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EX-99.1 - EX-99.1 - PTC THERAPEUTICS, INC.a16-5090_1ex99d1.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):  February 23, 2016

 

PTC THERAPEUTICS, INC.

(Exact Name of Company as Specified in Charter)

 

Delaware

 

001-35969

 

04-3416587

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

100 Corporate Court

 

 

South Plainfield, NJ

 

07080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Company’s telephone number, including area code:  (908) 222-7000

 

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 Instruction A.2. below):

 

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))

 

 

 



 

Item 8.01 Other Events.

 

On February 23, 2016, PTC Therapeutics, Inc. issued a press release announcing that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Translarna (ataluren).

 

The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d)                                 Exhibits:

 

99.1 Press Release dated February 23, 2016

 

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.

 

 

 

PTC THERAPEUTICS, INC.

 

 

 

Date: February 23, 2016

By:

/s/ Shane Kovacs

 

 

Shane Kovacs

 

 

Chief Financial Officer

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release dated February 23, 2016

 

2