TherapeuticsMD Says Imvexxy Awaits May PDUFA Date, Doesn't Acknowledge Website Error

TherapeuticsMD Inc TXMD clarified Wednesday that it hadn't received an FDA ruling on its hormone candidate despite indications suggesting otherwise. Imvexxy has a Prescription Drug User Fee Act (PDUFA) target date of May 29.

The biotech company's stock was halted at 11:39 a.m. ET after a temporarily live website marketing Imvexxy TX-004HR as approved and available for purchase in July catalyzed an 8.1-percent mid-day spike.

As the market reacted to the ostensible news, the site was quickly taken down, alerting investors to the content’s falsehood and indicating the stock’s movement was unjustified.

It's yet unclear whether the site was inadvertently published and subsequently removed by TherapeuticsMD, or if it was altogether fraudulent. The stock conceded gains and fell 5 percent off its intra-day high. It's scheduled to reopen at 1:10 p.m. ET.

At time of publication, TherapeuticsMD had not responded to Benzinga’s request for comment about the website.

Related Links:

TherapeuticsMD Up 40% After Mixed Q3, Plans To Resubmit NDA For TX-004HR

FDA Expresses Concern On TherapeuticsMD; Oppenheimer Downgrades

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