Category - Developments

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

Developments

MeiraGTx reports positive topline data from Phase 1/2 retinal dystrophy trial

MeiraGTx (NASDAQ:MGTX) reported that AAV-RPE65, its investigational gene therapy for the treatment of retinal dystrophy, met the primary endpoint of safety and tolerability in a Phase 1/2 study, as well as demonstrated...

May 14, 2019

Developments

Homology’s PKU gene therapy gets FDA fast track designation

Homology Medicines’ (NASDAQ:FIXX) received FDA fast track designation for HMI-102, a gene therapy for the treatment of adults with phenylketonuria (PKU), a rare genetic disease affecting metabolism. Individuals with PKU...

May 14, 2019

Category - Developments

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