- Mycapssa NDA: As previously announced, Chiasma received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) on April 15, 2016 regarding its New Drug Application (NDA) for Mycapssa. FDA expressed concerns regarding certain aspects of our single-arm, open-label Phase 3 clinical trial and strongly recommended that we conduct a randomized, double-blind and controlled trial that enrolls patients from the United States and is of sufficiently long duration to ensure that control of disease activity is stable at the time point selected for the primary efficacy assessment. In addition, the FDA advised that, during a site inspection, certain deficiencies were conveyed to the representative of one of our suppliers that would need to be resolved before approval. This feedback was reiterated in an End of Review Meeting with FDA during the second quarter, and in the minutes of which meeting where the FDA also introduced the concept that some of its concerns could potentially be addressed through a placebo controlled design. Chiasma acknowledges this feedback and continues to evaluate various paths forward to potentially secure approval in the U.S. for Mycapssa.
- August Restructuring: During the third quarter, the company further reduced its workforce by approximately 44%, primarily in the company's research and general and administrative functions, to lower its operating expenses and extend its cash runway.
- CEO Transition: Effective October 1, 2016, Mr. Fitzpatrick was promoted from Chief Financial Officer to Chief Executive Officer and he continues to serve as our Principle Financial Officer.
- VP Finance Appointment: Effective November 10, 2016, Mr. Drew Enamait was promoted from Director, Corporate Controller to VP, Finance and Administration and Principle Accounting Officer. Mr. Enamait earned a Certified Public Accountant certificate in 1999 and has over 20 years of professional experience in financial positions in both large and small companies.
WALTHAM, Mass., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ:CHMA), a biopharmaceutical company focused on improving the lives of patients with rare and serious chronic diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2016. "Chiasma is committed to the development of new treatment options for acromegaly and we are currently applying all of our resources to the development of Mycapssa® (octreotide) capsules for patients suffering from acromegaly, a rare and debilitating disease," said Mark J. Fitzpatrick, president and chief executive officer of Chiasma. "We continue to explore regulatory paths forward to potentially enable approval in the U.S. while enrollment of the MPOWERED™ Phase 3 trial of Mycapssa progresses in support of our planned Marketing Authorization Application (MAA) in Europe." Key Corporate Highlights: