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Biotech Stocks Facing FDA Decision In October 2019

Agile Therapeutics
Agile Therapeutics

Agile Therapeutics Inc.’s (AGRX) investigational low-dose combined hormonal contraceptive patch Twirla is all set to be reviewed by the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA on October 30, 2019.

Twirla is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen, and levonorgestrel (LNG), a type of progestin.

Agile Therapeutics has been pursuing FDA approval for Twirla since 2012.

The U.S. regulatory agency denied approval for the drug in February 2013, and the Company was asked to conduct a new clinical trial and provide additional information on the manufacturing process for the hormonal contraceptive patch.

Agile Therapeutics’ second attempt in 2017 to get FDA nod for Twirla was also futile as in December of that year, the regulatory agency issued a Complete response Letter and refused to approve the drug again, citing deficiencies relating to quality adhesion test methods and deficiencies in a facility of the Company's third-party manufacturer, Corium International Inc. (CORI).

Addressing the concerns raised in the 2017 Complete response Letter, the Company resubmitted the Twirla NDA in May of this year, and has been assigned the FDA decision date of November 16, 2019. Before the final decision, the FDA panel will review Twirla on the above-mentioned date (Oct.30) and make a recommendation.

It remains to be seen if Twirla will be lucky in its third attempt.

AGRX closed Friday’s (Sep.27, 2019) trading at $1.12, up 6.67%.