Clinical

Cymabay’s PPAR-delta dawn darkens; seladelpar bound for NASH mansion in sky?

November 25, 2019

Due to the “dynamic nature of the situation,” officials of Cymabay Therapeutics Inc. declined to comment on the stoppage of work with PPAR-delta agonist seladelpar, but in a press release they pointed to “a series of investigative actions [that have begun in order] to better understand these findings.”

Mologic begins recruitment of COPD urine-based home test

November 25, 2019

By Nuala Moran

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LONDON – Mologic Ltd. has started recruitment in a 263-patient trial to validate its urine-based home test for anticipating exacerbations of chronic pulmonary obstructive disease (COPD). The lateral flow immunoassay self-test detects five biomarkers of the lung disease in urine that are indicative of inflammation and infection.

Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing

November 22, 2019

By Michael Fitzhugh

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Shares of Eyegate Pharmaceuticals Inc. (NASDAQ:EYEG) rose 54.8% to $7.09 Friday on news that its ocular bandage gel (OBG) proved superior to standard of care in healing corneal wounds following photorefractive keratectomy (PRK) surgery.

Study supports long-term performance of Senseonics’ Eversense CGM

November 22, 2019

By Meg Bryant

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Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The real-world trial assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adults.

Apple Heart Study delivers results as 3 new app-based trials begin

November 22, 2019

By Stacy Lawrence

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Stanford University School of Medicine and Apple Inc.have published results from the largest digital-only study. The trial has been conducted in more than 400,000 people in the U.S. over more than eight months. It was set up to screen participants via their Apple Watch for heart irregularities and then to further monitor any of those with identified issues with a wearable ECG patch.

Primed with phase III glioblastoma data, Diffusion seeks partner for next step

November 21, 2019

By Michael Fitzhugh

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Diffusion Pharmaceuticals Inc., a company developing trans sodium crocetinate (TSC) for the treatment of cancer, has reported increased survival for inoperable glioblastoma patients enrolled in the lead-in portion of its open-label phase III study testing TSC plus standard-of-care (SOC) temozolomide and radiation therapy against SOC alone.

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

November 21, 2019

By David Ho

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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

No Comments

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

No Comments

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

No Comments

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.

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Cymabay’s PPAR-delta dawn darkens; seladelpar bound for NASH mansion in sky?

Mologic begins recruitment of COPD urine-based home test

Eyegate sees top-line corneal wound win as unlocking path to U.S. de novo filing

Study supports long-term performance of Senseonics’ Eversense CGM

Apple Heart Study delivers results as 3 new app-based trials begin

Primed with phase III glioblastoma data, Diffusion seeks partner for next step

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?

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