United Therapeutics targets 2026 FDA submission for Tyvaso IPF indication after TETON-2 success
TETON-2 phase 3 data show nebulized treprostinil slows IPF lung decline and cuts clinical worsening risk. Analysis of what the NEJM results mean.
Merck strengthens its women’s oncology position with KEYNOTE-B96 overall survival results
KEYNOTE-B96 shows overall survival gains for pembrolizumab in platinum-resistant ovarian cancer. Find out why this trial could reshape treatment strategy.
AiCuris pritelivir shows superior lesion healing in HIV-associated refractory HSV
AiCuris pritelivir shows superior lesion healing in HIV-associated refractory HSV. Explore what the Phase 3 data mean for regulation and practice.
Novo Nordisk’s CagriSema misses non-inferiority against tirzepatide: Why a 23% weight loss still reshapes the obesity pipeline
Novo Nordisk A/S disclosed headline Phase 3 data from the REDEFINE 4 trial showing that CagriSema, its fixed-dose combination of cagrilintide and semaglutide, achieved 23 percent weight loss over 84 weeks in people with obesity but failed to meet the primary endpoint of non-inferiority versus tirzepatide. The open-label head-to-head study compared once-weekly CagriSema 2.4 mg/2.4 […]
Merz Therapeutics files XEOMIN pediatric spasticity indication with EMA following Phase 3 success
Merz Therapeutics files EMA application to expand XEOMIN for pediatric spasticity. Find out how this could shift the treatment landscape for cerebral palsy.
RED-C setback for Bausch Health: What this failed Phase 3 trial reveals about cirrhosis care gaps
Bausch’s RED-C trial failed to meet endpoints in hepatic encephalopathy prevention. Find out what this means for rifaximin SSD’s future and the field.
Takeda’s zasocitinib hits key Phase 3 psoriasis goals, challenging oral and biologic rivals
Takeda Pharmaceutical Company Limited has reported positive topline results from two pivotal Phase 3 studies of its investigational drug zasocitinib (TAK-279), a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than 50 percent of participants achieving near-complete skin clearance (PASI […]
Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?
Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin […]
Why Eli Lilly’s triple agonist may become the first obesity drug with dual indications
Eli Lilly and Company has announced successful topline results from its Phase 3 TRIUMPH-4 clinical trial evaluating retatrutide, a triple hormone receptor agonist, in adults with obesity and knee osteoarthritis. The once-weekly investigational therapy delivered significant dual benefits: an average weight loss of 28.7 percent and a 75.8 percent reduction in joint pain, measured by […]
Can CRO-backed equity deals change biotech trial economics? Sen-Jam’s SJP-001 may be the test case
Sen-Jam Pharmaceutical has disclosed a significant equity-based agreement with TASK Clinical, under which the global contract research organization will fund two-thirds of the Phase 3 trial for SJP-001. The candidate, a first-in-class therapy targeting alcohol-induced inflammation, now becomes one of the few mid-stage biotech programs to receive such substantial CRO-driven capital support. The partnership is […]