Abby Hardy, Author at BioTuesdays

Developments

Savara’s AeroVanc fails Phase 3 cystic fibrosis trial

Savara (NASDAQ:SVRA) reported that its Phase 3 AVAIL trial evaluating AeroVanc for the treatment of cystic fibrosis failed to meet its primary endpoint. The trial enrolled 55 cystic fibrosis patients with methicillin...

December 10, 2020

Developments

TG Therapeutics reports positive topline results from 2 Phase 3 MS trials

TG Therapeutics (NASDAQ:TGTX) reported positive topline data from its two Phase 3 trials evaluating ublituximab, an anti-CD20 monoclonal antibody, for the treatment of relapsing forms of multiple sclerosis (MS)...

December 10, 2020

Developments

Pluristem terminates Phase 3 critical limb ischemia trial

Pluristem Therapeutics (NASDAQ:PSTI) reported disappointing results from an interim analysis of its Phase 3 study evaluating PLX-PAD for the treatment of critical limb ischemia. Based on the interim analysis, the study...

December 9, 2020

Developments

Cytokinetics reports positive interim results from Phase 2 hypertrophic cardiomyopathy trial

Cytokinetics (NASDAQ:CYTK) reported positive interim results from the first cohort of its Phase 2 REDWOOD-HCM clinical trial evaluating CK-274 for the treatment of hypertrophic cardiomyopathy. In the first cohort, 21...

December 9, 2020

Developments

BELLUS Health doses first patient in Phase 2b chronic cough trial

BELLUS Health (NASDAQ:BLU; TSX:BLU) dosed the first patient in its Phase 2b study evaluating BLU-5937 for the treatment of refractory chronic cough. The study, called SOOTHE, will evaluate three doses of BLU-5937 in...

December 8, 2020

Developments

electroCore reports positive topline results from migraine prevention study

electroCore (NASDAQ:ECOR) reported positive topline results from its PREMIUM II study evaluating gammaCore, a non-invasive vagus nerve stimulation (nVNS) device, for the prevention of migraines. The study was designed...

December 8, 2020

Developments

Precision BioSciences reports positive interim data from Phase 1/2a lymphoma, leukemia study

Precision BioSciences (NASDAQ:DTIL) reported positive interim results from its Phase 1/2a study evaluating PBCAR0191, an allogeneic chimeric antigen receptor (CAR-T) cell therapy, for the treatment of...

December 4, 2020

Developments

Taysha gets FDA rare pediatric and orphan drug designations for epilepsy

Taysha Gene Therapies’ (NASDAQ:TSHA) TSHA-103 received FDA rare pediatric and orphan drug designations for the treatment of SLC6A1-related epilepsy. SLC6A1-related epilepsy is caused by the loss of function of one copy...

December 3, 2020

Developments

Protagonist Therapeutics gets FDA fast track designation for polycythemia vera

Protagonist Therapeutics’ (NASDAQ:PTGX) PTG-300 received FDA fast track designation for the treatment of polycythemia vera, a rare disease characterized by the excessive production of red blood cells. PTG-300 is an...

December 2, 2020

Developments

Cara Therapeutics completes enrollment in Phase 2 pruritis trial

Cara Therapeutics (NASDAQ:CARA) completed enrollment in its Phase 2 KARE trial evaluating KORSUVA for the treatment of moderate-to-severe pruritus, or itchy skin, in atopic dermatitis patients. The trial enrolled 400...

December 2, 2020

Author - Abby Hardy

Savara’s AeroVanc fails Phase 3 cystic fibrosis trial

TG Therapeutics reports positive topline results from 2 Phase 3 MS trials

Pluristem terminates Phase 3 critical limb ischemia trial

Cytokinetics reports positive interim results from Phase 2 hypertrophic cardiomyopathy trial

BELLUS Health doses first patient in Phase 2b chronic cough trial

electroCore reports positive topline results from migraine prevention study

Precision BioSciences reports positive interim data from Phase 1/2a lymphoma, leukemia study

Taysha gets FDA rare pediatric and orphan drug designations for epilepsy

Protagonist Therapeutics gets FDA fast track designation for polycythemia vera

Cara Therapeutics completes enrollment in Phase 2 pruritis trial

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