Edition:
United States

TherapeuticsMD Inc (TXMD.OQ)

TXMD.OQ on NASDAQ Stock Exchange Global Select Market

6.62USD
15 Dec 2017
Change (% chg)

-- (--)
Prev Close
$6.62
Open
--
Day's High
--
Day's Low
--
Volume
--
Avg. Vol
573,078
52-wk High
$8.29
52-wk Low
$3.50

Latest Key Developments (Source: Significant Developments)

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

TherapeuticsMD Inc says to move stock listing to Nasdaq Global Select Market
Monday, 25 Sep 2017 07:12am EDT 

Sept 25 (Reuters) - TherapeuticsMD Inc :TherapeuticsMD Inc - announced that it will voluntarily move its stock exchange listing to Nasdaq Global Select Market from NYSE American Llc.  Full Article

‍TherapeuticsMD announces submission of additional endometrial safety information to new drug application for TX-004HR​
Thursday, 14 Sep 2017 04:30pm EDT 

Sept 14 (Reuters) - TherapeuticsMD Inc :‍TherapeuticsMD announces submission of additional endometrial safety information to new drug application for TX-004HR​.TherapeuticsMD Inc - ‍Company currently plans to re-submit NDA for TX-004HR shortly after meeting​.TherapeuticsMD Inc - ‍Scheduled a formal meeting with FDA for November 3, 2017 regarding TX-004HR​.  Full Article

TherapeuticsMD • Q2 loss per share $0.10
Thursday, 3 Aug 2017 04:05pm EDT 

Aug 3 (Reuters) - TherapeuticsMD Inc :TherapeuticsMD announces second quarter 2017 financial results.Q2 loss per share $0.10.Q2 revenue $4.3 million versus I/B/E/S view $4.9 million.Q2 earnings per share view $-0.11 -- Thomson Reuters I/B/E/S.  Full Article

TherapeuticsMD provides TX-004HR regulatory update
Monday, 17 Jul 2017 06:55am EDT 

July 17 (Reuters) - Therapeuticsmd Inc ::TherapeuticsMD provides TX-004HR regulatory update.TherapeuticsMD- ‍received minutes of meeting, per FDA's request, has formally submitted new information for consideration related to nda for TX-004HR​.Says ‍has not yet received a formal timeline from FDA for a conclusion of review​.TherapeuticsMD Inc - ‍expects to have additional clarity on pathway forward for NDA for TX-004HR in coming weeks​.  Full Article

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

BRIEF-TherapeuticsMD reports Q3 loss per share of $0.07

* TherapeuticsMD announces third quarter 2017 financial results