Edge Therapeutics, Inc. (NASDAQ:EDGE) Files An 8-K Other EventsItem 8.01. Other Events.
On December 29, 2017, EdgeTherapeutics, Inc. (“Edge”)issued a press release announcing that an independent Data Monitoring Committee recommended that Edge’s Phase 3 NEWTON 2 study of EG-1962 continue as planned based on the completion of a pre-planned futility analysis. A copy of the press release is filed herewith as Exhibit 99.1.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
Description |
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99.1 |
Press Release, dated December 29, 2017. |
EXHIBIT INDEX
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Exhibit Number |
Description |
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Press Release, dated December 29, 2017. |
Edge Therapeutics, Inc. ExhibitEX-99.1 2 s002009x1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Edge’s EG-1962 Phase 3 NEWTON 2 Study Continues as Planned Following Completion of Futility Analysis BERKELEY HEIGHTS,…To view the full exhibit click here
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.