Repligen Corporation (NASDAQ: RGEN) may be the biotech implosion of the day if the volume starts to catch up to some pre-market trading levels. The company received a complete response letter from the FDA for its new drug application for RG1068, and as with most complete response letters this is going to require more data. The FDA is seeking additional clinical efficacy and safety trial data.
RG1068 is a synthetic human secretin and it was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in MRI in patients with known or suspected pancreatitis. The FDA has completed its review of the RG1068 new drug application. The company noted that there were not any specific safety concerns brought up but safety will continue to be monitored with any future clinical trial.
Repligen also noted that no deficiencies were cited in the response letter regarding the manufacturing, pharmacology or toxicology sections of the application. It is also going to engage in dialogue with the FDA to determine the design and scope of a clinical program that will address the agency’s requirements for approval of RG1068. Management also maintains the stance that RG1068 can provide a safe and effective non-invasive image of the pancreas with MRI and that this is an unmet medical need for patients with pancreatitis.
Volume is low here, but the trading so far looks to be down very low. We have volume of only about 7,000 shares but the price is down 20% to $3.49 after a $4.38 close. The stock trades only about 225,000 shares per day and its market cap was only $135 million before the impact of this news. Repligen had almost $38 million in liquidity (cash, short-term, and long-term investments) on its books as of its March 30 balance sheet.
JON C. OGG