Ocular Therapeutix Inc (NASDAQ:OCUL) shares may have been falling almost 9% at the close on the heels of a class action lawsuit filed by investors, but in pre-market trading, the biotech firm’s shares are more than rallying at 20%, making OCUL the true comeback kid of the biotech-verse today. The surge emerges thanks to an FDA amendment that is Ocular’s counter for Form 438 questions the agency underscored as concerns overhanging Dextenza, the firm’s drug designed to treat ocular pain after ophthalmic surgery. Ocular is seeking this as a significant amendment to its NDA resubmission- one that might push the PDUFA extension three months to October of this year.
In reaction to the news, Cantor analyst Elemer Piros acknowledges that while it might take the agency more time to approve Dextenza, he maintains his bullish stance on the biotech firm, reiterating an Overweight rating on shares of OCUL with a $35 price target, which represents a 348% increase from where the stock is currently trading. (To watch Piros’ track record click here.) As far as the analyst sizes up the Dextenza bigger picture, “Adequate resolution of the outstanding issues is a prerequisite for DEXTENZA approval, which may require an extended review beyond the July 19, 2017, PDUFA.”
“In focus, Ocular has made a recent swap from an aluminum blade arm, used to cut strands into insert sizes, to a stainless steel arm. Previously, a manufacturing issue that was raised cited the observation of aluminum particulate matter, potentially associated with wear and tear of the aluminum blade arm. In order to fully address this issue, Ocular is requesting an extended review period of three months, in order to provide data from a full commercial batch with the changed equipment. We anticipate that these data could be available and complete within a month. If the extended review is granted, we believe an October action date could supply an adequate period of time for the FDA to thoroughly review Ocular’s comprehensive response to the Form 483,” explains Piros.
Therefore, even with prospective lag time standing in the way of Dextenza’s approval, the analyst surmises the drug’s overall profile keeps him staunchly confident on the stock’s prospects, voicing approval for Ocular’s strategy to tackle Form 483 manufacturing item concerns with full resolution first.
TipRanks analytics indicate OCUL as a Buy. Out of 3 analysts polled by TipRanks in the last 3 months, 1 is bullish on Ocular stock while 2 remain sidelined. With a return potential of nearly 293%, the stock’s consensus target price stands at $25.50.