FDA pushes back Gamida Cell’s PDUFA date by three months
Boston-based biotech Gamida Cell will have to wait on the FDA for a little while longer.
The biotech said that in the BLA review for its allogeneic hematopoietic stem cell transplant, called omidubicel, the FDA issued an “information request” and views the data in the response as a major amendment.
As a result, it has moved the PDUFA date for omidubicel from January 30, 2023, to May 1. The FDA has also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of next year as well.
Gamida Cell noted that the FDA requested laboratory results for “intermediate time points” for the patients that were enrolled in its Phase III study. However, the company said that the additional data provided to the FDA were “consistent with prior data submissions.”
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.
“If approved, omidubicel will be the first and only advanced cell therapy for patients with blood cancer in need of an allogeneic stem cell transplant. We are committed to bringing this potentially transformative therapy forward as quickly as possible,” said Abigail Jenkins, Gamida Cell president and CEO, in a statement.
The priority review was originally accepted in August for the therapy eight weeks after completing the rolling BLA, with a Phase III study showing that the cell therapy had a statistically significant reduction in time to neutrophil engraftment compared to the standard umbilical cord blood.
At the beginning of the year, Gamida Cell axed around 10% of its staff to extend its cash runway as it planned to file omidubicel to the FDA.
In September, Gamida looked to get even more cash as it offered up over 12 million shares in exchange for an estimated $20 million. The company plans to use the cash to help with the potential launch of its omidubicel therapy if it gets approved.