Agile Therapeutics Inc (NASDAQ:AGRX) said Wednesday that it plans to resubmit to the Food and Drug Administration its new-drug application for the contraceptive patch Twirla in the second quarter.
The women’s healthcare company said in its fourth-quarter earnings statement that its $7.8 million of cash and cash equivalents as of December 31, along with the proceeds from its private placement completed in
Agile said its planned resubmission is intended to address the complete-response letter it received from the
The company announced in February the results of a comparative-wear study that showed that Twirla was statistically noninferior to Xulane.
As announced in October, the FDA formally denied the company’s formal dispute resolution appeal and provided an alternative path forward for resubmission of the new-drug application for Twirla.
For fourth quarter, the company reported a loss of $0.11 per share, which was narrower than the average forecast, calling for a loss of $0.12.
Shares of Agile slipped US$0.02 to $1.65 in Wednesday’s Nasdaq trading.
Contact Dennis Fitzgerald at [email protected]