HC Wainwright Says Viaskin Benefit Affirmed In Toddlers...What's Next?

HC Wainwright Says Viaskin Benefit Affirmed In Toddlers...What's Next?
  • HC Wainwright believes the most significant takeaway from DBV Technologies SA's DBVT trial update was that 250ug treatment achieved the primary endpoint of difference between the percentage of treatment responders in the active compared to the placebo arm after 12 months. 
  • It reiterates a Buy rating and a $10 price target.
  • Moreover, the analysts highlight that the lower bound of the 95% confidence interval was 22.4%, comfortably exceeding the prespecified 15% threshold. 
  • The analysts emphasize that the Phase 3 EPITOPE trial was much more conservative in its safety assessment compared to the context of oral immunotherapy Palforzia.
  • They note that 1.6% of patients in the Viaskin arm, compared to 0% placebo, experienced an anaphylactic reaction related to or possibly related to treatment while not necessarily requiring epinephrine. 
  • HC Wainwright specifically compares it to Aimmune Therapeutics Inc's Palforzia.
  • Along with black box anaphylactic reaction risk, the analysts note Palforzia demonstrated 9.4% of patients with anaphylaxis in combined studies during dose escalation and up-dosing compared to 3.8% for placebo, highlighting Viaskin's EPIT differentiation from a safety standpoint, while delivering on efficacy with a minimal peanut allergen.
  • Price Action: DBVT shares are up 14.54% at $1.75 during the market session on the last check Wednesday.

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