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

Editor’s note: We had some technical issues this morning hence the late edition today, we apologize for the tardiness! 🙏 

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THE GOOD
Approvals & Labels

Australia approves BioArctic & Eisai’s Leqembi, an anti-amyloid antibody, for early Alzheimer's disease treatment
Antibody, neurological, monoclonal antibody, Alzheimer disease, amyloid target, early-stage disease - Read more

Marksans Pharma's UK subsidiary Relonchem receives MHRA approval for moxonidine tablets for hypertension treatment
Small molecule, cardiovascular, hypertension, regulatory approval, MHRA - Read more

THE GOOD
Business Development & Partnerships

Glenmark, Hengrui partner on HER2-targeted antibody-drug conjugate; $18M upfront with potential $1.1B in milestones
Licensing deal, oncology, antibody-drug conjugate, milestone payments, Asia, HER2-targeted - Read more

GCCL, Frontage Labs form strategic collaboration to enhance global clinical trial services in US and APAC regions
Strategic collaboration, clinical trials, CRO, global, US, Asia-Pacific - Read more

Taiho Pharmaceutical partners with Guardant Health to discover biomarkers for early-stage recurrent cancer treatment development
Research collaboration, oncology, biomarker discovery, early-stage cancer, drug discovery, R&D - Read more

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THE GOOD
Clinical Trials

Acella's North Star thyroid hormone therapy meets Ph2 endpoints for hypothyroidism, advancing toward FDA approval
Protein therapy, metabolic, thyroid hormone replacement, hypothyroidism, desiccated thyroid extract - Read more

uniQure's AMT-130 gene therapy shows 75% slowing of Huntington's disease progression in Ph2 trial, could have “massive effects on patients’ lives”
Gene therapy, neurological, Huntington's disease, neurodegenerative disorder, clinical trial success - Read more

Roche presents Ph2 data for fenebrutinib BTK inhibitor showing disease suppression in multiple sclerosis
Antibody, autoimmune, monoclonal antibody, multiple sclerosis, BTK inhibitor, disability progression - Read more

Synendos' endocannabinoid modulator SYT-510 shows promising Ph1 results for mental health disorders, Phase 2 planned
Small molecule, neurological, endocannabinoid system modulator, mental health, anxiolytic, CNS disorders - Read more

Hansa's imlifidase shows positive Ph3 results, plans FDA filing for kidney transplant IgG-cleaving therapy
Protein therapy, autoimmune, enzyme therapy, kidney transplantation, immunoglobulin G (IgG) cleaving, desensitization - Read more

THE GOOD
Fundraises

Sparrow Pharmaceuticals raises $95M Series B for clofutriben Phase II diabetes study targeting elevated cortisol
Diabetes, small molecule, clinical-stage, cortisol-related, metabolic disease - Read more

Kinea Bio raises $1.1M from Jain Foundation, developing AAV vector platform for large therapeutic genes
Gene therapy, rare disease, platform technology, AAV vector, preclinical - Read more

MBX Biosciences raises $199.9M public offering for peptide therapies targeting endocrine disorders
Endocrine disorders, peptide therapeutics, metabolic disorders, clinical-stage - Read more

Monopar Therapeutics raises $135M in underwritten offering for clinical-stage therapeutics development
Clinical-stage, biopharmaceutical, unmet medical needs - Read more

THE GOOD
Investments

Fujifilm Biotechnologies opens $3.2B antibody manufacturing facility in North Carolina, scaling to 1,400 employees
Monoclonal antibody, CDMO, manufacturing capacity, strategic, major investment - Read more

Moderna opens UK facility capable of producing 250M annual vaccine doses amid pharma exodus
mRNA vaccine, infectious disease, strategic investment, manufacturing expansion, international operations - Read more

THE GOOD
Product Launches

Dr. Reddy's, Hetero to sell generic HIV PrEP Yeztugo at $40/year in 120 low/middle income countries by 2027
Licensing deal, infectious disease, manufacturing agreement, global, emerging markets, royalty-free - Read more

THE GOOD
Strategic Plans

Cyclerion pivots, relaunches as neuropsychiatric company with MIT-licensed technology for depression treatment
Anesthetic-based therapy, treatment-resistant depression, neuropsychiatry, strategic pivot, operational restructuring - Read more

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THE BAD
Approvals & Labels

FDA rejects Biogen's high-dose Spinraza for spinal muscular atrophy, requests manufacturing information before resubmission
Antisense oligonucleotide, neurological, spinal muscular atrophy, dosing regimen, manufacturing challenges - Read more

THE BAD
Clinical Trials

Harmony's ZYN002, synthetic cannabidiol for Fragile X syndrome, fails Ph3 primary endpoint amid high placebo response
Small molecule, neurological, cannabidiol, Fragile X syndrome, FMR1 gene, clinical trial failure - Read more

Acadia's ACP-101 fails Ph3 study for Prader-Willi syndrome hyperphagia, abandons development after placebo comparison
Small molecule, rare disease, Prader-Willi syndrome, hyperphagia, failed clinical trial, genetic disorder - Read more

THE BAD
Market Reports

Biopharma deal trends shift: upfront payments rise while earnout potential decreases, SRS Acquiom reports
Financial, strategic, investment, deal structure - Read more

THE BAD
Politics & Policy

Eli Lilly CEO criticizes UK drug pricing, halts Mounjaro shipments amid pharma industry exodus
Drug pricing, strategic, financial, regulatory, competitive - Read more

THE UGLY
No Ugly News Today!

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