Shares of microcap biopharmaceutical company DBV Technologies (DBVT) - Get Report jumped more than 40% Friday after the company said it received positive responses from the U.S. Food and Drug Administration regarding its application for a peanut allergy treatment.
The U.S. FDA provided type A meeting requests to the questions the French company submitted in October following its receipt of a complete response letter in connection with its biologics license application (BLA) for Viaskin Peanut DBV712, its once-daily epicutaneous patch to treat peanut allergy in children ages four to 11.
"We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided," said Daniel Tassé, CEO of DBV Technologies. “We look forward to working with our investigators, clinical trial sites, and key stakeholders as we continue in our development of investigational Viaskin Peanut."
In its exchanges with the FDA, DBV proposed potential resolutions for its two main concerns: the impact of patch adhesion and the need for patch modifications.
DBV says it will address details about a new human factor validation study and additional chemistry, manufacturing and controls data in subsequent communication with the FDA.
"We intend to advance a remediation plan for Viaskin Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin Peanut, if approved, to patients suffering from peanut allergies," Tassé said.
Shares of DBV were rising 43.05% to $5.35 per share Friday morning on the news. However, the stock is down more than 70% over the past 12 months.
Shares were experiencing heavy volume, with nearly 10 million shares changing hands at last check, compared to its daily average volume of about 2 million shares.