Inovio Pharmaceuticals Inc (NASDAQ:INO) investors are having a rough day after the cancer vaccine maker announced that the FDA has placed a clinical hold on its proposed phase III clinical program for VGX-3100.
Inovio shares reacted to the news, falling nearly 15% to $7.13 in early trading Monday.
A clinical hold is a notification issued by the FDA to a trial sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial. This study has not yet been initiated and has not enrolled or dosed subjects. Additionally, the hold does not pertain to any of Inovio’s other ongoing clinical studies.
Inovio anticipates receiving a formal letter with complete information from the FDA within 30 days. In its initial communication, the FDA has requested additional data to support the shelf-life of the newly designed and manufactured disposable parts of the CELLECTRA® 5PSP immunotherapy delivery device. Inovio is working diligently with the FDA to address its concerns and anticipates that the requested data will be available before the end of this year. Inovio estimates that the start of the phase III clinical program will be delayed until the first half of 2017 pending resolution of the FDA’s requests. (Original Source)
On the ratings front, Inovio Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on October 4, Brean Captial analyst Jason Wittes initiated coverage with a Buy rating on INO and a price target of $18, which represents a potential upside of 159% from where the stock is currently trading. Separately, on August 29, H.C. Wainwright’s Ram Selvaraju reiterated a Buy rating on the stock and has a price target of $17.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Wittes and Ram Selvaraju have a total average return of 4.2% and -1.0% respectively. Wittes has a success rate of 53% and is ranked #646 out of 4190 analysts, while Selvaraju has a success rate of 39% and is ranked #3342.
The street is mostly Bullish on INO stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $18.00, which implies an upside of 159% from current levels.
Inovio Pharmaceuticals, Inc. is a bio-pharmaceutical company, which develops active DNA immunotherapies for cancer and infectious diseases. Its portfolio of immune therapies include SynCon immunotherapies and electroporation delivery systems. The company was founded on June 29, 1983 and is headquartered in Plymouth Meeting, PA.