According to the law firm press release, Chiasma, a late-stage biopharmaceutical company, focuses on developing and commercializing oral forms of therapies for patients suffering from orphan diseases. Chiasma was founded in 2001 and is headquartered in Newton, Massachusetts.
The Company’s lead product candidate is oral octreotide, or Mycapssa, for the treatment of acromegaly, a condition that results in the body’s production of excess growth hormone. As of June 2015, prior to Chiasma’s IPO, the Company had completed a multinational Phase 3 clinical trial of Mycapssa and submitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval for marketing and sale of Mycapssa.
On or about July 15, 2016, Chiasma completed its IPO, issuing 6.4 million shares and raising net proceeds of approximately $102 million.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Chiasma’s Phase 3 clinical trial methodology for Mycapssa was not sufficient to demonstrate efficacy and secure FDA approval; (ii) Chiasma’s supervision of its suppliers was not sufficient to prevent deficiencies that would delay FDA approval of Mycapssa; and (iii) as a result of the foregoing, Chiasma’s public statements were materially false and misleading at all relevant times.