According to David Fleischer, global principal investigator of the study, the levels of desensitization achieved in the study after one year of treatment are “highly clinically meaningful.”
- VIASKIN patch is designed to introduce microgram amounts of an allergen like peanuts to the immune system through intact skin to induce tolerance.
- The company now plans to submit an application to the U.S. Food and Drug Administration seeking approval for Viaskin Peanut in the first half of 2026.
- The company expects its application might be provided a priority review.
DBV Technologies (DBVT) said on Tuesday that its late-stage trial evaluating Viaskin Peanut patch for the treatment of peanut allergy in children resulted in significant drop in sensitivity, causing the stock to soar 63% after hours.
The company said that the patch demonstrated a statistically significant treatment effect in children aged 4 to 7 years with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria after 12 months as compared to just 14.8% children who received placebo. The trial enrolled 654 children, more than the target enrollment of 600, who were then randomised to receive the patch or a placebo.
According to David Fleischer, global principal investigator of the study, the levels of desensitization achieved in the study after one year of treatment are “highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option.”
Safety Results
Safety results were also consistent with the profile observed in previous trials, the company said.
Discontinuations due to adverse effects was 3.2% in patients who received the Viaskin Peanut patch as compared to 0.5% in the placebo arm, it added. While two children expected treatment-related serious adverse events and treatment-related anaphylaxis, they continued treatment, the company said.
Looking Forward
The France-headquartered company, which seeks to develop treatment options for food allergies, now plans to submit an application to the U.S. Food and Drug Administration seeking approval for Viaskin Peanut in the first half of 2026.
The company expects its application might be provided a priority review, provided that Viaskin Peanut patch was granted Breakthrough Therapy Designation by the FDA.
VIASKIN patch is designed to introduce microgram amounts of an allergen like peanuts to the immune system through intact skin to induce tolerance. The company is also studying the patch in peanut allergic toddlers of 1 through 3 years of age and expects to seek approval for the patch in the age group in the second half of 2026 upon completion of trials.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around DBVT stayed within the ‘extremely bullish’ territory over the past 24 hours while message volume stayed at ‘extremely high’ levels.
A Stocktwits user highlighted a huge market opportunity, citing the large number of people who are allergic to nuts.
Another sees the stock flying to the moon. “Must be mad crackers if you are even considering shorting this,” they added.
DBVT stock has multiplied by about 6 times this year.
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