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Antares Pharma Inc (ATRS.OQ)

ATRS.OQ on NASDAQ Stock Exchange Capital Market

3.07USD
18 Jan 2019
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Latest Key Developments (Source: Significant Developments)

Antares Pharma Says Now Projects FY 2018 Revenue Guidance To Be In The Mid-To-Upper Part Of Previously Announced Range Of $60-$65 Mln
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Antares Pharma Inc ::ANTARES PHARMA SAYS NOW PROJECTS FY 2018 REVENUE GUIDANCE TO BE IN THE MID-TO-UPPER PART OF PREVIOUSLY ANNOUNCED RANGE OF $60-$65 MILLION - PRESENTATION.ANTARES PHARMA - PROJECTED FY 2019 REVENUE GUIDANCE TO BE IN RANGE OF $95-$105 MILLION.FY2018 REVENUE VIEW $62.5 MILLION -- REFINITIV IBES DATA.FY2019 REVENUE VIEW $105.5 MILLION -- REFINITIV IBES DATA.  Full Article

Antares Pharma Enters Into Development Agreement With Pfizer
Monday, 6 Aug 2018 

Aug 6 (Reuters) - Antares Pharma Inc ::ANTARES PHARMA ENTERS INTO DEVELOPMENT AGREEMENT WITH PFIZER INC..ANTARES PHARMA - PFIZER TO PAY FOR DEVELOPMENT OF PRODUCT, TO BE RESPONSIBLE FOR OBTAINING FDA APPROVAL OF COMBINATION PRODUCT.ANTARES PHARMA INC - CO, PFIZER TO DEVELOP A COMBINATION DRUG DEVICE RESCUE PEN.ANTARES PHARMA - ANTARES TO RECEIVE ROYALTIES ON NET SALES ON COMBINATION PRODUCT.  Full Article

Antares Pharma Reports Q1 Loss Per Share Of $0.04
Tuesday, 8 May 2018 

May 8 (Reuters) - Antares Pharma Inc ::ANTARES PHARMA REPORTS FIRST QUARTER 2018 OPERATING AND FINANCIAL RESULTS.Q1 LOSS PER SHARE $0.04.Q1 REVENUE $12.7 MILLION VERSUS I/B/E/S VIEW $12.9 MILLION.Q1 EARNINGS PER SHARE VIEW $-0.03 -- THOMSON REUTERS I/B/E/S.  Full Article

Antares Pharma Provides Xyosted™ Regulatory Update
Tuesday, 27 Mar 2018 

March 27 (Reuters) - Antares Pharma Inc ::ANTARES PHARMA PROVIDES XYOSTED™ REGULATORY UPDATE.BELIEVES THAT IT DOES NOT NEED TO CONDUCT ANY NEW CLINICAL STUDIES TO SUPPORT RESUBMISSION.ANTARES PHARMA -ANTICIPATES RESUBMISSION TO INCLUDE RE-ANALYSES OF EXISTING DATA, ADDRESS LABELING, POTENTIAL POST-APPROVAL RISK MITIGATION STRATEGIES.ANTICIPATES SUBMITTING COMPLETE RESPONSE IN Q2 OF THIS YEAR.OFFICIAL MINUTES FROM TYPE A MEETING WITH FDA ON FEB. 21 HAVE BEEN RECEIVED.  Full Article

Antares Pharma Provides Xyosted Regulatory Update
Tuesday, 16 Jan 2018 

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 

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
Saturday, 21 Oct 2017 

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
Friday, 13 Oct 2017 

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 

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's testosterone drug gets FDA approval

The U.S. Food and Drug Administration on Monday approved Antares Pharma Inc's injectable drug to treat low testosterone levels in men, the company said, nearly a year after being rejected.

No consensus analysis data available.