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News
Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF
2+ day, 19+ hour ago (422+ words) The Clinical Trial Vanguard Insilico Medicine Begins Phase III Trial of AI-Discovered Drug Rentosertib for IPF Rentosertib just cleared a threshold no AI-discovered drug has reached before: 320 patients, 47 sites, 52 weeks of treatment in a randomized, double-blind, placebo-controlled Phase III. Insilico Medicine…...
Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease
3+ day, 19+ hour ago (336+ words) The Clinical Trial Vanguard Novartis Pays $50M Milestone as MRT-6160 Enters Phase 2 for Sjögren’s Disease A $50 million check is the clearest signal yet that Novartis believes VAV1 degradation works in humans. Monte Rosa Therapeutics triggered that milestone payment on September 8, 2026, when Novartis…...
BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC
3+ day, 19+ hour ago (322+ words) The Clinical Trial Vanguard BridgeBio Shifts BBO-8520 Focus to KRAS Combinations in Second-Line NSCLC A 63% objective response rate from a Phase 1 monotherapy arm is an unusual number to anchor a strategic pivot on, but that is what BridgeBio Oncology Therapeutics…...
A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue
3+ day, 19+ hour ago (790+ words) The Clinical Trial Vanguard A 25% Sample Size Cut Sounds Like a Win, Until You See the Amendment Queue A clinical operations lead gets the news from her biostatistics team: the new digitally enhanced composite endpoint just cut the required sample…...
Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal
5+ day, 19+ hour ago (334+ words) The Clinical Trial Vanguard Tekton Research Sites Enroll 60 Participants in Phase 2 Obesity Trial, Triple Goal Enrolling three times the planned number of participants is rare enough that it usually points to something structural, not just enthusiasm. Tekton Research’s San Antonio…...
FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models
6+ day, 19+ hour ago (383+ words) The Clinical Trial Vanguard FDA Guidance Expands Cancer Trial Eligibility, Reshaping Feasibility Models Forty percent of Phase III cancer trials explicitly barred patients with an ECOG performance status of 2 or higher, and among trials that allowed those patients, they made…...
Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome
1+ week, 2+ day ago (527+ words) The Clinical Trial Vanguard Ultragenyx’s apazunersen fails Phase 3 primary endpoint in Angelman syndrome Two years of Phase 1/2 momentum collapsed in a single readout: Ultragenyx’s Phase 3 Aspire study for apazunersen (GTX-102) in Angelman syndrome failed both its primary endpoint and its…...
NSABP B-59 Failed. The Real Question Is Why We Keep Designing Trials That Can’t Detect the Signal.
1+ week, 2+ day ago (198+ words) That failure carries weight far beyond the TNBC space. Every immuno-oncology sponsor running a Phase 3 program with a PD-L1 inhibitor, in any indication, should be reading the B-59 readout and asking a harder question than “did it work?” The harder question…...
When a Failed Primary Endpoint Teaches More Than a Win: What CARDIOTTRansform’s Secondary Analysis Reveals About Stratification in Complex Trials
1+ week, 5+ day ago (838+ words) The Clinical Trial Vanguard When a Failed Primary Endpoint Teaches More Than a Win: What CARDIOTTRansform’s Secondary Analysis Reveals About Stratification in Complex Trials The CARDIOTTRansform investigators already knew their Phase 3 trial had not met its primary endpoint when they…...
When Early Efficacy Data Forces a Site Ramp You Weren’t Budgeted For
1+ week, 5+ day ago (669+ words) The Clinical Trial Vanguard When Early Efficacy Data Forces a Site Ramp You Weren’t Budgeted For The email lands mid-monitoring visit. Early efficacy signals from the ACESOT-1051 first-in-human study. The sponsor wants to accelerate. New sites, faster enrollment, aggressive timelines....