HONG KONG – China-based Hua Medicine (Shanghai) Ltd.’s phase III trial of a potentially first-in-class dual-acting glucokinase (GK) activator, dorzagliatin (HMS-5552), has met its primary efficacy endpoint.
Aravive Biologics Inc. dispelled doubts that may have persisted after the disclosure of early data from the ongoing phase Ib portion of the phase Ib/II trial with AVB-500 in platinum-resistant ovarian cancer, and Wall Street rewarded the company’s shares (NASDAQ:ARAV) with an 48.1% hike, or $3.13, to close Wednesday at $9.64.
Myovant Sciences Ltd. reported that its lead candidate, relugolix, met its primary efficacy endpoint and all six secondary endpoints in a phase III study of men with advanced prostate cancer, adding new strength to the asset's story, analysts said.
DUBLIN – Crispr Therapeutics AG has delivered what appears, so far at least, to be a safe, functional cure for the first patient enrolled in each of its phase I/II trials of lead CRISPR/Cas9 gene editing therapy CTX-001, in beta-thalassemia and in sickle cell disease.
Cytomx Therapeutics Inc. CEO Sean McCarthy said earlier this month that the firm was “not ready to guide on specific response rates” that the company hopes for in the phase II study with anti-PD-L1 Probody CX-072 in combination with ipilimumab, or ipi (Yervoy, Bristol-Myers Squibb Co.) in patients with relapsed refractory melanoma.
Pairing the in-licensed muscarinic acetylcholine receptor agonist xanomeline with the well-known muscarinic antagonist trospium chloride in the single drug called Karxt gave Karuna Therapeutics Inc. the required phase II efficacy against acute psychosis in schizophrenia, while keeping a quite satisfactory safety and side-effect profile.
Restorbio Inc.'s PROTECTOR 1 phase III study failed to meet its primary endpoint and the company shares tracked deeply downward Friday. The trial was designed to evaluate RTB-101 in preventing clinically symptomatic respiratory illness (CSRI) in adults ages 65 and older.
A second phase II failure to differentiate from placebo in a test of benefits for people with depression has put AV-101, an NMDA receptor antagonist developed by Vistagen Therapeutics Inc., in uncertain territory.
HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).
Therapix Biosciences Ltd., of Tel Aviv, Israel, said top-line results of a small single-arm, phase IIa study of its combination of dronabinol (delta-9-tetrahydracannabinol) and Cannamide (palmitoylethanolamide), THX-110, showed a positive effect on symptoms of obstructive sleep apnea (OSA), a serious sleep disorder.
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