Agile Therapeutics Inc (NASDAQ: AGRX) has had a rough time in the market over the past few days. Unfortunately, the bloodshed continues today. The declines are here for a good reason. Unfortunately, it doesn’t look like Twirla’s going to be approved, and like the title of this article suggests, the company is nothing if it doesn’t have Twirla.
With the blues in mind AGRX is down another 13%. Unfortunately, it looks like the declines are likely to set in for the long run. Here’s why:
AGRX Stock Has Given Up More Than Half Of Its Value
Over the past few trading sessions, Agile Therapeutics has given up more than half of its value. The bloodshed started when the company issued its most recent quarterly report. In general, investors are looking for financial data, but in this case, the big kicker was a note about Twirla. Here’s a key snippet from the report:
The FDA has assigned the Twirla NDA a Prescription Drug User Fee Act (PDUFA) goal date of November 16, 2019. In advance of the Advisory Committee meeting, the FDA issued its briefing document in which it expresses a number of concerns regarding Twirla’s approvability, including but not limited to, concerns related to Twirla’s efficacy when balanced against safety. The FDA also did not appear to agree with the Company’s proposal to include a limitation of use based on patient weight and BMI in the product label.
Essentially, what AGRX is saying here is that it is unlikely that the FDA will approve Twirla. Unfortunately, the efficacy balanced with the safety profile doesn’t seem to jive well with what the regulatory authorities want to see.
This is horrible news for the company.
Those that follow Agile Therapeutics know that Twirla is the company’s flagship candidate. In fact, when you take a look at its investor relations website and click on pipeline, you’ll see “Twirla” and “All Other Candidates.”
Clicking on All Other Candidates shows that there are three combination therapies that AGRX is working on. All of these candidates include the use of Twirla, which if the FDA doesn’t approve the drug, might as well be flushed down the toilet.
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