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TXMD

TherapeuticsMD

$5.68

0.11 (1.97%)

16:20
08/10/17
08/10
16:20
08/10/17
16:20

TherapeuticsMD receives letter from FDA regarding TX-004HR

TherapeuticsMD announced a regulatory update regarding the New Drug Application, or NDA, for TX-004HR, the company's investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse, or dyspareunia, a symptom of vulvar and vaginal atrophy, or VVA, due to menopause. The Company has received a formal General Advice Letter from the FDA stating that an initial review of this information has been completed and requesting that the Company submit the additional endometrial safety information to the NDA for TX-004HR on or before September 18 including the safety data from a very large, observational study of long-term, real-world users of vaginal estrogens that is pending publication. The FDA requested approximately six weeks to perform a comprehensive review of these data and has requested a meeting with the Company to discuss the outcome of this review. A tentative meeting date of November 3 has been set by the Agency. At this meeting, the Company expects to learn if this additional endometrial safety data addresses the lack of long-term safety identified in the CRL. The Company currently plans to re-submit the NDA for TX-004HR shortly thereafter.

TXMD TherapeuticsMD
$5.68

0.11 (1.97%)

08/04/17
OPCO
08/04/17
NO CHANGE
Target $10
OPCO
Outperform
TherapeuticsMD talks with FDA increasingly collaborative, says Oppenheimer
After TherapeuticsMD provided an update on the regulatory process for both TX-004HR and TX-001HR, Oppenheimer analyst Jay Olson says he believes the narrative between the company and the FDA has become "more collaborative." This suggests next week's potential update on TX-004HR could be favorable, Olson tells investors in a research note. The analyst keeps an Outperform rating on TherapeuticsMD with a $10 price target.
07/21/17
DBAB
07/21/17
INITIATION
Target $10
DBAB
Buy
TherapeuticsMD initiated with a Buy at Deutsche Bank
Deutsche Bank analyst Esther Rajavelu started TherapeuticsMD with a Buy rating and $10 price target. Current trading levels do not fully reflect the TX-001 market opportunity and provide an attractive entry point for investors, the analyst contends. Rajavelu sees upside from current trading levels regardless of the regulatory outcome for TX-004.
07/17/17
STFL
07/17/17
NO CHANGE
Target $20
STFL
Buy
Stifel sees high likelihood FDA lets TherapeuticsMD do post-marketing study
Stifel analyst Annabel Samimy said a lack of clarity is pressuring TherapeuticsMD shares after the company provided a regulatory update on the status of its New Drug Application for TX-004HR, but he thinks there is a high likelihood that the FDA will allow the company to proceed with a post-marketing safety study. Samimy, who still expects a resubmission within weeks and FDA action within two months, keeps a Buy rating and $20 price target on TherapeuticsMD.
07/11/17
OPCO
07/11/17
UPGRADE
Target $10
OPCO
Outperform
TherapeuticsMD upgraded ahead of FDA meeting update at Oppenheimer
Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform from Perform with a $10 price target. The stock closed yesterday down 21c to $4.80. Details of the company's meeting with the FDA are likely to be announced around July 14 and there is a "reasonable probability" of positive news, Olson tells investors in a research note. Evidence supports a scenario where TherapeuticsMD is likely to resubmit TX-004HR by July 31 with a potential FDA approval by September 29 in the best case, the analyst adds. He assigns a 60% probability to this scenario.

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