Agile Therapeutics Denied Approval By FDA for Contraceptive Patch, But the Problem May Be With the FDA, Not the Patch

Agile Therapeutics

Agile Therapeutics, Inc. (NASDAQ:AGRX) took a nasty blow today when it announced that the FDA would not be approving Agile’s contraceptive patch Twirla. This is, in fact, the second time that Twirla has been denied approval from the FDA, this time being particularly painful as the company believed that it had fully addressed the issues the FDA had cited for its first dismissal.

Not unexpectedly, but certainly unfortunate for the company, Agile stock also took a huge blow as a result of the news, tanking over 50% to a near all-time low for the company. The stock is currently sitting at $2.26, which is $2.50 (-52.57%) down from Thursday’s close of $4.76. The stock actually plummeted during pre-market trading, when the announcement was first released, to $1.94, the lowest the stock has been in five years.

Twirla, the contraceptive patch made by Agile, has been eagerly anticipated by many, as it is said to be safer than other patches due to its lower dosage of ethinyl estradiol and levonorgestrel and given the fact that a patch is less demanding of attention than an oral birth control.

The FDA denied Twirla’s approval because it claimed that there were issues with the patch’s adhesion and also some concerns about Agile’s manufacturing facility, which is actually run by Corium International Inc. (NASDAQ:CORI). Both Agile and Corium responded to the FDA’s concerns on both points and Agile said that it had submitted amendments to the FDA in regards to its adhesion issues, citing the positive results it achieved in earlier tests on the patch’s adhesion. The FDA, however, said that it hadn’t actually looked at the submitted amendments before making a decision. This is possibly because it was working quickly to meet the December 26 deadline and didn’t have enough time to properly review any changes.

Agile says that they are working towards setting up a meeting with the FDA to review its decision and find out more information. Judging from the fact that the FDA neglected to review the amendments that Agile made explicitly based off the Administration’s concerns, Agile could probably dispute the FDA’s decision fairly easily – and get a successful approval for Twirla out of it. Were that to happen, Agile’s stocks would probably return to their normal level, if not higher if anticipation for Twirla is as high as it is said to be given that the stock has been fairly steady in the weeks prior to the FDA dismissal.

Despite the blow this whole debacle has had on the company, Agile is confident in its product and will continue to fight for Twirla.

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