ICON’s San Antonio Expansion Looks Like Opportunity—Your IRB Timeline Says Otherwise
ICON opens early-phase units in San Antonio, Houston, and Lawrence, KS—but sponsors activating satellite clinics face IRB, contract, and...
Zentalis’s Azenosertib Strategy Hinges on DENALI Phase 2 Data
Zentalis's azenosertib strategy depends on DENALI Phase 2 data readout expected before year-end 2026 in Cyclin E1-positive ovarian cancer...
Capricor Sues Distributor NS Pharma Over Deramiocel Deal Structure
Capricor sues NS Pharma over deramiocel deal structure, claiming the pricing model prevents Medicare and Medicaid coverage ahead of...
Ajax Presents Phase 1 Data for Type II JAK2 Inhibitor AJ1-11095 at EHA
Ajax's type II JAK2 inhibitor AJ1-11095 shows early VAF reduction in Phase 1 data for myelofibrosis patients who failed...
Foundayo Maintains Weight Loss in Lilly Trial After Injectable Switch
Foundayo maintained weight loss in Lilly's ATTAIN-MAINTAIN trial after patients switched from Wegovy, losing only 0.9 kg over 52...
Oral semaglutide showed 21.6% weight loss in early responders, 77% mobility gains
Oral semaglutide showed 21.6% weight loss in early responders and 77% mobility gains in patients with obesity-related physical impairment.
When the Sponsor’s Name Changes Mid-Trial, Sites Pay the Operational Price
BioMarin's $4.8B Amicus acquisition closed April 27—now sites running Amicus trials face contract ownership gaps, monitoring voids, and enrollment...
Kyverna’s SPS CAR-T Therapy Advances to BLA Based on Natural History Study Data
Kyverna's SPS CAR-T Therapy advances to BLA submission based on natural history study data showing disease progression on existing...
Agios Seeks FDA Accelerated Approval for Mitapivat in Sickle Cell Disease
Agios pursues accelerated approval for mitapivat in sickle cell disease based on hemoglobin response, pending FDA review in Q3...
DIPG’s Biomarker Reckoning: What BIOMEDE Tells Us About Precision Oncology Trial Design When the Primary Endpoint Fails
BIOMEDE screened 279 DIPG patients across 45 centers using biopsy-driven tumor profiling — and its biomarker signals outlasted its...