Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Hepion to present CRV431 preclinical data at liver congress

Hepion Pharmaceuticals (NASDAQ:HEPA) will present a poster on CRV431’s antifibrotic activity at the Digital International Liver Congress 2020, taking place from Aug. 27-29. Dr. Joseph Kuo will present a preclinical...

August 27, 2020

Developments

Outlook Therapeutics reports topline results from Phase 2 wet AMD trial

Outlook Therapeutics (NASDAQ:OTLK) reported topline results from its Phase 2 NORSE 1 trial evaluating ONS-5010 for the treatment of wet age-related macular degeneration (AMD). The study, whose primary endpoint is the...

August 26, 2020

Developments

Ovid Therapeutics soticlestat meets primary endpoint in Phase 2 epilepsy trial

Ovid Therapeutics (NASDAQ:OVID) reported positive topline results from its Phase 2 study evaluating soticlestat in children with Dravet syndrome or Lennox-Gastaut syndrome, two highly refractory epilepsy syndromes...

August 25, 2020

Developments

Imara gets EC orphan drug designation for sickle cell disease

Imara’s (NASDAQ:IMRA) IMR-687 received European Commission orphan drug designation for the treatment of sickle cell disease. In a statement, Imara’s president and CEO, Rahul Ballal, said the designation reinforces “the...

August 25, 2020

Developments

Bristol Myers Squibb to acquire TIAP’s Forbius

Bristol Myers Squibb (NYSE:BMY) entered a definitive agreement to acquire closely-held Forbius, a clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and...

August 24, 2020

Developments

CohBar begins Phase 1b trial with CB4211 for NASH and obesity

CohBar (NASDAQ:CWBR) dosed first subjects with CB4211 in the Phase 1b stage of its Phase 1a/1b clinical trial for non-alcoholic steatohepatitis (NASH) and obesity. The Phase 1b study is designed to evaluate one dose...

August 24, 2020

Developments

Bionano Genomics acquires Lineagen to boost genetics diagnostics

Bionano Genomics (NASDAQ:BNGO) acquired closely-held Lineagen, a genetics diagnostic company, to further support its leadership in digital cytogenetics and comprehensive genetic diagnostics for pediatric...

August 24, 2020

Developments

Entera Bio reports interim data from Phase 2 osteoporosis trial

Entera Bio (NASDAQ:ENTX) reported interim results from its Phase 2 trial assessing EB613 for the treatment of osteoporosis. The trial has currently enrolled 131 postmenopausal female subjects with osteoporosis, or low...

August 20, 2020

Developments

Precision BioSciences gets FDA fast track designation for allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR0191, received FDA fast track designation for the treatment of advanced B-cell precursor acute lymphoblastic leukemia...

August 20, 2020

Developments

Kazia gets FDA fast track designation for glioblastoma

Kazia Therapeutics’ (NASDAQ:KZIA) paxalisib received FDA fast track designation for the treatment of glioblastoma. Interim data from the company’s Phase 2 trial demonstrated overall survival of 17.7 months for patients...

August 20, 2020

Developments

IntelGenx in feasibility pact with ATAI for film-based psychedelics

IntelGenx (TSXV:IGX; OTCQB:IGXT) and ATAI Life Sciences signed a feasibility agreement for the development of novel formulations of pharmaceutical-grade psychedelics, based on IntelGenx’s film technologies. Under...

August 20, 2020

Developments

Albireo Pharma ends development of elobixibat for NASH/NAFLD

Albireo Pharma (NASDAQ:ALBO) reported topline results from its Phase 2 trial evaluating elobixibat for the treatment of non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). The trial...

August 18, 2020

Developments

Vanda Pharma reports interim results from Phase 3 COVID-19 trial

Vanda Pharmaceuticals (NASDAQ:VNDA) reported interim results from its Phase 3 trial assessing tradipitant for the treatment of COVID-19 pneumonia. The data are based on the first 60 patients enrolled in the study, who...

August 18, 2020

Developments

Mustang Bio MB-107 gets FDA rare pediatric disease designation

The FDA granted Mustang Bio’s (NASDAQ:MBIO) MB-107 rare pediatric disease designation for the treatment of X-linked severe combined immunodeficiency. Patients with X-linked severe combined immunodeficiency produce...

August 17, 2020

Developments

Imara doses first patient in Phase 2b sickle cell disease trial

Imara (NASDAQ:IMRA) dosed the first patient in its Phase 2b Ardent trial evaluating IMR-687 for the treatment of sickle cell disease. The trial will enrol some 99 patients with sickle cell disease, who will receive...

August 13, 2020

Developments

Scholar Rock gets FDA rare pediatric disease designation for spinal muscular atrophy

Scholar Rock (NASDAQ:SRRK) received FDA rare pediatric disease designation for SRK-015 for the treatment of spinal muscular atrophy. Spinal muscular atrophy is a rare genetic disease that leads to motor function...

August 13, 2020

Developments

AzurRx BioPharma reports positive interim data from Phase 2 cystic fibrosis trial

AzurRx BioPharma (NASDAQ:AZRX) reported positive results from the first five patients in its Phase 2 combination therapy trial of MS1819 for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients...

August 12, 2020

Developments

FDA approves Lantheus’ VIALMIXRFID activation device

The FDA approved Lantheus’ (NASDAQ:LNTH) supplemental drug application for VIALMIXRFID, a device that activates the company’s DEFINITY injectable suspension. DEFINITY injectable suspension is an ultrasound imaging agent...

August 12, 2020

Developments

Hepion CRV431 antiviral benefits published in PLOS ONE

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that the peer-reviewed journal, PLOS ONE, has published a paper highlighting the antiviral effects of CRV431. Co-authored by Hepion’s CSO, Dr. Daren Ure and CEO...

August 12, 2020

Developments

Ocugen OCU400 gets fourth FDA orphan drug designation for retinal disease

Ocugen’s (NASDAQ:OCGN) OCU400 received FDA orphan drug designation for the treatment of PDE6B gene mutation-associated retinal disease. OCU400 consists of a nuclear hormone receptor gene, NR2E3, which is delivered to...

August 10, 2020

Developments

Omeros reports positive results from COVID-19-associated ARDS trial

Omeros (NASDAQ:OMER) reported positive results from a study evaluating narsoplimab for the treatment of COVID-19-associated acute respiratory distress syndrome (ARDS). Narsoplimab is a human monoclonal antibody that is...

August 10, 2020

Developments

Seres SER-109 meets primary endpoint in Phase 3 study of C. difficile infection

Seres Therapeutics (NASDAQ:MCRB) reported positive topline results from its Phase 3 trial evaluating SER-109 for the treatment of recurrent C. difficile infection. The study enrolled 182 patients with multiply...

August 10, 2020

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