What happened
Shares of DBV Technologies (DBVT 2.18%) were up 14.5% early Thursday afternoon after the New England Journal of Medicine published phase 3 data on DBV's trial on its peanut allergy therapy for children aged one to three. The biotech company's shares are up more than 15% so far this year.
So what
In the trial, the company's Viaskin Peanut 250 microgram patch was shown to be superior compared to a placebo in desensitizing children to allergic reactions to peanuts. The results constitute a big victory for the company. In 2020, the Food and Drug Administration (FDA) had issued a complete response letter considering the therapy, citing a lack of efficacy for the product. Last December, the FDA lifted its clinical hold on the company's phase 3 trial for the therapy.
Peanut allergies are the most common food allergy in the U.S., but there are no FDA-approved options for children younger than 4. One study showed that approximately 1.2 million U.S. children and teens -- just more than 2% of the nonadult population -- have peanut allergies. The patch, if approved by the FDA, could see wide usage.
Now what
As a clinical-stage biopharmaceutical company, DBV has no marketed products yet and very little income -- just $2.2 million in the first quarter. As of March 31, it reported it had $192.3 million in cash, enough at its current burn rate to fund operations into 2025, which is the earliest that the Viaskin Peanut 250 microgram patch could likely be launched.
The news, however, makes it easier for the company to raise funds for more research and development to bring the product to market, along with its pipeline, which includes therapies to treat milk allergies.
