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- Biotech & Pharma Updates | September 16 - 17, 2025
Biotech & Pharma Updates | September 16 - 17, 2025
🧬 Ollin's $100M eye disease drug launch (going after Roche and Amgen), Biogen lands EC approval for Zurzuvae (zuranolone) in postpartum depression, Novo Nordisk and Eli Lilly both announce Ph3 oral GLP-1 data, J&J aims to snatch BMS' psoriasis crown with new icotrokinra data, ARTHEx Biotech Series B upsized to $87M (going after Myotonic Dystrophy Type 1), ArsenalBio cuts 50% of staff despite $325M raise last year, Novo Nordisk + BMS announce 250+ layoffs a piece in New Jersey
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Alteogen's EYLUXVI, an aflibercept biosimilar for macular degeneration, receives European Commission marketing approval
Protein therapy, ophthalmology, biosimilar, aflibercept, macular degeneration, diabetic macular edema - Read more
Biogen's Zurzuvae receives EU approval as first oral GABA modulator for postpartum depression
Small molecule, neurological, postpartum depression, neuroactive steroid, oral therapy, rapid-acting - Read more
THE GOOD
Business Development & Partnerships
ALK, GenSci partner on house dust mite allergy immunotherapy in China, GenSci gaining exclusive rights until 2039
Licensing deal, allergy immunotherapy, commercialization, respiratory diseases - Read more
OncoZenge, UCLA collaborating on patient study for BupiZenge oral pain treatment, exploring US IND application pathway
Research collaboration, oncology, drug discovery, small molecule, regulatory - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Regeneron's garetosmab shows 90% reduction in bone lesions in Ph3 fibrodysplasia ossificans progressiva trial
Protein therapy, rare disease, monoclonal antibody, fibrodysplasia ossificans progressiva (FOP), anti-activin A mechanism - Read more
J&J's IL-23 inhibitor icotrokinra outperforms Sotyktu in Ph3 trials for moderate to severe plaque psoriasis
Small molecule, autoimmune, oral peptide, plaque psoriasis, IL-23 inhibitor, comparative trial - Read more
UCB's BIMZELX shows sustained three-year efficacy in hidradenitis suppurativa targeting IL-17A/F in Ph3 extension
Antibody, autoimmune, monoclonal antibody, hidradenitis suppurativa, IL-17 inhibitor, inflammatory skin disease - Read more
Roivant's brepocitinib succeeds in Ph3 trial for dermatomyositis, showing significant symptom reduction over placebo
Small molecule, autoimmune, inflammatory disease, dermatomyositis, TYK2/JAK1 inhibitor, steroid-sparing - Read more
Sanofi's Ph2 dual-target nanobody brivekimig achieves 67% response in hidradenitis suppurativa trial
Antibody, autoimmune, nanobody, hidradenitis suppurativa, TNF-alpha inhibitor, OX40L inhibitor - Read more
MindRank's oral GLP-1 agonist MDR-001 achieves 10.3% weight reduction in Ph2b obesity trial
Small molecule, metabolic, GLP-1 receptor agonist, obesity, AI drug discovery, oral formulation - Read more
AstraZeneca's Saphnelo (anifrolumab) meets Ph3 endpoint for subcutaneous delivery in systemic lupus erythematosus patients
Antibody, autoimmune, monoclonal antibody, systemic lupus erythematosus, subcutaneous delivery, phase III trial - Read more
Navigator Medicines' NAV-240 shows promising Ph1 data targeting OX40L/TNFα for inflammatory disorders and autoimmune diseases
Antibody, autoimmune, bispecific antibody, inflammatory disorders, TNFα inhibitor, hidradenitis suppurativa - Read more
Ascletis presents positive Ph3 results for denifanstat, a FASN inhibitor for moderate to severe acne vulgaris
Small molecule, dermatological, FASN inhibitor, acne vulgaris, first-in-class - Read more
Eli Lilly's orforglipron outperforms Novo's Rybelsus in Ph3 head-to-head GLP-1 trial for type 2 diabetes
Small molecule, metabolic, GLP-1 receptor agonist, type 2 diabetes, oral therapy, weight loss - Read more
LEO Pharma's temtokibart shows positive Ph2b results targeting IL-22RA1 in moderate-to-severe atopic dermatitis
