Passage Bio slides after FDA calls for controlled trial of dementia gene therapy
20/04/2026 16:52
Updates ** Shares of biotech firm Passage Bio PASG.O fall about 36% to $7.36 ** Co says U.S. FDA did not support a single‑arm pivotal trial for its experimental dementia gene therapy, PBFT02, and has indicated that a randomized controlled trial would be required for approval ** Says such a study poses ethical, logistical and financial challenges due to the rarity of the condition ** PBFT02 targets a rare inherited form of frontotemporal dementia, a brain disease that affects behaviour and language and causes brain shrinkage over time ** PASG says early‑stage data showed treated patients had less brain shrinkage and stable levels of a key protein marker versus untreated patients ** Adds it has initiated a review of strategic alternatives, including a merger, acquisition, reverse merger, asset sale, licensing or partnership ** Says it has hired Wedbush PacGrow as financial adviser and does not plan further updates until its board approves a specific action ** Including session’s moves, stock down ~32% YTD (Reporting by Sahil Pandey in Bengaluru) ((Sahil.Pandey@thomsonreuters.com))