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Antares Pharma Inc (ATRS.OQ)

ATRS.OQ on NASDAQ Stock Exchange Capital Market

2.35USD
23 Feb 2018
Change (% chg)

$0.15 (+6.82%)
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Volume
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Latest Key Developments (Source: Significant Developments)

AMAG Gets FDA Approval Of Makena Subcutaneous Auto-Injector
Wednesday, 14 Feb 2018 06:03pm EST 

Feb 14 (Reuters) - Amag Pharmaceuticals Inc ::AMAG PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF MAKENA® (HYDROXYPROGESTERONE CAPROATE INJECTION) SUBCUTANEOUS AUTO-INJECTOR TO REDUCE THE RISK OF PRETERM BIRTH IN CERTAIN AT-RISK WOMEN.AMAG PHARMACEUTICALS - EXPECTS TO FILE A NEW DRUG APPLICATION THIS QUARTER FOR A NEW CHEMICAL ENTITY (BREMELANOTIDE) ​.AMAG PHARMACEUTICALS INC - ‍EXPECTS SUBCUTANEOUS AUTO-INJECTOR TO BE AVAILABLE IN SECOND HALF OF MARCH​.AMAG PHARMACEUTICALS INC - WILL CONTINUE TO OFFER IM FORMULATION OF MAKENA IN BOTH SINGLE-DOSE AND MULTI-DOSE VIALS​.AMAG PHARMACEUTICALS INC - ‍MAKEN'S 7-YEAR ORPHAN DRUG EXCLUSIVITY EXPIRED EARLIER THIS MONTH​.AMAG PHARMACEUTICALS - ANNOUNCES FDA APPROVAL OF MAKENA (HYDROXYPROGESTERONE CAPROATE INJECTION) SUBCUTANEOUS AUTO-INJECTOR ‍​.  Full Article

Antares Pharma Provides Xyosted Regulatory Update
Tuesday, 16 Jan 2018 07:00am EST 

Jan 16 (Reuters) - Antares Pharma Inc ::ANTARES PHARMA PROVIDES XYOSTED™ REGULATORY UPDATE.ANTARES PHARMA INC - TYPE A MEETING HAS BEEN SCHEDULED WITH U.S. FOOD AND DRUG ADMINISTRATION ON FEBRUARY 21, 2018 FOR XYOSTED.ANTARES PHARMA - REQUEST FOR MEETING WAS IN RESPONSE TO COMPLETE RESPONSE LETTER RECEIVED BY ANTARES REGARDING NEW DRUG APPLICATION FOR XYOSTED.  Full Article

Antares Pharma Q3 loss per share $0.03
Tuesday, 7 Nov 2017 07:00am EST 

Nov 7 (Reuters) - Antares Pharma Inc :Antares Pharma reports third quarter 2017 operating and financial results.Q3 loss per share $0.03.Q3 revenue $15.1 million versus I/B/E/S view $14 million.Q3 earnings per share view $-0.03 -- Thomson Reuters I/B/E/S.Antares Pharma - ‍at September 30, 2017, cash, cash equivalents and short-term investments were $37.4 million compared to $27.7 million at December 31, 2016​.  Full Article

Antares Pharma receives complete response letter from FDA for Xyosted
Friday, 20 Oct 2017 06:48pm EDT 

Oct 20 (Reuters) - Antares Pharma Inc :Antares pharma receives complete response letter from the fda for Xyosted.‍CRL indicates that FDA cannot approve NDA in its present form​.‍FDA is concerned that Xyosted could cause a clinically meaningful increase in blood pressure​.‍CRL identified two deficiencies related to clinical data for Xyosted injection​.Complete response ‍letter also raised a concern regarding occurrence of depression and suicidality​.  Full Article

Antares Pharma ‍says received FDA letter regarding deficiencies of its drug Xyosted
Thursday, 12 Oct 2017 05:00pm EDT 

Oct 12 (Reuters) - Antares Pharma Inc :Antares Pharma provides Xyosted™ regulatory update.Antares Pharma Inc - ‍anticipate receiving further clarification from FDA on or before prescription drug user fee act (PDUFA) date of October 20, 2017​.Antares Pharma Inc - ‍intends to work with FDA to understand nature of deficiencies once identified.Antares Pharma Inc - ‍received a letter from FDA regarding Xyosted .Antares Pharma Inc - ‍ letter from U.S. FDA does not specify deficiencies identified with respect to review of Xyosted NDA​.Antares Pharma Inc - got letter on Oct 11 stating FDA identified deficiencies precluding continuation of discussion of labeling, postmarketing needs at this time​.  Full Article

Antares Pharma announces sale of Zomajet™ needle-free delivery system to Ferring Pharmaceuticals
Tuesday, 10 Oct 2017 07:00am EDT 

Oct 10 (Reuters) - Antares Pharma Inc ::Antares Pharma announces sale of Zomajet™ needle-free delivery system to Ferring Pharmaceuticals.Antares Pharma Inc - deal for ‍up to $14.5 million​.Antares - to sell worldwide rights, including certain fixed assets, for Zomajet needle-free auto injector device to Ferring Pharmaceuticals​.Antares - deal with Ferring generates non-dilutive cash which co intends to use to invest to support launch of Xyosted​.  Full Article

Antares Pharma Q2 loss per share $0.02
Tuesday, 8 Aug 2017 07:00am EDT 

Aug 8 (Reuters) - Antares Pharma Inc ::Antares pharma reports second quarter 2017 operating and financial results.Q2 loss per share $0.02.Q2 revenue $13.4 million versus I/B/E/S view $12.5 million.Q2 earnings per share view $-0.03 -- Thomson Reuters I/B/E/S.  Full Article

Antares Pharma files $200 mln mixed shelf
Tuesday, 9 May 2017 05:03pm EDT 

May 9 (Reuters) - Antares Pharma Inc :Files for mixed shelf of up to $200 million - sec filing.  Full Article

Antares Pharma reports Q1 loss per share $0.03
Tuesday, 9 May 2017 07:00am EDT 

May 9 (Reuters) - Antares Pharma Inc : :Antares Pharma reports first quarter 2017 operating and financial results.Q1 revenue $12 million versus I/B/E/S view $12.3 million.Q1 loss per share $0.03.Q1 earnings per share view $-0.03 -- Thomson Reuters I/B/E/S.  Full Article

Antares Pharma Q4 loss per share $0.03
Tuesday, 14 Mar 2017 07:00am EDT 

Antares Pharma Inc : Antares pharma reports fourth quarter and full year 2016 operating and financial results . Q4 loss per share $0.03 . Q4 earnings per share view $-0.04 -- Thomson Reuters I/B/E/S .Revenue was $14.2 million for three months ended december 31, 2016 compared to $11.8 million for comparable period in 2015.  Full Article

BRIEF-Antares Pharma Provides Xyosted Regulatory Update

* ANTARES PHARMA INC - TYPE A MEETING HAS BEEN SCHEDULED WITH U.S. FOOD AND DRUG ADMINISTRATION ON FEBRUARY 21, 2018 FOR XYOSTED

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