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TherapeuticsMD Inc (TXMD.A)

TXMD.A on American Stock Exchange

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Latest Key Developments (Source: Significant Developments)

TherapeuticsMD receives complete response letter from FDA for TX-004hr NDA
Monday, 8 May 2017 07:55am EDT 

May 8 (Reuters) - Therapeuticsmd Inc :Therapeuticsmd receives complete response letter from fda for tx-004hr new drug application.Therapeuticsmd inc - no approvability issues identified by fda related to efficacy or cmc.Therapeuticsmd inc - crl did not identify any issues related to efficacy of tx-004hr.Therapeuticsmd inc - no cases of endometrial hyperplasia were observed in rejoice trial at end of week 12 for all doses studied and included in nda.Therapeuticsmd-Concern raised by fda was lack of long-term endometrial safety data for tx-004hr beyond 12-weeks studied in pivotal phase 3 rejoice trial.Therapeuticsmd - crl did not identify issues related to efficacy of tx-004hr, did not identify approvability issues related to chemistry and controls.Therapeuticsmd inc - co believes that nda was approvable as filed and intends to meet with fda as soon as possible to address concerns raised by fda.Therapeuticsmd-Continuing to prepare nda for tx-001hr and anticipate that co will submit that nda to fda as early as q3 of 2017.  Full Article

TherapeuticsMD announces Q1 loss per share $0.11
Tuesday, 2 May 2017 04:30pm EDT 

May 2 (Reuters) - TherapeuticsMD Inc :TherapeuticsMD announces first quarter 2017 financial results.Q1 loss per share $0.11.Q1 earnings per share view $-0.11 -- Thomson Reuters I/B/E/S.Q1 revenue $4.0 million versus $4.9 million.Q1 revenue view $5.2 million -- Thomson Reuters I/B/E/S.TherapeuticsMD - Anticipate FDA action on NDA for TX-004HR on or before scheduled prescription drug user fee act target action date of May 7, 2017.  Full Article

TherapeuticsMD provides additional information on TX-004HR regulatory update
Wednesday, 19 Apr 2017 06:45am EDT 

April 19 (Reuters) - TherapeuticsMD Inc ::TherapeuticsMD provides additional information on TX-004HR regulatory update.TherapeuticsMD - expects FDA will finalize an action on NDA for TX-004HR on or before originally scheduled PDUFA target action date of May 7, 2017.At this time, company is not aware of nature of deficiencies in NDA identified by FDA.  Full Article

Therapeuticsmd provides TX-004HR regulatory update
Monday, 10 Apr 2017 08:00am EDT 

Therapeuticsmd Inc : Therapeuticsmd provides tx-004hr regulatory update . Therapeuticsmd Inc - on April 7, received a letter from fda . Therapeuticsmd-FDA says as part of review of tx-004hr nda, has identified deficiencies preclude discussion of labeling, postmarketing requirements/at this time . Therapeuticsmd inc - letter states that notification does not reflect a final decision on information under review . Therapeuticsmd Inc - letter does not specify deficiencies identified by FDA and at this time company is not aware of nature of deficiencies .Therapeuticsmd Inc - intends to work with fda to understand nature of deficiencies and resolve them as quickly as possible.  Full Article

Therapeuticsmd reports Q4 loss per share $0.12
Thursday, 23 Feb 2017 06:45am EST 

TherapeuticsMD Inc : TherapeuticsMD announces fourth quarter and full-year 2016 financial results . Q4 loss per share $0.12 . Q4 revenue $4.5 million versus $5.6 million . Q4 revenue view $5.9 million -- Thomson Reuters I/B/E/S . Q4 earnings per share view $-0.12 -- Thomson Reuters I/B/E/S .TherapeuticsMD - pipeline of 2 late-stage product candidates advancing towards commercialization,launch of tx-004hr expected in Q4 pending regulatory approval.  Full Article

Franklin Resources reports 5.7 pct passive stake in TherapeuticsMD as of Dec. 31, 2016 - SEC filing
Tuesday, 7 Feb 2017 03:27pm EST 

:Franklin Resources, Inc reports 5.7 percent passive stake in TherapeuticsMD Inc as of Dec. 31, 2016 - SEC filing.  Full Article

TherapeuticsMD reports positive top-line results from pivotal phase 3 replenish trial in postmenopausal women with moderate to severe vasomotor symptoms (vms) treated with tx-001hr
Monday, 5 Dec 2016 04:05pm EST 

Therapeuticsmd Inc : TherapeuticsMD announces positive top-line results from pivotal phase 3 replenish trial in postmenopausal women with moderate to severe vasomotor symptoms (vms) treated with tx-001hr . To submit new drug application for tx-001hr to food and drug administration as early as q3 of 2017 . Very low reported incidence of adverse events of somnolence with tx-001hr .Additional efficacy and safety analyses of replenish trial data are ongoing.  Full Article

TherapeuticsMD announces Q3 2016 financial results
Thursday, 3 Nov 2016 04:05pm EDT 

TherapeuticsMD Inc : Qtrly revenues, net $ 5.5 million versus $ 5.2 million . TherapeuticsMD announces third quarter 2016 financial results . Q3 loss per share $0.13 .Q3 earnings per share view $-0.11 -- Thomson Reuters I/B/E/S.  Full Article

Therapeuticsmd reports Q2 loss per share $0.11
Thursday, 4 Aug 2016 04:05pm EDT 

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

TherapeuticsMD, Inc announces pricing of common stock offering
Thursday, 7 Jan 2016 06:45am EST 

TherapeuticsMD, Inc:Announces pricing of $125 million common stock offering.Says public offering priced at $8.25 per share.  Full Article

More From Around the Web

UPDATE 1-FDA rejects TherapeuticsMD's vaginal pain drug; shares slump

May 8 Women's healthcare company TherapeuticsMD Inc said the U.S. Food and Drug Administration had rejected its application to market its drug to treat vaginal pain, sending its shares down about 13 percent in premarket trading on Monday.