French drug developer DBV Technologies SA said on Tuesday the U.S. health regulator declined to approve its experimental skin patch for peanut allergy in children, citing concerns about its effectiveness.
The decision deals a blow to the Montrouge-based anti-allergy therapy developer, which in June said it would scale down its other ongoing clinical programs to focus on the stick-on patch therapy called Viaskin Peanut.
U.S.-listed shares of the DBV Technologies fell 31% in trading before the bell.
Unlike rival Aimmune Therapeutics Inc's oral drug Palforzia, the first U.S. approved drug to enter the lucrative peanut allergy market, Viaskin Peanut delivers allergens directly to the immune system through skin.
The U.S. Food and Drug Administration has identified concerns regarding the impact of patch-site adhesion on Viaskin and requires the patch to be modified, the company said.
The agency has also asked for supplementary clinical data to support the modified patch, but did not raise any concerns over the patch's safety.
DBV plans on meeting the FDA to discuss the agency's response and said it would provide an update after the meeting about the impact on its cash runway from restructuring measures it announced in June.
The company in June said it had cash and cash equivalents of 262.4 million euros ($309.00 million) at the end of the first quarter of 2020.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)
