Clinical

Hua Medicine achieves primary efficacy endpoint in phase III trial for type 2 diabetes candidate

November 21, 2019

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 apperceived: Invariant ovarian outcome backs first phase Ib results

November 20, 2019

By Randy Osborne

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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's relugolix shines in phase III prostate cancer study

November 19, 2019

By Michael Fitzhugh

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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.

Promising but preliminary

Crispr Therapeutics’ interim data: First two patients functionally cured by CRISPR/Cas9 therapy?

November 19, 2019

By Cormac Sheridan

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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.

TRAEs companies: Rolling dice in melanoma debate as combo efforts proceed

November 19, 2019

By Randy Osborne

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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.

Intestinal resurfacing startup Fractyl plans 2020 pivotal trial as it reports positive data

November 19, 2019

By Stacy Lawrence

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Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.

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

November 19, 2019

By Jihyun Kim

No Comments

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).

Karuna schizophrenia bid wins phase II, researchers conquer PANSS labyrinth

November 19, 2019

By Randy Osborne

No Comments

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.

Sapien bests Corevalve Evolut in twin French TAVR studies

November 18, 2019

By Mark McCarty

No Comments

Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies.

Restorbio's failed phase III study in CSRI tanks stock

November 18, 2019

By Lee Landenberger

No Comments

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.

Clinical
RSS

Hua Medicine achieves primary efficacy endpoint in phase III trial for type 2 diabetes candidate

Aravive apperceived: Invariant ovarian outcome backs first phase Ib results

Myovant's relugolix shines in phase III prostate cancer study

Crispr Therapeutics’ interim data: First two patients functionally cured by CRISPR/Cas9 therapy?

TRAEs companies: Rolling dice in melanoma debate as combo efforts proceed

Intestinal resurfacing startup Fractyl plans 2020 pivotal trial as it reports positive data

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

Karuna schizophrenia bid wins phase II, researchers conquer PANSS labyrinth

Sapien bests Corevalve Evolut in twin French TAVR studies

Restorbio's failed phase III study in CSRI tanks stock

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