OCULAR THERAPEUTIX INVESTOR ALERT: Legal Investigation Continues After FDA Denies Dextenza New Drug Application

By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA -- Girard Gibbs LLP is investigating potential claims on behalf of investors of Ocular Therapeutix, Inc. (NASDAQ:OCUL). On July 11, 2017, the company revealed that the FDA denied its new drug application for Dextenza, citing manufacturing and testing issues. A class action lawsuit has been filed alleging that Ocular made false or misleading statements regarding the manufacturing and testing issues impacting Dextenza. To speak privately with an attorney regarding this class action lawsuit investigation, click here. Ocular Therapeutix disclosed on May 5, 2017 that it received a Form 483 from the U.S. Food and Drug Administration containing "inspectional observations" related to the Company's manufacturing and analytical testing procedures (see also Pharmaceutical Companies).

On July 6, 2017, shortly before the end of the trading day, Seeking Alpha published an article reporting that the Ocular Therapeutix management may have misled investors regarding the severity of ongoing manufacturing issues and downplayed the significance of FDA communications regarding these issues.

Then, on July 11, 2017, Ocular Therapeutix announced that it received a Complete Response Letter from the FDA denying Ocular's resubmission of a New Drug Application for Dextenza. According to the company, the FDA's letter referenced deficiencies in manufacturing processes and analytical testing discovered in the May 2017 inspection. This news sent the share price tumbling in after-hours trading by more than 30%.

If you purchased or acquired shares of Ocular Therapeutix, Inc. and would like to speak privately with a securities attorney to learn more about the investigation and your legal rights, visit our website or contact the securities team directly at (800) 254-9493.

Girard Gibbs LLP is one of the nation's leading firms representing individual and institutional investors in securities litigation to correct abusive corporate governance practices, breaches of fiduciary duty, and proxy violations. The firm has recovered over a billion dollars for its clients against some of the world's largest corporations, and has earned Tier-1 rankings and been named in the U.S. Lawyers - Best Law Firms list for five consecutive years.

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Keywords for this news article include: Pharmaceutical Companies, Therapy, FDA Actions, Legal Issues, Girard Gibbs LLP, Government Agencies Offices and Entities.

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