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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 20, 2024
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.)
500 Warren Corporate Center Drive
Warren 07059
,
NJ
(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 ((s)230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 ((s)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.
On May 20, 2024, PTC Therapeutics, Inc. issued a press release announcing that
the European Commission has decided not to adopt the negative opinion issued
by the Committee for Medicinal Products for Human Use (the "CHMP") of the
European Medicines Agency for the renewal of the conditional marketing
authorization for Translarna
TM
(ataluren) and has returned the opinion to the CHMP for re-evaluation
. The press release is furnished as Exhibit 99.1 to this Report
The information in this Item 7.01 of this Report, including Exhibit 99.1 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 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Press Release, dated May 20, 2024 issued by PTC Therapeutics, Inc.
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 20, 2024 By: /s/ Pierre Gravier
Name: Pierre Gravier
Title: Chief Financial Officer
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