rdus-8k_20170316.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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): March 10, 2017

 

RADIUS HEALTH, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-35726

 

80-0145732

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

 

 

950 Winter Street,

Waltham, MA

 

02451

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (617) 551-4000

Not Applicable

(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 (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 


 

Item 8.01

Other Events.

On March 10, 2017, Radius Health, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has extended the Prescription Drug User Fee Act date for the Company’s New Drug Application (“NDA”) for abaloparatide-SC by three months to June 30, 2017 to allow time to review information submitted by the Company in response to information requests from the FDA.  The Company’s submission of the additional information has been determined by the FDA to constitute a Major Amendment to the NDA.  A copy of the press release is filed as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

 

 

99.1

 

Press Release dated March 10, 2017.

 

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.

 

 

 

 

 

RADIUS HEALTH, INC.

 

 

 

 

 

 

 

Date: March 10, 2017

 

 

 

By:

 

/s/ B. Nicholas Harvey

 

 

 

 

Name:

 

B. Nicholas Harvey

 

 

 

 

Title:

 

Chief Financial Officer

 

3


 

EXHIBIT INDEX

 

Exhibit
No.

  

Description

 

 

99.1

 

Press Release dated March 10, 2017.

 

4