DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
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DBV Technologies has confirmed alignment with the U.S. FDA on an accelerated approval pathway for its Viaskin Peanut patch for toddlers aged 1-3. The COMFORT Toddlers study is set to begin in Q2 2025, with a BLA submission expected in the second half of 2026.
December 11, 2024 | 9:30 pm
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POSITIVE IMPACT
DBV Technologies has reached an agreement with the FDA on an accelerated approval pathway for its Viaskin Peanut patch for toddlers. This regulatory alignment is a positive step towards the product's market entry.
The alignment with the FDA on an accelerated approval pathway is a significant regulatory milestone for DBV Technologies. It indicates a clear path forward for the Viaskin Peanut patch, potentially speeding up its market entry. This news is likely to positively impact DBVT's stock price in the short term as it reduces regulatory uncertainty and demonstrates progress in their product pipeline.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100