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TXMD

TherapeuticsMD

$6.07

0.05 (0.83%)

16:32
11/29/17
11/29
16:32
11/29/17
16:32

TherapeuticsMD resubmits NDA for TX-004HR with FDA

TherapeuticsMD announced that it has resubmitted the New Drug Application 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, with the U.S. Food and Drug Administration. The company expects to learn of the acceptance of the NDA resubmission within 30 calendar days. The FDA will classify the NDA resubmission as Class 1 or Class 2 upon acceptance of the resubmission. A Class 1 review constitutes a two-month review from the date of resubmission and a Class 2 review constitutes a six-month review from the date of resubmission.

TXMD TherapeuticsMD
$6.07

0.05 (0.83%)

11/02/17
CANT
11/02/17
NO CHANGE
Target $32
CANT
Overweight
TherapeuticsMD could rally above $8 on FDA meeting outcome, says Cantor
Absent an announcement to the contrary, TherapeuticsMD is likely to meet with the FDA on Friday, November 3, to discuss the next steps for TX-004's new drug application in vulvar vaginal atrophy, Cantor Fitzgerald analyst William Tanner tells investors in a research note. The analyst reiterates an Overweight rating on the shares with a $32 price target. He expects the company will disclose the meeting outcome next week. Gathering long-term safety data post-approval is the highest probability outcome given that the FDA likely has comfort with the safety profile of vaginally delivered, low-dose estrogen, the analyst contends. He believes this outcome could yield a stock price above $8. TherapeuticsMD closed yesterday down 10c to $4.62.
11/06/17
COWN
11/06/17
NO CHANGE
Target $16
COWN
Outperform
TherapeuticsMD price target raised to $16 from $13 at Cowen
Cowen analyst Ken Cacciatore raised TherapeuticsMD's price target to $16 from $13 and reiterated his Outperform rating following the FDA's agreement for the TX-004HR NDA resubmission. The analyst now believes the product could be approved by mid-2018 and said the even larger TX-001HR program is also moving forward on schedule.
11/06/17
STFL
11/06/17
NO CHANGE
Target $20
STFL
Buy
TherapeuticsMD likely to get Class 1 review for TX-004HR, says Stifel
After the FDA allowed TherapeuticsMD to resubmit its TX-004HR NDA without an additional 12-month safety study, Stifel analyst Annabel Samimy believes it will be a Class 1 submission with a 60-day review period, which would give the drug a PDUFA date in the first quarter of next year. The analyst, who sees this news removing an overhang on TherapeuticsMD, keeps a Buy rating and $20 price target on the stock.
11/14/17
CANT
11/14/17
NO CHANGE
Target $31
CANT
Overweight
Cantor sees TherapeuticsMD being added to Biotechnology Index on Dec. 15
Cantor Fitzgerald's Tracker Quants team predicts TherapeuticsMD (TXMD) will be added to the Nasdaq Biotechnology Index (IBB) on December 15 and that passive trackers will need to buy 34.5M shares of the company. This may provide additional share upside in the short term, Cantor analyst William Tanner tells investors in a research note. He reiterates an Overweight rating on TherapeuticsMD while trimming his price target for the shares to $31 from $32. The women's healthcare company closed yesterday up 23c to $5.90. Tanner continues to believe TherapeuticsMD's TX-004 will be an important new therapy for vulvar vaginal atrophy.

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