Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

aTyr Pharma posts positive topline results from Phase 2 COVID-19 study

aTyr Pharma (NASDAQ:LIFE) announced positive topline results from its Phase 2 clinical trial of its lead therapeutic candidate, ATYR1923, in hospitalized COVID-19 patients with severe respiratory complications who do...

January 5, 2021

Developments

Hepion Pharma posts positive Phase 2a low dose data for CRV431 in advanced NASH

Hepion Pharmaceuticals (NASDAQ:HEPA) reported positive top line data from the low dose cohort in its Phase 2a AMBITION clinical trial of 75 mg CRV431, an oral, once-daily novel cyclophilin inhibitor, for the treatment...

December 30, 2020

Developments

DSMB recommends continuation of Hepion Pharma Phase 2a AMBITION trial in NASH

An independent data safety monitoring board (DSMB) has approved continuation of Hepion Pharmaceuticals’ (NASDAQ:HEPA) Phase 2a AMBITION clinical trial for the treatment of advanced non-alcoholic steatohepatitis (NASH)...

December 29, 2020

Developments

FDA accepts Hepion Pharma IND for CRV431 to treat COVID-19

The FDA accepted an IND application from Hepion Pharmaceuticals (NASDAQ:HEPA) for the use of CRV431, a novel cyclophilin inhibitor, for the treatment of COVID-19. Hepion is developing CRV431 as part of its artificial...

December 22, 2020

Developments

Profound Medical in pact with GE Healthcare to expand access to TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) and GE Healthcare agreed to a non-exclusive, worldwide license that will enable Profound to interface its TULSA-PRO system with certain GE Healthcare MRI scanners. The...

December 21, 2020

Developments

Albireo initiates Phase 3 Alagille syndrome trial

Albireo Pharma (NASDAQ:ALBO) launched a Phase 3 trial evaluating odevixibat for the treatment of Alagille syndrome, a rare genetic disorder that affects multiple parts of the body. Most Alagille patients present with...

December 17, 2020

Developments

Aldeyra initiates 3 Phase 2 trials of ADX-629

Aldeyra Therapeutics (NASDAQ:ALDX) launched three Phase 2 trials evaluating ADX-629 for the treatment of COVID-19, atopic asthma, and psoriasis. ADX-629 is an orally administered RASP inhibitor designed to modulate the...

December 17, 2020

Developments

Soricimed to investigate SOR-C13 to treat COVID-19

Closely-held Soricimed Biopharma, benefiting from funding support from the National Research Council of Canada Industrial Research Assistance Program, will investigate the potential therapeutic role its cancer drug...

December 17, 2020

Developments

vTv Therapeutics azeliragon fails Phase 2 AD and T2D trial

vTv Therapeutics’ (NASDAQ:VTVT) Phase 2 trial of azeliragon in patients with Alzheimer’s disease (AD) and Type 2 diabetes (T2D) failed to meet its primary endpoint. The trial enrolled 43 patients who were randomized to...

December 16, 2020

Developments

Durect gets FDA fast track designation for alcoholic hepatitis

Durect’s (NASDAQ:DRRX) DUR-928 received FDA fast track designation for the treatment of alcoholic hepatitis (AH), a life-threatening form of alcohol-associated liver disease. In August 2020, Durect reported results of...

December 16, 2020

Developments

First patients enrolled in Eyenovia Phase 3 MicroLine study for presbyopia

Eyenovia (NASDAQ:EYEN) announced that the first set of patients has been enrolled in the company’s Phase 3 VISION-1 study of MicroLine, a proprietary pilocarpine formulation delivered via its Optejet dispenser for the...

December 16, 2020

Developments

Verastem initiates Phase 2 non-small lung cancer trial

Verastem (NASDAQ:VSTM) initiated a Phase 2 registration-directed trial evaluating VS-6766 for the treatment of KRAS-G12V-mutant non-small cell lung cancer (NSCLC). In the first part of the study, VS-6766, a RAF/MEK...

December 15, 2020

Developments

Kiniksa Pharma initiates dosing in Phase 2b prurigo nodularis trial

Kiniksa Pharmaceuticals (NASDAQ:KNSA) initiated dosing in its Phase 2b trial evaluating vixarelimab for the treatment of prurigo nodularis. Prurigo nodularis is a skin disease that causes hard, itchy nodules to form on...

December 15, 2020

Developments

Aerpio reports positive topline results from Phase 2 glaucoma trial

Aerpio Pharma (NASDAQ:ARPO) reported positive topline results from its Phase 2 trial evaluating razuprotafib for the treatment of elevated intraocular pressure (IOP). The study enrolled 194 patients with elevated IOP...

December 14, 2020

Developments

Prevail Therapeutics doses first patient in Phase 1/2 frontotemporal dementia trial

Prevail Therapeutics (NASDAQ:PRVL) dosed the first patient in its Phase 1/2 PROCLAIM trial evaluating PR006 for the treatment of frontotemporal dementia patients with GRN mutations. Frontotemporal dementia is the second...

December 11, 2020

Developments

Geron begins enrollment in Phase 3 refractory myelofibrosis trial

Geron (NASDAQ:GERN) reported that its Phase 3 IMpactMF clinical trial, which is evaluating imetelstat for the treatment of refractory myelofibrosis, is open for patient screening and enrollment. The trial is designed to...

December 11, 2020

Developments

Lexicon gets FDA fast track designation for diabetic peripheral neuropathic pain

Lexicon Pharmaceuticals’ (NASDAQ:LXRX) LX9211 received FDA fast track designation for the treatment of diabetic peripheral neuropathic pain. The company is currently enrolling patients with diabetic peripheral...

December 11, 2020

Developments

Hepion completes 75 mg CRV431 dosing, initiates 225 mg dosing in AMBITION trial

Hepion Pharmaceuticals (NASDAQ:HEPA) completed patient dosing in the 75 mg cohort of its Phase 2a ‘AMBITION’ clinical trial, which is evaluating CRV431 for the treatment of non-alcoholic steatohepatitis (NASH). In...

December 10, 2020

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

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