Passage Bio (PASG) shared feedback from a recent Type C meeting with the FDA on the likely registrational pathway for PBFT02 in FTD-GRN. The FDA has indicated that a randomized controlled registrational study design is required for PBFT02 in this indication. The company noted that a randomized controlled registrational trial poses substantial ethical concerns for patients and their families as well as logistical and financial challenges. As such, it is evaluating potential next steps in the clinical development of PBFT02 in FTD-GRN and FTD-C9orf72 in the upliFT-D trial.
Passage Bio said it has initiated a review of strategic alternatives to maximize shareholder value. These strategic alternatives may include merger or acquisition transactions, a reverse merger, a sale of assets of the company, strategic partnerships, licensing opportunities, or other potential paths. The company has engaged Wedbush PacGrow as a financial advisor to assist in the strategic review process.
Passage Bio also reported updated data from the ongoing Phase 1/2 upliFT-D clinical trial evaluating PBFT02 for the treatment of frontotemporal dementia with granulin mutations. Patients earlier in their disease progression who received PBFT02 exhibited reduced rates of whole brain atrophy and frontotemporal cortex atrophy compared to natural history data from patients at the same stage of disease progression. In contrast, patients with more advanced disease progression showed no improvements on either atrophy measure versus natural history data from a comparable global CDR 2 population.
In pre-market trading on NasdaqCM, Passage Bio shares are down 23.65 percent to $8.91.
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May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.