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Long Position on TXMD @ $6.37 on 9/6/2017 (Momentum)

trading channel on TXMDTherapeuticsMD, Inc. (TXMD) operates as a women's health care product company.

The company manufactures and distributes prescription and over-the-counter product lines, including prenatal vitamins, iron supplements, and natural menopause relief products under the vitaMedMD brand, as well as generic formulations of its prescription prenatal vitamins products under the BocaGreenMD Prena1 name.

Its pipeline of hormone therapy drug candidates include TX-001HR, a combination of estradiol and progesterone drug candidate under clinical trials for the treatment of moderate to severe vasomotor symptoms due to menopause; TX-002HR, a natural progesterone formulation for the treatment of secondary amenorrhea without the potentially allergenic component of peanut oil; and TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of vulvar and vaginal atrophy in post-menopausal women with vaginal linings that do not receive enough estrogen.

The company markets its products primarily through a direct national sales force to health care providers in the OB/GYN market space. Shares are heading higher in an upward trading channel. Shares are currently at the lower boundary of the said channel. Note the 30-day moving average shown in brown. 

Company's lead drug, TX-004HR, is on the verge of being approved by the FDA. Here is a re-cap of the evenets: 

  • On July 5, 2017, the Company submitted additional endometrial safety information to the FDA, as requested by the Agency, to address the only approvability issue raised in the Complete Response Letter (CRL) for the NDA for TX-004HR, which was the lack of long-term safety data beyond the 12 weeks studied in the REJOICE Trial.
  • The Company has received a formal General Advice Letter from the FDA stating that an initial review of this information has been completed and requesting that the Company submit the additional endometrial safety information to the NDA for TX-004HR on or before September 18, 2017, including the safety data from a very large, observational study of long-term, real-world users of vaginal estrogens that is pending publication.
  • The FDA requested approximately six weeks to perform a comprehensive review of these data and has requested a meeting with the Company to discuss the outcome of this review. A tentative meeting date of November 3, 2017 has been set by the Agency. 

Higher share prices are expeceted for this stock.

52-Weeks Trading Range: $3.50 - 8.30

Entry Point: $6.37

Stop Loss: $5.95

Target Price: $6.98

 

Updates

9/29/2017 10:17:35 AM

TXMD closed at $5.30 after filling to selll shares

Position closed on 9/29/2017 at price of $6.00 with a -5.81% loss in 23 days.

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