After some tough feedback from the FDA on the path forward for its lead gene therapy, Passage Bio has launched a strategic review and set out a plan to whittle down its headcount by 75%.
Philadelphia-based Passage expects the layoffs to be complete by the second or third quarter of this year and cost around $3.3 million, according to a filing with the Securities and Exchange Commission.
Passage reported 24 full-time employees as of December 31, 2025, in its recent annual report. A 75% reduction from that number would leave just six employees remaining at the company.
Passage did not respond to requests for comment from Fierce Biotech. The company previously laid off 55% of its workforce in January 2025, as part of an effort to extend its cash runway into 2027.
The biotech deemed this workforce reduction part of a plan unveiled on April 20 to search for strategic alternatives for the company, including a possible merger, sale or partnership. The review was sparked by the FDA’s refusal to allow Passage to run a single-arm trial of its gene therapy candidate for frontotemporal dementia, PBFT02.
“Despite the rare, underserved nature of this devastating disease and the availability of robust natural history data, FDA did not support a single-arm trial design for this indication and instead indicated that a randomized controlled trial would be required for registrational purposes,” Passage president and CEO Will Chou, M.D., said in the release. “In light of this outcome and the associated ethical, logistical, and financial challenges, we are currently evaluating potential next steps for the PBFT02 clinical development program and for the company.”
Opposition to single-arm trials has been a hallmark of the FDA’s Center for Biologics Evaluation and Research (CBER) under Vinay Prasad, M.D. Notably, the agency was recently in a high-profile dustup with Dutch biotech uniQure after calling on the company to conduct a sham-controlled trial for its Huntington’s disease gene therapy candidate.
Similar to uniQure, Passage cited “ethical concerns” with a randomized controlled trial for PBFT02, which is directly injected into the brain through a surgical procedure.
Prasad has since left CBER, with his deputy Katherine Szarama, Ph.D., taking over as director in an acting capacity on May 1.
Passage is not the first biotech to blame the FDA’s rigidity for layoffs. After facing a second rejection from the agency for its melanoma candidate last month, Replimune laid off 60% of its workforce in a move the company directly attributed to the FDA’s actions.