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      FDA’s Response: TherapeuticsMD Inc. (TXMD) Plummets Further Aftermarket - Stocks Telegraph

      By Gule Rukhsar

      Published on

      December 13, 2021

      8:52 AM UTC

      FDA’s Response: TherapeuticsMD Inc. (TXMD) Plummets Further Aftermarket - Stocks Telegraph

      TherapeuticsMD Inc. (TXMD) stock extended losses by 5.41% aftermarket when the company announced FDA’s response. The FDA declined TXMD’s Annovera’s previously submitted sNDA.

      During regular trading, the stock lost 3.30% at a volume of 4.71 million, closing the session at $0.4510. Following the announcement, the stock plunged further down to reach $0.4266 in the after-hours at 431.79K shares.

      The current market capitalization of TXMD is $191.64 million with its 424.93 million outstanding shares.

      FDA’s Response to TXMD

      On December 10, the company announced the response of the FDA to some manufacturing testing limits for ANNOVERA. The company had previously submitted an sNDA with the FDA for this purpose. As per the announcement, FDA did not approve the company’s revisions in the sNDA. Further, the FDA requested additional information and also suggested some recommendations.

      TXMD’s Annovera is the only long-lasting, reversible, procedure-free birth control, approved in August 2018 by the FDA. The president of TXMD said in the announcement that Annovera’s supply will be continued under existing specifications. Furthermore, the company will continue working with the FDA regarding the revisions.

      U.S. Patent Litigation with Amneal

      Previously, TXMD announced the settlement of U.S. litigation for Bijuva® with Amenal, on December 08. As per the previous announcement, the company was under patent litigation with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC, and Amneal Pharmaceuticals of New York LLC.

      According to the announcement, TXMD granted a license to Amneal for the commercialization of a generic version of Bijuva in the U.S. This will start on May 25, 2032, with earlier commencement under specific circumstances. Further, TXMD’s last patent for Bijuva with FDA is set to expire on November 21, 2032.

      In addition, this litigation was pending in the U.S. District Court for New Jersey District since the year 2020.

      TXMD’s Financials

      On November 11, TXMD announced its financial results for the third quarter of 2021. As per the Q3 of 2021, the total net products revenue was $25.4 million. This shows an increase of 41.1% from the year-ago quarter.

      Moreover, the company incurred a net loss of $47.4 million in the third quarter of 2021, against $32.6 million in Q3 of 2020. Consequently, the net loss per basic and diluted share was $011 in Q3 of 2021, against $0.12 in the year-ago quarter.

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