Aimmune Therapeutics Inc (NASDAQ: AIMT)'s peanut allergy product candidate Palforzia to treat peanut allergy in children and adolescents has received the backing of an FDA panel that reviewed the NDA.
Following the positive verdict, H.C. Wainwright looked at what the decision means for DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT), which has a competing drug in late-stage development.
Andrew Fein reiterated a Buy rating on DBV with a $25 price target.
Friday's Adcom meeting validated safety concerns over Aimmune's AR101 treatment, with its peanut protein exposure possibly resulting in anaphylaxis reactions during therapy, Fein said in a Monday note. (See his track record here.)
Anaphylaxis is a serious allergic reaction that occurs quickly and could cause death.
The point about anaphylaxis arising from AR101 treatment that could necessitate epinephrine treatment could ultimately give DBV's competing treatment candidate, the Viaskin Peanut patch, an edge if it is approved, the analyst said.
Viaskin offers a demonstrated exceptional safety profile because of its prescribed mode of slow-release epicutaneous immunotherapy delivery, he said.
The Phase 3 development of Viaskim Peanut in children ages 1-3 years old not only underlines its safety but also possibly expands the future marketability of the product, Fein said.
H.C. Wainwright's readthrough of the AR101 Adcom verdict is that patients could miss dosing an incomplete treatment regimes could occur, as the panel recommended initial dose escalation and up-dosing stages of therapy be administered in a hospital setting capable of treating systemic allergic reactions.
Treatment with AR101 resulted in patients needing epinephrine twice as frequently as those not on drug during the dosing stages, the analyst said, citing the FDA panel's remarks.
This could prompt parents to look for an alternative safer treatment option, he said.
" ... If both an oral immunotherapy and an epicutaneous immunotherapy can ultimately be approved in peanut allergy, there could be room for both products with parents prioritizing considerations for safety and convenience."
The Price Action
Aimmune shares were down 5.88% at $23.22 at the close Monday, while DBV shares were up 0.93% at $24.47.
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|Dec 2018||Initiates Coverage On||Neutral|
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