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Steadymed Ltd (STDY.OQ)

STDY.OQ on NASDAQ Stock Exchange Global Market

3.30USD
15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

SteadyMed Announces FDA Agreed Pathway To Trevyent NDA Resubmission
Friday, 8 Dec 2017 

Dec 8 (Reuters) - SteadyMed Ltd ::STEADYMED ANNOUNCES FDA AGREED PATHWAY TO TREVYENT NDA RESUBMISSION.STEADYMED LTD - EXPECTS BOTH NDA SUBMISSION AND ACCEPTANCE OF TREVYENT TO OCCUR BEFORE END OF 2018.STEADYMED LTD - ‍ STEADYMED HAS BEGUN PRE-DV ACTIVITIES, WHICH PRECEDE DV TESTING, WITH TREVYENT PERFORMANCE DATA BEING AVAILABLE AROUND MID 2018​.STEADYMED LTD - FDA IS NOT REQUIRING STEADYMED TO CONDUCT ANY CLINICAL TRIALS TO PROVE SAFETY OR EFFICACY OF TREVYENT.STEADYMED - FDA AGREED REPEATING IN VITRO DESIGN VERIFICATION TESTING ON FINAL TREVYENT PRODUCT SHOULD BE ADEQUATE FOR RESUBMISSION, ACCEPTANCE OF NDA.  Full Article

STEADYMED RECEIVES FAVORABLE RULING FROM U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
Tuesday, 14 Nov 2017 

Nov 14 (Reuters) - Steadymed Ltd ::‍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​.‍INVALIDITY DECISION WILL PRECLUDE UNITED THERAPEUTICS FROM ASSERTING '393 PATENT PRIOR TO STEADYMED'S LAUNCH OF ITS TREVYENT PRODUCT​.‍FDA REGULATIONS REQUIRE THAT UNITED THERAPEUTICS "PROMPTLY NOTIFY FDA TO…WITHDRAW PATENT" FROM FDA'S "ORANGE BOOK."​.  Full Article

Steadymed reports Q3 earnings per share $0.35
Monday, 13 Nov 2017 

Nov 13 (Reuters) - Steadymed Ltd :Steadymed reports third quarter 2017 financial results and provides corporate update.Q3 earnings per share $0.35.  Full Article

Steadymed files for offering of up to 13.1 mln ordinary shares
Friday, 2 Sep 2016 

Steadymed Ltd : Files for offering of up to 13.1 million shares of ordinary shares by selling securityholders - SEC filing Source: (http://bit.ly/2c1ajAV) Further company coverage: [STDY.O] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

Steadymed has finished manufacturing all Trevyen batches
Thursday, 1 Sep 2016 

Steadymed Ltd : Has completed manufacture of all of Trevyen batches for shelf-life studies needed to support submission of its NDA in q1 of 2017 .Says "believe we have necessary capital to launch Trevyent in U.S. In late 2017, if approved by FDA".  Full Article