Category - Developments

Developments

Caladrius Biosciences reports positive data from coronary microvascular dysfunction study

Caladrius Biosciences (NASDAQ:CLBS) reported positive results from its proof-of-concept study of CLBS16 for the treatment of coronary microvascular dysfunction (CMD). CMD is a non-obstructive coronary artery disease...

November 18, 2019

Developments

Axovant gets FDA orphan drug designation for gangliosidosis gene therapy

Axovant Gene Therapies (NASDAQ:AXGT) received FDA orphan drug designation for AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a rare genetic disease where mutations in the GLB1 gene impair...

November 18, 2019

Developments

Aerie Pharma to acquire dry eye specialist Avizorex Pharma of Spain

Aerie Pharmaceuticals (NASDAQ:AERI) agreed to acquire Avizorex Pharma, a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease. Under the accord, Aerie would make an...

November 18, 2019

Developments

Valeritas V-Go achieves reduced A1c and daily insulin usage

Type 2 diabetes (T2D) patients achieved significantly lower average A1c levels and daily insulin usage when switching to Valeritas Holdings‘ (NASDAQ:VLRX) V-Go wearable insulin delivery device. A retrospective...

November 15, 2019

Developments

Trovagene reports positive ovansertib data from Phase 2 prostate cancer trial

Trovagene (NASDAQ:TROV) reported new positive data from its Phase 2 trial of onvansertib in combination with Zytiga in patients with metastatic castration-resistant prostate cancer (mCRPC). The study’s primary efficacy...

November 14, 2019

Developments

FDA approves Axonics sacral neuromodulation system

Axonics Modulation Technologies (NASDAQ:AXNX) received FDA premarket approval for its rechargeable-sacral neuromodulation (r-SNM) system for overactive bladder (OAB) and urinary retention indications. The r-SNM system...

November 14, 2019

Developments

Therapix reports positive topline results from Phase 2a obstructive sleep apnea trial

Therapix Biosciences (NASDAQ:TRPX) reported topline results from its Phase 2a clinical study of THX-110 for the treatment of obstructive sleep apnea (OSA). THX-110 is a combination of dronabinol, or synthetic THC, and...

November 13, 2019

Developments

Kadmon KD025 meets primary endpoint at interim analysis of pivotal GvHD trial

Kadmon Holdings’ (NYSE:KDMN) KD025 met its primary endpoint at an interim analysis of its registrational chronic graft-versus-host disease (cGVHD) trial. cGvHD is a deadly complication of hematopoietic stem cell...

November 12, 2019

Developments

X4 Pharma’s mavorixafor gets FDA breakthrough therapy designation for WHIM syndrome

The FDA granted X4 Pharmaceuticals’ (NASDAQ:XFOR) mavorixafor breakthrough therapy designation for WHIM syndrome. WHIM stands for warts; hypogammaglobulinemia, or low antibody levels; infections; and myelokathexis, or...

November 12, 2019

Developments

BriaCell to present clinical findings at San Antonio Breast Cancer Symposium

BriaCell Therapeutics (TSXV:BCT; OTCQB:BCTXF) will highlight its lead product candidate, Bria-IMT, in two poster sessions during the 2019 San Antonio Breast Cancer Symposium. The Dec. 12 poster will summarize the data...

November 12, 2019

Category - Developments

Caladrius Biosciences reports positive data from coronary microvascular dysfunction study

Axovant gets FDA orphan drug designation for gangliosidosis gene therapy

Aerie Pharma to acquire dry eye specialist Avizorex Pharma of Spain

Valeritas V-Go achieves reduced A1c and daily insulin usage

Trovagene reports positive ovansertib data from Phase 2 prostate cancer trial

FDA approves Axonics sacral neuromodulation system

Therapix reports positive topline results from Phase 2a obstructive sleep apnea trial

Kadmon KD025 meets primary endpoint at interim analysis of pivotal GvHD trial

X4 Pharma’s mavorixafor gets FDA breakthrough therapy designation for WHIM syndrome

BriaCell to present clinical findings at San Antonio Breast Cancer Symposium

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