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Regulatory Update Sinks TherapeuticsMD Inc (TXMD)

TherapeuticsMD Inc (NYSEMKT:TXMD) has sunk almost 20%  after it has received a letter from the FDA notifying the company of deficiencies related to an NDA that preclude at this time discussions of labeling/postmarketing for TX-004HR, TherapeuticsMD Inc (NYSEMKT:TXMD)’s applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia. Although the FDA letter does not specify the exact deficiencies identified, TherapeuticsMD Inc (NYSEMKT:TXMD) intends to work with the FDA to understand the nature of the deficiencies and to hopefully resolve them as quickly as possible. TX-004HR’s current/previous PDUFA date is May 7 of this year. The FDA letter does state that the notification does not reflect a final decision on the information under review.

Despite the market reaction, some on Wall Street are still bullish. Specifically, Ken Cacciatore of Cowen maintained his ‘Outperform’ rating and $13 target price, saying that he believes the FDA letter of deficiencies could just lead to a minor delay. Likewise, Annabel Samimy of Stifel doesn’t believe the deficiencies are clinical related given TX-001HR’s co-primary endpoint data.

What Does The Smart Money Sentiment Say?

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Of the 742 elite funds we track, 17 funds were long $72.95 million of TherapeuticsMD Inc (NYSEMKT:TXMD) and accounted for 6.50% of the float on December 31, up from 13 funds and $56.9 million respectively on September 30.

The Bottom Line

TherapeuticsMD Inc (NYSEMKT:TXMD) are down due to a FDA letter notifying the company of deficiencies related to the NDA of TX-004HR. For more reading, check out ‘Bayer Heroin, Coca-Cola’s Cocaine, and Mrs. Winslow’s Soothing Syrup: Is Sugar More Addictive Than Drugs?‘.

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