Agile Therapeutics (AGRX) Stock Continues Skyward

Agile Therapeutics Inc (NASDAQ: AGRX) is running for the top in the market today, following up on the gains that we’ve seen from the stock since Wednesday of last week. Today, the gains are 28.15%, bringing the stock to $1.73 per share so far. On Tuesday of last week, the stock closed at just $0.37 per share.

The gains come after the company announced a favorable outcome from the FDA Advisory Committee meeting surrounding Twirla. Here’s what happened:

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AGRX Stock Continues Climbing On FDA Advisory Committee Outcome

On Wednesday of last week, Agile Therapeutics announced the results of an FDA Advisory Committee meeting regarding Twirla. In the release, the company said that the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA voted 14, 1, with 1 abstention, that the benefit of Twirla in the prevention of pregnancy outweigh risks to support approval.

In a statement, Al Altomari, Chairman and CEO at AGRX, had the following to offer:

We are very pleased that BRUDAC voted in favor of Twirla. We look forward to continuing our dialogue with the FDA about the important data presented today and working toward a potential approval of Twirla,. This vote represents a key step toward providing an important new contraceptive option for women.

At the end of the day, the FDA Advisory Committee meetings don’t end in an approval or rejection. It’s also worth mentioning that these committees aren’t the bodies that make the final decisions with regard to approval or rejection.

Nonetheless, the FDA generally tends to follow along the same lines as advisory commitees. So, with a favorable vote for approval of Twirla, there’s now a strong chance that the drug will be approved by the FDA.

Why Such A Massive Reaction?

Although positive advisory commitee meetings generally result in gains in the stock market, it’s rare to see a stock that gains in multiples on this news. In the case of AGRX, that’s just what we’re seeing. So, what’s the big deal?

The truth of the matter is that just before the news broke that the FDA Advisory Committee voted in favor of approval, there were serious concerns that the drug would be rejected.

In fact, along with its financial results, the company issued an update surrounding the Twirla New Drug Application. In the update, AGRX said that the FDA provided a letter stating that it had a number of concerns with regard to the balance of efficacy and risk when it comes to Twirla.

Since Twirla is the lead asset at AGRX, numerous concerns from the FDA led the masses to believe that the drug would be rejected, sending the stock tumbling to less than half of its value.

So, when the news hit, it hit a stock that was heavily undervalued and heavily shorted, leading to a massive run in value. With the prospect of FDA approval head, the stock is seeing further gains!

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