Shares of Achillion Pharmaceuticals (ACHN) are up another 60% on Tuesday, adding to gains that coincided with Monday’s acquisition of fellow early HCV competitor, Idenix Pharmaceutical (IDIX). The stock is up 125% for the week.
On Tuesday, Achillion announced before the bell that the FDA has partially lifted a clinical hold on Sovaprevir, the company’s next-generation NS3/4A protease inhibitor, and initial dosing has begun with ACH-3422, its nucleotide NS5B polymerase Inhibitor. Achillion can begin dosing with sovaprevir 200mg once daily in HCV patients, though the company will need the FDA’s nod before beginning multiple-dose studies in healthy volunteers. Prior to the hold, which was put in place in July 2013, Sovaprevir had been tested at 200, 400 and 800mgs.
Achillion will report proof-of-concept results from the phase 1 ACH-3422 study in the fall, and plans on initiating all-oral combination studies with ACH-3422 by the end of 2014. Achillion ended the first quarter with $140 million in cash/equivalents and an operational burn rate of around $13M quarterly.
In comparison to Idenix, both companies have NS5A inhibitors in phase two clinical trials. They also have nucleotide polymerase prodrugs for HCV, but Idenix’s is preclinical, whereas Achillion has already commenced phase one trials.
Prior to the FDA hold, ACHN was trading at $6.00 to $9.00. Trading back to this range makes sense pending the company’s next value-driving event, later this year with the release of PoC for -3422.
