Tobira Therapeutics Shares Initiated With Buy, $22 Target At HC Wainwright

Tobira Therapeutics Inc TBRA currently has one drug candidate, which has shown promising results in the treatment of non-alcoholic steatohepatitis [NASH] and HIV patients. HC Wainwright’s Ed Arce initiated coverage of the company with a Buy rating and a price target of $22.

Tobira’s sole drug candidate, cenicriviroc [CVC], is focused on the treatment NASH, which currently has no approved therapies and affects around 10-15 million patients in the US, three times those with hepatitis C.

“CVC has shown not only a favorable safety profile in about 600 subjects (mostly mild nausea, fatigue and headache), but also a favorable lipid profile (reduces LDL-C), as well,” analyst Ed Arce wrote.

CENTAUR Study

The Phase IIb CENTAUR study readout is scheduled for 3Q16. Arce believes this “represents a potentially transformative event for the company and the shares.” He mentioned the reasons for this as:

1. It would be the first data for CVC in NASH patients
2. Clinical endpoints include the current consensual approvable surrogate endpoint for NASH
3. Positive results are likely to result in the initiation of a Phase III trial in NASH in the back half of 2017

“With what we view as a highly de-risked development program, a clear regulatory path to accelerated approval, and Fast Track status, Tobira is well-positioned for clinical and regulatory success, in our view,” Arce commented.