PTC THERAPEUTICS, INC. 8-K

What Happened
PTC Therapeutics, Inc. announced on February 12, 2026 (via an 8-K and accompanying press release) that it has withdrawn its New Drug Application (NDA) resubmission for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy following feedback from the U.S. Food and Drug Administration (FDA).

Key Details

• Company: PTC Therapeutics, Inc. (PTCT).
• Drug: Translarna™ (ataluren) for nonsense mutation Duchenne muscular dystrophy.
• Event date: February 12, 2026 — withdrawal announced in an 8-K; press release furnished as Exhibit 99.1.
• Reason given: Withdrawal followed FDA feedback on the application review (no additional clinical or commercial details provided in the filing).

Why It Matters
This filing is a regulatory update: by withdrawing the NDA resubmission, PTC has paused the current FDA review process for Translarna. For investors, that means the company will need to address the FDA feedback before any potential refiling or further regulatory progress can occur. Monitor PTC communications for details on next steps, timelines, or additional regulatory or clinical information.