Ocular Therapeutix investors may receive additional information about the case by clicking the link "Join this Class Action" above.
According to the complaint, Ocular Therapeutix focuses on the development and commercialization of therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology in the United States. The company’s lead product is DEXTENZA, which is in Phase III clinical trial for the treatment of post-surgical pain and inflammation, allergic conjunctivitis; and in Phase II clinical trial for the treatment of inflammatory dry eye disease.
The Class Period commences on May 5, 2017, when Ocular Therapeutix issued a press release disclosing that is had received a Form 483, which is a form used by the U.S. Food and Drug Administration (“FDA”) to document and communicate concerns discovered during inspection, related to DEXTENZA. On that same day, the company held an earnings conference call, during which Defendant Ankerud stated, in part, “We feel quite comfortable that we have the situation under control and we are preparing responses to the 43 as of this morning in anticipation of responding within 15 calendar days to the agency. [We] expect that we can resolve the 43 issues in a timely manner.”
The complaint alleges that, on July 6, 2017, Seeking Alpha published an article on Ocular Therapeutix concerning DEXTENZA manufacturing issues, stating in pertinent part “Dextenza unlikely to get approved by the FDA.” On that same day, STAT published an article on Ocular Therapeutix asserting that DEXTENZA could be rejected by the FDA because of product contamination, including aluminum, found by an FDA inspector during a visit to the company’s manufacturing facility.
Following this news, shares of Ocular Therapeutix fell $3.06 per share or over 30% over two trading days to close at $7.12 per share on July 7, 2017.
The complaint alleges that, throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (1) the company’s management has been misleading investors about DEXTENZA manufacturing issues, including that more than 50% of lots manufactured by Ocular Therapeutix contain bad product; (2) such manufacturing issues could imperil the approval of DEXTENZA by the FDA; and (3) as a result, the defendants’ public statements were materially false and misleading at all relevant times.
If you are a member of the class described above, you may no later than September 5, 2017 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 firstname.lastname@example.org. For more information about Kessler Topaz Meltzer & Check, LLP, please visit our website at http://www.ktmc.com. If you would like additional information about the suit, please fill out the attached form as promptly as possible and return it by fax to 610-667-7056, or by mail in the enclosed envelope.
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