Agile Therapeutics Inc (NASDAQ:AGRX) stock shot up Wednesday after it announced that the US Food and Drug Administration has accepted for review its new drug application resubmission for Twirla, a promising investigational low-dose combined hormonal contraceptive patch.
Investors hailed the news sending shares in Agile Therapeutics up nearly 8.5% to $1.53 before the opening bell.
The Princeton, New Jersey-based women’s health-care company had originally submitted an application for FDA approval in June 2017.
The NDA resubmission was submitted on May 16, and Agile said it is intended to satisfy a complete response letter the regulator sent Agile, questioning the manufacturing process at a third-party facility and the adhesion properties of it proprietary patch technology called Skinfusion, among other issues.
In a statement, Agile said its resubmitted application also includes the comprehensive results from a comparative wear study (Twirla vs. Xulane, produced by Mylan Pharmaceuticals Inc (NASDAQ:MYL) that was requested by the FDA to address patch adhesion questions, information on the company’s manufacturing process with partner Corium Inc, and other analyses.
The company had earlier expected the FDA to acknowledge its submission as a complete response in about 30 days.
The regulator has now acknowledged the resubmission as a “complete, class 2 response to the CRL” and has assigned November 16, 2019 as the Prescription Drug User Fee Act (PDUFA) goal date. That date actually is when the FDA could approve the patch.
The PDUFA is a law passed by the US Congress which allows the FDA to collect fees from drug manufacturers to fund the new drug approval process.
“The acceptance of our NDA for review represents a significant milestone for Agile," Agile Therapeutics CEO Al Altomari said in a statement. “Now that the FDA has acknowledged our NDA resubmission as a complete response to the CRL, we look forward to continuing to work with the FDA during their review.”
Twirla, also known as AG200-15, is designed to be applied once weekly for three weeks, followed by a week without a patch. The company has eight patents covering Twirla. Its active ingredients are ethinyl estradiol, a synthetic estrogen, and levonorgestrel, a progestin.
Contact Uttara Choudhury at [email protected]