Peanut allergy drug receives an indirect nod of approval from FDA

Aimmune Therapeutics

In the world of biotech, the biggest news of the day came from a relatively niche company. Not many of you likely have heard of Aimmune Therapeutics (NASDAQ: AIMT), but some of you might be dealing with its main target condition right now.

This biotech company is focused on developing a possible peanut allergy treatment option for those who suffer from severe allergic reactions to peanuts. The stock ended up surging on Wednesday after it received an indirect nod of approval from the Food and Drug Administration (FDA), sending shares surging by a double-digit margin.

It was announced by the FDA that this Friday they will bring together a group of physicians to talk about Aimmune’s treatment drug, known as Palforzia. or AR101. What they released on Wednesday, however, are the briefing documents that outline any concerns that agency had with the application.

The most noteworthy thing was that the agency didn’t have any major concerns. This is a big deal in and of itself as its rare for a drug candidate to be relatively clear of any issues from the FDA, which is more than willing to clearly state any major red flags it sees.

At the same time, the FDA doesn’t bring together an advisory committee for every single drug application it considers, so the fact that Palforzia is receiving this kind of treatment is good news as well.

While the data shared in the document is fairly dry and complex, one potential worry that the agency had with Palforzia was on its safety-to-benefit ratio. Patients that had been steadily dosing with Palforzia saw reduced adverse allergic events.

However, the FDA is worried by the fact that 6.1% of patients had needed to use epinephrine to stop a reaction most likely caused by the drug itself. This is almost twice the rate seen in the placebo group, where only 3.1% of patients needed epinephrine.

Shares of Aimmune Therapeutics ended the day up 15.4 percent, gaining an additional 1.34 percent in after-hours trading. The $1.6 billion market cap biotech company has been a mild decrease in value over the past six-months, shedding around 20 percent since September 2018 in a process that’s quite common for biotech stocks.

Many of these companies see their shares slowly decline until they make a major breakthrough, in which their stock jumps substantially.

Overall, investors and analysts alike remain optimistic about Aimmune’s chances to see a blockbuster peanut allergy drug enter the market. Considering the number of people who are allergic to peanuts across America as well as globally, a treatment option would result in tens of billions of dollars worth of revenue for the biotech company.

Aimmune Therapeutics Company Profile

Aimmune Therapeutics Inc is a company operating in the United States biotechnology industry. Its main focus is in the development of product candidates to combat peanut and other food allergies.

The company’s therapeutic approach, which is referred to as Characterized Oral Desensitization Immunotherapy, is a system designed to desensitize patients to food allergens using characterized biologic products, defined treatment protocols, and support services. – Warrior Trading News