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

Biotech & Pharma Updates | December 2 - 3, 2025

🧬 FDA proposes cutting fees for US-based early-stage trials + adding charges for overseas development, Triana Biomedicines raises $120M Series B to continue development of molecular glue degrader for ALK+ lung cancer, AtomVie invests $138M to expand Ontario radiopharmaceutical facility - creating 70 jobs for cancer treatments, Excelsior raises $95M Series A to progress AI-driven small molecule discovery platform, Next-gen CRO Avetra launches with 350-plus US sites + plans gastrointestinal program, Capricor Therapeutics' deramiocel hits primary endpoint in Ph3 trial for Duchenne muscular dystrophy cardiomyopathy, Harmony Biosciences' EPX-100 reduces seizures by 50% in Ph3 open-label study for Dravet syndrome, Terray Therapeutics + Bristol Myers Squibb achieve discovery milestone in AI-driven small molecule development partnership

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

Celltrion receives FDA approval for 300mg strength of OMLYCLO (omalizumab-igec) interchangeable biosimilar to Xolair
Antibody, autoimmune, biosimilar, omalizumab, asthma, IgE inhibitor - Read more

FDA expands Eli Lilly's Jaypirca (pirtobrutinib) BTK inhibitor approval for chronic lymphocytic leukemia small lymphocytic lymphoma
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, non-covalent binding - Read more

THE GOOD
Business Development & Partnerships

Théa, Iolyx partner on phase 3-ready dry eye disease drug ILYX-002, $280M milestones
Licensing deal, autoimmune, immunomodulator, milestone payments, ophthalmology - Read more

Althera Laboratories, Tabuk Pharmaceuticals partner on Type 2 diabetes therapy commercialization in MENA region
Licensing deal, metabolic disease, commercialization, combination therapy - Read more

Terray Therapeutics, Bristol Myers Squibb achieve discovery milestone in AI-driven small molecule development partnership
Research collaboration, small molecule, AI/ML, milestone payments - Read more

Simcere Pharmaceutical Group, Vigonvita Life Science license deuterated remididevir for RSV, HMPV in Greater China
Licensing deal, infectious disease, nucleoside analogue, milestone payments - Read more

Orion receives €180M ($209.3M) milestone payment for Nubeqa sales, recorded in Q4 2025
Small molecule, oncology, financial, milestone payment - Read more

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 More Good News 

THE GOOD
Clinical Trials

Muvon's muscle precursor cell therapy shows 60% reduction in stress urinary incontinence episodes in Ph2 trial
Cell therapy, urological disorders, muscle precursor cells, stress urinary incontinence, muscle regeneration - Read more

Cosmo's clascoterone hits Ph3 goals for male-pattern hair loss with 539% improvement over placebo
Small molecule, dermatological, topical androgen receptor inhibitor, male pattern baldness, dihydrotestosterone target - Read more

Pharvaris' deucrictibant (bradykinin B2 receptor antagonist) succeeds in Ph3 trial for hereditary angioedema attacks
Small molecule, rare disease, bradykinin B2 receptor antagonist, hereditary angioedema, oral therapy - Read more

Harmony Biosciences' EPX-100 reduces seizures by 50% in Ph3 open-label study for Dravet syndrome
Small molecule, neurological, epilepsy, Dravet syndrome, seizure reduction - Read more

Capricor Therapeutics' deramiocel hits primary endpoint in Ph3 trial for Duchenne muscular dystrophy cardiomyopathy
Cell therapy, cardiomyopathy, Duchenne muscular dystrophy, cardiac-derived cells, non-ambulatory population - Read more

Clene reports positive CNM-Au8 biomarker results supporting accelerated approval pathway for amyotrophic lateral sclerosis treatment
Small molecule, neurological, amyotrophic lateral sclerosis, neurofilament light biomarker, accelerated approval - Read more

Black Diamond reports 60% response rate for silevertinib EGFR inhibitor in Ph2 non-small cell lung cancer trial
Small molecule, cancer, EGFR inhibitor, non-small cell lung cancer, glioblastoma - Read more [Paywall]

THE GOOD
Company Launches

Next-gen CRO Avetra launches with 350-plus US sites, plans gastrointestinal program
Clinical research services, gastrointestinal, strategic, operational - Read more

THE GOOD
Fundraises

Excelsior raises $95M Series A, AI-driven small molecule discovery platform
AI/ML platform, small molecule, drug discovery, platform technology, automated synthesis - Read more

Triana Biomedicines raises $120M Series B, molecular glue degrader for ALK+ lung cancer
Oncology, molecular glue degrader, targeted protein degradation, clinical-stage - Read more

AlzeCure secures €2.5M ($2.9M) EU grant for Alzheimer's drug NeuroRestore trial
Alzheimer disease, small molecule, neurological, clinical-stage - Read more

STRM.BIO awarded $8.4M ARPA-H contract, megakaryocyte-derived vesicle gene therapy platform
Gene therapy, platform technology, non-viral delivery, immune cell engineering - Read more

Junevity raises $10M seed extension for siRNA obesity/diabetes treatment development
AI/ML platform, siRNA, obesity, diabetes, preclinical - Read more

Lyric Bio raises $6.6M Seed, human-tissue-based biomanufacturing for donor-derived therapeutics
Biomanufacturing, tissue engineering, immunoglobulin production, platform technology - Read more

Curi Bio raises $10M Series B, human tissue models for drug discovery
Platform technology, drug discovery, cardiac, neuromuscular, 3D tissue models - Read more

THE GOOD
Investments

AtomVie invests $138M to expand Ontario radiopharmaceutical facility, creating 70 jobs for cancer treatments
Radiopharmaceutical, oncology, major transaction, operational - Read more

THE GOOD
Lawsuits

Daiichi Sankyo wins ADC patent appeal, reversing $41.8M Seagen verdict and royalty obligations
Antibody-drug conjugate, oncology, strategic, major transaction - Read more

THE GOOD
Market Reports

Eli Lilly, Novo Nordisk GLP-1 Medicare pricing deals create clearer pathway for future obesity drug competitors
Small molecule, metabolic, strategic, competitive, major transaction, regulatory - Read more

THE GOOD
Politics & Policy

EU Council backs critical medicines act to strengthen drug supply chains, prevent shortages
Critical medicines, supply chain, regulatory, operational - Read more

THE GOOD
Regulatory

FDA proposes cutting fees for US early-stage trials, adding charges for overseas development
Regulatory, strategic, operational, financial - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Bristol Myers Squibb delays Cobenfy muscarinic Ph3 Alzheimer's disease psychosis trial results to 2026 after irregularities
Small molecule, neurological, muscarinic receptor antagonist, Alzheimer's disease psychosis - Read more

Lipigon Pharmaceuticals' Lipisense (A24110He) shows no significant lipid reduction in Ph2 high blood lipid study
Antisense oligonucleotide, metabolic, lipid disorders, hypertriglyceridemia, insulin resistance - 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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