Shares of
DBV Technologies S.A.
DBVT
were up 22% on Dec 23 after the company announced that the FDA has lifted the 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 evaluating the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 μg patch (DBV712) in peanut-allergic children between four to seven years of age.
The FDA placed a partial clinical hold on the VITESSE study in September 2022. 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.
While lifting the clinical hold, the FDA mentioned that DBVT has satisfactorily addressed all clinical hold issues, which were identified in the partial clinical hold letter. The company may proceed with the VITESSE study after certain changes are to be included in the revised protocol.
DBV is planning to screen the first patient in the VITESSE study in the first quarter of 2023 and the last patient by the first half of 2024. Top-line data from the study is expected in the first half of 2025.
DBV’s stock has fallen 10% year to date compared with the
industry
’s decline of 20.5%.
Image Source: Zacks Investment Research
The VITESSE study was initiated in September 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.
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.
In August 2020, DBV received a complete response letter 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.
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.
Zacks Rank & Stocks to Consider
DBVT currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are
ASLAN Pharmaceuticals Limited
ASLN
,
Adaptimmune Therapeutics plc
ADAP
and
Immunocore Holdings plc
IMCR
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Loss per share estimates for ASLAN Pharmaceuticals have narrowed 7.7% for 2022 and 7.4% for 2023 in the past 60 days.
Earnings of ASLAN Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. ASLN witnessed an earnings surprise of 1.64% on average.
Loss per share estimates for Adaptimmune Therapeutics have narrowed 4.3% for 2022 and 22.3% for 2023 in the past 60 days.
Earnings of Adaptimmune Therapeutics surpassed estimates in one of the trailing four quarters, met the same once and missed on the remaining two occasions. ADAP witnessed a negative earnings surprise of 5.61% on average.
Loss per share estimates for Immunocore have narrowed 56.8% for 2022 and 58.5% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
7 Best Stocks for the Next 30 Days
Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers “Most Likely for Early Price Pops.”
Since 1988, the full list has beaten the market more than 2X over with an average gain of +24.8% per year. So be sure to give these hand-picked 7 your immediate attention.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.
Click to get this free report