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THE GOOD
Approvals & Labels

Merck & Co.'s Winrevair sotatercept receives FDA label expansion for pulmonary arterial hypertension hospitalization risk reduction
Protein therapy, cardiovascular, activin signaling inhibitor, pulmonary arterial hypertension, subcutaneous injection - Read more

Health Canada grants conditional approval for Eisai and Biogen's Leqembi lecanemab targeting early Alzheimer's disease
Monoclonal antibody, neurological, Alzheimer disease, amyloid-beta target, early stage disease - Read more

Eli Lilly's Omvoh mirikizumab gains FDA approval for single-injection maintenance regimen in ulcerative colitis
Antibody, autoimmune, monoclonal antibody, ulcerative colitis, IL-23 inhibitor, maintenance therapy - Read more

Syndax receives FDA approval to expand Revuforj revumenib menin inhibitor label for relapsed refractory acute myeloid leukemia
Small molecule, cancer, menin inhibitor, acute myeloid leukemia, NPM1 mutation - Read more

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THE GOOD
Business Development & Partnerships

Evotec, Bristol Myers Squibb advance neuroscience partnership with $25M milestone payment for neurodegenerative diseases
Research collaboration, neurological, milestone payments, R&D - Read more

GSK, Syndivia partner on preclinical prostate cancer ADC, $357M in potential milestones
Licensing deal, oncology, antibody-drug conjugate, milestone payments - Read more

GSK, Empirico enter exclusive worldwide license agreement for first-in-class siRNA EMP-012 targeting respiratory diseases
Licensing deal, respiratory disease, oligonucleotide, milestone payments - Read more

OpenAI, Thermo Fisher Scientific, Lundbeck partner on AI-powered drug development and clinical research operations
Research collaboration, AI/ML, drug discovery, neurological, clinical trials - Read more

Granata Bio Corporation, Georgetown Equity Partners form joint venture to develop hypoglycosylated follicle-stimulating hormone therapeutic
Joint venture, reproductive health, recombinant protein, licensing deal - Read more

Incyte, Enable Injections partner on enFuse delivery system for mutCALR antibody therapy
Licensing deal, rare disease, antibody, drug delivery, milestone payments - Read more

WuXi AppTec, Hillhouse sign definitive agreement for acquisition of China-based clinical research services business
Divestiture, clinical research services, CRO services, private equity investment - Read more

THE GOOD
Clinical Trials

Qureight's Vascul8 AI model validated for predicting residual pulmonary hypertension risk in chronic thromboembolic pulmonary hypertension patients
AI imaging platform, cardiovascular, pulmonary vascular disease, chronic thromboembolic pulmonary hypertension, diagnostic biomarker - Read more

BridgeBio's BBP-418 hits Ph3 endpoints for limb-girdle muscular dystrophy type 2I/R9, targeting FKRP protein
Small molecule, neurological, limb-girdle muscular dystrophy, FKRP protein, muscle disorders - Read more

Zenas' obexelimab shows 95% brain lesion reduction in Ph2 multiple sclerosis trial
Antibody, autoimmune, monoclonal antibody, multiple sclerosis, B cell inhibition - Read more

Innovent, Eli Lilly's mazdutide GLP-1/glucagon dual agonist outperforms Novo Nordisk’s semaglutide in Ph3 diabetes and obesity trial
Protein therapy, metabolic, GLP-1 receptor agonist, type 2 diabetes, obesity, dual receptor agonist - Read more

AskGene Pharma reports positive results for ASKB589 anti-CLDN18.2 antibody in advanced gastric cancer
Antibody, cancer, monoclonal antibody, gastric cancer, CLDN18.2 target, combination therapy - Read more

Johnson & Johnson's icotrokinra IL-23 receptor blocker shows sustained efficacy in Ph2b ulcerative colitis study
Small molecule, autoimmune, IL-23 receptor antagonist, ulcerative colitis, inflammatory bowel disease - Read more

Genentech's Gazyva obinutuzumab hits Ph3 primary endpoint in idiopathic nephrotic syndrome pediatric trial
Antibody, autoimmune, monoclonal antibody, idiopathic nephrotic syndrome, CD20 target, pediatric population - Read more

Causeway Therapeutics reports positive Ph2 results for synthetic microRNA drug targeting lateral epicondylitis tendon injuries
Small molecule, musculoskeletal, microRNA, tendinopathy, tennis elbow, pain reduction - Read more [Paywall]

Neumora's NMRA-215 NLRP3 inhibitor shows 19% weight loss in preclinical obesity studies, clinic entry planned
Small molecule, metabolic, NLRP3 inhibitor, obesity, combination therapy, GLP-1 agonist - Read more

Xencor's XmAb819 ENPP3 x CD3 bispecific shows 25% response rate in Ph1 clear cell renal cell carcinoma trial
Antibody, cancer, bispecific T-cell engager, clear cell renal cell carcinoma, ENPP3 target - Read more

THE GOOD
Fundraises

Hemab Therapeutics raises $157M Series C, advancing blood clotting disorder treatments
Blood disorders, clinical-stage, coagulation disorders, rare disease - Read more

Adaptam Therapeutics raises €3M ($3.5M) pre-seed, cancer immunotherapies targeting immunosuppressive myeloid cells
Cancer immunotherapy, antibody, ADCs, preclinical, myeloid cells - Read more

Genenta raises $15M registered direct offering, immuno-oncology working capital and corporate purposes
Immuno-oncology, cancer, clinical-stage - Read more

MapLight Therapeutics raises $250M IPO to advance Cobenfy competitor for schizophrenia treatment
Neurological, small molecule, clinical-stage, schizophrenia - Read more

Vivani Medical raises $15.7M equity offering, developing ultra long-acting drug implants
Clinical-stage, drug delivery, implantable devices, ultra long-acting - Read more

THE GOOD
Market Reports

Dyne Therapeutics shares surge 38% pre-market as Novartis' $12B Avidity buyout validates antisense space
Antisense oligonucleotide, rare disease, strategic, major transaction - Read more

2025 biopharma M&A surges: $65B in deals exceeds 2024's $37B total, says Leerink Partners
Multiple modalities, cardiovascular, strategic, major transaction - Read more

THE GOOD
Strategic Plans

Cigna Express Scripts adopts rebate-free PBM model with upfront discounts starting 2027-2028
Pharmacy benefits, operational, cost reduction, strategic - Read more

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THE BAD
Clinical Trials

Intellia Therapeutics pauses Ph3 trials of nexiguran ziclumeran CRISPR therapy for transthyretin amyloidosis after severe liver toxicity
Gene therapy, neurological, CRISPR, transthyretin amyloidosis, liver toxicity, TTR gene - Read more

THE BAD
Layoffs

Ferring cuts 64 Parsippany jobs as part of global 500-employee layoffs for cost efficiency
Reproductive health, operational, cost reduction, strategic - Read more

THE BAD
Regulatory

UK watchdog rules AstraZeneca, Organon breached marketing codes, brought industry discredit
Respiratory, contraception, regulatory, operational - Read more

THE BAD
Strategic Plans

BioMarin to divest hemophilia gene therapy Roctavian following sluggish sales performance
Licensing deal, rare disease, gene therapy, hemophilia - Read more

THE UGLY
No Ugly News Today!

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