NEW YORK, Sept. 1, 2017 /PRNewswire/ -- Kaplan Fox & Kilsheimer LLP
(www.kaplanfox.com) is investigating claims on behalf of investors
of SteadyMed Ltd. ("SteadyMed" or the "Company") (NASDAQ:
STDY).
On April 5, 2017, SteadyMed, a
specialty pharmaceutical company, announced the successful
completion of a clinical study for its lead drug product candidate,
Trevyent, for the treatment of Pulmonary Arterial Hypertension
(PAH). Further, the Company stated that it remains on track
for a New Drug Application (NDA) submission for Trevyent to treat
PAH in the second quarter of 2017.
On June 30, 2017, SteadyMed
announced that it had submitted the NDA to the FDA for its lead
drug product candidate, Trevyent, for the treatment of PAH.
On August 31, 2017, SteadyMed
announced receipt of a Refusal to File letter from the FDA
concerning its NDA for Trevyent. Based on a preliminary
review of the NDA, the FDA determined that the application is not
sufficiently complete to permit a substantive review. The FDA
also requested further information on certain device specifications
and performance testing and has requested additional design
verification and validation testing on the final, to-be-marketed
Trevyent product.
Following the August 31, 2017
disclosure of the Refusal to File letter, SteadyMed's shares
declined by $2.00 per share, nearly
34%, to close at $3.90 per share on
heavy trading volume on August 31,
2017.
If you are an investor in SteadyMed and would like to discuss
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