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THE GOOD
Approvals & Labels

Boehringer Ingelheim's Jascayd wins FDA approval for progressive pulmonary fibrosis targeting phosphodiesterase 4B
Small molecule, respiratory disease, PDE4B inhibitor, progressive pulmonary fibrosis, antifibrotic - Read more

Omeros wins first FDA approval for Yartemlea (narsoplimab) treating hematopoietic stem cell transplant-associated thrombotic microangiopathy
Protein therapy, hematologic, monoclonal antibody, thrombotic microangiopathy, MASP-2 inhibitor, stem cell transplant - Read more

Vanda Pharmaceuticals receives FDA approval for Nereus (tradipitant) targeting neurokinin-1 receptor for motion sickness prevention
Small molecule, neurological, neurokinin-1 receptor antagonist, motion sickness, oral therapy - Read more

Agios Pharmaceuticals' AQVESME (mitapivat) wins FDA approval for anemia in alpha- or beta-thalassemia
Small molecule, hematological disorder, pyruvate kinase activator, thalassemia, anemia - Read more

FDA approves Cytokinetics' Myqorzo for obstructive hypertrophic cardiomyopathy, marking company's first U.S. drug approval
Small molecule, cardiovascular, hypertrophic cardiomyopathy, cardiac myosin inhibitor, heart failure - Read more

FDA approves Novo Nordisk's Wegovy (semaglutide) oral pill for obesity treatment, first oral GLP-1 approval
Small molecule, metabolic, GLP-1 receptor agonist, obesity, semaglutide, oral formulation - Read more

Sanofi's Wayrilz (rilzabrutinib) wins EU approval for immune thrombocytopenia following Ph3 trial success
Small molecule, autoimmune, BTK inhibitor, immune thrombocytopenia, platelet disorder - Read more

Axsome Therapeutics secures FDA priority review for AXS-05 (dextromethorphan/bupropion) targeting Alzheimer's disease agitation following mixed Ph3 results
Small molecule, neurological, Alzheimer's disease, agitation, combination therapy, dextromethorphan-bupropion - Read more

Chugai Pharmaceutical's Tecentriq wins Japan approval for unresectable thymic carcinoma, first checkpoint inhibitor for indication
Antibody, cancer, monoclonal antibody, thymic carcinoma, immune checkpoint inhibitor, PD-L1 - Read more

mAbxience and Amneal Pharmaceuticals receive FDA approval for denosumab biosimilars targeting osteoporosis and oncology conditions
Antibody, cancer, monoclonal antibody, bone metastases, biosimilar, RANK ligand inhibitor - Read more

Shenzhen Beimei Pharmaceutical and Deva Holding secure NMPA approval for Bocaan (posaconazole) targeting invasive fungal infections
Small molecule, infectious disease, antifungal, invasive aspergillosis, candidiasis, pediatric indication - Read more

Roche's Lunsumio (mosunetuzumab) subcutaneous formulation wins FDA approval for relapsed or refractory follicular lymphoma
Antibody, cancer, bispecific antibody, follicular lymphoma, CD20/CD3, subcutaneous formulation - Read more

THE GOOD
Business Development & Partnerships

AstraZeneca, Niowave extend 10-year isotope supply deal for radiopharmaceutical cancer therapy development
Manufacturing agreement, oncology, radiopharmaceuticals, supply chain - Read more

AbbVie, Suzhou Zelgen Biopharmaceuticals partner on trispecific DLL3 asset ZG006, $100M upfront, $1.2B total
Licensing deal, oncology, trispecific antibody, milestone payments - Read more

Gilead Sciences acquires Repare Therapeutics' RP-3467 inhibitor for $25M upfront, $30M total
Acquisition, oncology, small molecule, milestone payments - Read more

Gilead Sciences, Assembly Biosciences expand antiviral partnership with herpes inhibitors license, $35M option fee
Licensing deal, infectious disease, small molecule, milestone payments - Read more

Boehringer Ingelheim, Rectify Pharmaceuticals partner on oral chronic kidney disease drugs, $448M milestones
Research collaboration, chronic kidney disease, small molecule, milestone payments - Read more

