Ptc Therapeutics, Inc.
3 products tracked · names used in filings: Ptc Therapeutics, Inc., PTC Therapeutics International Limited
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Vatiquinone: PDUFA target action date (Friedreich's ataxia)
Ptc Therapeutics, Inc. (PTCT); NDA; status: set; "…th a target regulatory action date of July 29, 2025 o Japan regulatory submission under review and a decision is expected in Q4 2025 ● Vatiquinone o NDA for pediatric and adult patients with Friedreich’s ataxia accepted and granted Priority Review by the FDA, with a target regulatory action date of August 19, 2025…"; filed 2025-05-06 · source
Sephience: PDUFA target action date (phenylketonuria (PKU))
Ptc Therapeutics, Inc. (PTCT); sepiapterin; NDA; status: set; "PTC Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results – Strong revenue performance of $190 million – – Positive CHMP opinion for Sephience ™ (sepiapterin) received in April 2025, NDA review remains on track for July 29, 2025 PDUFA date – – Global Sephience launch activities…"; filed 2025-05-06 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Sephience sepiapterin | Authorised | 2025-06-19 |
| 🇪🇺 | Upstaza eladocagene exuparvovec | Authorised | 2022-07-18 |
| 🇪🇺 | Translarna ataluren | Expired | 2014-07-31 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.