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.
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.
A little more than two months after completing enrollment, an interim analysis shows Kadmon Holdings Inc.'s pivotal trial of ROCKstar (KD-025-213) testing KD-025 in patients with chronic graft-vs.-host disease (cGVHD) met its primary endpoint of overall response rate.
Solid Biosciences Inc.'s chief technology officer, Joel Schneider, said the company is "not going to leave any stone unturned" as investigators begin to explore the severe adverse event (SAE) that led to the FDA's clinical hold on the phase I/II study with SGT-001 in Duchenne muscular dystrophy (DMD).
LONDON – Sanifit Therapeutics SA has delivered positive phase IIb data demonstrating SNF-472 significantly reduces progression of cardiovascular calcification (CVC) in patients with end-stage kidney disease who are on dialysis.
Roche Holding AG and PTC Therapeutics Inc. together with their partner, the SMA Foundation, reported success in part two of the pivotal Sunfish study testing their survival motor neuron-2 splicing modifier risdiplam in patients with type 2 or 3 spinal muscular atrophy (SMA).
Shares of Nextcure Inc. (NASDAQ:NXTC) have alternately been up sharply lately or down dramatically. Following the weekend release of updated positive clinical data from its NC-318 phase I/II study, the share price nosed down 52.9% Monday.
Within the first few minutes of a key opinion leader webinar on Alzheimer's disease sponsored by AC Immune SA, CEO Andrea Pfeifer brought up the decision by Biogen Inc. to file for regulatory approval of amyloid beta targeter aducanumab in early AD, based on results from a subset of patients in the phase III study called Engage.
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