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TherapeuticsMD Inc (TXMD.OQ)

TXMD.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

TherapeuticsMD Says FDA Has Granted AnnoveraTM Marketing Exclusivity As New Chemical Entity
7:00am EDT 

Sept 20 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES THE FDA HAS GRANTED ANNOVERATM MARKETING EXCLUSIVITY AS A NEW CHEMICAL ENTITY.THERAPEUTICSMD - FIVE-YEAR NCE EXCLUSIVITY RUNS FOR FIVE YEARS FROM FDA APPROVAL OF NEW DRUG APPLICATION FOR ANNOVERA.  Full Article

TherapeuticsMD Announces FDA Acceptance Of New Drug Application For Tx-001Hr
Thursday, 8 Mar 2018 04:15pm EST 

March 8 (Reuters) - Therapeuticsmd Inc ::THERAPEUTICSMD ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION (NDA) AND PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE FOR TX-001HR.THERAPEUTICSMD INC - PDUFA TARGET ACTION DATE FOR COMPLETION OF FDA'S REVIEW IS OCTOBER 28, 2018 FOR TX-001HR.  Full Article

TherapeuticsMD Q4 Loss Per Share $0.10
Tuesday, 20 Feb 2018 04:05pm EST 

Feb 20 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.10.Q4 REVENUE $4.1 MILLION VERSUS $4.5 MILLION.  Full Article

TherapeuticsMD Submits New Drug Application For TX-001HR
Thursday, 28 Dec 2017 04:30pm EST 

Dec 28 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION FOR TX-001HR.THERAPEUTICSMD - EXPECTS TO LEARN OF ACCEPTANCE OF NDA FROM FDA ABOUT 74 DAYS AFTER NDA SUBMISSION.  Full Article

Therapeuticsmd Announces FDA Acceptance Of New Drug Application And PDUFA Date For TX-004HR
Tuesday, 19 Dec 2017 04:36pm EST 

Dec 19 (Reuters) - Therapeuticsmd Inc ::THERAPEUTICSMD ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION AND PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE FOR TX-004HR.THERAPEUTICSMD INC - PDUFA TARGET ACTION DATE SET OF MAY 29, 2018.THERAPEUTICSMD INC - COMPANY CURRENTLY PLANS TO LAUNCH TX-004HR IN Q3 OF 2018 IF APPROVAL OCCURS ON OR BEFORE PDUFA TARGET ACTION DATE.  Full Article

TherapeuticsMD Announces Resubmission Of New Drug Application For TX-004HR
Wednesday, 29 Nov 2017 04:30pm EST 

Nov 29 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES RESUBMISSION OF NEW DRUG APPLICATION FOR TX-004HR.THERAPEUTICSMD INC - COMPANY EXPECTS TO LEARN OF ACCEPTANCE OF NDA RESUBMISSION WITHIN 30 CALENDAR DAYS.  Full Article

TherapeuticsMD reports Q3 loss per share of $0.07
Monday, 6 Nov 2017 06:05am EST 

Nov 6 (Reuters) - Therapeuticsmd Inc ::TherapeuticsMD announces third quarter 2017 financial results.Q3 loss per share $0.07.Q3 earnings per share view $-0.11 -- Thomson Reuters I/B/E/S.Q3 revenue $4.4 million versus i/b/e/s view $5.2 million.  Full Article

TherapeuticsMD announces plan to resubmit the new drug application for TX-004HR
Monday, 6 Nov 2017 06:00am EST 

Nov 6 (Reuters) - TherapeuticsMD Inc :TherapeuticsMD Inc announces plan to resubmit the new drug application for TX-004HR.TherapeuticsMD Inc - Division of bone,reproductive & urologic products, US FDA agreed to NDA resubmission for TX-004HR without additional pre-approval study​.TherapeuticsMD Inc - ‍on Nov 3 co participated in an in-person meeting with division of bone, reproductive, and urologic products of US FDA​.TherapeuticsMD Inc - ‍co will commit to conduct a post-approval observational study​.  Full Article

TherapeuticsMD prices offering of 12.4 mln shares at $5.65 per share
Monday, 25 Sep 2017 10:28pm EDT 

Sept 25 (Reuters) - TherapeuticsMD Inc - :TherapeuticsMD announces pricing of common stock offering.TherapeuticsMD - Announced pricing of an underwritten public offering of 12.4 million shares of its common stock at a price to public of $5.65 per share.  Full Article

TherapeuticsMD announces public offering of 12.4 mln shares of common stock
Monday, 25 Sep 2017 04:52pm EDT 

Sept 25 (Reuters) - TherapeuticsMD Inc :TherapeuticsMD announces public offering of 12.4 million shares of common stock.  Full Article

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TherapeuticsMD's therapy for menopause-related condition gets approval

Women's healthcare company TherapeuticsMD Inc won its first-ever U.S. approval on Wednesday with the drug regulator clearing its hormone therapy for a painful condition triggered by menopause after rejecting it a year earlier.