OCULAR THERAPEUTIX INVESTOR ALERT: Legal Investigation Continues After FDA Denies Dextenza New Drug Application
July 12 2017 - 8:30AM
Business Wire
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.
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.
This press release may constitute Attorney Advertising in some
jurisdictions under the applicable law and ethical rules.
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Girard Gibbs LLPEileen Epstein,
510-350-9728EJE@CLASSLAWGROUP.COM
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