Agile Therapeutics Reports First Quarter 2018 Financial Results

Agile Therapeutics (Nasdaq:AGRX), a women’s healthcare company, today reported financial results for the three months ended March 31, 2018 and provided a corporate update.

As quoted in the press release:

Twirla® Update – As previously announced, on December 22, 2017, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in connection with its review of the New Drug Application (NDA) for the Company’s investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15). The CRL informed the Company that the FDA could not approve the NDA in its present form due to deficiencies related to the manufacturing process for Twirla, and questions on the in vivo adhesion properties of Twirla and their potential relationship to the Phase 3 clinical trial results.  At the Company’s request, the FDA had a Type A meeting with the Company to discuss the deficiencies in the Twirla NDA and the potential regulatory path for approval of Twirla. The Company plans to provide an update on the outcome of the Type A meeting after it receives the official meeting minutes from the FDA and it will then be better able to determine when it will resubmit its Twirla NDA.

“We remain focused on working with the FDA to determine a potential path forward for the approval of Twirla,” said Al Altomari, Chairman and Chief Executive Officer of Agile.  “We believe that women continue to seek alternative contraceptive options that are convenient and that Twirla, if approved, will provide women with an important option they do not currently have, a contraceptive patch designed to deliver a low dose of estrogen.”

Click here to read the full press release.