DBV rises, FDA clears Viaskin Peanut clinical trial to resume











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PARIS (Reuters) – DBV Technologies shares rose on the Paris Stock Exchange on Friday morning after the company announced the lifting of the partial clinical suspension by the United States Food and Drug Administration (FDA) of a clinical study on Viaskin Peanut , his treatment for peanut allergy.

The biotech title gained 17.95% to 2.812 euros at 08:56 GMT, the strongest increase in the CAC Mid & Small index, then up 0.23%.

DBV announced that the FDA has lifted the partial clinical hold of the VITESSE Phase 3 trial of the Viaskin Peanut patch in children ages 4-7.

The group indicates in a press release that the FDA has “confirmed that DBV has satisfactorily addressed all the points” mentioned in the clinical suspension letter, in which the American agency requested changes to certain elements of the protocol so that the trial can serve as the basis for a biological license application.

“Excellent news,” Portzamparc said, adding that the suspension will only have delayed the trial by one term, which will have only a limited impact on the schedule.

The group expects to begin the patient selection process in the first quarter of 2023.

(Laetitia Volga, edited by Blandine Hénault)










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