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Steadymed Ltd (STDY.OQ)

STDY.OQ on NASDAQ Stock Exchange Global Market

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23 Feb 2018
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Fri, Dec 8 2017

BRIEF-SteadyMed Announces FDA Agreed Pathway To Trevyent NDA Resubmission

* STEADYMED ANNOUNCES FDA AGREED PATHWAY TO TREVYENT NDA RESUBMISSION

BRIEF-STEADYMED RECEIVES FAVORABLE RULING FROM U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT

* ‍COURT OF APPEALS AFFIRMED A MARCH 31 RULING BY PATENT TRIAL & APPEAL BOARD INVALIDATING U.S. PATENT NO 8,497,393 OWNED BY UNITED THERAPEUTICS​

BRIEF-Steadymed reports Q3 earnings per share $0.35

* Steadymed reports third quarter 2017 financial results and provides corporate update

BRIEF-Steadymed receives notice of allowance for European patent

* Steadymed receives notice of allowance for its European patent relating to enhanced reduction of infusion-site pain Source text for Eikon: Further company coverage:

BRIEF-SteadyMed submits type A meeting request package to FDA

* SteadyMed Ltd - ‍type A meeting is being requested in response to FDA's August 28, refusal to file letter relating to co's NDA for Trevyent​ Source text for Eikon: Further company coverage:

BRIEF-SteadyMed receives refusal to file letter from FDA for Trevyent new drug application

* SteadyMed Ltd - FDA determined that application is not sufficiently complete to permit a substantive review

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