Carr maintains a Buy rating on Intercept with a $500 price target due to the submission of a New Drug Application for OCA in PBC (Primary Biliary Cholangitis), which he believes will raise the share price upon approval.
The analyst states, “Intercept (ICPT) submitted an NDA and MAA for Obeticholic Acid (OCA) in Primary Biliary Cholangitis in June 2015… The PDUFA date was recently pushed to 5/29/16. We do not believe the delay, which was tied to a request by the agency for additional information, impacts chances of approval. We assume launch in the U.S. in June 2015…. In our opinion, OCA commercial potential in PBC and NASH is not adequately reflected in the share price and we believe the stock may have a positive move around approval in PBC this year. Intercept may be an attractive M&A target given interest in companies at time of commercialization.”
According to TipRanks, 6 analysts are bullish on Intercept, 2 are bearish, and 2 remain on the sidelines. The average 12-month price target between these 10 analysts is $318.75, marking over a 100% potential upside from current levels.
Carr maintains a Buy rating on Cempra with a $48 price target due to the potentially positive effects solithromycin will have on the share price if approved. He believes there is a high likelihood of approval given recent developments.
He states, “[the company] announced positive results from two Phase 3 trials of solithromycin in Community Acquired Bacterial Pneumonia (CABP) in 2015. The company has guided for submission of an NDA in early 2016. The first trial evaluated oral solithromycin against moxifloxacin and met all primary efficacy endpoints. The second trial evaluated IV and oral solithromycin against moxifloxacin and met FDA primary endpoints and one of two EMA non-inferiority endpoints. We expect approval in both territories, with the assumption that European regulators will be flexible.Based on available safety and efficacy data, we expect commercial success, particularly if partnered in the retail setting (>$2B peak sales).”
According to TipRanks, 8 out of the 9 analysts who have recently rated Cempra are bullish on the company while one analyst remains on the sidelines. The average 12-month price target for the stock is $39.67, marking a 34% potential upside from current levels.