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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
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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!
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Thanks for reading! -Anis
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