Nano cap Agile Therapeutics (AGRX +62.4%) is up on a healthy 15x surge in volume on the heels of its announcement that the FDA has provided a path forward for contraceptive patch Twirla (levonorgestrel/ethinyl estradiol transdermal system).
The agency's Office of New Drugs has suggested a wear study to assess if Twirla has similar adhesion performance to Mylan's (MYL -5.2%) Xulane (norelgestromin and ethinyl estradiol transdermal system), a generic version of Ortho's Evra. If successful, the study should be sufficient to support Twirla's adhesion claim.
The FDA will still need to review the efficacy data, however, if and when Agile resubmits its marketing application. An advisory committee meeting and review is also expected.
Shares collapsed in May on the news that the FDA would require bioadhesion and bioequivalence studies to support a marketing application.
Previously: Agile Therapeutics down 76% on additional work needed for U.S. approval of Twirla (May 18)
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