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BioWorld - Tuesday, December 16, 2025
Home » Keywords » Dbv Technologies SA

Items Tagged with 'Dbv Technologies SA'

ARTICLES

Palforzia capsules

As FDA crunch bars DBV, Nestle gobbles Aimmune for $2.6B

Aug. 31, 2020
By Randy Osborne
Less than a month after would-be competitor DBV Technologies SA suffered a regulatory setback with its peanut allergy patch candidate, Aimmune Therapeutics Inc. – which at the start of the year gained FDA clearance for Palforzia in the same space – is undergoing an all-cash takeover valued at $2.6 billion by Nestle SA unit Nestle Health Science SA.
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Child pushing away bowl of peanuts

Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch

Aug. 4, 2020
By Randy Osborne
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
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FDA icons

Back to ‘normal’? FDA adcom meets, but questions loom over others

June 17, 2020
By Mari Serebrov
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
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Peanut allergy

Nuts! DBV to peel adhesive (red) tape from allergy bid; stock plunges

March 17, 2020
By Randy Osborne
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
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