Tue, Dec. 6, 9:13 AM
Mon, Dec. 5, 4:58 PM
- TherapeuticsMD (NYSEMKT:TXMD) is up 24% after hours on robust volume in response to its announcement of positive results from a Phase 3 clinical trial assessing four doses of TX-001HR (estradiol and progesterone) in postmenopausal women with moderate-to-severe vasomotor symptoms (hot flashes, night sweats).
- TX-001HR (e-1 mg/p-100 mg) and TX-001HR (e-0.5 mg/p-100 mg) met all four co-primary endpoints and the primary safety endpoint.
- TX-001HR (e-0.5 mg/p-50 mg) and TX-001HR (e-0.25 mg/p-50 mg) did not meet all co-primary endpoints.
- The incidence of consensus endometrial hyperplasia or malignancy was 0% across all four doses, meeting the FDA's recommendations in its draft guidance.
- The company says it is continuing its analysis of the data. It expects to file a New Drug Application (NDA) with the FDA as early as Q3 2017.
- TX-001HR, if approved, will be the first product for the indication that combines the two hormones in a single dose.
Thu, Dec. 1, 10:46 AM
- Notable Calls reports that, according to Goldman Sachs, 70 members of Congress (mostly female) have sent a letter to the FDA emphasizing their support for increasing patient access to TherapeuticsMD's (TXMD -2.2%) Yuvvexy (estradiol softgel capsule) for the potential treatment of women with moderate-to-severe dyspareunia (vaginal pain during intercourse).
- According to sell-side shop Jefferies, more patients will have access to the product, once approved, if the Black Box warning is removed from the label, a realistic objective considering the low-dose non-systemic estradiol formulation in the product. Jefferies believes this would expand the available market to 32M from 8M.
- The company's marketing application is currently under FDA review with an action date (PDUFA) of May 7, 2017.
- Previously: TherapeuticsMD's TX-004 HR successful in late-stage trial in dyspareunia (Dec. 7, 2015)
Tue, Nov. 29, 12:42 PM
Tue, Nov. 29, 11:00 AM
Tue, Nov. 29, 10:54 AM
- TherapeuticsMD (TXMD -16.6%) slumps on almost a 5x surge in volume apparently stoked by news of a short position by Lakewood Capital's Anthony Bozza, a featured speaker at JPMorgan's Robin Hood Investors Conference in New York.
- The company's U.S. marketing application for its estradiol softgel capsule (TX-004HR) for dyspareunia is currently under review. The FDA's action date is May 7, 2017.
Tue, Nov. 22, 1:05 PM
- Oppenheimer initiates coverage of TherapeuticsMD (TXMD +2.2%) with an Outperform rating and $12 (69% upside) price target.
Tue, Nov. 22, 9:17 AM
Thu, Nov. 3, 4:37 PM
Wed, Nov. 2, 5:35 PM
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Mon, Sep. 19, 6:36 PM
- TherapeuticsMD (NYSEMKT:TXMD) is ahead 6% after hours on light volume in response to its announcement that the FDA has accepted for review its New Drug Application (NDA) seeking approval of TX-004HR (estradiol softgel capsule) for the treatment of moderate-to-severe dyspareunia (vaginal pain during intercourse). The agency's action date is May 7, 2017.
- TX-004HR, if approved, will be marketed under the brand name Yuvvexy.
Thu, Aug. 4, 4:32 PM
Wed, Aug. 3, 5:35 PM
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Fri, Jul. 8, 7:45 AM
- Women's health firm TherapeuticsMD (NYSEMKT:TXMD) submits a New Drug Application (NDA) to the FDA seeking approval of Yuvvexy (vaginal estradiol) for the treatment of dyspareunia, moderate-to-severe vaginal pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause.
- The agency will assign an action date (PDUFA) after it accepts the filing for review.
Tue, May 3, 4:15 PM
- TherapeuticsMD (NYSEMKT:TXMD): Q1 EPS of -$0.11 misses by $0.02.
- Revenue of $4.9M (+9.4% Y/Y) misses by $0.83M.
Mon, May 2, 5:35 PM
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