It was just announced that Valeant Pharmaceuticals (VRX) received a complete response letter for the NDA that was submitted for IDP-108 (efinaconazole) for the treatment of toenail Onychomycosis (fungus growth).
This really puts a dent in the company’s rally after the acqusition of Bausch & Lomb for $8.7 B (investors seemed to like the price that Valeant paid), as well as its recent acqusition of Obagi Medical Products one month ago.
According to the company, the CRL was issued due to questions that the FDA brought up about Chemistry, Manufacturing and Controls (CMC) related areas part of the NDA. The drug itself seemed to be fine and primed for FDA approval since the FDA brought up no concerns with the safety and efficacy profile of IDP-108, although this CRL will delay the process a bit.
Here is a link to the press release.
Investors, who seem to view this as more a “minor annoyance” than anything worth worrying about, did not drop the share price significantly despite today’s 7.6% rally (at time of writing). Valeant Pharmaceuticals is now up 21% in the last 5 days and 35% in the last 30 days, and is poised to be the biggest winner in the big pharma space today.