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TXMD

TherapeuticsMD

$5.30

-0.33 (-5.86%)

14:53
07/17/17
07/17
14:53
07/17/17
14:53

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.

TXMD TherapeuticsMD
$5.30

-0.33 (-5.86%)

05/23/17
STFL
05/23/17
NO CHANGE
Target $20
STFL
Buy
TherapeuticsMD scheduled to meet FDA on June 14, says Stifel
Stifel analyst Annabel Samimy says TherapeuticsMD's Type A meeting with the FDA to discuss last month's Complete Response Letter is scheduled for June 14. The analyst sees two likely scenarios from the meeting. The first has TherapeuticsMD seeking class labeling with a Phase 4 post-marketing study to eventually amend the label. And the second has the company seeking an appeal should FDA hold firm in the 12-month safety requirement to justify a differentiated label. Samimy is "convinced" that TX-004HR remains approvable and she keeps a Buy rating on the shares with a $20 price target.
06/13/17
JEFF
06/13/17
NO CHANGE
JEFF
TherapeuticsMD could use data to push post-approval study, says Jefferies
Jefferies analyst Matthew Andrews says that TherapeuticsMD could use prior data - including a finding that low-dose vaginal estrogen is safe for women with breast cancer and a finding that estrogen delivered in a patch is safe for two years - to convince an FDA panel to allow the company to address concerns raised in a complete response letter for its TX-004 drug with a post-approval study instead of a pre-approval study. Andrews keeps a $15 price target and a buy rating on the shares.
07/11/17
OPCO
07/11/17
UPGRADE
Target $10
OPCO
Outperform
TherapeuticsMD upgraded to Outperform from Perform at Oppenheimer
Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform with a $10 price target.
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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MOBL

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