorder, chemosensory modulation - Read more

THE BAD
Layoffs

Intercept Pharmaceuticals restructures with 146 layoffs following Ocaliva withdrawal from U.S. market
Small molecule, rare disease, operational, cost reduction - Read more

Voyager Therapeutics lays off 30 employees after Novartis returns rights to two discovery programs
Gene therapy, neurological, operational, cost reduction - Read more

THE BAD
Politics & Policy

Biosecure Act heads to Trump's desk, targeting Chinese biotech companies in defense bill
Biotech services, regulatory, strategic, operational - Read more

THE BAD
Regulatory

Fired NIAID director Marrazzo sues Trump officials seeking reinstatement claiming illegal whistleblower retaliation
Infectious disease, regulatory, operational, strategic - Read more

CDC ends routine newborn hepatitis B vaccination, recommends delaying dose until two months
Vaccine, infectious disease, operational, strategic - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

You’re all caught up on the latest Pharma & Biotech News!

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