These days, while success and victory still have 1,000 fathers, failure and defeat have its outspoken champions as well.
With its clinical development program for a new obesity drug in limbo following the unexplained deaths of two patients, Zafgen reported today that the troubled Phase III study hit its co-primary efficacy endpoints in treating a rare eating disorder.
Just hours after Zafgen reported that a second patient had died in its pivotal study for the obesity drug beloranib, the biotech announced that the FDA had put a "complete hold" on the study. Under the order the biotech is required to halt all clinical work on the drug as regulators and investigators explore potential safety issues.
Six weeks after Zafgen finally broke an uncomfortable silence and acknowledged that a patient taking its experimental obesity drug beloranib had died, the company is reporting that a second patient has died--this time from bilateral pulmonary emboli.
Forced to at least temporarily delay the clinical development of its obesity drug beloranib as it explores the reasons why a patient in a late-stage study died, Zafgen has decided to simply wrap up the randomized portion of two studies early and analyze the data it has now.
Two days after belatedly acknowledging the death of a patient in its Phase III study of the obesity drug beloranib, Zafgen put out word this morning that the FDA had imposed a partial clinical hold on the trials underway in the program. The hold will require added time to complete special patient screening, and the news blasted its already battered share price, which swiftly plunged 26%.
More than two days after Zafgen's stock started to get crushed under the heavy weight of speculation surrounding its sudden decision to cancel a roadshow presentation to investors, the biotech has finally revealed that a patient died in its late-stage study of its lead obesity drug for Prader-Willi syndrome.
With investors spooked at the sudden cancellation of an RBC Capital roadshow appearance slated for today, Zafgen's shares plunged 35% on Monday and another 7% on Tuesday morning.
Zafgen's in-development obesity treatment led to significant weight loss in patients with obesity triggered by a brain injury, meeting its goals and sending the biotech's shares up nearly 8%.
Zafgen charted a third major victory for its in-development obesity drug, spurring weight loss for patients who have endured brain injuries and stoking hopes for success in Phase III.