Category - Developments

Developments

Axovant doses first patient in gangliosidosis gene therapy trial

Axovant Gene Therapies (NASDAQ:AXGT) has dosed the first patient in a clinical study of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a rare genetic disease where mutations in the GLB1 gene...

May 17, 2019

Developments

Mustang Bio gets FDA orphan drug designation for malignant glioma

Mustang Bio (NASDAQ:MBIO) and development partner, Nationwide Children’s Hospital (NCH), received FDA orphan drug designation for MB-108 for the treatment of malignant glioma. Malignant glioma is a type of brain cancer...

May 17, 2019

Developments

Achillion reports positive interim Phase 2 data in paroxysmal nocturnal hemoglobinuria

Achillion Pharmaceuticals (NASDAQ:ACHN) reported interim data from its Phase 2 trial of ACH-4471, in combination with eculizumab, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In PNH, the complement...

May 17, 2019

Developments

Abstracts for BeyondSpring Plinabulin-Neulasta combination accepted at ASCO

Two of BeyondSpring’s (NASDAQ:BYSI) abstracts about its lead asset, Plinabulin, were accepted for publication in the proceedings of this year’s ASCO annual meeting May 31 to June 4 in Chicago. The data, derived from...

May 16, 2019

Developments

MacroGenics reports positive Phase 3 results in HER2-positive metastatic breast cancer

MacroGenics’ (NASDAQ:MGNX) Phase 3 trial of margetuximab met its first sequential primary endpoint of progression-free survival (PFS) in patients with HER2-positive metastatic breast cancer. The median PFS of patients...

May 16, 2019

Developments

FDA accepts Cue Biopharma IND for HPV-associated cancer candidate

Cue Biopharma’s (NASDAQ:CUE) IND for CUE-101, an immuno-oncology candidate for human papilloma virus (HPV)-associated cancers, had been accepted by the FDA. The majority of HPV-associated cancers are caused by the HPV16...

May 16, 2019

Developments

Rigel Pharma enrolls first patient in Phase 3 autoimmune hemolytic anemia trial

Rigel Pharmaceuticals (NASDAQ:RIGL) enrolled the first patient in its pivotal Phase 3 trial of fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia (AIHA).

May 16, 2019

Developments

Ceapro receives site license from Health Canada

Ceapro’s (TSXV:CZO) two bioprocessing plants in Alberta received a site license from the Health Canada Natural and Non-Prescription Health Products Directorate, which enables the company to fabricate, package, label...

May 15, 2019

Developments

Principia Biopharma doses first patient in Phase 2b MS trial

Principia Biopharma (NASDAQ:PRNB) has dosed the first patient in its Phase 2b clinical trial of SAR442168 in patients with relapsing multiple sclerosis (MS). Neuroinflammation and an increase in the number of B cells in...

May 15, 2019

Developments

Athersys gets FDA fast track designation for acute respiratory distress syndrome

Athersys’ (NASDAQ:ATHX) MultiStem cell therapy for the treatment of acute respiratory distress syndrome (ARDS) has received FDA fast track designation. ARDS is a widespread inflammation of the lungs that can be...

May 15, 2019

Category - Developments

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