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  • Biotech & Pharma Updates | September 17 - 18, 2025

Biotech & Pharma Updates | September 17 - 18, 2025

🧬 Roche dives into MASH space with $2.4B 89bio buy, T.Rx Capital launches with $77.5M to bet on companies at the "intersection of technology & biology", MilliporeSigma opens €150M (+200 jobs) filtration plant in Ireland, Lexicon pushes non-opioid pain hopeful pilavapadin to Ph3 after post-hoc analysis, Fujifilm + argenx partner on US-based Vyvgart manufacturing, Carisma looks all but sunk as reverse-merger slips and BioNTech leaves partnership, bluebird bio rebrands as (old name) Genetix Biotherapeutics

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

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

European Commission approves Deciphera's ROMVIMZA (vimseltinib), targeting CSF1R, for tenosynovial giant cell tumour treatment
Small molecule, cancer, kinase inhibitor, tenosynovial giant cell tumour, CSF1R inhibitor, rare disease - Read more

FDA approves OWP Pharmaceuticals' SUBVENITE, first lamotrigine oral suspension for epilepsy and bipolar disorder patients
Small molecule, neurological, anticonvulsant, epilepsy, alternative formulation, medication accessibility - Read more

THE GOOD
Business Development & Partnerships

Fujifilm Biotechnologies, argenx expand manufacturing partnership to produce Vyvgart in US, with production starting in 2028 at Holly Springs facility
Manufacturing agreement, autoimmune, antibody, US, capacity expansion - Read more

VectorY, Shape partner on brain-penetrant capsid for vectorized antibody delivery; $1.2B+ deal value
Option-and-license deal, neurological, gene therapy, rare disease, milestone payments - Read more

Infinimmune, Immunome partner on antibody discovery and optimization, with Immunome gaining target exclusivity rights
Research collaboration, antibody discovery, drug optimization, AI/ML, R&D, milestone payments - Read more

Avant Technologies, Austrianova form 50/50 joint venture, Klothonova, to develop encapsulated Klotho-producing cell therapies for multiple diseases
Joint venture, licensing deal, cell therapy, neurological, longevity, global - Read more

Frame Bio, Mercury Bio partner on exosome delivery platform for bone and collagen therapies, development fees tied to milestones
Licensing deal, drug delivery, regenerative medicine, bone disorders, milestone payments - Read more

Sunflower Therapeutics, SK bioscience achieve first milestone in collaboration developing cost-effective 10-valent HPV vaccine
Manufacturing agreement, vaccine, infectious disease, milestone payments, global - Read more

Wheeler Bio, MindImmune partner on Alzheimer's antibody MITI-101 development, providing CDMO services through ModularCMC platform
Manufacturing agreement, Alzheimer's disease, neurological, monoclonal antibody, CDMO, drug development - Read more

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 More Good News 

THE GOOD
Clinical Trials

QL Biopharm's monthly GLP-1 zovaglutide shows up to 14.4% weight loss in Ph2 obesity trial
Peptide therapy, metabolic, GLP-1 receptor agonist, obesity, long-acting injectable, weight loss - Read more

Lexicon Pharmaceuticals' pilavapadin advances to Ph3 for diabetic peripheral neuropathic pain despite mixed Ph2b results
Small molecule, neurological, pain management, diabetic peripheral neuropathic pain, non-opioid analgesic, chronic pain - Read more

UCB's galvokimig targeting Th2/Th17 pathways shows promising Ph1/2a results in moderate-to-severe atopic dermatitis
Antibody, autoimmune, multi-specific antibody, atopic dermatitis, inflammatory disease, dermatology - Read more

CorestemChemon's Neuronata-R (lenzumestrocel) Ph3 data shows efficacy in slow-progressing amyotrophic lateral sclerosis subgroup with biomarker validation
Cell therapy, neurological, mesenchymal stem cells, amyotrophic lateral sclerosis, biomarker, neuroprotection - Read more

Kairos Pharma' ENV105 (carotuximab) targeting CD105 shows promising Ph2 results in metastatic castration-resistant prostate cancer patients
Antibody, cancer, monoclonal antibody, prostate cancer, CD105 antagonist, combination therapy - Read more

Elicio Therapeutics' ELI-002 7P shows 99% T cell response rate against mKRAS in Ph2 pancreatic cancer trial
Vaccine, cancer, immunotherapy, pancreatic cancer, KRAS target, T cell response - Read more

