The U.S. Food and Drug Administration has rejected Chiasma Inc’s experimental drug to treat adults with a type of growth disorder, the company said on Friday.
Chiasma was evaluating the drug, Mycapssa, in patients with acromegaly, a growth disorder that can result in serious illness and premature death.
The Food and Drug Administration issued a complete response letter for Mycapssa indicating that the review cycle for the application was complete and that the therapy was not ready for approval in its present form, Chiasma said in a statement.
The company said it was reviewing the communication and would provide an update on Monday.
Acromegaly, a condition caused by excessive growth hormone, can lead to the enlargement of body parts, including hands, feet and facial features.
The company’s stock closed up 1.3 percent at $10.17 on Friday. News of the rejection came after the market closed.
(Reporting by Arunima Banerjee in Bengaluru; Editing by Chris Reese and Fiona Ortiz)