TherapeuticsMD Drops As TX-004HR Update Seen Not Reading 'Well At All'

Shares of TherapeuticsMD (TXMD), a women's healthcare company, plunged in pre-market trading after the company provided a regulatory update on the status of its New Drug Application for TX-004HR.

Image result for TherapeuticsMD

REGULATORY UPDATE: In a statement, TherapeuticsMD provided an update on the status of its NDA for TX-004HR, its investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse, saying that it participated in a Type A Post-Action Meeting on June 14 with the FDA's Division of Bone, Reproductive, and Urologic Products. At the meeting, the two sides discussed the complete response letter that TherapeuticsMD previously received for the NDA, which also allowed the company to present new information it believes could address concerns raised in the letter and "positively" impact the status of the NDA. TherapeuticsMD said it has formally submitted the new information for consideration per the FDA's request. However, the company noted that while it continues to have "productive" dialogue with the FDA related to its review, it has not yet received a formal timeline for a conclusion of this review. TherapeuticsMD said it "looks forward" to working with the FDA to address its concerns and sees further clarity on the pathway forward for the NDA "in the coming weeks," adding that it "reserves the right to pursue the FDA's formal dispute resolution process if a reasonable timeline to address such concerns cannot be established."

WHAT'S NOTABLE: On May 8, TherapeuticsMD said it received the CRL from the FDA regarding the TX-004HR NDA. At the time, the company said it planned to meet with the FDA as soon as possible to address the concerns raised in the letter, which involved "the lack of long-term endometrial safety data for TX-004HR beyond the 12-weeks studied in the pivotal phase 3 Rejoice Trial." Adam Feuerstein, who previously wrote about biotech stocks for TheStreet and currently is a senior writer for StatNews, tweeted in May that the company lacks the cash to conduct the type of safety study of TX-004HR requested by the FDA, without cutting expenses or raising more money, adding that a delay for this product "could be fatal" for the company. This morning, Feuerstein tweeted that TherapeuticsMD's regulatory update on resolving the CRL "does not read well at all."

1 2
View single page >> |

Disclosure: None. 


How did you like this article? Let us know so we can better customize your reading experience. Users' ratings are only visible to themselves.


Leave a comment to automatically be entered into our contest to win a free Echo Show.