Windward Bio, Qyuns Therapeutics license TSLP/IL-13 bispecific WIN027, $700M total deal value
Licensing deal, immunology, bispecific antibody, milestone payments - Read more

AstraZeneca, Jacobio Pharma license pan-KRAS inhibitor JAB-23E73, $100M upfront, $2B+ total deal value
Licensing deal, oncology, small molecule, milestone payments - Read more

Royalty Pharma, PTC Therapeutics complete Evrysdi royalty acquisition for $240M upfront, $60M milestones
Acquisition, rare disease, small molecule, royalties - Read more

Aosaikang Pharmaceutical, Adlai Nortye collaborate on pan-RAS(ON) molecular glue inhibitor AN9025 for China
Licensing deal, oncology, small molecule, milestone payments - Read more

BioAtla, GATC Health announce $40M SPV transaction to advance ozuriftamab vedotin registrational trial
Special purpose vehicle, oncology, antibody, milestone payments - Read more

Windtree Therapeutics sells cardiovascular drug candidates to Seismic Pharmaceutical Holdings, retains 20% future proceeds
Asset sale, cardiovascular, acute heart failure, milestone payments - Read more

Shionogi acquires Mitsubishi Tanabe Pharma's ALS drug Radicava for $2.5 billion
Acquisition, rare disease, neurological, small molecule - Read more

Ipsen, Simcere Zaiming partner on LRRC15-targeting ADC SIM0613, $1.06B potential milestones
Licensing deal, oncology, antibody-drug conjugate, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Foresee Pharmaceuticals' Camcevi (leuprolide mesylate) shows Ph3 success for central precocious puberty treatment
Small molecule, endocrine disorders, GnRH agonist, central precocious puberty, leuprolide mesylate - Read more

Hengrui Pharmaceuticals' Ivarmacitinib ointment targeting JAK pathway shows positive Ph3 results for atopic dermatitis
Small molecule, autoimmune, JAK inhibitor, atopic dermatitis, topical formulation - Read more

Promontory Therapeutics' PT-112 meets interim efficacy requirement in Ph2 trial for recurrent thymoma
Small molecule, cancer, thymoma, immunomodulatory therapy, PT-112 - Read more

Lexaria Bioscience's DehydraTECH GLP-1 drug delivery platform achieves Ph1b primary endpoint success
Small molecule, metabolic, GLP-1 agonist, diabetes, drug delivery platform, DehydraTECH - Read more

Altimmune's pemvidutide (dual GLP-1/glucagon receptor agonist) shows sustained fibrosis improvement in Ph2 metabolic dysfunction-associated steatohepatitis trial
Small molecule, metabolic, GLP-1/glucagon receptor agonist, MASH, pemvidutide - Read more

THE GOOD
Earnings & Finances

Ironwood Pharmaceuticals surges 30% after forecasting Linzess reentry into blockbuster territory by 2026
Small molecule, gastrointestinal, financial, revenue impact, strategic - Read more

THE GOOD
Fundraises

Aktis Oncology files IPO, radiopharmaceutical miniprotein radioconjugates for cancer treatment
Radiopharmaceuticals, oncology, protein design, clinical-stage - Read more

Vaccinex raises $60M revenue sharing agreement for Alzheimer's pepinemab Phase 2b trial
Neurological, antibody, Alzheimer disease, clinical-stage - Read more

Insilico Medicine raises $296M IPO, AI-driven drug discovery platform
AI/ML platform, drug discovery, oncology, small molecule, fibrosis, platform-enabled - Read more

Vyriad raises $25M Series B tranche for in vivo CAR-T cancer therapy
Cancer, cell therapy, clinical-stage, gene therapy - Read more

Maxvax Biotechnology raises D+ funding for recombinant herpes zoster, RSV vaccines
Vaccines, recombinant protein, infectious disease, adjuvant technology - Read more

Suzhou Xueji Biotechnology raises B1 round, advancing in vitro platelet regeneration
Cell therapy, platelet regeneration, rare disease, clinical-stage - Read more

THE GOOD
Mergers & Acquisitions

Sanofi to acquire Dynavax Technologies for $2.2B to gain hepatitis B vaccine Heplisav-B
Vaccine, infectious disease, strategic, major transaction - Read more

