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TXMD

TherapeuticsMD

$5.63

0.06 (1.08%)

06:58
07/17/17
07/17
06:58
07/17/17
06:58

TherapeuticsMD reports results of meeting with FDA regarding NDA for 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, a symptom of vulvar and vaginal atrophy due to menopause. On June 14 the Company participated in a Type A Post-Action Meeting with the Division of Bone, Reproductive, and Urologic Products of the FDA to discuss the Complete Response Letter that the Company previously received for the NDA for TX-004HR. The meeting enabled the Company to present new information that the Company believes could address concerns raised by the FDA in the CRL and positively affect the status of the NDA for TX-004HR. The Company has received the minutes of the meeting and, per the FDA's request, has formally submitted the new information for consideration related to the NDA for TX-004HR. The Company expects to have additional clarity on the pathway forward for the NDA for TX-004HR in the coming weeks.

TXMD TherapeuticsMD
$5.63

0.06 (1.08%)

05/09/17
OPCO
05/09/17
DOWNGRADE
OPCO
Perform
TherapeuticsMD downgraded to Perform from Outperform at Oppenheimer
Oppenheimer analyst Jay Olson downgraded TherapeuticsMD to Perform saying he's surprised by the FDA's request for long-term safety data. The analyst prefers to move to the sidelines amid uncertainty resulting from the Complete Response Letter.
05/09/17
JEFF
05/09/17
NO CHANGE
Target $15
JEFF
Buy
TherapeuticsMD price target lowered to $15 from $18 at Jefferies
Jefferies analyst Matthew Andrews lowered his price target for TherapeuticsMD to $15 citing a lower probability of success for TX-004HR following the Complete Response Letter. The analyst, with a 55% probability of approval now, believes the FDA's endometrial safety concerns appear addressable. If FDA agrees to approve '004 with a post-approval study, it could obtain a class label with boxed warning, Andrews tells investors in a research note. He keeps a Buy rating on TherapeuticsMD.
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.

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