Abby Hardy, Author at BioTuesdays

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

Feature

Chiasma readies U.S. launch of first oral somatostatin analog for acromegaly

On the heels of an FDA approval, Chiasma (NASDAQ:CHMA) is preparing for the U.S. launch of MYCAPSSA, the first orally administered somatostatin analog for the long-term maintenance treatment of acromegaly in patients...

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

Author - Abby Hardy

Entera Bio reports interim data from Phase 2 osteoporosis trial

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

Kazia gets FDA fast track designation for glioblastoma

IntelGenx in feasibility pact with ATAI for film-based psychedelics

Albireo Pharma ends development of elobixibat for NASH/NAFLD

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

Chiasma readies U.S. launch of first oral somatostatin analog for acromegaly

Mustang Bio MB-107 gets FDA rare pediatric disease designation

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

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

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