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BioWorld - Thursday, June 12, 2025
Home » Topics » Clinical

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Restorbio's failed phase III study in CSRI tanks stock

Nov. 18, 2019
By Lee Landenberger
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.
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Vistagen's AV-101 fails to separate from placebo in phase II MDD trial

Nov. 15, 2019
By Michael Fitzhugh

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.


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Aslan's varlitinib clinical study for BTC patients failed to meet primary endpoints

Nov. 14, 2019
By Jihyun Kim
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).
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Therapix shares rise on early positive sleep apnea data

Nov. 14, 2019
By Michael Fitzhugh
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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Chinatrials12 Summit

With the help of trial experts, Chinese biotechs set sail for global market

Nov. 13, 2019
By Elise Mak
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.
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Pivoting like a rock star: Kadmon study hits primary endpoint

Nov. 13, 2019
By Lee Landenberger
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.
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Stop sign

Solid gassed by trial hold; third degree for DMD SAE puts a scare into shares

Nov. 13, 2019
By Randy Osborne

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). 


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Medtronic study shows potential of pacemaker to treat more patients

Nov. 12, 2019
By Liz Hollis
Dublin-based Medtronic plc is highlighting results from the MARVEL 2 study showing that an investigational set of algorithms in the Micra Transcatheter Pacing System (TPS) helps those with normal sinus node function and atrioventricular (AV) block.
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Solid phase IIb CVC data clear path for Sanifit phase III study

Nov. 12, 2019
By Nuala Moran
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.
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Roche and PTC check off another SMA win, but the devil is in the details

Nov. 12, 2019
By Brian Orelli
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).
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