Oryzon Genomics, S.A. received feedback from the FDA regarding the Phase III protocol for evaluating vafidemstat in borderline personality disorder (BPD). The FDA’s guidance includes study endpoints and non-clinical considerations. Oryzon will incorporate this feedback and resubmit the revised protocol. Oryzon’s ongoing clinical programs in CNS continue as planned. Vafidemstat is also being evaluated in a Phase IIb trial for improving negative symptoms in schizophrenia. The company is actively revising the protocol and looks forward to continued engagement with the FDA as they finalize the next steps. Further updates will be provided once the revised protocol is submitted and discussions with the FDA are underway.

Read more at GlobeNewswire: ORYZON Receives Feedback From the FDA in Response to the