Monoclonal antibody, autoimmune, atopic dermatitis, IL-22RA1 inhibitor, Phase 2b trial - Read more
Eli Lilly's Mounjaro shows 2.2% A1C reduction in Ph3 trial for children with type 2 diabetes
Protein therapy, metabolic, peptide agonist, type 2 diabetes, GIP/GLP-1 receptor, pediatric patients - Read more
Novo Nordisk's oral Wegovy shows comparable weight loss to injectable in Ph3 obesity trial
Small molecule, metabolic, GLP-1 receptor agonist, obesity, oral formulation, weight loss - Read more
Skyhawk's SKY-0515 shows promising Ph1 results with 62% mHTT reduction in Huntington's disease patients
Small molecule, neurological, RNA splicing modifier, Huntington's disease, oral administration, HTT protein target - Read more
THE GOOD
Company Launches
Aditum launches Kalexo Bio with Mabwell siRNA asset, pays $12M upfront in deal worth up to $1B for cardiovascular drug
Licensing deal, cardiovascular disease, siRNA, R&D, milestone payments, equity investment - Read more
Ollin Biosciences launches with $100M to advance eye disease drugs, aiming to rival Roche’s Vabysmo and Amgen’s Tepezza
Ophthalmology, antibody, diabetic macular edema, age-related macular degeneration, clinical-stage - Read more
THE GOOD
Fundraises
ARTHEx Biotech raises $87M Series B for RNA medicines targeting myotonic dystrophy
Rare disease, RNA medicine, neuromuscular disorders, clinical-stage, myotonic dystrophy - Read more
Trially AI raises $4.7M Seed for AI-powered clinical trial recruitment platform
Clinical trial platform, AI/ML platform, healthcare software, data analytics, services - Read more
AltrixBio raises $5M Series A for oral therapy targeting cardiometabolic diseases
Cardiometabolic disease, type 2 diabetes, oral therapy, preclinical, platform-enabled, metabolic diseases - Read more
RevOpsis Therapeutics receives investment from ExSight, developing novel antibody therapies for retinal diseases
Ophthalmology, retinal diseases, antibody, AMD, preclinical, platform technology - Read more
Enhanced Genomics raises $19M Series A, 3D multi-omics platform targeting autoimmune diseases
Platform technology, autoimmune, 3D multi-omics, drug target discovery, AI-driven - Read more
Cytokinetics raises $550M in convertible notes to fund aficamten commercialization and pipeline development
Cardiovascular, small molecule, clinical-stage, drug discovery - Read more
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❌ The Bad News ❌
THE BAD
Clinical Trials
AstraZeneca's Fasenra fails Ph3 RESOLUTE trial for chronic obstructive pulmonary disease, missing exacerbation reduction endpoint
Antibody, respiratory disease, monoclonal antibody, COPD, eosinophilic inflammation, IL-5 targeting - Read more
THE BAD
Layoffs
Novo Nordisk cuts 263 jobs in New Jersey amid global restructuring; BMS eliminates 282 positions
Layoffs, operational, cost reduction, financial, strategic - Read more
X4 Pharmaceuticals cuts workforce by 50% to save $13M annually while completing Xolremdi phase 3 trial
Small molecule, neutropenia, cost reduction, operational, clinical trial - Read more
ArsenalBio cuts 50% of workforce in strategic shift to clinical-stage company; maintains Bristol Myers Squibb partnership
CAR-T cell therapy, oncology, strategic restructuring, workforce reduction, clinical pipeline prioritization - Read more
Innate Pharma cuts 30% of staff, narrows focus to three key assets amid funding challenges
Antibody-drug conjugate (ADC), oncology, monoclonal antibody, financial, cost reduction, strategic - Read more
👹 The Ugly News 👹
THE UGLY
Politics & Policy
RFK Jr. fired CDC director after demanding evidence-free vaccine policy changes, Senate testimony reveals
Vaccines, infectious disease, regulatory, policy - Read more
Former CDC director Monarez claims RFK Jr. plans to alter childhood vaccine schedule without scientific basis
Vaccines, infectious disease, regulatory, policy - Read more
You’re all caught up on the latest Pharma & Biotech News!

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