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Steadymed Ltd (STDY.OQ)

STDY.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Steadymed Reports Q4 Loss Per Share $0.22
Friday, 30 Mar 2018 03:12pm EDT 

March 30 (Reuters) - Steadymed Ltd ::Q4 LOSS PER SHARE $0.22.  Full Article

SteadyMed Announces FDA Agreed Pathway To Trevyent NDA Resubmission
Friday, 8 Dec 2017 06:55am EST 

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 09:56am EST 

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 08:30am EST 

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 submits type A meeting request package to FDA
Thursday, 28 Sep 2017 08:30am EDT 

Sept 28 (Reuters) - SteadyMed Ltd : :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​.  Full Article

SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
Thursday, 31 Aug 2017 06:45am EDT 

Aug 31 (Reuters) - Steadymed Ltd :SteadyMed Ltd - FDA determined that application is not sufficiently complete to permit a substantive review.SteadyMed - ‍within next 30 days, will request a type a meeting with FDA for clarification on additional information required for resubmission​ of NDA.SteadyMed - ‍FDA requested further information on certain device specifications and performance testing on final, to-be-marketed Trevyent product​.SteadyMed ltd - FDA requested additional design verification and validation testing on final, to-be-marketed Trevyent product​.  Full Article

Steadymed Ltd reports Q2 loss per share of $0.33
Friday, 11 Aug 2017 08:30am EDT 

Aug 11 (Reuters) - Steadymed Ltd ::Steadymed reports second quarter 2017 financial results and provides corporate update.Q2 loss per share $0.33.On track for mid-2018 U.S. Commercial launch of Trevyent, subject to FDA approval .  Full Article

Steadymed Ltd says its largest institutional shareholders has exercised warrants to purchase additional ordinary shares of co
Friday, 26 May 2017 08:42am EDT 

May 26 (Reuters) - Steadymed Ltd : :Steadymed Ltd says of its largest institutional shareholders has exercised warrants to purchase additional ordinary shares of co.Steadymed Ltd says as a result of exercise, steadymed has received additional proceeds totaling approximately $5 million.Steadymed Ltd says remains on track to submit a new drug application (nda), for trevyent in Q2 of 2017.  Full Article

Steadymed files for sale of 7.5 million shares
Wednesday, 24 May 2017 05:28pm EDT 

May 24 (Reuters) - Steadymed Ltd :Steadymed files for sale of 7.5 million shares of co by selling stockholders- SEC filing.  Full Article

Steadymed reports Q1 loss per share $0.92
Friday, 12 May 2017 08:30am EDT 

May 12 (Reuters) - Steadymed Ltd :Steadymed reports first quarter 2017 financial results and provides corporate update.Q1 loss per share $0.92.On track to file a new drug application (NDA) for trevyent for treatment of pulmonary arterial hypertension (PAH) in Q2 2017.Recorded licensing revenues of $315,000 in Q1 of 2017, compared to $375,000 revenues in Q1 of 2016..  Full Article

BRIEF-SteadyMed Reports Q1 Loss Per Share Of $0.39

* STEADYMED PROVIDES CORPORATE UPDATE AND REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS