H.C. Wainwright raised the firm’s price target on DBV Technologies (DBVT) to $7 from $5 and keeps a Buy rating on the shares after DBV reached an agreement with the FDA regarding the regulatory pathway for the Viaskin Peanut patch in toddlers aged one to three under the Accelerated Approval pathway. The firm believes the recent regulatory updates for the peanut patch brings “long-awaited clarity” and addresses one of the “significant regulatory overhangs for its advancement toward potential appr
Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results