Peanut

Jonathan Wolleben reiterated a Buy rating on DBV Technologies, citing Viaskin Peanut's efficacy and safety in treating peanut allergies in toddlers. Data showed significant tolerance improvement and safety over three years. Adherence to patch wear time enhanced clinical responses, aligning with FDA methodology for potential regulatory success.

Stallergenes Greer's Palforzia®, the first EMA and FDA-approved oral immunotherapy for peanut allergy, now extends to toddlers aged 1-3 in Europe. This approval, based on the Phase 3 POSEIDON study, aims to reduce severe allergic reactions and improve quality of life for young patients and their families.

Stallergenes Greer announced the European Commission's approval of Palforzia® for treating peanut allergy in toddlers aged 1-3. This follows FDA approval, marking Palforzia® as the first oral immunotherapy for this age group. The treatment aims to desensitize children to peanuts, reducing severe allergic reaction risks.

Stallergenes Greer's Palforzia®, the first EMA and FDA-approved oral immunotherapy for peanut allergy, now extends to toddlers aged 1-3 in Europe, following U.S. approval. This milestone, based on the Phase 3 POSEIDON study, aims to reduce severe allergic reactions and improve quality of life for young patients and their families.

DBV Technologies' EPITOPE study shows Viaskin Peanut Patch improves efficacy over 36 months, with 83.5% reaching ≥1000 mg eliciting dose. Low wear time variability correlates with better efficacy. Safety data supports proposed FDA labeling strategy, with no serious treatment-related adverse events in Year 3.

Peanut allergy treatments are advancing, with options like oral immunotherapy, biologics, and epicutaneous immunotherapy offering hope for better management. These methods aim to reduce severe reactions by gradually increasing tolerance to peanuts. While no cure exists, these treatments can significantly improve quality of life for those affected.

DBV Technologies confirms alignment with FDA on Accelerated Approval for Viaskin Peanut patch in toddlers 1-3 years-old. COMFORT Toddlers study to start in 2Q 2025, with BLA submission anticipated in 2H 2026. FDA confirmed criteria for post-marketing confirmatory study.

DBV Technologies announced a clear regulatory pathway for Viaskin Peanut patch in toddlers 1-3 years old, with FDA guidance on Accelerated Approval. Key design elements for a post-marketing confirmatory study were agreed upon. Modifications to the patch for commercialization were made, and a Phase 3 study, COMFORT Toddlers, will assess safety and adhesion. A BLA submission is anticipated in 2H 2026.