Zafgen, Inc.’s ZFGN shares plunged 60.6% on news regarding a second patient death in a study being conducted on its lead pipeline candidate, beloranib. The company said that a patient receiving beloranib as part of the open label extension (OLE) part of the pivotal phase III ZAF-311 bestPWS study was diagnosed with bilateral pulmonary emboli and has died. The study is evaluating beloranib in patients with Prader-Willi syndrome (PWS), the most common known genetic cause of life-threatening obesity.
Zafgen also announced that the FDA has informed the company verbally that its beloranib investigational new drug (IND) application is now under complete clinical hold. A complete clinical hold is an order under which all clinical work requested under the company’s IND application must be suspended.
Zafgen’s troubles started in October when the company announced a patient death in the phase III double-blind, randomized, placebo-controlled bestPWS study. The patient was on beloranib. Shortly after that, the company said that it had received a verbal notice from the FDA placing beloranib on partial clinical hold. The partial clinical hold impacted ongoing or planned clinical studies including ZAF-311 and ZAF-312.
Later in October, Zafgen said that it would go ahead with efficacy and safety data analysis but would close the randomized portion of the ZAF-311 study and its ZAF-203 phase study evaluating beloranib in patients with severe obesity complicated by type II diabetes.
The second patient death and the full clinical hold are major setbacks for Zafgen. The company’s shares touched a 52-week low on the news regarding the second patient death.
Meanwhile, some well-ranked stocks in the healthcare sector include Corcept Therapeutics Incorporated CORT, Baxalta Incorporated BXLT and Achillion Pharmaceuticals, Inc. ACHN – all three are Zacks Rank #1 (Strong Buy) stocks.
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