Tobira Therapeutics (TBRA) Fetches $31 Price Target at H.C. Wainwright
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H.C. Wainwright maintained a Buy rating on Tobira Therapeutics (NASDAQ: TBRA) and raised its price target to $31.00 (from $22.00). Analyst Ed Arce thinks CENTAUR is a breakthrough in NASH.
Arce explained, "Since Tobira reported top-line results of CENTAUR on July 25, TBRA shares have dropped 65% (vs NBI +5%). Over this period, trading in the shares has focused on the failure of the study to meet the primary endpoint of a 2-point improvement in NAS without worsening in fibrosis, the same endpoint met by obeticholic acid (OCA) in the FLINT trial. However, we believe the market's focus has been wholly misplaced, amounting to a knee-jerk reaction that CVC does not work. As strange and unorthodox as it may seem to some investors, we believe that, in this particular case, the primary endpoint does not matter because the FDA has made it clear that it is not an approvable surrogate endpoint for NASH drugs."
The analyst added, "What does matter, we believe, are the two secondary endpoints in CENTAUR, because they are the only two currently viewed by the Agency as approvable in pre-cirrhotic NASH patients (see Exhibit 1). To wit, these two are also the co-primary endpoints of the pivotal REGENERATE trial of OCA (Exhibit 2). However, in CENTAUR, CVC became the first NASH drug candidate to meet a pre-specified approvable endpoint: improvement in fibrosis stage without worsening of NASH. Critically, not only is this an approvable endpoint, but the reduction in fibrosis stage (say, to F2 from F3), has been shown in multiple studies to be the only independent predictor of a decrease in long-term outcomes in NASH patients, such as death, hepatocellular carcinoma (HCC), and liver transplant (Angulo, Gastroenterology, 2015; Ekstedt, Hepatology, 2015; Younossi, Hepatology, 2011)."
Shares of Tobira Therapeutics closed at $3.95 yesterday.
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