Agile Therapeutics Inc (NASDAQ:AGRX)’s shares nosedived after the U.S. Food and Drug Administration (FDA) declined to approve Twirla, a stick-on contraceptive by the company the second time in a row. According to Agile, FDA is not convinced about the adhesion properties of the contraceptive patch. The company’s shares dropped 75% after Agile stated that it will continue to pursue the issues related to the contraceptive with the health regulators.
FDA Declines Agile’s Twirla Second Time
Twirla is the chief experimental product of the New Jersey-based American company. The women’s healthcare company announced the details about its meetings with FDA stating that the health regulators have declined its investigational low-dose, non-daily, combination hormonal contraceptive patch due to deficiencies related to the manufacturing process and facility of Twirla.
The product is a combination of female hormones that should be applied once every week for three weeks continuously. However, according to FDA, the patches will not deliver the required amount of hormones necessary for birth control as it tends to fall off quickly. According to the Chief Executive Officer of Agile, Al Altomari, “In light of the feedback from the FDA we also are re-evaluating our business plan to identify ways to extend our ability to fund the company’s operations.”
During the meeting, the FDA asked Agile to reformulate certain formalities of its experimental product and conduct a new study and made its assessment through an independent advisory committee mandatory. But the CEO of Agile has completely disagreed with the assessment of FDA and is planning to dispute resolution against it. He said that the company has enough funds available to put up the appeal if it puts other businesses of the company on hold.
Agile Announces First Quarter 2018 Report
The company recently provided an update related to its First Quarter 2018 report. As per the report, the company had $28.3 million cash and cash equivalents which are a bit less than the $35.9 million of cash and cash equivalents reported for December 31, 2017. While talking about FDA’s disapproval for Twirla, Altomari said that the company had enough of FDA’s rejection and now they need to go forward and appeal. The company is expecting the overall appeal process to take around 60 days.