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  • Biotech & Pharma Updates | November 2 - 3, 2025

Biotech & Pharma Updates | November 2 - 3, 2025

🧬 Eli Lilly invests $3B in Netherlands oral medicines plant + plans 500 hires for GLP-1 manufacturing expansion, AAVantgarde raises $141M Series B to advance retinal gene therapies for inherited diseases, Vertex and CRISPR Therapeutics' Casgevy shows efficacy in younger children with sickle cell disease in Ph3 trials, Roche's Gazyva (obinutuzumab) hits Ph3 primary endpoint for systemic lupus erythematosus, Neurocrine in-licenses TransThera NLRP3 inhibitors for multiple diseases for up to $881.5M, Roche + Manifold Bio partner on blood-brain barrier shuttle development - $55M upfront + $2B milestones, UCB's Kygevvi (doxecitine and doxribtimine) wins FDA approval as first therapy for thymidine kinase 2 deficiency

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

UK MHRA agrees to conditional marketing authorization application for Belite Bio's Tinlarebant targeting Stargardt disease
Small molecule, ophthalmology, retinal dystrophy, Stargardt disease, RPE65 pathway - Read more

UCB's Kygevvi (doxecitine and doxribtimine) wins FDA approval as first therapy for thymidine kinase 2 deficiency
Small molecule, metabolic, nucleoside therapy, thymidine kinase 2 deficiency, mitochondrial disorder, ultra-rare disease - Read more

THE GOOD
Business Development & Partnerships

CNX Therapeutics acquires Sativex multiple sclerosis treatment from Jazz Pharmaceuticals, financial terms undisclosed
Acquisition, neurological, CNS therapeutics, cannabinoid medicine - Read more

Roche, Manifold Bio partner on blood-brain barrier shuttle development, $55M upfront, $2B milestones
Licensing deal, neurological, AI/ML, milestone payments - Read more

Neurocrine, TransThera license NLRP3 inhibitors for multiple diseases, up to $881.5M milestones
Licensing deal, small molecule, inflammatory diseases, milestone payments - Read more

Eder Therapeutics, XCubeBio form joint Swiss entity for global rare disease development and commercialization
Joint venture, rare disease, market entry, clinical development - Read more

Kaigene, Celltrion license autoimmune antibody therapeutics KG006 and KG002, $8M upfront, $736M milestones
Licensing deal, autoimmune, antibody, milestone payments - Read more

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 More Good News 

THE GOOD
Clinical Trials

UCB's Bimzelx (bimekizumab) shows sustained three-year benefits in hidradenitis suppurativa patients from BE HEARD trials
Monoclonal antibody, autoimmune, bimekizumab, hidradenitis suppurativa, IL-17 inhibitor - Read more

Caribou Biosciences reports 80% response rate for vispa-cel CAR-T therapy in Ph2 lymphoma trial
Cell therapy, cancer, CAR-T, lymphoma, allogeneic, HLA-matching - Read more

Roche's Gazyva (obinutuzumab) hits Ph3 primary endpoint for systemic lupus erythematosus in ALLEGORY study
Antibody, autoimmune, monoclonal antibody, systemic lupus erythematosus, CD20 target - Read more

Servier reports positive Ph3 longer-term data for VORANIGO (vorasidenib) targeting IDH1/2 mutant glioma published in Lancet Oncology
Small molecule, cancer, IDH inhibitor, glioma, brain tumor - Read more

Vertex and CRISPR Therapeutics' Casgevy shows efficacy in younger children with sickle cell disease in Ph3 trials
Gene therapy, blood disorders, CRISPR, sickle cell disease, beta thalassemia, pediatric patients - Read more [Paywall]

Lilly's Jaypirca (pirtobrutinib) matches Imbruvica in Ph3 trial for chronic lymphocytic leukemia and small lymphocytic lymphoma
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, blood cancer - Read more [Paywall]

Iovance reports 25.6% response rate for lifileucel TIL therapy in Ph2 non-small cell lung cancer trial
Cell therapy, cancer, TIL therapy, non-small cell lung cancer, tumor infiltrating lymphocytes - Read more

Rein Therapeutics receives FDA clearance to resume LTI-03 Ph2 trial for idiopathic pulmonary fibrosis
Small molecule, pulmonary disease, idiopathic pulmonary fibrosis, fibrosis, orphan disease - Read more

THE GOOD
Fundraises

NeuracleGenetics raises $8.1M Series C extension, advancing AAV gene therapy clinical trials
Gene therapy, AAV platform, clinical-stage, platform technology - Read more

BOOST Pharma raises $4M investment, stem cell therapy for osteogenesis imperfecta
Cell therapy, rare disease, osteogenesis imperfecta, clinical-stage, pediatric - Read more

AAVantgarde raises $141M Series B, advancing retinal gene therapies for inherited diseases
Gene therapy, inherited retinal diseases, AAV vector, clinical-stage - Read more

Courage Therapeutics raises undisclosed Seed funding for obesity and wasting disease treatments
Obesity, small molecule, preclinical, neurological - Read more

HLB Group raises $145M strategic investment for clinical development and global commercialization
Clinical-stage, platform technology - Read more

MindMed raises $259M public offering, developing treatments for brain health disorders
Brain health disorders, clinical-stage, neurological, biopharmaceutical - Read more

THE GOOD
Investments

Eli Lilly invests $3B in Netherlands oral medicines plant, plans 500 hires for GLP-1 manufacturing expansion
Small molecule, metabolic disease, operational, major transaction - Read more

THE GOOD
Mergers & Acquisitions

Kimberly-Clark acquires Kenvue for $48.7B, creating $32B consumer health giant despite Tylenol concerns
Consumer health products, strategic, major transaction, financial - Read more

THE GOOD
Regulatory

FDA developing expedited approval pathway for gene editing therapies targeting rare diseases following CRISPR success
Gene editing, rare disease, regulatory, strategic - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Tempero Bio pauses Ph2 trial of TMP-301 targeting mGluR5 for alcohol use disorder treatment
Small molecule, addiction disorders, mGluR5 negative allosteric modulator, alcohol use disorder, program discontinuation - Read more

Sarepta Therapeutics's Vyondys 53 (golodirsen) and Amondys 45 (casimersen) fail Ph3 confirmatory trial for Duchenne muscular dystrophy
Antisense oligonucleotide, neurological, Duchenne muscular dystrophy, exon skipping, confirmatory trial failure - Read more

THE BAD
Lawsuits

Pfizer files second lawsuit against Novo Nordisk over $9 billion Metsera acquisition battle
GLP-1 agonist, obesity, strategic, major transaction - Read more

Metsera calls Pfizer legal threats "nonsense" amid $6.5B Novo Nordisk takeover battle
Small molecule, metabolic disease, strategic, major transaction, competitive - Read more [Paywall]

THE BAD
Layoffs

TScan Therapeutics cuts 30% workforce, halts solid tumor trial to focus on blood cancer program
TCR therapy, oncology, strategic, operational, cost reduction - Read more

THE BAD
Market Reports

Pharma reputation drops to 52% among neurology patient groups citing drug access challenges
Neurological, strategic, operational, competitive - Read more

THE BAD
Regulatory

UniQure plunges 65% after FDA unexpectedly shifts stance on Huntington's gene therapy approval timeline
Gene therapy, Huntington’s disease, neurological, regulatory, strategic - Read more

FDA places clinical hold on Serina Therapeutics' SER-252 Parkinson's drug over formulation excipient concerns
Small molecule, neurological, operational, strategic - Read more [Paywall]

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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

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