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TXMD

TherapeuticsMD

$5.67

0.1 (1.80%)

07:23
08/11/17
08/11
07:23
08/11/17
07:23

TherapeuticsMD launch may be only delayed six months, says Stifel

After the FDA said it would review additional data from TherapeuticsMD on vaginal estrogen use and set a November 3 meeting date with the company, Stifel analyst Annabel Samimy thinks the FDA's moves indicate "the data are meaningful enough to satisfy the safety question in the CRL." She thinks that the company's program may be no more than six months delayed from the original plan, and she keeps a $20 price target and a Buy rating on the shares.

TXMD TherapeuticsMD
$5.67

0.1 (1.80%)

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.
07/21/17
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.
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.
08/11/17
DBAB
08/11/17
NO CHANGE
Target $10
DBAB
Buy
TherapeuticsMD announcement a 'small positive,' says Deutsche Bank
Deutsche Bank analyst Esther Rajavelu views TherapeuticsMD's announcement that the FDA will review in detail, as part of the data package for TX-004, a large NIH-sponsored observational study on long-term, real world use of vaginal estrogens as a "small positive." While the analyst remains cautious on the timing and outcome of the review, she sees the news as an "incremental step in the right direction." Rajavelu continues to model for a TX-004 launch in 2019. The analyst keeps a Buy rating on TherapeuticsMD with a $10 price target.

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