A while back I posted that HSGX (histogenics) had trouble with their phase 3 study for NeoCart. Neocart was the closest to market competitor for Vericel’s MACI product. The FDA has told HSGX that they would need to do another clinical trial before they would approve Neocart. Due to the cost and time it would take to do another phase 3 study HSGX is dropping NeoCart.
Based on the feedback received from the FDA, while the NeoCart Phase 3 clinical trial resulted in certain compelling data, the FDA indicated that an additional clinical trial would need to be completed before it would accept a submission of a Biologics License Application (BLA) for NeoCart. The FDA indicated receptivity to novel clinical trial methodologies and regenerative medicine advanced therapy designations in order to support additional data for a future potential submission. However, considering the time and funding required to conduct such a trial, Histogenics expects to suspend the development of NeoCart and does not plan to submit a BLA at this time.