Category - Developments

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

Developments

Ocular Therapeutix doses first patient in Phase 3 allergic conjunctivitis trial

Ocular Therapeutix (NASDAQ:OCUL) has dosed the first patients in its Phase 3 efficacy trial of DEXTENZA for the treatment of symptoms of allergic conjunctivitis (AC). DEXTENZA is a corticosteroid that is FDA-approved...

September 24, 2019

Developments

MDACC begins dosing pancreatic cancer patients in Phase 1b trial of Soricimed’s SOR-C13

Closely-held Soricimed reported that The University of Texas MD Anderson Cancer Center (MDACC) has begun dosing the first cohort of three late-stage pancreatic cancer patients in its investigator-initiated trial of SOR...

September 24, 2019

Developments

Zenabis receives final license amendment for Zenabis Atholville site

Zenabis Global (TSX:ZENA) has received the licensing of Phase 2C – Part 2 at its Zenabis Atholville site in New Brunswick for an additional 3,000 kg of licensed annual cultivation capacity of cannabis. The amendment...

September 23, 2019

Category - Developments

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