8-K - PTC Therapeutics, Inc. | StockGist

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PTC Therapeutics, Inc. withdrew its New Drug Application resubmission for Translarna (ataluren) for nonsense mutation Duchenne muscular dystrophy following U.S. Food and Drug Administration feedback that the data are unlikely to meet the threshold of substantial evidence of effectiveness. The press release is furnished as Exhibit 99.1 and not deemed filed under Section 18 of the Exchange Act.

Key Takeaways

1PTC Therapeutics withdrew NDA resubmission for Translarna (ataluren) on February 12, 2026

2Withdrawal followed FDA feedback on application review

3FDA indicated NDA data unlikely to meet substantial evidence threshold for approval

4Translarna targets nonsense mutation Duchenne muscular dystrophy

5Press release issued from Warren, N.J., furnished as Exhibit 99.1

6Matthew B. Klein, M.D., Chief Executive Officer, commented on the decision

Current Report Details

Event Type

Regulation Fd

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

. 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

Regulation Fd

9.01

. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated February 12, 2026 issued by PTC Therapeutics,

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1