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TXMD

TherapeuticsMD

$5.67

0.5 (9.67%)

08:11
04/12/18
04/12
08:11
04/12/18
08:11

TherapeuticsMD talks with FDA 'tacit sign' of approval, says Cantor Fitzgerald

Cantor Fitzgerald analyst William Tanner views TherapeuticsMD's disclosure of label negotiations with the FDA regarding TX-004 as a "tacit sign that the drug will be approved." The FDA action date is May 29 "so such an activity would be expected were the Agency prepared to issue a positive decision, in our experience," Tanner told investors yesterday in a research note. He cautions investors from viewing as probable an approval with a label that does not contain the estrogen class black box warning. However, given the drug's "tortuous development path," he believes any approval is a "clear positive." The analyst has an Overweight rating on TherapeuticsMD with a $28 price target.

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TXMD TherapeuticsMD
$5.67

0.5 (9.67%)

12/29/17
CANT
12/29/17
NO CHANGE
Target $28
CANT
Overweight
TherapeuticsMD's TX-001 could be 'far bigger' than TX-004, says Cantor
Cantor Fitzgerald analyst William Tanner reiterates his belief that TherapeuticsMD's TX-001 could be a "far-bigger" drug than the company's TX-004. Consistent with previous guidance, TherapeuticsMD filed yesterday the new drug application for TX-001, the estrogen plus progesterone hormone replacement therapy for treating vasomotor symptoms associated with menopause in women, Tanner tells investors in a research note. If approved, TX-001 could enter a vasomotor symptoms market "characterized by the absence of FDA-approved therapies," the analyst contends. He believes investors may be overlooking TX-001 "with all the fireworks over TX-004 in the past six months." Tanner reiterates an Overweight rating on TherapeuticsMD with a $28 price target. The stock in premarket trading is up 4% to $6.19.
01/16/18
JEFF
01/16/18
NO CHANGE
Target $15
JEFF
Buy
TherapeuticsMD undervalued at current share levels, says Jefferies
Following a dinner with management, Jefferies analyst Matthew Andrews calls shares of TherapeuticsMD undervalued. TX-004HR is a differentiated novel estrogen drug while TX-001HR is a potential new "gold standard" in vasomotor symptoms, Andrews tells investors in a research note partially titled "2018 to Bring Innovation Back to Women's Health." With new drug applications for both under FDA review, TherapeuticsMD is on track for two approvals in 2018, a "rare biopharma achievement," in the multi-billion vaginal atrophy and vasomotor symptoms markets, the analyst writes. He keeps a Buy rating on TherapeuticsMD with a $15 price target.
02/21/18
JEFF
02/21/18
NO CHANGE
Target $15
JEFF
Buy
TherapeuticsMD undervalued into 'transformative' 2018, says Jefferies
Jefferies analyst Matthew Andrews believes 2018 is set up to be a "transformative" year for TherapeuticsMD with two FDA approvals, which he notes is a rarity in small-cap biotech. Finalization of a $200M term loan prior to TX-004HR approval will remove any financing overhang and helps fund both drugs' launches, Andrews tells investors in a research note. He views the stock as undervalued and thinks TX-001HR can become the vasomotor symptoms "gold-standard drug" with $2B-plus in sales. The analyst keeps a Buy rating on TherapeuticsMD with a $15 price target.
02/21/18
CANT
02/21/18
NO CHANGE
Target $28
CANT
Overweight
TherapeuticsMD could have 'breakout year' in 2018, says Cantor Fitzgerald
Cantor Fitzgerald analyst William Tanner reiterates an Overweight rating and $28 price target on shares of TherapeuticsMD following the company's Q4 results. The possibility of dual approvals could make for a "breakout year" in 2018, Tanner tells investors in a post-earnings research note. He believes TX-004 could become an important therapy with which to treat vulvar vaginal atrophy. Further, the "evolving regulatory landscape" for drug compounders should position TX-001 as an attractive alternative commercial product for compounding pharmacies, the analyst adds.

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