PTC Therapeutics raises 2026 product revenue guidance as Sephience sales reach $182m in third quarter
The company also bought Fabry gene therapy ST-920 for $111m upfront, while the FDA meeting on votoplam in Huntington's disease has slipped to the first quarter of 2027.
PTC Therapeutics reported total revenue of about $358m for the third quarter of 2026, of which $276m was product revenue. The company announced the figures on 29 October 2026 and raised its full-year product revenue guidance to $960m-$990m.
Sephience (sepiapterin) contributed $182m in the quarter, making it a major part of the product revenue total.
PTC also acquired ST-920, a gene therapy for Fabry disease, paying $111m upfront. The company expects to complete its biologics licence application (BLA) submission to the US Food and Drug Administration in the fourth quarter of 2026. It says the product could receive accelerated approval in 2027. Accelerated approval is a US pathway that allows earlier authorisation on the basis of a surrogate or intermediate endpoint, with confirmatory evidence required afterwards.
On other pipeline items, the FDA Type C meeting on votoplam in Huntington's disease has moved to the first quarter of 2027. In Friedreich's ataxia, the PROVE-FA study of vatiquinone has started and is intended to support a resubmission of the new drug application (NDA).
What it means for your team
- Regulatory teams should note the planned Q4 2026 BLA completion for ST-920 and the possible accelerated approval route in 2027.
- The votoplam Type C meeting slipping to Q1 2027 pushes back FDA feedback on the Huntington's disease programme.
- The vatiquinone NDA resubmission now depends on data from the PROVE-FA study, which has begun.
- Market-access teams may see a stronger commercial base for Sephience, given the raised guidance, though the source gives no pricing or reimbursement detail.
Company's press release (SEC filing): Ptc Therapeutics, Inc. ↗
Article written by VigiEye from the official source (Ptc Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.