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DBV Technologies To Conduct New Pivotal Trial For Peanut Allergy Patch, Shares Plunge To 52-Week Low

Benzinga2021-12-21

After reviewing the FDA's information requests and considering all other options, DBV Technologies has decided not to pursue the sequential approach to develop Viaskin Peanut (allergen uptake/transport study before STAMP).

  • DBV estimates that heeding to the FDA's newly proposed sequential approach would require at least five rounds of exchanges requiring FDA alignment before initiating STAMP, a 6-month safety, and adhesion study.
  • Instead, DBV will initiate a Phase 3 study for a modified Viaskin Peanut patch in children in the intended patient population.
  • The study will feature the modified Viaskin Peanut (mVP) patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut (cVP) patch.
  • The Company is finalizing the protocol and expects to submit the protocol to the FDA by the end of February 2022.
  • DBV Technologies has also decided to withdraw the European marketing application Viaskin Peanut.
  • At the time of the withdrawal, it was under review by the EMA's Committee for Medicinal Products for Human Use (CHMP).
  • Price Action: DBVT shares are down 25.90% at $2 during the premarket session on the last check Tuesday.

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  • BBBBBBBBBB
    ·2021-12-21
    Ok
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  • lost0star
    ·2021-12-21
    Okay
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  • 7a262f6
    ·2021-12-21
    Like ty
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  • DylanYii
    ·2021-12-21
    Pls like
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    • crystaly
      done
      2021-12-21
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    • neoh
      ok
      2021-12-21
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  • neoh
    ·2021-12-21
    Like
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    • neoh
      thanks
      2021-12-28
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    • DylanYii
      👍
      2021-12-21
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  • 一初心一
    ·2021-12-21
    Please like, thanks
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