Current Report Filing (8-k)

Date : 06/24/2019 @ 11:02AM
Source : Edgar (US Regulatory)
Stock : Amag Pharmaceuticals, Inc. (AMAG)
Quote : 8.64  -0.16 (-1.82%) @ 12:49AM

Current Report Filing (8-k)



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K

CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): June 21, 2019

AMAG_RGB.JPG
AMAG Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)
001-10865
 
04-2742593
(Commission File
Number)
 
(IRS Employer Identification
No.)
1100 Winter St.
 
 
Waltham, Massachusetts
 
02451
(Address of principal executive
offices)
 
(Zip Code)
(617) 498-3300
(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, par value $0.01 per share
 
AMAG
 
NASDAQ Global Select Market

1




Item 7.01. Regulation FD Disclosure.

On June 21, 2019, AMAG Pharmaceuticals, Inc. (“AMAG”) issued a press release announcing the approval of Vyleesi TM (bremelanotide injection) granted by the U.S. Food and Drug Administration (the “FDA”). A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

Item 8.01. Other Events.  

On June 21, 2019, AMAG announced that the FDA has approved Vyleesi TM (bremelanotide injection) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.


Item 9.01. Financial Statement and Exhibits.

(d) Exhibits.


2




SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
AMAG PHARMACEUTICALS, INC.
 
By:
/s/ Joseph D. Vittiglio
 
 
Joseph D. Vittiglio
Executive Vice President, General Counsel, Quality & Corporate Secretary
 
Dated:
June 21, 2019




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