TherapeuticsMD drops as TX-004HR update seen not reading ‘well at all’
Shares of TherapeuticsMD (TXMD) plunged in pre-market trading on Monday after the company provided a regulatory update on the status of its New Drug Application for TX-004HR.
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.”
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.
Feuerstein tweeted this morning that TherapeuticsMD’s regulatory update on resolving the CRL “does not read well at all.”
ANALYST COMMENTARY PRIOR TO UPDATE
Oppenheimer analyst Jay Olson upgraded TherapeuticsMD to Outperform recently ahead of the FDA meeting update, and said there was a “reasonable probability” of positive news.
Olson argued that data on complete response letters provides confidence that there are likely no other TX-004HR approvability issues besides lack of long-term endometrial safety data beyond the 12 weeks studied in REJOICE and that there are likely no approvability issues that would have any implications for TX-001HR.
In pre-market trading on Monday, TherapeuticsMD is down 12%.
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