TherapeuticsMD Results 'Worse Than Expected'

Shares of TherapeuticsMD Inc TXMD, a healthcare company that focuses on creating and commercializing products for women, fell more than 11 percent Monday morning after the company announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration.

The letter is in response to the company's New Drug Application (NDA) for its investigational applicator-free estradiol vaginal softgel capsule called TX-004HR. The therapy is used for the treatment of moderate-to-severe vaginal pain during sexual intercourse.

'Worse Than Expected'

TherapeuticsMD said in its press release that while the letter didn't identify any issues related to the efficacy of the therapy, the FDA couldn't approve TX-004HR at this time. Specifically, the FDA cited a lack of long-term endometrial safety data beyond the 12-week period, which was explored in a Phase 3 clinical study called Rejoice Trial.

Nevertheless, the company believes the NDA was approvable and management plans to meet with the FDA to address the concerns raised by the FDA.

TheStreet's senior columnist and biotechnology expert Adam Feuerstein Tweeted that TherapeuticsMD's announcement is "worse than expected." Feuerstein also noted the lack of any safety data beyond 12 weeks "could be a MAJOR problem."

"While we are disappointed that the NDA for TX-004HR was not approved at this time and respectfully disagree with the FDA's decision, we believe there are multiple paths forward to address the concerns raised by the FDA. The FDA has encouraged us to request a meeting to discuss our path forward and we intend to meet with the FDA as quickly as possible," TherapeuticsMD CEO Robert G. Finizio said. "We are also continuing to prepare the NDA for TX-001HR, our investigational oral bio-identical combination of estradiol and progesterone, and anticipate that we will submit that NDA to the FDA as early as the third quarter of 2017."

Shares traded recently at $4.15, down 11.2 percent in the pre-market session.

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Posted In: NDATherapeuticsMDTX 004HRBiotechNewsHealth CareFDAGeneral