Phase II trial alone may not support BLA for Voyager's Parkinson's gene therapy

Voyager Therapeutics Inc. (NASDAQ:VYGR) said late Wednesday that FDA now considers a randomized Phase II trial of VY-AADC to be an "early phase exploratory study," suggesting that the Phase II trial by itself may no longer be sufficient to support a BLA for the Parkinson's disease gene therapy. The company plans to meet with FDA this year to clarify the agency's responses.

Voyager, which announced the news in its 3Q18 earnings after market close, added $0.36 to $13.99 on Wednesday. The company lost $1.69 (12%) to $12.30 in after-hours trading...