Agile Therapeutics' stock more than doubles after completing dispute resolution process with FDA

Shares of Agile Therapeutics Inc (NASDAQ:AGRX) rallied on Tuesday after completing a formal dispute resolution process with the FDA’s Office of New Drugs (OND) over its contraceptive product, Twirla.

The company had appealed the decision by the FDA’s Division of Bone, Reproductive and Urological Products (DBRUP) that concerns surrounding the adhesion properties of Twirla prevented its approval. Twirla is a once-weekly contraceptive patch.

While OND has formally denied the company’s appeal, it provided a path forward without the need to reformulate Twirla or conduct a bioequivalence study between formulations, as previously suggested by the DBRUP.

Agile stock more than doubled to the session high of $1.10 and were trading late on Tuesday up 62.16% at $0.749. 

READ: Agile Therapeutics shares plunge on FDA’s criticism of its contraceptive patch

The OND suggested that Agile conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane, the generic version of the previously marketed Ortho Evra contraceptive patch, a product the FDA considers to have acceptable adhesion. 

If this result is demonstrated, OND said that the study would support the conclusion of adequate Twirla adhesion.

Agile Therapeutics is a women’s health care company dedicated to fulfilling the unmet health needs of women. The product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method.

The company is based in Princeton, New Jersey.

Story by ProactiveInvestors