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59,246 Results for "endpoint clincal".
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Brain cancer
Imvax Heads to FDA With 6-Month Survival Gain in Glioblastoma, Despite Endpoint Miss
While Imvax’s autologous immunotherapy IGV-001 missed the primary endpoint of progression-free survival in a Phase IIb trial, the company will request a meeting with the FDA to discuss next steps for “synergistic” treatment.
December 2, 2025
·
2 min read
·
Dan Samorodnitsky
Regulatory
FDA’s Tidmarsh Singles Out Aurinia’s Drug in LinkedIn Post About Surrogate Endpoints
Without naming Aurinia Pharmaceuticals, the CDER director in a now-deleted LinkedIn post claimed that for lupus nephritis, companies have not conducted post-approval studies “to demonstrate a benefit on hard clinical endpoints.”
September 30, 2025
·
2 min read
·
Tristan Manalac
Lymphoma
AbbVie, Genmab’s Bispecific Misses Key Overall Survival Endpoint in Phase III Lymphoma Study
Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.
January 19, 2026
·
2 min read
·
Tristan Manalac
Press Releases
PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
January 9, 2026
·
6 min read
Press Releases
Press Release: Sanofi’s venglustat met all primary endpoints in a phase 3 study of type 3 Gaucher disease
February 2, 2026
·
11 min read
Press Releases
Privo Technologies Announces Milestone in PRV211 Arm of CLN-004 Clinical Trial: Primary Endpoint Met; No Serious Adverse Events Reported
January 26, 2026
·
3 min read
Depression
Alto Digs Into Exploratory Outcomes as Depression Drug Misses Phase II Endpoint
While ALTO-203 missed its depression-related endpoints, improvements in EEG biomarkers, attention and wakefulness point to signals of drug activity, William Blair said, though the analysts pointed to other indications as potentially more promising for future development.
June 27, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
January 23, 2026
·
7 min read
Press Releases
Beacon Biosignals Announces Partnership with Harmony Biosciences to Advance Objective Clinical Endpoints in Hypersomnia Conditions Through Quantitative EEG
December 16, 2025
·
3 min read
Press Releases
InnoCare Announces Achievement of Primary Endpoint in Phase IIb Study of Orelabrutinib for SLE and Approval of Phase III Clinical Trial
December 15, 2025
·
4 min read
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