Passage Bio Inc. (NASDAQ: PASG) reported updated interim data from its Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for frontotemporal dementia with granulin mutations. The company also announced it has engaged Wedbush PacGrow as a financial advisor and initiated a review of strategic alternatives.

The trial data showed that patients with early-stage disease who received PBFT02 experienced reduced brain atrophy rates compared to natural history data. Specifically, patients with a Clinical Dementia Rating score of 1 at baseline showed a 64% reduction in whole brain atrophy and a 54% reduction in frontotemporal cortex atrophy at 12 months compared to untreated patients from natural history data.

Plasma neurofilament levels among PBFT02-treated patients showed stabilization at 12 months, with an average reduction of 1.0 pg/mL compared to baseline. Natural history data showed an average increase of 13.5 pg/mL over the same period.

The treatment resulted in sustained increases in cerebrospinal fluid progranulin levels. Dose 1 patients saw levels increase from below 3 ng/mL at baseline to a mean of 22.8 ng/mL at 12 months and 24.2 ng/mL at 18 months.

PBFT02 was generally well-tolerated, with no new treatment-related serious adverse events reported as of March 23, 2026. Two patients previously experienced three asymptomatic serious adverse events related to treatment.

Following a Type C meeting with the FDA, the agency indicated that a randomized controlled registrational trial would be required for PBFT02 approval, rather than the single-arm trial design the company had hoped to pursue. The company stated this requirement poses ethical, logistical and financial challenges.

The strategic review process may include merger or acquisition transactions, asset sales, strategic partnerships, licensing opportunities or other alternatives. The company does not intend to provide updates until the board approves a specific action.