Shares of DBV Technologies DBVT fell 7.24% on Sep 22 after the company announced that the FDA instituted a partial clinical hold on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) phase III study.
The phase III VITESSE study is a placebo-controlled, randomized study evaluating the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 μg patch in peanut-allergic children between four to seven years of age.
The VITESSE study was initiated earlier this month and is expected to enroll 600 patients.
Previously, the company had plans to screen the first patient in the study by the fourth quarter of 2022 and the last patient by the end of 2023.
Though DBV has not yet begun screening the recruitment for the study, the conditions may change after the announcement of the partial hold.
The partial hold imposed by the FDA is specific to the VITESSE study and does not impact any other ongoing clinical studies conducted by the company.
In the partial hold letter provided by the FDA, the regulatory body specified changes to certain elements of the VITESSE protocol, which may be supportive of a future biologics license application (“BLA”) submission of the Viaskin Peanut Patch. DBV intends to provide further updates regarding the partial hold post an FDA consultation.
Shares of DBV technologies have returned 28.2% in the year-to-date period against the industry’s decline of 26%.
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Investors must note that in August 2019, DBV submitted a BLA to the FDA for Viaskin Peanut to treat peanut allergy in children aged four to 11 years. The BLA was accepted by the FDA for review in October 2019.
The BLA for Viaskin Peanut was supported by a global development program that consisted of eight clinical studies, including two phase I, four phase II and two phase III clinical studies (PEPITES and REALISE).
In August 2020, DBV received a complete response letter (CRL) from the FDA regarding the company’s BLA for Viaskin Peanut, stating that the candidate cannot be approved in its present form. The FDA also identified concerns regarding the impact of patch-site adhesion on efficacy. It further indicated the need for patch modifications and a new human factor study.
The FDA also indicated the need for supplementary clinical data to support the modified patch. Additionally, FDA requested additional Chemistry, Manufacturing and Controls (CMC) data. However, the regulatory body did not raise any safety concerns related to Viaskin Peanut.
In June 2022, DBV reported top-line data from its pivotal phase III study EPITOPE (EPIT in TOddlers with peanut allergy), evaluating the safety and efficacy of Viaskin Peanut 250 μg for the treatment of peanut-allergic toddlers between one to three years of age. The study met its primary endpoint, demonstrating a statistically significant improvement in patients treated with the Viaskin Peanut patch.
DBV Technologies S.A. Price
DBV Technologies S.A. price | DBV Technologies S.A. Quote
Zacks Rank and Other Stocks to Consider
DBV Technologies currently has a Zacks Rank #2 (Buy).
Some similar-ranked stocks in the same sector include Aridis Pharmaceuticals ARDS, Immunocore IMCR and Satsuma Pharmaceuticals STSA, each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
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ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Immunocore’s loss per share estimates for 2022 widened from $1.34 to $1.46 in the past 30 days. The same for 2023 has narrowed from $1.78 to $1.65 in the same time frame.
Earnings of Immunocore missed estimates in three of the trailing four quarters, while beating the same in the reaming occasion. The average earnings surprise for IMCR is 33.28%.
Satsuma’s loss per share estimates for 2022 widened from $1.88 to $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.
Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.
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