BTIG analyst Dane Leone is out today with a research note on shares of Ocular Therapeutix Inc (NASDAQ:OCUL), following Ocular’s receipt of a complete response letter (CRL) from the FDA for its NDA resubmission of DEXTENZA in post-surgical ocular pain. On a call with investors yesterday, the management team highlighted the submission of a major amendment to the NDA filing that requested a 3- month review extension. The company stated that the request was submitted on July 10th, essentially 24 hours before the CRL.
Leone opined, “As we have written about since our May downgrade, this has seemed like a possible outcome given the breadth of issues stated within the recent manufacturing inspection. We remain Neutral as the timeline for DEXTENZA to garner FDA approval is likely delayed until 2H2018.”
“The material delay in DEXTENZA coupled with the management turnover could create significant pressure on the organization: We would not expect investors to become comfortable with the current strategy at Ocular until the new CEO is able to present his vision for the company later this year,” the analyst added.
As such, Leone reiterated a Neutral rating on shares of Ocular Therapeutix, without providing a price target. (To watch Leone’s track record click here.)
Out of the 5 analysts polled by TipRanks, in the past 12 months, 3 are bullish on Ocular stock, while 2 remain neutral. With a return potential of 393%, the stock’s consensus target price stands at $29.67.