Edge Therapeutics, Inc. (NASDAQ: EDGE) was founded on January 22, 2009. It is a Delaware company headquartered in Berkeley Heights, New Jersey. It has 18 full-time employees (8/14/2015). A clinical-stage biotechnology company engaged in the discovery, development and commercialization of innovative treatments for hospital-based life-threatening acute diseases.
Edge Therapeutics (EDGE):
Edge Therapy’s initial product candidates are aimed at rare diseases and severely life-threatening neurological diseases, because the company believes that the currently approved drugs are far from meeting the treatment needs.
Edge Therapeutics’ lead product candidate, EG-1962, can fundamentally improve the treatment effect of patients with aneurysmal subarachnoid hemorrhage (abbreviation: ASAH, rupture of blood vessels around the brain tissue due to cerebral aneurysm). A single dose of EG-1962 can provide high concentrations of nimodipine directly to the brain for 21 days in accordance with current treatment standards.
EG-1962 utilizes Edge Therapeutics’ patent-protected, programmable, biodegradable polymer-based development platform, which the company calls: Precisa® development platform, adopts a novel transmission mechanism, targeting and sustained The administration of nimodipine potentially avoids the side effects related to the dose of nimodipine and damage to normal cells.
In April 2015, Edge Therapeutics completed the North American Phase I/II clinical trial of EG-1962. The trial reached the primary and secondary safety, tolerability endpoints, determination of the maximum tolerated dose (MTD) and pharmacokinetics. At the same time, the results of this trial show that 60% of patients have achieved a positive response, which is a very big improvement compared to 28% of traditional treatment methods. At the same time, 45% of patients can achieve GOSE = 8, which is a qualitative leap compared to the traditional 6%.
On May 28, 2015, the US Food and Drug Administration (FDA) granted Edge Therapeutics EG-1962 orphan drug for the treatment of aneurysmal subarachnoid hemorrhage (ASAH) license.
The company is currently preparing for phase III clinical trials and plans to produce results in mid-2016. If it goes well, the company will submit an NDA new drug application as soon as possible.
Edge Therapeutics (EDGE) investment:
EDGE submitted its IPO prospectus on the same day as Penumbra on 8/14/2015 . It plans to land on Nasdaq and raise US$115 million. The stock code is EDGE.
Company official website: http://www.edgetherapeutics.com/
American Stock Encyclopedia: https://www.thisyear.com/edge.html