0001070081 false 0001070081 2023-05-17 2023-05-17

​

​

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): May 17, 2023

​

PTC THERAPEUTICS, INC.

​

(Exact Name of Company as Specified in Charter)

​

​ | ​ | ​ | ​ | ​
Delaware |  | 001-35969 |  | 04-3416587
(State or Other Jurisdiction | ​ | (Commission | ​ | (IRS Employer
of Incorporation) | ​ | File Number) | ​ | Identification No.)

​

​

​ | ​ | ​
100 Corporate Court |  | ​
South Plainfield, NJ | ​ | 07080
(Address of Principal Executive Offices) | ​ | (Zip Code)

​

Registrant’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):

​

☐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))

​

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, $0.001 par value per share | ​ | PTCT | ​ | Nasdaq Global Select Market

​

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. ☐

​

​

​

​

​

​

Item 7.01. Regulation FD Disclosure.

​

PTC Therapeutics, Inc. (the “Company”) will host a conference call on May 17, 2023 at 8:00 a.m. eastern time. During this conference call, the Company expects to discuss the results from its Phase 3 registration-directed clinical trial of sepiapterin for phenylketonuria. Directions on how to access the conference call are included in the press release furnished as Exhibit 99.1 hereto. A copy of the slide deck that will be presented during the conference call is furnished as Exhibit 99.2 hereto.

​

The information in this Item 7.01 of this Current Report on Form 8-K (“Report”), including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. All website addresses given in this Report or incorporated herein by reference are for information only and are not intended to be an active link or to incorporate any website information into this Report.

​

Item 8.01. Other Events.

​

On May 17, 2023, the Company announced that the primary endpoint was achieved in its Phase 3 registration-directed clinical trial of sepiapterin in adult and pediatric patients with phenylketonuria.

​

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

​ | ​ | ​
Exhibit No. |  | Description
99.1 | ​ | Press Release, dated May 17, 2023 issued by PTC Therapeutics, Inc.
99.2 | ​ | Corporate Presentation – APHENITY Topline Results
104 | ​ | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

​

​

​

Signature

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: May 17, 2023 | By: | /s/ Emily Hill
​ | Name: | Emily Hill
​ | Title: | Chief Financial Officer

​

​

​

​