Aerie Pharmaceuticals Inc (NASDAQ:AERI) reported that it has been notified by its third party manufacturing vendor that the manufacturing line related to Rhopressa in their Tampa, Florida facility will not be ready for pre-approval inspection by the FDA until the end of February 2017.
In October 2016, the Rhopressa NDA (New Drug Application) was withdrawn due to the contract drug product manufacturer not being prepared for pre-approval inspection by the FDA. The contract drug product manufacturer had previously advised Aerie and the FDA that it expected to be prepared for FDA inspection in January 2017. The delay apparently does not result from any new findings, but rather additional time needed to complete validation of new equipment.
Aerie now expects to resubmit the Rhopressa NDA filing near the end of the first quarter of 2017 after receiving notification from the contract drug product manufacturer that the manufacturing line related to Rhopressa at the Tampa, Florida site is inspection ready. (Original Source)
Shares of Aerie Pharmaceuticals Inc closed yesterday at $37.2, down $-0.45 or -1.20%. AERI has a 1-year high of $43.40 and a 1-year low of $10.82. The stock’s 50-day moving average is $38.48 and its 200-day moving average is $28.01.
On the ratings front, Aerie Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on December 20, Canaccord Genuity analyst John Newman assigned a Buy rating on AERI, with a price target of $50, which implies an upside of 34% from current levels. Separately, on November 3, H.C. Wainwright’s Corey Davis reiterated a Buy rating on the stock and has a price target of $66.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, John Newman and Corey Davis have a yearly average loss of -16.4% and -4.3% respectively. Newman has a success rate of 28% and is ranked #4208 out of 4286 analysts, while Davis has a success rate of 36% and is ranked #3920.
Sentiment on the street is mostly bullish on AERI stock. Out of 6 analysts who cover the stock, 6 suggest a Buy rating . The 12-month average price target assigned to the stock is $55.00, which represents a potential upside of 48% from where the stock is currently trading.
Aerie Pharmaceuticals, Inc. is a clinical stage pharmaceutical company, which is focused on the discovery, development and commercialization of therapies for the treatment of patients with glaucoma and other diseases of the eye. It product candidates are Rhopressa and Roclatan.