- 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)
- Now read: Healthcare - Top 5 Gainers / Losers as of 11:00 AM (10/09/2018)
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