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