Repligen put out the word this morning that the FDA has cancelled an expert panel review of its pancreatic imaging agent, signaling that a complete response letter is in the works which will detail demands for additional data. This latest setback, following a mid-stage failure of a bipolar treatment last year, triggered a meltdown in the Waltham, MA-based biotech's shares ($RGEN), which plunged 40% on the news.
"While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need," said Repligen CEO Walter C. Herlihy. "We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068."
Last fall Repligen made a move to boost revenue, acquiring Novozymes Biopharma Sweden for $22.7 million upfront and more than $5 million in future payments. That deal followed a clinical setback when its bipolar depression drug, RG2417, flunked a mid-stage study, sending its shares into a tailspin.
Repligen's PDUFA date on the imaging agent is June 21. But it's likely returning to the drawing board now to plot its next steps in the clinic.
- read the press release
- here's the Dow Jones report