FDA rejects Chiasma's Mycapssa

Chiasma Inc. (NASDAQ:CHMA) said it received a complete response letter from FDA for acromegaly candidate Mycapssa octreotide. The company did not disclose FDA's rationale for the decision and did not respond to inquiries.

Mycapssa is an oral formulation of octreotide acetate, a somatostatin analog, using Transient Permeability Enhancer technology. The company submitted the NDA through FDA's 505(b)(2) pathway, which allows sponsors to reference safety and efficacy from the scientific literature or from previously approved products. ...