@bio_clouseau This is what $KRYS sent me in response to my question about the study shutdown:
“We are continuously reviewing resource allocation across our pipeline to maximize investment in programs with the greatest potential impact and clearest path to approval. The regulatory landscape is a key consideration in this process. Accordingly, the decision to close enrollment in KB707-01 was driven in part by heightened uncertainty regarding potential accelerated approval pathways for intratumoral therapies targeting cutaneous cancers.”
This is what $KRYS sent to participating investigators:
“We would like to inform you of an important update regarding the KB707-01 clinical study:
A recent decision by the regulatory agency has signaled a shift in their approach to drug approvals. Following extensive internal discussions and careful consideration of this evolving landscape, Krystal Biotech, Inc. has made the difficult decision to close future enrollment to the KB707-01 study.”
