Needham’s Serge Belanger has reiterated his Buy rating on Aerie Pharma (NASDAQ: AERI) despite a stalled manufacturing pre-inspection that has caused the firm to delay filing a New Drug Application (NDA) for its pipeline drug, eye drop Rhopressa.
The Bauch + Lomb-operated facility in Tampa, Florida is a third-party contract drug manufacturer for Rhopressa, which has already encountered an issue with inspection preparation back in October. At the time, the facility had given both AERI and the FDA an expectation that the site would be prepared in January 2017 for inspection. Following this new update, it is now unlikely that the facility will be ready for FDA pre-approval inspection until February 2017.
As a result, AERI has subsequently withdrawn its NDA for the drug. However, Belanger remains bullish, as he does not see the delay as a serious setback for Rhopressa’s long-term prospects. Additionally, the manufacturer notes the delay stems from a desire for supplemental time to validate new equipment. Looking ahead, the firm is expected to resubmit the NDA by the close of the first quarter of 2017.
Belanger lists a price target for Aerie of $52, which marks an upside of 34.54% from the current share price. The analyst has a 41% success rate and a 4.8% average return per recommendation according to TipRanks’ financial accountability engine.
TipRanks analytics demonstrate AERI stock as a Strong Buy, with all 7 analysts polled by TipRanks in the last 3 months recommending to Buy Aerie stock.