Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

Ocular Therapeutix doses first patients in Phase 2 dry eye disease trial

Ocular Therapeutix (NASDAQ:OCUL) dosed the first patients in its Phase 2 trial evaluating OTX-CSI for the treatment of dry eye disease. The trial will enroll some 105 patients who will receive either one of two...

September 29, 2020

Developments

Forte Biosciences doses first patient in Phase 2 atopic dermatitis trial

Forte Biosciences (NASDAQ:FBRX) dosed the first patient in its Phase 2 trial evaluating FB-401 for the treatment of atopic dermatitis. FB-401 is a topical mixture comprised primarily of three strains of the commensal...

September 29, 2020

Developments

Concert completes enrollment in Phase 2 schizophrenia trial

Concert Pharmaceuticals (NASDAQ:CNCE) completed enrollment in its Phase 2 study evaluating CTP-692 as an adjunctive treatment in patients with schizophrenia. The trial enrolled 325 patients already on a stable course...

September 29, 2020

Developments

Field Trip Psychedelics completes GLP synthesis of FT-104

Closely-held Field Trip Psychedelics successfully completed GLP synthesis of its psychedelic molecule, FT-104. FT-104 is a new chemical substance designed to be a commercially viable alternative to naturally derived...

September 29, 2020

Developments

Imagin Medical to host KOL webcast on Oct. 29

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) will host a virtual investor event with key opinion leaders on Oct. 29 at 12:00 pm ET to highlight the potential of the company’s i/Blue...

September 29, 2020

Developments

Soricimed receives $500,000 in Government of Canada funding

Closely-held Soricimed Biopharma received $500,000 in funding from the Government of Canada to support the company’s continued research and development work. The Government of Canada provided the repayable contribution...

September 29, 2020

Developments

Zucara doses first subject in Phase 1 trial of ZT-01

Closely-held Zucara Therapeutics dosed the first subject in its Phase 1 trial of ZT-01, a once-daily somatostatin inhibitor designed to prevent insulin-induced hypoglycemia. The first, single ascending dose portion...

September 29, 2020

Developments

Kane Biotech, Animalcare to form STEM Animal Health

Kane Biotech (TSX-V:KNE) and UK-based Animalcare Group (AIM:ANCR) signed a pact to form STEM Animal Care, a company dedicated to treating biofilm-related ailments in animals. Under the accord, Animalcare will launch...

September 28, 2020

Developments

Leap Therapeutics DKN-01 gets FDA fast track designation for gastric and gastroesophageal junction cancer

The FDA granted Leap Therapeutics’ (NASDAQ:LPTX) DKN-01 fast track designation for gastric and gastroesophageal junction cancer. Specifically, the designation was granted for patients whose tumors express high Dickkopf...

September 24, 2020

Developments

Mereo setrusumab gets FDA rare pediatric disease designation for osteogenesis imperfecta

The FDA granted Mereo BioPharma’s (NASDAQ:MREO) setrusumab rare pediatric disease designation for the treatment of osteogenesis imperfecta (OI). OI, also known as brittle bone disease, is caused by a genetic mutation in...

September 24, 2020

Developments

Applied Therapeutics AT-007 gets FDA rare pediatric disease and orphan drug designations

The FDA granted Applied Therapeutics’ (NASDAQ:APLT) AT-007 rare pediatric disease and orphan drug designations for the treatment of PMM2-congenital disorder of glycosylation (PMM2-CDG). PMM2-CDG is a rare disease caused...

September 24, 2020

Developments

Calithera treats first patient in Phase 2 non-small cell lung cancer trial

Calithera Biosciences (NASDAQ:CALA) treated the first non-small cell lung cancer (NSCLC) patient in its Phase 2 trial evaluating telaglenastat, a glutaminase inhibitor. The trial will enroll some 120 patients with stage...

September 24, 2020

Developments

AC Immune semorinemab fails Phase 2 Alzheimer’s disease trial

AC Immune (NASDAQ:ACIU) reported disappointing topline results from a Phase 2 trial evaluating semorinemab for the treatment of early Alzheimer’s disease (AD). Semorinemab, an anti-tau antibody, did not meet its primary...

September 23, 2020

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