According to the complaint, a late-stage biopharmaceutical company, focuses on developing and commercializing oral forms of therapies for patients suffering from orphan diseases. 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.
The complaint alleges that the defendants made materially false and misleading statements regarding the company’s business, operational and compliance policies. Specifically, the complaint alleges that the 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.
On or about July 15, 2016, Chiasma completed its IPO, issuing 6.4 million shares and raising net proceeds of approximately $102 million.
According to the complaint, on April 18, 2016, before the market opened, the company announced that the FDA had issued a Complete Response Letter regarding its New Drug Application for Mycapssa. In a press release, Chiasma stated, in part, “the FDA advised Chiasma that the Agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency.”
Following this news, Chiasma’s share price fell $6.42, or 63.13%, to close at $3.75 on April 18, 2016.
If you are a member of the class described above, you may no later than August 8, 2016 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at info@ktmc.com. For more information about Kessler Topaz Meltzer & Check, LLP, please visit our website at http://www.ktmc.com.
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