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FDA places clinical hold on Concert Pharma's hair loss drug
May 17, 2017 / 11:44 AM / 4 months ago

FDA places clinical hold on Concert Pharma's hair loss drug

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed

(Reuters) - Concert Pharmaceuticals Inc said on Wednesday the U.S. Food and Drug Administration (FDA) imposed a clinical hold on a trial testing the company’s drug to treat alopecia areata, a type of hair loss.

Shares of Concert Pharma fell as much as 11 percent but trimmed some losses. The stock was down 7 percent at $14.93 in afternoon trading.

The FDA had asked for more data before Concert Pharma could proceed with dosing patients in the mid-stage trial, but the agency did not raise any concerns over the safety of Concert’s drug, the drug developer said.

Concert Pharma added it would submit the requested data soon.

The FDA will review the company’s response within 30 days of submission and, if positive, the trial will be allowed to continue, Aegis Capital analyst Difei Yang said in a client note.

“We believe this issue to be easily resolvable and do not expect a long delay in clinical trial or a significant impact to the timeline of the trial read-out,” Yang said.

The trial had already been delayed due to a separate issue the company was investigating, Concert Pharma had said last month.

Its drug, CTP-543, is competing with Aclaris Therapeutics Inc’s ATI-50001 to be the first FDA-approved treatment for alopecia areata.

Aclaris said earlier this month it would begin a mid-stage trial testing ATI-50001 in the second half of this year.

Lexington, Massachusetts-based Concert Pharma is also developing drugs to treat neurological disorders, cystic fibrosis and narcolepsy.

Alopecia areata is an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss.

The disease affects about 4.6 million people in the United States, according to the North American Hair Research Society.

Reporting by Divya Grover in Bengaluru; Editing by Sai Sachin Ravikumar

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