FDA rejects Chiasma’s new drug application for therapy to treat rare growth disorder
Shares in Chiasma Inc (Nasdaq: CHMA) plunged to more than halve on the Nasdaq Monday as the company reported the US regulators have rejected its trial drug to treat a rare growth disorder.
The US Food and Drug Administration (FDA) advised Chiasma that the agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval and asked for another another clinical trial.
The company was studying the drug, Mycapssa, to treat acromegaly, a growth disorder that can lead to serious illness and premature death.
Mark Leuchtenberger, chief executive of Chiasma, said: “We are surprised, disappointed and respectfully disagree with the FDA’s decision. The FDA has encouraged us to request an End of Review meeting with the Agency to discuss the path forward, and we will do so.”
Acromegaly is a rare condition caused by excessive growth hormone and can lead to the enlargement of body parts, including hands, feet and facial features.
Shares in the company dropped over 60% to $4.10 Monday on the Nasdaq.
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