Chiasma sinks after FDA requests new Mycapssa trial

Chiasma Inc. (NASDAQ:CHMA) plummeted $6.42 (63%) to $3.75 on Monday after it said FDA wants another trial of acromegaly candidate Mycapssa octreotide. The company disclosed Friday that it had received a complete response letter for Mycapssa's NDA (see BioCentury Extra, April 15).

On Monday, Chiasma said FDA thinks the NDA had not provided "substantial evidence of efficacy to warrant approval," and expressed concern about the single-arm, open-label Phase III trial that supported the submission. ...