Astria Therapeutics' STAR-0310 OX40 antagonist shows positive Ph1a results with extended half-life for atopic dermatitis
Antibody, autoimmune, monoclonal antibody, atopic dermatitis, OX40 antagonist, immunology - Read more

Nektar Therapeutics's IL-2 agonist Rezpegaldesleukin shows deepening efficacy in Ph2b atopic dermatitis trial with extended dosing
Protein therapy, autoimmune, IL-2 agonist, atopic dermatitis, Treg mechanism - Read more

Nanobiotix reports promising Ph1 results for JNJ-1900 in anti-PD-1 resistant primary cutaneous melanoma patients
Nanotherapy, cancer, immunotherapy, melanoma, checkpoint inhibitor, radiotherapy-enhancer - Read more

THE GOOD
Fundraises

T.Rx Capital raises $77.5M fund, investing in early-stage techbio and biotech startups
Venture capital, biotech, early-stage, platform technology, next-generation modalities, AI-driven - Read more

Mondego Bio raises Series A funding, developing PTPN2 inhibitors for immuno-oncology therapies
Oncology, immuno-oncology, small molecule, PTPN2 inhibitors, preclinical - Read more

Character Biosciences raises undisclosed Series B extension, advancing treatments for age-related macular degeneration
Precision medicine, ophthalmology, AI-driven, genomics, clinical-stage - Read more

Immuto Scientific raises $8M seed financing for surfaceomics-based cancer antibody therapeutics
Oncology, platform technology, antibody, AI-driven, cancer, surfaceomics - Read more

BioCardia raises $12M public offering for cardiovascular and pulmonary disease therapeutics
Cardiovascular, cell therapy, clinical-stage, regenerative medicine - Read more

Prologis pledges £3.9B ($5.3B) to expand UK life sciences manufacturing, creating jobs at Cambridge Biomedical Campus
Manufacturing infrastructure, life sciences, major investment, strategic, operational - Read more [Paywall]

THE GOOD
Investments

MilliporeSigma opens €150M ($177.4M) filtration plant in Ireland, creating 200 jobs as part of larger investment strategy
Manufacturing infrastructure, life science services, strategic, operational, manufacturing expansion, major investment - Read more

THE GOOD
Mergers & Acquisitons

Roche acquires 89bio for $2.4B, betting on pegozafermin for MASH treatment against Madrigal Pharmaceuticals' approved Rezdiffra
FGF21 analog, MASH, strategic, major acquisition, competitive - Read more

Biogen acquires Alcyone Therapeutics for $85 million to advance ThecaFlex DRx RNA drug delivery system
Antisense oligonucleotide, neurological, strategic acquisition, drug delivery, rare disease - Read more

THE GOOD
Marketing

Bluebird bio rebrands as Genetix Biotherapeutics following private equity acquisition, focusing on commercializing three FDA-approved gene therapies
Acquisition, gene therapy, rare disease, rebranding - Read more

THE GOOD
Product Launches

Closed Loop Medicine launches WeDosify platform to address poor adherence in GLP-1 obesity treatment market
GLP-1 receptor agonist, metabolic disease, digital health, medication adherence, strategic - Read more

❌ The Bad News

THE BAD
Business Development & Partnerships

Carisma Therapeutics, Moderna end partnership as merger plans collapse; Moderna pays $4M termination fee
Partnership termination, cell therapy, oncology, autoimmune, milestone payments - Read more

THE BAD
Layoffs

Pfizer, Arvinas seek third-party partner for vepdegestrant commercialization, triggering 15% Arvinas layoffs
Licensing deal, oncology, PROTAC inhibitor, breast cancer, out-licensing - Read more

THE BAD
Politics & Policy

NIH's intramural research director Nina Schor departing for University of Rochester amid federal health leadership exodus
Healthcare administration, neurological, organizational leadership, government research - Read more

THE BAD
Regulatory

Replimune's melanoma immunotherapy faces uncertain future after FDA rejects accelerated approval pathway
Oncolytic immunotherapy, melanoma, regulatory, clinical trial - Read more

Revamped CDC vaccine panel votes against Merck &Co.'s MMRV for young children, sparking confusion
Vaccine, infectious disease, regulatory, operational - Read more

THE BAD
Strategic Plans

Acadia indefinitely postpones UK launch of Rett syndrome drug Daybue due to high taxes and reimbursement challenges
Small molecule, rare neurological disease, regulatory, market access, reimbursement, 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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