Category - Developments

Developments

ImmunoGen IMGN632 gets FDA breakthrough therapy designation

The FDA granted ImmunoGen’s (NASDAQ:IMGN) IMGN632 breakthrough therapy designation for the treatment of relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). BPDCN is a rare and aggressive form of...

October 5, 2020

Developments

Hepion launches AI-POWR platform, forms clinical pharmacology analytics team

Hepion Pharmaceuticals (NASDAQ:HEPA) launched AI-POWR, a proprietary AI machine learning platform, which is designed to select novel drug targets, biomarkers, and appropriate patient populations for clinical trials...

October 5, 2020

Developments

FDA approves Chembio’s dual path platform HIV-syphilis testing system

The FDA approved Chembio Diagnostics’ (NASDAQ:CEMI) dual path platform (DPP) HIV-syphilis system, a 15-minute test designed to detect HIV Type 1 and 2 antibodies and the bacteria that causes syphilis. The system...

October 2, 2020

Developments

Synthetic Biologics discontinues Phase 2b irritable bowel syndrome trial

Synthetic Biologics (NYSE American:SYN) reported disappointing results from an interim futility analysis of its Phase 2b clinical study of SYN-010 for the treatment of irritable bowel syndrome with constipation. While...

October 2, 2020

Developments

Otonomy completes enrollment in Phase 3 Meniere’s disease trial

Otonomy (NASDAQ:OTIC) completed enrollment in its Phase 3 study evaluating OTIVIDEX for the treatment of Meniere’s disease, a disorder of the inner ear that can lead to vertigo and hearing loss. The trial enrolled 149...

October 2, 2020

Developments

Windtree doses first patient in Phase 2 cardiogenic shock study

Windtree Therapeutics (NASDAQCM:WINT) dosed the first patient in its Phase 2 study evaluating istaroxime in patients with early cardiogenic shock due to heart failure. Cardiogenic shock is a condition where the heart...

October 1, 2020

Developments

Athira initiates dosing in Phase 2/3 Alzheimer’s disease study

Athira Pharma (NASDAQ:ATHA) initiated patient dosing in its Phase 2/3 trial evaluating ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecule designed to regenerate brain...

October 1, 2020

Developments

Enlivex posts positive COVID-19 results in severe/critical patients

Enlivex Therapeutics (NASDAQ:ENLV) reported positive topline results of an investigator-initiated clinical trial of Allocetra in five COVID-19 patients, three of which were in severe condition and two in critical...

October 1, 2020

Developments

Clarigent Health launches Clairity suicide risk identification app

Closely-held Clarigent Health launched Clairity, an app-based listening tool designed to provide clinical decision support to mental health professionals. Clairity uses AI to analyze speech and identify vocal...

October 1, 2020

Developments

Soleno Therapeutics updates topline data from Phase 3 Prader-Willi Syndrome trial

Soleno Therapeutics (NASDAQ:SLNO) updated topline results from its Phase 3 trial evaluating diazoxide choline controlled-release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). The randomized, double...

September 30, 2020

Category - Developments

ImmunoGen IMGN632 gets FDA breakthrough therapy designation

Hepion launches AI-POWR platform, forms clinical pharmacology analytics team

FDA approves Chembio’s dual path platform HIV-syphilis testing system

Synthetic Biologics discontinues Phase 2b irritable bowel syndrome trial

Otonomy completes enrollment in Phase 3 Meniere’s disease trial

Windtree doses first patient in Phase 2 cardiogenic shock study

Athira initiates dosing in Phase 2/3 Alzheimer’s disease study

Enlivex posts positive COVID-19 results in severe/critical patients

Clarigent Health launches Clairity suicide risk identification app

Soleno Therapeutics updates topline data from Phase 3 Prader-Willi Syndrome trial

General

More