PRODUCTMYCAPSSA^®

MYCAPSSA® (octreotide capsules) is being developed for the maintenance treatment of adult patients with acromegaly in whom prior treatment with somatostatin analogs has been shown to be effective and tolerated. In January 2020, the FDA accepted Chiasma’s NDA resubmission seeking marketing approval of MYCAPSSA in the U.S. The PDUFA target action date is June 26, 2020.

Background

As Chiasma was preparing for the launch of MYCAPSSA in the U.S., the company was seeking non-dilutive financing to support pre-commercial and commercial activities.  In April 2020, Chiasma and HCR announced a non-dilutive financing of up to $75 million, including $25 million funded at closing, $25 million funded upon FDA approval of MYCAPSSA, an additional $15 million upon the availability of commercial drug supply and first commercial sale of MYCAPSSA, and an additional $10 million in early 2022 subject to the achievement of a commercial milestone. “HealthCare Royalty Partners is a top-tier investment firm that provides important validation for Chiasma as we near our PDUFA date and move towards our goal of bringing the first oral somatostatin analog to acromegaly patients,” said Raj Kannan, Chief Executive Officer of Chiasma.  “We appreciate the extensive due diligence conducted by Healthcare Royalty Partners and plan to use the proceeds from this non-dilutive financing to support our ongoing activities as we prepare for a robust U.S. commercial launch of MYCAPSSA, if approved.”