Gamida Cell Gets Short PDUFA Setback from FDA

The US Food and Drug Administration (FDA) gave Gamida Cell a short setback on its therapeutic omidubicel. The agency issued an information request in the review of the stem cell transplant therapy and set back the PDUFA for the treatment by three months. Although the delay is short, it has had an impact already.

According to Tyler Patchen, “The move is not what investors want to hear at present as the company stock price $GMDA is down almost 30% since opening this morning and has been down over 40% since the beginning of the year. However, the leadership at Gamida Cell is still hoping for approval.”

To read more, click here.

(Source: Endpoints News, November 23^rd, 2022)