Chiasma endocrine/metabolic news
Chiasma will reduce headcount by about 33% after FDA issued a complete response letter in April to an NDA for Mycapssa octreotide ( RG3806) as a maintenance treatment for adults with acromegaly. At May 1, before the restructuring was announced, Chiasma had 65 employees; a 33% reduction would cut 21 employees, with 44 remaining. The cuts include Chief Commercial Officer Anand Varadan. During an end-of-review meeting with FDA, Chiasma said the agency reiterated concerns expressed in the CRL regarding aspects of the single-arm, open-label Phase III trial upon which the NDA was based and the agency’s belief that the NDA “had failed to provide substantial evidence of efficacy to warrant approval.” The company said it will explore all potential paths forward, including whether it can address FDA’s concerns through the submission of additional clinical analyses or data or other means. Chiasma declined to disclose specific headcount numbers or anticipated savings (see BioCentury, April 25). ...