Shares of Agile Therapeutics Inc. plunged 71% toward a record low in premarket trade Friday, after the company said it received a complete response letter (CRL) from the Food and Drug Administration stating that the new drug application (NDA) for the company’s contraceptive patch, Twirla, could not be approved in its present form. The CRL was in response to the NDA resubmission, which was seeking approval for Twirla, that was accepted for review earlier this year. Among the issues stated in the CRL were deficiencies relating to quality adhesion test methods, issues identified at a facility of a third-quarter manufacturer and the in vivo adhesion properties of Twirla and their potential relationship to phase 3 clinical trial results. “We are clearly disappointed, and we are evaluating the FDA’s response,” said Chief Executive Al Altomari. “We intend to request a meeting with the FDA as soon as possible to discuss the points raised in the CRL and discuss a path to approval for Twirla.” The stock had rallied 18.7% over the past three months through Thursday, while the S&P 500 had gained 7.3%.
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