Last April, Repligen did everything it could short of taking an ad out in The Wall Street Journal to signal that the FDA was preparing to reject its pancreatic imaging agent. Once the agency canceled an expert panel review, noted the Waltham, MA-based biotech, it was clear that regulators were preparing a CRL detailing demands for new data. And its stock ($RGEN) went into a meltdown, losing 40% of its value.
But this morning, as Repligen delivered the expected news, there was still some air left to come out of the flat stock price. The stock price slid 10%, hovering around $4 a share.
RG1068 completed a Phase III trial for improving detection of pancreatic duct abnormalities--in combination with MRI--in patients with known or suspected pancreatitis. "The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA," according to the company's statement.
"We will continue to engage in dialog with the FDA to determine the design and scope of a clinical program that will address the agency's requirements for approval of RG1068," said Repligen CEO Walter C. Herlihy. "We believe that RG1068, if approved, will provide a safe and effective means to non-invasively image the pancreas with MRI and will meet an important unmet medical need for patients with pancreatitis."
There's nothing new about volatile stock prices at Repligen. Shares also went into a tailspin after its therapy for bipolar depression--RG2417--flunked a mid-stage study.
- here's the press release