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)
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Delaware |
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001-35726 |
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80-0145732 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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950 Winter Street, Waltham, MA |
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02451 |
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(Address of principal executive offices) |
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(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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.
(d) Exhibits
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Exhibit |
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Description |
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99.1 |
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Press Release dated March 10, 2017. |
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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.
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RADIUS HEALTH, INC. |
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Date: March 10, 2017 |
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By: |
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/s/ B. Nicholas Harvey |
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Name: |
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B. Nicholas Harvey |
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Title: |
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Chief Financial Officer |
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