Edge Therapeutics, Inc. (NASDAQ:EDGE) Files An 8-K Other Events
ITEM 8.01.
|
Other Events.
|
announcing that it received a product-specific pediatric waiver
from the European Medicines Agency for its lead product
candidate, EG-1962, which is currently in Phase 3 clinical
development for the treatment of aneurysmal subarachnoid
hemorrhage. A copy of the press release is filed herewith as
Exhibit 99.1.
|
ITEM 9.01.
|
Financial Statements and Exhibits.
|
|
Exhibit
|
Description
|
|
|
99.1
|
Press release dated June 8, 2017.
|
About Edge Therapeutics, Inc. (NASDAQ:EDGE)
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize, hospital-based therapies capable of transforming treatment paradigms in the management of life-threatening neurological and other conditions. Edge is evaluating EG-1962, its lead product candidate, in the Phase 3 NEWTON 2 study in adult patients with aneurysmal subarachnoid hemorrhage (aSAH). This study will evaluate EG-1962’s ability to improve patient outcomes versus standard of care oral nimodipine after an aSAH resulting from a ruptured brain aneurysm. Edge’s product candidates utilize Precisa, a platform with a approach that seeks to enable targeted and sustained drug exposure at the site of injury, while potentially avoiding off-target side effects associated with systemic delivery. Edge is also using its Precisa development platform to develop additional product candidates targeting other acute, serious conditions where limited or no current therapies exist.
