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TherapeuticsMD Inc (TXMD.OQ)

TXMD.OQ on NASDAQ Stock Exchange Global Select Market

4.53USD
7 Dec 2018
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$-0.10 (-2.16%)
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Latest Key Developments (Source: Significant Developments)

TherapeuticsMD Announces FDA Approval Of Bijuva Capsules For Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause
Monday, 29 Oct 2018 06:00am EDT 

Oct 29 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES FDA APPROVAL OF TX-001HR: BIJUVA™ (ESTRADIOL AND PROGESTERONE) CAPSULES FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE.THERAPEUTICSMD INC - BIJUVA IS EXPECTED TO BE AVAILABLE IN PHARMACIES IN Q2 OF 2019.THERAPEUTICSMD INC - BIJUVA IS EXPECTED TO BE AVAILABLE IN PHARMACIES IN Q2 OF 2019.  Full Article

Therapeuticsmd Files For Potential Mixed Shelf Offering
Tuesday, 31 Jul 2018 05:29pm EDT 

July 31 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD INC FILES FOR POTENTIAL MIXED SHELF OFFERING; SIZE NOT DISCLOSED - SEC FILING.  Full Article

Knight Therapeutics And TherapeuticsMD Announce Strategic Partnership
Tuesday, 31 Jul 2018 04:13pm EDT 

July 31 (Reuters) - Knight Therapeutics Inc ::KNIGHT THERAPEUTICS AND THERAPEUTICSMD ANNOUNCE STRATEGIC PARTNERSHIP.KNIGHT THERAPEUTICS - CO, THERAPEUTICSMD ENTERED LICENSING AGREEMENT THAT GRANTS CO RIGHTS TO COMMERCIALIZE TX-004HR AND TX-001HR IN CANADA AND ISRAEL.KNIGHT THERAPEUTICS INC - WILL PAY THERAPEUTICSMD A MILESTONE FEE UPON FIRST REGULATORY APPROVAL IN CANADA OF EACH OF TX-004HR AND TX-001HR.KNIGHT THERAPEUTICS - AGREED TO INVEST $20 MILLION IN THERAPEUTICSMD COMMON STOCK ALONG WITH CLOSING OF PUBLIC OFFERING OF THERAPEUTICSMD COMMON STOCK.  Full Article

TherapeuticsMD Announces Q2 Financial Results
Monday, 30 Jul 2018 06:15am EDT 

July 30 (Reuters) - TherapeuticsMD Inc ::THERAPEUTICSMD ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS.Q2 LOSS PER SHARE $0.15.Q2 EARNINGS PER SHARE VIEW $-0.12 -- THOMSON REUTERS I/B/E/S.Q2 REVENUE $3.8 MILLION VERSUS I/B/E/S VIEW $4.2 MILLION.PDUFA TARGET ACTION DATE OF OCTOBER 28, 2018 FOR TX-001HR.ENDED QUARTER WITH APPROXIMATELY $154.4 MILLION IN CASH AND APPROXIMATELY $73.1 MILLION IN OUTSTANDING DEBT.  Full Article

TherapeuticsMD Gets FDA Approval Of TX-004HR IMVEXXY For Treatment Of Moderate To Severe Dyspareunia
Wednesday, 30 May 2018 06:00am EDT 

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 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

FDA approves TherapeuticsMD's menopause drug

The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD's oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats, the company said on Monday.