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.

$TXMD appears to have won approval for its vagina hormone Imvexxy. https://t.co/ZlOEkE9jcI

This me-too product (entering a market with cheaper generics) was previously known as Yuvvexy, so real innovation from the Boca Raton-based company.

— Adam Feuerstein (@adamfeuerstein) May 23, 2018

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.

$TXMD - The Imvexxy webpage is offline, I took a screenshot of when it was up, fwiw pic.twitter.com/IWFccYw16u

— BioRunUp (@BioRunUp) May 23, 2018

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.

Ha! $TXMD blames “media reports” for their FDA screw up. I guess it will be our fault, too, when Imvexxy is a commercial flop. https://t.co/3nOONVCnui

— Adam Feuerstein (@adamfeuerstein) May 23, 2018

Related Links:

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

FDA Expresses Concern On TherapeuticsMD; Oppenheimer Downgrades