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Agile plans to resubmit contraceptive patch’s new-drug application with FDA

The company said it has funds sufficient to meet its projected operating requirements into the fourth quarter of 2019
The Twirla contraceptive patch
The company expects resubmission of the Twirla application in the second quarter

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 March will be sufficient to meet its projected operating requirements into the fourth quarter of 2019. 

READ: Agile Therapeutics rallies as contraceptive patch company announces $7.8M private placement

Agile said its planned resubmission is intended to address the complete-response letter it received from the FDA in December 2017 and will include the results from a comparative-wear study, additional information on its manufacturing process and other analyses.

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]

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