Agile Therapeutics Inc (NASDAQ:AGRX) stock nearly tripled after it announced a positive outcome for its lead product candidate, Twirla, an investigational prescription contraceptive from Wednesday’s meeting of the Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC).
The BRUDAC met to discuss the Princeton, New Jersey-based women’s healthcare company’s New Drug Application (NDA) for Twirla (AG200-15), a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch.
According to the company, the BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval.
Investors responded well, with the stock nearly tripling to $1.38 a share midday Thursday.
“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 Agile Therapeutics CEO Al Altomari.
“This vote represents a key step toward providing an important new contraceptive option for women,” he added.
Agile resubmitted the NDA for Twirla on May 16, 2019. The advisory committee’s non-binding vote is taken into consideration by the FDA as part of its evaluation of the NDA. The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16 for the completion of its review of the Twirla NDA.
Agile expects to ship the product to wholesalers and start its commercial launch in the fourth quarter of 2020. The company’s marketing efforts will initially focus on obstetrician-gynecologists in the US, and it plans to use a significant number of samples in the early stage of commercial launch to gain patient trial and acceptance.
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