Tag Archive for: Phase III trial

Acadia Pharmaceuticals is terminating development of its antipsychotic drug pimavanserin, which did not demonstrate a statistically significant improvement over placebo in the late-stage study’s primary endpoint.

Topline data from the Phase III PHOENIX trial of Relyvrio, which won approval in 2022, showed no significant difference on either the primary or secondary endpoints, according to Amylyx.

Otsuka Pharmaceuticals on Monday announced that its investigational drug candidate AVP-786 fell short of its primary efficacy endpoint in a Phase III trial evaluating its effects as a treatment for agitation in Alzheimer’s disease.

Hit with lower sales of its COVID-19 antiviral Veklury and the weak performance of its HIV franchise, Gilead Sciences reported a 4% year-over-year revenue loss in the fourth quarter of 2023.

The company’s three-drug combination met all primary and key secondary endpoints in two randomized controlled trials in cystic fibrosis patients, paving the way for an application to regulators.

Yesterday the company posted findings from an interim analysis of the Phase III DREAMM-7 trial showing that its antibody-drug conjugate Blenrep, when used in a three-drug regimen, led to a significant improvement in progression-free survival in patients with relapsed or refractory multiple myeloma.

After VX-548 demonstrated significant pain relief in surgical and non-surgical settings, Vertex Pharmaceuticals is preparing to file a New Drug Application for the non-opioid candidate by mid-2024.

Bristol Myers Squibb’s PD-1 blocker Opdivo (nivolumab) failed part B of the Phase III CheckMate-914 study, bearing no significant disease-free survival benefit for patients with localized renal cell carcinoma who are at high-risk of relapse after surgery.

The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.

Saturday’s readout, which were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium, could position BMS to challenge Merck’s dominant PD-1 blocker Keytruda.