Investors sent shares of Agile Therapeutics Inc (NASDAQ:AGRX) plunging by as much as 74% on the news that the U.S. Food and Drug Administration has “significant concerns” about the adhesion of its contraceptive patch Twirla.
In the official minutes from its April 16 meeting with the company, the FDA said that Agile would have to “reformulate” the way its contraceptive patch sticks to the skin and conduct a formal “adhesion” study after it comes up with another method.
The announcement triggered a huge loss in the group's share price, which plummeted by 74% to trade below $1 at US$0.65.
Agile faces a lengthy process to encourage US regulators to overturn their verdict on its lead product, which has already failed to be vetted by the FDA two times prior to this one.
Twirla, which includes a number of female hormones, is meant to be stuck to a woman's skin once per week for a period of three weeks. The FDA's principal criticism is that these patches drop off and fail to provide the adequate hormones required for birth control.
For its part, the FDA says that once Agile satisfies its questions on adhesion, it will discuss the safety and efficacy of Twirla at an advisory committee meeting to weigh whether its benefits are greater than its risks.
Al Altomari, Agile’s chairman and chief executive officer, disagreed with the FDA’s conclusions on the adhesion of Twirla and says he is looking for ways to fund the additional manufacturing work required to bring Twirla to market.
“While we continue to evaluate all of our options on next steps, we expect we will pursue formal dispute resolution,” he said in a statement. “In light of the feedback from the FDA, we are reevaluating our business plan to identify ways to extend our ability to fund the company’s operations.”