At just $68 million in market capitalization, Agile Therapeutics (AGRX) is anything but what you’d call “Big Pharma” — but it’s getting bigger. Over the past 52 weeks, Agile Therapeutics stock has just about quadrupled in market cap, and in two months it could go up even more.
On October 30, an FDA Advisory Committee (AdCom) is scheduled to meet to discuss Agile’s once-weekly contraceptive patch for women, “Twirla,” the subject of a New Drug Application that Agile resubmitted to the FDA in May. That submission, by the way, started the clock running on the drug’s “PDUFA date,” which refers to the statutorily mandated deadline for the FDA to issue a ruling on a drug application, as set by the Prescription Drug User Fee Act . In Agile’s case, Twirla’s PDUFA date is November 16, 2019.
Janney analyst Esther Hong is optimistic that Twirla will be approved shortly after completion of the AdCom, noting that the SECURE trial showed Twirla to be 95.8% effective at preventing unintended pregnancies, which is actually slightly better than the average 95.2% effectiveness of similar drugs on the market. Furthermore, Hong notes that there have been no concerns regarding Twirla’s safety raised. Accordingly, she predicts that the upcoming PDUFA date will mark a “transformative event for AGRX,” to wit, FDA approval of its product for sale, generating sales of $23 million in 2020.
Hong believes Agile shares would be worth around $4 over the next 12 month, as she rates the stock a ‘buy.’ For perspective, the stock closed at $1.11 yesterday, so this implies upside of more than 250%.
Similarly optimistic about the AdCom is RBC analyst Randall Stanicky. In a separate note, Stanicky rated Agile stock ‘outperform’ with a $3 price target. He based this price target on somewhat fewer sales than Hong postulated in 2020 — $21 million, based on Twirla hitting the market in the first half of 2020 immediately following an FDA approval.
Stanicky then proceeded to lay out his thoughts on Agile in the years to follow. Sales could more than double to $53 million in 2021, and could peak at perhaps $381 million annually by 2024, at which point Stanicky predicts Twirla will control about 2.2% of the market.
For a company that’s been in business since 1997 but has yet to record its first dollar of revenue, the $381 million prediction will be more than enough to please Agile Therapeutics investors.
Stanicky concluded, “Not only could we see meaningful stock upside on approval (low expectations priced in), we also think AGRX could be a compelling take-out target if approved.”
All in all, Wall Street’s confidence backing this women’s healthcare company is strong, with TipRanks analytics showcasing AGRX as a Strong Buy. Based on 4 analysts polled by TipRanks in the last 3 months, all 4 rate the stock a Buy. The 12-month average price target stands at $3.50, marking a nearly 215% upside from where the stock is currently trading.
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