Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Regulation FD Disclosure

ME Staff 8-k
-
0

Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.

On July26, 2017, Eagle Pharmaceuticals,Inc., or the Company, issued a press release announcing that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company’s 505(b)(2)New Drug Application for RYANODEX® (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.

A copy of the above referenced press release is furnished as Exhibit99.1 to this Current Report on Form8-K. The information furnished to Item 7.01 of this current report shall not be deemed to be “filed” for the purposes of Section18 of the Securities Exchange Act of 1934, as amended. As such, this information shall not be incorporated by reference into any of the Company’s reports or other filings made with the Securities and Exchange Commission. The furnishing of the information in this current report is not intended to, and does not, constitute a determination or admission by the Company that the information in this current report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

ExhibitNo.

Description

99.1

Press Release of the Company dated July26, 2017


EAGLE PHARMACEUTICALS, INC. Exhibit
EX-99.1 2 a17-18459_1ex99d1.htm EX-99.1 Exhibit 99.1     For Immediate Release   Eagle Pharmaceuticals Receives Complete Response Letter from FDA on RYANODEX for Exertional Heat Stroke Application   WOODCLIFF LAKE,…
To view the full exhibit click here

About Eagle Pharmaceuticals,Inc. (NASDAQ:EGRX)

Eagle Pharmaceuticals, Inc. is a specialty pharmaceutical company. The Company focuses on developing and commercializing injectable products in the critical care and oncology areas. The Company’s product portfolio includes EP-1101 (argatroban); Ryanodex (dantrolene sodium); docetaxel injection, non-alcohol formulation (Non-Alcohol Docetaxel Injection); diclofenac-misoprostol; EP-3101 (Bendamustine Hydrochloride Injection, ready-to-dilute (RTD) concentrate solution), and EP-3102 (rapidly infused bendamustine RTD) (EP-3102 Bendeka). It has over four product candidates in advanced stages of development, and/or under review for approval by the United States Food and Drug Administration (FDA), which include EP-6101 Kangio ready-to-use (RTU) bivalirudin; EP-4104 (dantrolene sodium) (EP-4104) for exertional heat stroke (EHS), and EP-5101 (pemetrexed) (EP-5101). Its near-term product candidate, Kangio is a liquid intravenous form of Angiomax for percutaneous transluminal angioplasty.