On Sunday, Inovio Pharmaceuticals Inc (NASDAQ:INO) announced that the FDA has placed a clinical hold on its prospective Phase 3 pivotal trial evaluating VGX-3100 for the treatment of HPV-16/18-related high grade cervical dysplasia. The biotech firm’s management team has expressed that the FDA via initial communication has requested further data with regards to the shelf-life of the newly designed and manufactured disposal element of the Cellectra 5PSP delivery service, which contains the needles and is meant to be sterile with a shelf-life of six months.
Despite the clinical delay, H.C. Wainwright analyst Ram Selvaraju notes there are “no changes in trial design” and therefore reiterates a Buy rating on shares of INO with a $17 price target, which represents a 146% increase from where the stock is currently trading.
Selvaraju explains, “We note that this Phase 3 study has not been initiated nor has it enrolled any patients. In fact, Inovio has not disclosed the details of the trial design thus far, which is slated to be revealed when the trial commences.”
Furthermore, the analyst opines that importantly the delay does not stem from the architecture of the study, underscoring, “The FDA has not indicated that the design of the trial, in terms of efficacy endpoints or enrollment size, needs to be modified, according to company management. Inovio currently estimates that the FDA-requested data should be available in December 2016, and the Phase 3 study should be initiated in 1H 2017, instead of 4Q16 as originally planned.”
Ultimately, “Though this clinical hold is a bump in the road, it does not change our overall view on the efficacy and safety of VGX-3100 in treating high grade cervical dysplasia, nor does it have a meaningful impact on our valuation of the product,” Selvaraju contends.
As usual, we recommend taking analyst notes with a grain of salt. According to TipRanks, one-star analyst Ram Selvaraju is ranked #3,342 out of 4,190 analysts. Selvraju has a 39% success rate and faces a loss of 1.0% in his annual returns. When recommending INO, Selvaraju loses 10.2% in average profits on the stock.
TipRanks analytics exhibit INO as a Strong Buy. Based on 4 analysts polled in the last 3 months, 3 rate a Buy on INO, while 1 maintains a Hold. The 12-month average price target stands at $17.50, marking a 154% upside from where the shares last closed.