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Aimmune Therapeutics Inc (NASDAQ:AIMT) shares, which recovered Monday following an earnings-induced sell-off Friday, are adding to the gains.
The Aimmune Catalyst: Shares of Brisbane, California-based Aimmune — which has a commercial product in Palforzia, used to treat peanut allergy in patients ages 4-17 — are moving in sympathy with DBV TECHNOLOGIE/S ADR (NASDAQ:DBVT).
DBV faces a regulatory setback, as the FDA handed down a complete response letter to its BLA for Viaskin Patch, an epicutaneous patch to treat peanut allergies in children ages 4-11.
The decision has been expected since the FDA's decision to cancel an Adcom meeting scheduled for May 15.
The nature of concerns raised by the FDA in the CRL has aggravated the negativity triggered by the adverse ruling.
The agency expressed concerns about the impact of patch site adhesion on efficacy and indicated the need for patch modifications that would necessitate a new human factor study.
FDA has also sought supplementary clinical data to support the modified patch and additional Chemistry, Manufacturing and Controls data.
The agency did not raise safety concerns.
DBV's Pain Is Aimmune's Gain: Aimmune's competing drug Palforzia, an oral immunotherapy, was approved for the same indication in February.
Given the COVID-19 disruptions, the commercial launch is slowly taking off. Aimmune did not report any Palforzia revenues for the second quarter, which generated some selling in the stock after its earnings report.
Aimmune said in its second-quarter earnings release last week that, as the U.S economy opens up, allergists are beginning to offer Palforzia to peanut allergy patients.
About 100 allergists have enrolled patients in the REMS, and half of these allergists have enrolled more than one patient, the company said.
With DBV's launch now delayed, Aimmune has gained more time to commercialize its product and enjoy the first-mover advantage for an extended period.
AIMT, DBVT Price Action: Aimmune shares trading 2.35% higher to $13.93 at last check Tuesday, while DBV shares were plunging 41.46% to $2.40.
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