Chiasma tanks as FDA calls for further study on Mycapssa

US biopharma company Chiasma (Nasdaq: CHMA) suffered a share price collapse, after it revealed the news that the US Food and Drug Administration would require further clinical evidence in order to approve its Mycapssa (octreotide) capsules for the maintenance treatment of adult patients with acromegaly, a rare ailment related to the pituitary gland. Its shares plunged more than 60% to $4.02.

Upon completion of its review, the FDA advised Chiasma that the agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency.

The FDA expressed concerns regarding certain aspects of the company’s single-arm, open-label Phase III clinical trial and strongly recommended that the company conduct a randomized, double-blind and controlled trial that enrolls patients from the USA and be of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment. In addition, the FDA advised that, during a recent site inspection, certain deficiencies were conveyed to the representative of one of Chiasma’s suppliers that would need to be resolved before approval. The FDA did not note any safety concerns related to Mycapssa in its letter.