TherapeuticsMD Falls Despite Acceptance Of NDA: Here's Why
Zacks Investment Research | Dec 19, 2017 10:11PM ET
TherapeuticsMD, Inc. (NASDAQ:TXMD) announced that the FDA has accepted the resubmission of the New Drug Application (“NDA”) for its dyspareunia candidate, TX-004HR. The FDA also set a PDUFA date of May 29, 2018.
Shares of the company however fell 6.8% in after-hours trading on Dec 19, presumably due to classification of resubmission as a Class 2 response by the FDA. Classification as a Class 1 response would have shortened the timeframe for a potential approval from six months to two months.
We remind investors that the company had received a complete response letter (“CRL”) from the FDA in May for the same.
However, TherapeuticsMD’s share price has increased 6.4% in the past six months, outperforming the industry ’s decline 0.4%.
TX-400HR is an applicator-free vaginal estradiol softgel drug for the treatment of moderate-to- severe vaginal pain during sexual intercourse (dyspareunia) due to vulvar and vaginal atrophy (VVA) in post-menopausal women.
The resubmission was supported by data from phase III Rejoice study, which demonstrated statistically significant and clinically meaningful improvements in dyspareunia and vaginal dryness from baseline compared to a placebo.
We note that the resubmission includes data only for two dosages – 4 mcg and 10 mcg – of the candidate.
The CRL was a major setback for the company. Any issue with the resubmission may further delay the candidate’s approval and result in a decline in shares.
According to the press release, an estimated 32 million women are currently suffering from symptoms of VVA in the United States.
We note that in April 2017, AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) had acquired commercial rights to Intrarosa, the only FDA-approved non-estrogen product for the treatment of moderate-to-severe dyspareunia from privately held Endoceutics, Inc.
TherapeuticsMD, Inc. Price
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