Oppenheimer reiterates Outperform rating, price target $309
- The Gastrointestinal Drugs Advisory Committee of the FDA met yesterday to discuss the safety/efficacy of Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis. The panel voted 17-0 in favor of recommending approval of Ocaliva in PBC, as firm had anticipated based on the strong effects of the drug on ALP, and the positive opinion by FDA on the appropriateness of ALP as a surrogate marker, which was conveyed in the briefing documents released on Tuesday. Firm expects FDA to approve Ocaliva on May 29th and anticipate good uptake of the drug based on the positive opinion of KOLs about the efficacy and safety/tolerability of Ocaliva, in particular using 5->10mg titration dosing.