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PTC THERAPEUTICS, INC. (PTCT) filed an 8-K current report with the SEC on April 28, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item EX-99.1 (Exhibit EX-99.1). Positive 24-month interim PIVOT-HD results for votoplam, supporting continued development in Huntington’s disease.
PTC THERAPEUTICS, INC. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Positive 24-month interim PIVOT-HD results for votoplam, supporting continued development in Huntington’s disease
- Results presented April 28, 2026 at 4:30 p.m. Eastern time via investor webcast
- Full press release and slide presentation furnished as Exhibits 99.1 and 99.2
Item EX-99.1 · Exhibit EX-99.1
- Month 24 PIVOT-HD data showed dose-dependent cUHDRS progression slowing versus natural history: 52% at 10 mg and 28% at 5 mg
- Favorable safety maintained through 24 months, with no treatment-related NfL increases and mean levels below baseline
- Novartis initiated global Phase 3 INVEST-HD, enrolling approximately 770 early-stage HD patients randomized 3:2 to 10 mg votoplam or placebo
- INVEST-HD’s primary endpoint is cUHDRS change through Month 36, creating the pivotal regulatory test for votoplam
- Positive efficacy signal strengthens PTC’s partnered economics, including potential development, regulatory and sales milestones, profit sharing and royalties
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