What happened
DBV Technologies (DBVT 3.23%), a biopharmaceutical company based in France, provided a business update today regarding Viaskin, a potential peanut allergy treatment the company developed that is currently being reviewed by the U.S. Food and Drug Administration (FDA). DBV Technologies expressed concerns that the review process for Viaskin could be delayed, and the company announced a comprehensive restructuring plan to prepare for that possibility. As a result of these announcements, shares of the company are sinking lower today, and are down by 14.4% as of 3:35 p.m. EDT on Friday.
So what
Viaskin is a "peanut patch" that can desensitize a patient's immune system by gradually exposing the patient to increased amounts of peanut protein. DBV Technologies first submitted a Biologics License Application (BLA) for Viaskin in August of 2019. However, in March, the company announced that the FDA had questioned the effect of patch adhesion on Viaskin's efficacy during its review process. DBV Technologies submitted more data to the health industry regulator to address these issues, but the company has yet to hear back from the FDA.
Image source: Getty Images.
The target action date for the application, which is Aug. 5, remains the same. But considering the lack of update from the FDA, DBV Technologies "is implementing a restructuring plan that will provide the flexibility to continue the BLA review process, prepare to bring Viaskin Peanut to patients, if approved, and preserve the Company's cash runway." The company will reduce its workforce and scale several clinical programs.
Now what
DBV Technologies has at least one other thing to worry about, namely competition for Viaskin. In January, Aimmune Therapeutics (AIMT +0.00%) became the first company to receive FDA approval for a treatment for peanut allergy. The drug in question is called Palforzia, and it works by gradually increasing a patient's tolerance to peanuts. Between the competition from Palforzia and the uncertainty surrounding its BLA for Viaskin, DBV Technologies' future seems a bit hazy. In short, this healthcare stock is not worth investing in right now.
