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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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