Zafgen Inc (NASDAQ:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, received verbal notice from the U.S. Food and Drug Administration (FDA) that its beloranib investigational new drug (IND) application has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal Phase 3 ZAF-311 bestPWS clinical trial in patients with Prader-Willi syndrome (PWS). A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the Company’s IND application.
“We are working diligently to assemble and analyze the data from our ZAF-311 clinical trial to be able to provide a clear view of the safety and efficacy of beloranib in the PWS population,” said Dr. Thomas Hughes, Chief Executive Officer of Zafgen. “Together with PWS and thrombosis experts, we are developing a comprehensive approach to better understand the incidence and mechanisms underlying thromboembolic disease in the setting of PWS. We remain committed to advancing beloranib as a potential new therapy for this underserved patient population.”
As previously announced, the Company continues to expect top-line results of the randomized portion of the ZAF-311 clinical trial in the first quarter of 2016. (Original Source)
Shares of Zafgen are down 8.92% to $5.72 in pre-market trading. ZFGN has a 1-year high of $55.36 and a 1-year low of $5.93. The stock’s 50-day moving average is $12.99 and its 200-day moving average is $30.14.
On the ratings front, Zafgen has been the subject of a number of recent research reports. In a report released yesterday, RBC analyst Simos Simeonidis downgraded ZFGN to Hold, with a price target of $7, which represents a potential upside of 11.5% from where the stock is currently trading. Separately, on November 30, Cowen’s Phil Nadeau reiterated a Buy rating on the stock and has a price target of $20.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Simos Simeonidis and Phil Nadeau have a total average return of -14.2% and 16.7% respectively. Simeonidis has a success rate of 28.9% and is ranked #3541 out of 3644 analysts, while Nadeau has a success rate of 62.7% and is ranked #176.
Overall, 2 research analysts have assigned a Hold rating and 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $25.00 which is 298.1% above where the stock closed yesterday.
Zafgen Inc is a biopharmaceutical company dedicated to improving the health and well-being of patients affected by obesity. Beloranib is the Company’s product candidate.