Agile Therapeutics (NASDAQ: AGRX) stock price soared by over 270% on Thursday after the Company announced a positive outcome from a meeting with the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug Administration (FDA).
The Company met with regulators to discuss its New Drug Application (NDA) for its lead product candidate, Twirla, an investigational combined hormonal contraceptive patch.
Twirla is a prescription patch that contains the active ingredients ethinyl estradiol (EE), which is a synthetic estrogen, and levonorgestrel (LNG), which is a synthetic steroid hormone. The patch delivers both hormones over a seven-day period and is supposed to be applied once weekly for three weeks, followed by a week without a patch.
The BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweighs the risk to support approval, according to Agile Therapeutics’ press release.
“We are very pleased that BRUDAC voted in favor of Twirla. We look forward to continuing our dialogue with the FDA about the important data presented today and working toward a potential approval of Twirla,” said Al Altomari, Chairman and Chief Executive Officer of Agile. “This vote represents a key step toward providing an important new contraceptive option for women.”
Agile’s announcement comes after its stock price plummeted by almost 60% earlier this week after the Company reported in its third-quarter financial results that the FDA issued a document expressing its concern regarding Twirla’s approvability.