Larimar Therapeutics Inc (LRMR)

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Zafgen Says Another Patient Dies in Beloranib Study
FDA had placed beloranib on partial clinical hold in October following another patient’s death
By ANNE STEELE

Updated Dec. 2, 2015 7:59 a.m. ET

Zafgen Inc. said Wednesday that another patient died during a continuing study of a rare genetic disorder, two months after U.S. regulators temporarily halted its clinical trial to investigate circumstances surrounding the previous death.

Shares, which closed Tuesday at $15.93, fell 55% to $7.11 in premarket trading.

The biopharmaceutical company said it learned Tuesday that a patient being treated with beloranib for Prader-Willi syndrome was diagnosed with bilateral pulmonary emboli—blood clots to the lung—and died.

The patient was receiving the drug during the open-label extension portion of the late-stage trial.

Prader-Willi syndrome is a genetic disorder that results in life-threatening obesity because of unrelenting hunger. There is no cure for the disease, which affects one in 12,000 to 15,000 people, according to Prader-Willi Syndrome Association.

In October, Zafgen disclosed that a patient had died during the belanorib study. The U.S. Food and Drug Administration placed beloranib on partial clinical hold because of the thromboembolic events—blood clots that move after forming and block other vessels—in other trials of beloranib and the unknown nature of that death.

On Tuesday, Chief Executive Thomas Hughes said Zafgen is in talks with the FDA while determining next steps for the program.

“Our thoughts are with the patient and their family at this time,” he said. “Patient safety remains our top priority, and we are investigating the circumstances around this event.”

The company reiterated its expectation for “top-line results” of the randomized portion of the clinical trial in the first quarter of 2016.

Zafgen Says Another Patient Dies in Beloranib Study - WSJ
http://www.wsj.com/articles/zafgen-says-another-patient-dies-in-beloranib-study-1449059965