Biotech Values

[DewDiligence]

FIXX—FDA lifts clinical hold but investors apparently don’t like the modified trial protocol:

https://www.globenewswire.com/news-release/2022/06/13/2461189/0/en/Homology-Medicines-Announces-FDA-Lifted-Clinical-Hold-on-pheNIX-Gene-Therapy-Trial-for-PKU.html

As previously disclosed, the clinical hold on the pheNIX trial pertained to elevated liver function tests observed in the trial, which were all resolved with no hospitalizations required. Homology’s response to the FDA included changes to the protocol intended to enhance risk-mitigation measures and a new immunosuppression regimen with the T-cell inhibitor tacrolimus, which will be used in combination with a reduced duration of prophylactic steroids.