DBV Technologies (NASDAQ:DBVT) is up 24% at 12:31 p.m. EST after announcing that it's worked out the context for submitting the marketing application for its peanut allergy treatment, Viaskin Peanut, with the Food and Drug Administration.
Normally, pre-application meetings don't result in double-digit increases for biotechs, but DBV is in a precarious situation.
Viaskin Peanut showed an effect in the phase 3 Pepites trial with 35.3% of patients considered responders after taking Viaskin Peanut for 12 months compared to 13.6% of patients who received a placebo. But the trial technically failed because the difference in the lower end of the 95% confidence interval -- a statistical measure -- failed to meet the 15% threshold.
DBV's disclosure implies that the FDA may be giving the company a pass on not meeting the confidence interval threshold. DBV Chairman and CEO Pierre-Henri Benhamou characterized the feedback from the FDA as "supporting submission" of the marketing application, but without seeing the written response to DBV's meeting package, it's hard to know if the FDA is giving strong support.
DBV plans to file the application in the second half of 2018. An acceptance of the application by the FDA will be the first hurdle, but it probably won't be until an FDA advisory committee meeting -- assuming there is one -- when investors will get a true sense of the agency's feelings about DBV's data package.
In the meantime, DBV investors should be watching Aimmune Therapeutics (NASDAQ:AIMT), which is scheduled to release top-line data from the phase 3 Palisade trial testing its peanut allergy therapy AR101 this month. Aimmune plans to present the full data at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress next month.