Chiasma endocrine/metabolic news
Chiasma will reduce headcount by about 44% to less than 25 in its second wave of reductions since FDA issued a complete response letter in April to an NDA for Mycapssa octreotide ( RG3806) as a maintenance treatment for adults with acromegaly. The cuts will primarily come from its research and general administrative functions and will be completed this quarter. In June, the company reduced headcount by about 33%, primarily from commercial personnel. Chiasma said the combined cuts will total over 60% of its workforce at May 1, when the company had 65 employees. The company expects the combined reductions to save over $7 million in annualized payroll and related expense savings.
In June, Chiasma said FDA had 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 would 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 (see BioCentury, April 25 & June 27). ...