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DBVT

DBV Technologies

$8.26

-0.52 (-5.92%)

, AIMT

Aimmune

$19.72

-0.04 (-0.20%)

13:42
06/12/19
06/12
13:42
06/12/19
13:42

FARE, partners say 'discouraged' by ICER review of peanut allergy therapies

Food Allergy Research & Education, or "FARE," the American College of Allergy, Asthma and Immunology and the Allergy & Asthma Network jointly issued a statement regarding ongoing review of the comparative clinical effectiveness and value of treatments for peanut allergy currently being conducted by the Institute for Clinical and Economic Review, or "ICER." The joint statement said in part: "On Tuesday, June 11, 2019, ICER convened a meeting of the California Technology Assessment Forum to review its assessment of Viaskin Peanut from DBV Technologies (DBVT) and AR101 from Aimmune Therapeutics (AIMT), two therapies designed to induce immune tolerance. These emerging therapies represent the most significant breakthroughs to date for patients managing food allergies and their caregivers...We thank ICER for the extensive work undertaken to collect and review evidence and data, and for engaging with a variety of stakeholders throughout this process. While ICER appropriately took into account the psychosocial burden of peanut allergy in its assessment, recognizing recently published quality-of-life data, we are discouraged that ICER did not more thoroughly consider the complexity and nuances of available research on immunotherapy in evaluating the benefit these therapies can have on patients managing peanut allergy...We agree that more data on the long-term benefit and protection that can be achieved are needed. However, we have serious concerns about the impact of using computed data on reactions during therapy on ICER's evidence rating without appropriate consideration of the distinctions between medical risks occurring with predictable adverse events during therapy and an unforeseen accidental exposure to peanut in an environment where no emergency treatment is readily available...As organizations representing the voice of patients and thousands of practicing allergists, we are disappointed that ICER did not adopt a more patient-driven approach in assessing the value and benefit of AR101 and Viaskin Peanut. We strongly urge ICER in its final report to reach a decision that ultimately increases their accessibility and takes into account the true impact of treatment and the breakthrough nature of these therapies." In early afternoon trading, shares of DBV are down 4.5% to $8.38 while Aimmune is flat at $19.75.

DBVT

DBV Technologies

$8.26

-0.52 (-5.92%)

AIMT

Aimmune

$19.72

-0.04 (-0.20%)

  • 12

    Jun

  • 13

    Sep

DBVT DBV Technologies
$8.26

-0.52 (-5.92%)

03/06/19
STFL
03/06/19
NO CHANGE
Target $10
STFL
Hold
Stifel keeps Hold on DBV pending execution, capital overhang removal
Not much was new in DBV Technologies' earnings press release and the several additional management departures are "probably not a huge surprise" given new CEO, Daniel Tasse, recently took the helm, Stifel analyst Derek Archila tells investors in a post-earnings research note. The analyst remains on the sidelines with a Hold rating and $10 price target until management executes on its near-term regulatory initiatives and addresses its current capital overhang. Archila, however, says DBV's risk/reward is "probably more favorable at these levels" if management is able to re-file its biologics license application on time in Q3, gain BLA acceptance from the FDA and its panel meeting is eventually positive.
03/08/19
HCWC
03/08/19
NO CHANGE
Target $25
HCWC
Buy
DBV resubmission of BLA could be 'meaningful catalyst,' says H.C. Wainwright
H.C. Wainwright analyst Andrew Fein says that with the manufacturing update in February, as well as Julie O'Neil's engagement with the process, he does not foresee any other roadblocks as DBV Technologies moves towards the resubmission of its Biologics License Application in Q3. DBV should "now have the right stewardship to remedy the issues at hand," Fein tells investors in a research note. He thinks a "smooth and successful" execution of the BLA resubmission could reinvigorate investors' confidence in the management team, remove the regulatory overhang, and be a "meaningful catalyst" for the shares. The analyst reiterates a Buy rating on DBV Technologies with a $25 price target.
04/10/19
STFL
04/10/19
NO CHANGE
STFL
Hold
ICER draft report presents modest headwind for DBV, Aimmune, says Stifel
Stifel analyst Derek Archila noted that ICER, an independent and non-partisan research organization that analyzes the benefits along with costs of treatments, issued a draft report assessing the value and effectiveness of Aimmune's (AIMT) AR101 and DBV Technologies' (DBVT) Viaskin peanut for peanut allergy. He believes ICER's cost-effectiveness analysis re-affirms his cautious approach on the peanut immunotherapy category and believes the report presents a modest headwind for the stocks. However, this was only a draft report in which ICER made assumptions for costs since no official pricing has been announced for either therapy, Archlia noted. He maintains Hold ratings on both Aimmune and DBV Technologies.
05/20/19
FBCO
05/20/19
INITIATION
Target $30
FBCO
Outperform
Aimmune assumed with an Outperform at Credit Suisse
Credit Suisse analyst Evan Seigerman assumed coverage of Aimmune Therapeutics (AIMT) with an Outperform rating and lowered the price target on the stock to $30 from the firm's prior $36 target, citing his belief that AR101 is likely to be approved to reduce risk from exposure in children and adults with peanut allergy. Aimmune's only competitor in peanut allergy treatment, DBV Therapeutics (DBVT), is at least a year behind in his view, Seigerman tells investors.Target $30.
AIMT Aimmune
$19.72

-0.04 (-0.20%)

06/03/19
PIPR
06/03/19
NO CHANGE
Target $60
PIPR
Overweight
Aimmune MAA submission is on track, says Piper Jaffray
Piper Jaffray analyst Christopher Raymond remains a buyer of Aimmune Therapeutics following the company's presentation of topline results from the Phase 3 Artermis trial yesterday. As expected, the update was in line with data from previous trials, with 58.3% of patients treated with AR101 versus 2.3% of placebo-treated patients tolerating 1,000 mg of peanut protein, Raymond tells investors in a research note. He believes Aimmune's Marketing Authorisation Application for AR101 is on track for mid-year and keeps an Overweight rating on the shares with a $60 price target.
06/04/19
JMPS
06/04/19
NO CHANGE
Target $40
JMPS
Outperform
Aimmune data firm up AR101 efficacy profile, says JMP Securities
JMP Securities analyst Liisa Bayko said data from the Phase 3 ARTEMIS study of AR101 for peanut allergy appear consistent with the Phase 3 PALISADE study, even at an earlier time point, and firm up the drug's efficacy profile. Meanwhile, safety looks "slightly better" in ARTEMIS, but this may be due to a shorter trial or differences in the patient population, Bayko added. She thinks the data support an expected MAA submission in mid-2019 and Bayko keeps an Outperform rating on Aimmune shares with a $40 price target.
06/10/19
CANT
06/10/19
NO CHANGE
Target $45
CANT
Overweight
Cantor has increased conviction in approvability of Aimmune's AR101
After hosting management for investor meetings in Europe and the as well the recent data presentations, Cantor Fitzgerald analyst Charles Duncan has increased conviction about the approvability of Aimmune Therapeutics' AR101 in peanut allergy. The analyst believes the "clear benefit/risk of the candidate" will fuel a "paradigm shift" in the treatment of peanut allergy for, "at least, the highest burden patient cohort" as early as Q4 of 2019. He reiterates an Overweight rating on Aimmune shares with a $45 price target.

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