DBV Technologies Provides Update on Regulatory Status of Viaskin Peanut for the Treatment of Peanut-Allergic Children 4 to 11...
February 13 2019 - 4:00PM
DBV Technologies Provides Update on Regulatory Status of Viaskin
Peanut for the Treatment of Peanut-Allergic Children 4 to 11 Years
of Age
Montrouge, France, February 13, 2019
DBV Technologies Provides Update on
Regulatory Status of Viaskin Peanut for the Treatment of
Peanut-Allergic Children 4 to 11 Years of Age
Progress made to date to enable BLA
resubmission in Q3 2019
Company to hold conference call today,
February 13th, at 4:30 ET / 22:30 CET
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced that its planned
resubmission of the Biologics License Application (BLA) to the U.S.
Food and Drug Administration (FDA) for Viaskin Peanut in the
treatment of peanut-allergic children 4 to 11 years of age is
anticipated in the third quarter of 2019.
“We appreciate the detailed feedback the FDA
provided in December 2018, which has allowed us to make meaningful
headway in addressing the information requests needed for a BLA
resubmission,” said Daniel Tasse, Chief Executive
Officer of DBV Technologies. “We are working diligently on our
Viaskin Peanut BLA, bringing us one step closer to potentially
providing an FDA-approved treatment for peanut-allergic children
and their families.”
In December 2018, DBV voluntarily withdrew its
BLA for Viaskin Peanut following correspondence with the FDA
regarding additional data needs on manufacturing procedures and
quality controls. Based on the progress in addressing the FDA’s
guidance, the Company anticipates compiling the required
information for the resubmission of its Viaskin Peanut BLA in the
third quarter of 2019.
Viaskin Peanut previously received Breakthrough
and Fast Track designations for the treatment of peanut-allergic
children from the FDA in 2015 and 2012, respectively.
Conference Call InformationThe
Company will host a conference call to discuss this update on
February 13th, 2019 at 4:30 PM ET (22:30 CET). The conference call
may be accessed by dialing 1 (888) 424-8151 for U.S. callers and 1
(847) 585-4422 for international callers. The passcode for the call
is 6564 506#. A replay of the call will be available for 30
days following the call. The replay number is 1 (888) 843-7419 in
the United States and 1 (630) 652-3042 internationally. The
conference call ID number is 6564 506#.
About DBV
Technologies
DBV Technologies is developing Viaskin®, a
proprietary technology platform with broad potential applications
in immunotherapy. Viaskin is based on epicutaneous immunotherapy,
or EPIT®, DBV’s method of delivering biologically active compounds
to the immune system through intact skin. With this new class of
self-administered and non-invasive product candidates, the Company
is dedicated to safely transforming the care of food allergic
patients, for whom there are no approved treatments. DBV’s food
allergies programs include ongoing clinical trials of Viaskin
Peanut and Viaskin Milk, and preclinical development of Viaskin
Egg. DBV is also pursuing a human proof-of-concept clinical study
of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and
exploring potential applications of its platform in vaccines and
other immune diseases. DBV Technologies has global headquarters in
Montrouge, France and offices in Bagneux, France, Summit, NJ and
New York, NY. The Company’s ordinary shares are traded on segment B
of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of
the SBF120 index, and the Company’s ADSs (each representing
one-half of one ordinary share) are traded on the Nasdaq Global
Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking
statements and estimates, including statements regarding the
potential of Viaskin Peanut and the Company’s regulatory plans
regarding Viaskin Peanut, particularly with respect to the
Company’s expectations regarding its plan to resubmit its BLA to
the FDA and whether any additional clinical trials may be required
to support the BLA resubmission. These forward-looking statements
and estimates are not promises or guarantees and involve
substantial risks and uncertainties. At this stage, the products of
the Company have not been authorized for sale in any country. Among
the factors that could cause actual results to differ materially
from those described or projected herein include uncertainties
related to the Company’s ability to address the concerns raised by
the FDA with respect to its BLA, as well as those associated with
regulatory reviews and approvals and clinical trials more
generally. A further list and description of these risks,
uncertainties and other risks can be found in the Company’s
regulatory filings with the French Autorité des Marchés Financiers,
the Company’s Securities and Exchange Commission filings and
reports, including in the Company’s Annual Report on Form 20-F for
the year ended December 31, 2017 and future filings and reports by
the Company. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements and
estimates, which speak only as of the date hereof. Other than as
required by applicable law, DBV Technologies undertakes no
obligation to update or revise the information contained in this
Press Release.
DBV Investor Relations Contact
Sara Blum ShermanSenior Director, Investor Relations & Strategy
+1 212-271-0740sara.sherman@dbv-technologies.com
DBV Media Contact Joe Becker VP,
Global Corporate Communications+1-646-650-3912
joseph.becker@dbv-technologies.com
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