Shares of Idenix Pharmaceuticals Inc. (IDIX) plunged more than 50 percent to $3.06 in Tuesday trading, the most intraday since the company went public in July 2004. The Cambridge, Massachusetts – based drugmaker said that U.S. regulators are placing two of its hepatitis C drug programs on hold over safety concerns.
The drugs were placed on hold after Idenix detected liver function abnormalities in three healthy volunteers during an early-stage study of a combination of the compounds — IDX184 and IDX320.
“Based upon the safety and antiviral activity we observed in the IDX184 14-day study and the IDX320 3-day proof-of-concept study, both in HCV-infected patients, we remain committed to the future potential of these drug candidates,” said in a statement Idenix CEO Jean-Pierre Sommadossi. “We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible.”
The company said it has not yet received a formal letter nor has the FDA reviewed the safety and efficacy data from the recently completed clinical trials with IDX184 and IDX320.
No clinical trials involving either IDX184 or IDX320 are ongoing, the company added.
Idenix shed 47%, or $2.80, to $3.19 in recent action. The stock closed at around $6.00 in regular trading earlier Friday.