Four months af­ter DBV Tech­nolo­gies stock was crushed by a shaky set of piv­otal da­ta for its peanut al­ler­gy drug, ri­val Aim­mune Ther­a­peu­tics $AIMT says its Phase III has come through with a promis­ing set of re­sults. And the win sets up an FDA ap­pli­ca­tion lat­er this year for the pi­o­neer­ing drug, with a Eu­ro­pean pitch to fol­low soon af­ter.

Of the 554 pa­tients in the study, 67.2% of the group in the AR101 drug arm were able to tol­er­ate at least a 600 mg dose of peanut pro­tein, pro­tect­ing them from a po­ten­tial­ly dead­ly al­ler­gic re­ac­tion against a small ex­po­sure. In the place­bo arm, on­ly 4% of the 4- to 17-year-olds in the study could say the same.

The da­ta were put on a slid­ing scale based on ex­po­sure, with 96.3% OK with a 300 mg dose of peanut pro­tein (about one peanut) and 50.3% of AR101 pa­tients tol­er­at­ing the sin­gle high­est dose of 1000 mg of peanut pro­tein.

Aim­mune shares ini­tial­ly shot up 21% in ear­ly trad­ing, while DBV saw its stock $DB­VT slide an­oth­er 10%. But the ral­ly didn’t last long. Aim­mune’s shares were down 3% Tues­day af­ter­noon.

Wes­ley Burks

“It’s great to have pa­tients go from man­ag­ing to tol­er­ate at most the amount of peanut pro­tein in a tenth of a peanut with­out re­act­ing to suc­cess­ful­ly eat­ing the equiv­a­lent of be­tween two to four peanuts with noth­ing more than mild, tran­sient symp­toms, if any at all,” said prin­ci­pal in­ves­ti­ga­tor Wes­ley Burks, from the Uni­ver­si­ty of North Car­oli­na School of Med­i­cine.

There was a high drop out rate, though, with 20.4% of AR101 pa­tients — ver­sus 6.5% of place­bo pa­tients — dis­con­tin­u­ing the tri­al, of­ten as a re­sult of an ad­verse event.

Com­pare those re­sults to DBV, and you’ll see a wide gulf sep­a­rat­ing the two.

The place­bo re­sponse in the DBV study — 13.6% — came in just a tiny bit high­er than the 12% re­sponse rate seen in a mid-stage con­trol arm. But the pos­i­tive re­sponse to their Vi­askin Peanut 250 μg dose — de­signed to get re­ac­tive im­mune sys­tems to tol­er­ate peanut pro­tein — tailed off con­sid­er­ably, drop­ping from 48% in Phase II to on­ly 35.3% in the late-stage tri­al af­ter 12 months of ther­a­py.

DBV nev­er­the­less said it would push for an FDA OK in any case.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.