Category - Developments

Developments

Precipio points to completed validation studies of IV-Cell and HemeScreen

Several large laboratories have successfully completed validation studies to test Precipio’s (NASDAQ:PRPO) IV-Cell cytogenetics media product, as well as its HemeScreen assay, and are proceeding towards placing orders...

September 26, 2019

Developments

Cortexyme begins European screening for Phase 2/3 Alzheimer’s disease trial

Cortexyme (NASDAQ:CRTX) began screening patients in Europe for its international Phase 2/3 trial, called GAIN, to evaluate COR388 in patients with mild-to-moderate Alzheimer’s disease (AD). The company has been...

September 26, 2019

Developments

Marinus Pharma reports positive topline data from Phase 2 epileptic seizure trial

Marinus Pharmaceuticals (NASDAQ:MRNS) reported positive topline results from its Phase 2 trial of intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE). Status epilepticus is a prolonged...

September 26, 2019

Developments

Imagin Medical has positive FDA meeting about i/Blue regulatory pathway

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) recently met with the FDA to discuss its premarket approval regulatory pathway for marketing authorization of its i/Blue Imaging System. Based...

September 26, 2019

Developments

Urogen Pharma reports data from two urinary tract cancer trials

UroGen Pharma (NASDAQ:URGN) reported results from its Phase 3 and Phase 2b trials of its mitomycin gel in patients with low-grade upper tract urothelial cancer (UTUC) and intermediate risk low-grade non-muscle invasive...

September 25, 2019

Developments

Achillion gets FDA breakthrough therapy designation for danicopan

Achillion Pharmaceuticals’ (NASDAQ:ACHN) danicopan received FDA breakthrough therapy designation for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). In PNH, the complement system destroys red blood cells in...

September 25, 2019

Developments

Salarius achieves dose-escalation milestones in sarcoma and solid tumor trials

The Safety Review Committees overseeing Salarius Pharmaceuticals’ (NASDAQ:SLRX) Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors...

September 25, 2019

Developments

Mateon Therapeutics gets FDA pediatric disease designation for DIPG drug candidate

Mateon Therapeutics’ (NASDAQ:MATN) OT-101 received FDA pediatric disease designation for the treatment of diffuse intrinsic pontine glioma (DIPG). DIPG is a rare pediatric brainstem tumor that has a very low survival...

September 24, 2019

Developments

Ovid Therapeutics reports positive initial data from Phase 2 epilepsy trial

Ovid Therapeutics (NASDAQ:OVID) reported positive initial data from its Phase 2 study of soticlestat, a cholesterol 24-hydroxylase inhibitor, in patients with rare developmental and epileptic encephalopathies (DEE). ...

September 24, 2019

Developments

Aldeyra gets FDA fast track designation for vitreoretinopathy drug candidate

Aldeyra Therapeutics’ (NASDAQ:ALDX) ADX-2191 received FDA fast track designation for the prevention of proliferative vitreoretinopathy (PVR). PVR is an inflammatory disorder of the retina that leads to severe retinal...

September 24, 2019

Category - Developments

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