NEW YORK, July 19, 2017 /PRNewswire/ -- Kaplan Fox & Kilsheimer LLP
(www.kaplanfox.com) is investigating claims on behalf of investors
of Ocular Therapeutix, Inc. ("Ocular Therapeutix" or the "Company")
(NASDAQ: OCUL).
Class action litigation has been filed in the United States
District Court for the District of New
Jersey against Ocular Therapeutix and Company executives on
behalf of investors who purchased or otherwise acquired Ocular
Therapeutix securities between May 5,
2017 and July 6, 2017,
inclusive (the "Class"), alleging violations of the Securities
Exchange Act of 1934.
According to the complaint, on May 5,
2017 Ocular Therapeutix disclosed that it received a Form
483 from the U.S. Food and Drug Administration ("FDA") documenting
FDA concerns discovered during inspection of Ocular Therapeutix's
manufacturing operations. During an earnings conference call
held the same day, Ocular Therapeutix's Executive Vice President of
Regulatory, Quality, and Compliance, Eric Ankerud, represented that
the Company expected to resolve the issue in a timely manner by
responding to the FDA within 15 days. On July 6, 2017, STAT published an article
asserting that Ocular Therapeutix's drug 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, Ocular Therapeutix's
stock price fell $3.06 per share, or
more than 30%, over two trading days to close at $7.12 per share on July 7,
2017.
Then, after the Class Period, on July 10,
2017, the Company issued a press release disclosing its
submission of a "major amendment" to its New Drug Application
("NDA") that "modified a piece of manufacturing equipment
referenced in the NDA resubmission" and that the Company "will be
submitting data on a new commercial batch to demonstrate that this
modification, along with other improvements, has addressed
outstanding issues regarding particulate matter."
On July 11, 2017 after market, the
Company issued a press release disclosing receipt of a Complete
Response Letter ("CRL") from the FDA stating that the FDA has
determined that it cannot approve the NDA in its present
form. The CRL also reportedly states that the amendment was
not reviewed prior to the FDA's issuance of the CRL.
Following this news, the Company's share price declined by
$0.93 per share, or 12.2%, to close
at $6.67 per share on July 12, 2017.
The complaint alleges, among other things, that throughout the
Class Period defendants made false and misleading statements and/or
failed to disclose that (1) Ocular Therapeutix was experiencing
significant manufacturing issues with respect to DEXTENZA,
including that more than 50% of lots manufactured by Ocular
Therapeutix contained bad product, and (2) such manufacturing
issues could imperil DEXTENZA's approval by the FDA.
If you are a member of the proposed Class, you may move the
court no later than September 5, 2017
to serve as a lead plaintiff for the purported class. You
need not seek to become a lead plaintiff in order to share in any
possible recovery. If you would like to discuss the complaint
or our investigation, please contact us by emailing
pmayer@kaplanfox.com or by calling 800-290-1952.
This press release may be considered Attorney Advertising in
some jurisdictions under the applicable law and ethical rules.
Kaplan Fox & Kilsheimer LLP,
with offices in New York,
San Francisco, Los Angeles, Chicago and New
Jersey, has many years of experience in prosecuting investor
class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit
our website at www.kaplanfox.com. If you have any questions
about this Notice, the action, your rights, or your interests,
please contact:
Donald R. Hall
KAPLAN FOX & KILSHEIMER LLP
850 Third Avenue, 14th Floor
New York, New York 10022
(800) 290-1952
(212) 687-1980
Fax: (212) 687-7714
E-mail: dhall@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
350 Sansome Street, Suite 400
San Francisco, California
94104
(415) 772-4700
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
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SOURCE Kaplan Fox &
Kilsheimer LLP