Yesterday, private law firm Pomerantz Law issued a press release announcing they had begun an investigation on behalf of investors into DBV Technologies regarding whether the comany and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
DBV is developing Viaskin Peanut, an immunotherapy patch designed to desensitize patients with peanut allergy.
The company submitted a Biologics License Application (BLA) to the US Food & Drug Administration (FDA) in 2019 as a prerequisite to begin marketing the therapy.
In March of 2020, the FDA issued a response to DBV voicing their concern over the patch’s ability to adhere where applied. The company was then obligated to redesign the patch to address the FDA’s concerns resulting in a lengthy delay.
Last week, DBV announced it was beginning the phase 3 clinical trial of the redesigned patch in 4-7-year-olds.
On Wednesday, the company disclosed the FDA issued a partial hold disclosed by the company.
It is unknown how this development will affect the ability of the company to eventually offer Viaskin Peanut as an FDA-approved therapy.
The press release can be read in its entirety below.
September 22, 2022 17:49 ET | Source: Pomerantz LLP
NEW YORK, Sept. 22, 2022 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of DBV Technologies S.A. (“DBV” or the “Company”) (NASDAQ: DBVT). Such investors are advised to contact Robert S. Willoughby at firstname.lastname@example.org or 888-476-6529, ext. 7980.
The investigation concerns whether DBV and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
[Click here for information about joining the class action]
On October 26, 2021, DBV disclosed that it had “received communication from the FDA [U.S. Food and Drug Administration] concerning [DBV’s] STAMP protocol submission of May 6, 2021.” DBV advised investors that “[t]he FDA has requested a stepwise approach to DBV’s modified Viaskin Peanut (mVP) development program. The FDA would like to review the data from DBV’s protein uptake release study prior to providing additional comments on the STAMP protocol design.”
On this news, DBV’s stock price fell $1.45 per share, or 28.71%, to close at $3.60 per share on October 27, 2021.
Then, on September 21, 2022, DBV disclosed that the FDA had put a partial clinical hold on its phase 3 clinical study evaluating its Viaskin Peanut patch for the treatment of peanut allergy in children aged 4 through 7, specifying certain changes to elements of the protocol of the trial.
On this news, DBV’s stock price fell $0.18 per share, or 8.14%, to close at $2.03 per share on September 22, 2022.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980