Agile Therapeutics Inc (NASDAQ: AGRX) is diving in the market this morning, trading on losses of more than 52%. The declines come after the company announced its financial results for the third quarter. The concerns had little to do with finances and more to do with the FDA. Here’s what’s going on:
AGRX Stock Loses Half It’s Value On Quarterly Results
Agile Therapeutics issued its financial results for the third quarter this morning. While the company showed that it has plenty of money on the books, enough to get through at least a year of operations, the report led to serious concerns.
The main value proposition offered by AGRX is a treatment known as Twirla. The treatment is a clinical-stage low-dose contraceptive patch that the company hopes to get approved by the FDA. However, according to today’s report, approval may be a long way off if it ever were to happen.
In the release, the company said that the FDA issued a briefing document. In the document, the regulatory agency expressed “a number of concerns related to Twirla’s approvability.”
Ultimately, the concerns surround the efficacy of the potential treatment when compared to its safety profile. In the release, AGRX said:
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 on the product label.
Essentially, the FDA seems to be in contention with everything having to do with the Twirla New Drug Application. Concerns with regard to safety seem to outweigh any potential benefit of the treatment and the company’s work to provide warnings on the label to reduce risks seem to fall on deaf ears at the FDA.
Why Investors Are So Upset
Ultimately, the news today is bad for Agile Therapeutics on multiple different levels:
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