BioMarin Pharmaceutical to acquire Amicus Therapeutics for $4.8 billion in all-cash deal
Small molecule, rare disease, strategic, major transaction - Read more

THE GOOD
Politics & Policy

CMMI proposes GLOBE, GUARD models linking Medicare drug rebates to international prices, saving $11.9B.
Biologics, regulatory, cost reduction, financial, strategic - Read more

Trump Administration reaches Most Favored Nation drug pricing agreements with nine major biopharma companies
Pharmaceutical pricing, regulatory, strategic, major transaction - Read more

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THE BAD
Approvals & Labels

FDA rejects Corcept Therapeutics' relacorilant (glucocorticoid receptor antagonist) for hypertension secondary to hypercortisolism despite Ph3 success
Small molecule, endocrine disorders, glucocorticoid receptor antagonist, Cushing's syndrome, antibody, ophthalmology - Read more

FDA rejects Sanofi's tolebrutinib BTK inhibitor for non-relapsing secondary progressive multiple sclerosis treatment
Small molecule, neurological, BTK inhibitor, multiple sclerosis, brain-penetrant - Read more

THE BAD
Clinical Trials

Ultragenyx's setrusumab (UX143) fails Ph3 trials for osteogenesis imperfecta, missing primary fracture reduction endpoint
Antibody, rare disease, monoclonal antibody, osteogenesis imperfecta, bone metabolism, sclerostin target - Read more

Biohaven's BHV-7000 (opakalim) fails Ph2 trial in major depressive disorder targeting potassium channels
Small molecule, neurological, potassium channel agonist, major depressive disorder, epilepsy - Read more

Johnson & Johnson halts Ph2 study of JNJ-5939 bispecific targeting IL-4Rα/IL-31 for atopic dermatitis after interim analysis
Antibody, autoimmune, bispecific antibody, atopic dermatitis, IL-4Ra target, IL-31 target - Read more

Verastem Oncology discontinues Ph1/2 trial of Avmapki (avutometinib) plus Lumakras in KRAS G12C non-small cell lung cancer
Small molecule, cancer, KRAS G12C inhibitor, non-small cell lung cancer, combination therapy - Read more

Pfizer reports patient death in long-term trial of Hympavzi for hemophilia A treatment
Antibody, bleeding disorder, monoclonal antibody, hemophilia A, tissue factor pathway inhibitor - Read more

Neurocrine Biosciences' Ingrezza (valbenazine) fails Ph3 trial for dyskinetic cerebral palsy motor symptoms
Small molecule, neurological, VMAT2 inhibitor, cerebral palsy, movement disorders - Read more

Ipsen's fidrisertib (fidrisertib) fails Ph2 trial in fibrodysplasia ossificans progressiva targeting ALK2 variants
Small molecule, rare disease, ALK2 inhibitor, fibrodysplasia ossificans progressiva, bone disorder - Read more

AstraZeneca's ceralasertib (ATR inhibitor) plus Imfinzi fails Ph3 trial in non-small-cell lung cancer
Small molecule, cancer, ATR inhibitor, non-small cell lung cancer, combination therapy, immunotherapy - Read more

THE BAD
Lawsuits

Johnson & Johnson ordered to pay record $1.56B to talc plaintiff in Baltimore court ruling
Consumer product, oncology, financial, major transaction - Read more

THE BAD
Regulatory

NIH neurological institute director Walter Koroshetz exits, leaving half of institutes under interim leadership
Neurological, operational, strategic, institutional leadership - Read more

THE BAD
Strategic Plans

AstraZeneca withdraws Andexxa from US market citing increased thrombosis risk after FDA rejection
Reversal agent, cardiovascular, strategic, operational - Read more

Genmab axes late-stage lung cancer bispecific acasunlimab despite encouraging Phase III data
Bispecific antibody, oncology, strategic, operational - Read more

THE BAD
Company Shutdown

Nido Biosciences closes after NIDO-361 fails Ph2 trial for spinal and bulbar muscular atrophy
Small molecule, neurological, Kennedy's disease, spinal and bulbar muscular atrophy, transcriptional dysregulation - Read more

THE UGLY
No Ugly News Today!

You’re all caught up on the latest Pharma & Biotech News!

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