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TherapeuticsMD Inc (TXMD.OQ)

TXMD.OQ on NASDAQ Stock Exchange Global Select Market

6.61USD
20 Jul 2018
Change (% chg)

$-0.09 (-1.42%)
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Volume
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Latest Key Developments (Source: Significant Developments)

TherapeuticsMD Gets FDA Approval Of TX-004HR IMVEXXY For Treatment Of Moderate To Severe Dyspareunia
Wednesday, 30 May 2018 

May 30 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES FDA APPROVAL OF TX-004HR: IMVEXXY (ESTRADIOL VAGINAL INSERTS), THE LOWEST DOSE VAGINAL ESTROGEN PRODUCT APPROVED FOR THE TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VVA, DUE TO MENOPAUSE.ANTICIPATES THAT IMVEXXY WILL BE AVAILABLE FOR COMMERCIAL DISTRIBUTION IN JULY.AS PART OF FDA'S APPROVAL, THERAPEUTICSMD HAS COMMITTED TO CONDUCT A POST-APPROVAL OBSERVATIONAL STUDY.  Full Article

TherapeuticsMD Submits New Drug Application For TX-001HR
Thursday, 28 Dec 2017 

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 

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 

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 

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 

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 reports Q2 loss per share $0.11
Thursday, 4 Aug 2016 

Therapeuticsmd Inc : Therapeuticsmd announces second quarter 2016 financial results . Q2 loss per share $0.11 . Q2 earnings per share view $-0.10 -- Thomson Reuters I/B/E/S .Topline phase 3 data for tx-001hr replenish trial on track for q4 of 2016.  Full Article

UPDATE 2-TherapeuticsMD's therapy for menopause-related condition gets approval

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