AllSci News
MetaVia posts strong Phase 1b data for DA-1726 in metabolic disease
MetaVia Inc., a clinical-stage biotech focused on cardiometabolic disorders, announced positive, statistically significant results from its Phase 1b clinical trial of its…
Corcept’s NDA for Cushing syndrome drug relacorilant met with FDA’s CRL
Corcept Therapeutics (NASDAQ: CORT) revealed that its New Drug Application (NDA) filing for relacorilant as a treatment for hypertension secondary to endogenous…
J&J halts Phase 2b for BsAb in atopic dermatitis after interim readout
US multinational Johnson & Johnson (J&J) announced that its Phase 2b DUPLEX-AD proof-of-concept study evaluating investigational therapy JNJ-95475939 (also known as JNJ-5939)…
FDA accepts Inovio BLA for INO-3107 but with accelerated approval questions
Inovio Pharmaceuticals, Inc. announced that the US FDA has accepted for review its Biologics License Application (BLA) for INO-3107, an investigational DNA…
Mereo, Ultragenyx’s setrusumab falls short in Phase 3 against osteogenesis imperfecta
Ultragenyx Pharmaceutical Inc. and Mereo BioPharma Group plc have reported topline results from the pivotal Phase 3 ORBIT and COSMIC trials evaluating…
Verge Genomics terminates Phase 1b ALS trial of VRG50635
Verge Genomics has terminated its Phase 1b clinical trial evaluating VRG50635 in patients with amyotrophic lateral sclerosis (ALS), according to an update…
Rockefeller discovery zalunfiban shows promise as pre-hospital treatment for STEMI
Subcutaneous zalunfiban, an investigational glycoprotein IIb/IIIa (integrin αIIbβ3) inhibitor, significantly improved early coronary reperfusion and reduced the likelihood of worse 30-day clinical…
Novo Nordisk’s Wegovy pill gains FDA approval
Novo Nordisk A/S secured US FDA approval for its Wegovy pill (once-daily oral semaglutide, 25 mg), marking the first oral glucagon-like peptide-1…
Mondego Bio to test AI-designed PTPN2 inhibitor ZE00-0388 in first study
Portugal-based Mondego Bio has selected ZE00-0388, a highly selective small-molecule inhibitor of PTPN2, as its lead clinical candidate, formally transitioning the Portugal-based…
Cytokinetics’ Myqorzo picks up FDA approval for symptomatic obstructive HCM
Cytokinetics Inc., trumpeted US FDA approval for Myqorzo (aficamten) tablets (5 mg, 10 mg, 15 mg, and 20 mg strengths) for the…
Takeda’s zasocitinib Phase 3 Psoriasis Data Show Strong Efficacy
Takeda’s investigational oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) delivered positive topline results in two pivotal Phase 3 trials in adults…
Insmed halts brensocatib rhinosusitis program after Phase 2b miss
New Jersey-based biotech Insmed Inc., announced that the Phase 2b BiRCh study assessing brensocatib in chronic rhinosinusitis without nasal polyps (CRSsNP) failed…
GSK’s Exdensur wins US FDA approval as twice-yearly biologic for severe eosinophilic asthma
GSK plc revealed US FDA approval for Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for patients aged 12 years and older with…
Astellas/Pfizer’s Padcev plus Keytruda hits endpoints in latest Phase 3 for early-stage bladder cancer
Astellas Pharma Inc., and Pfizer Inc., unveiled positive topline results from a Phase 3 trial assessing the perioperative combination of Padcev (enfortumab…
Recludix’s oral STAT6 inhibitor enters clinic with FDA IND clearance
San Diego-based biotech Recludix Pharma revealed a successful Investigational New Drug (IND) application to the US FDA for REX-8756, a potent, selective…
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