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AIMT

Aimmune

$19.89

-1.05 (-5.01%)

08:12
07/11/19
07/11
08:12
07/11/19
08:12

Aimmune cautions stakeholders on ICER report on treatments for peanut allergy

Aimmune cautioned stakeholders against drawing conclusions from the Institute for Clinical and Economic Review's, or ICER's, final report on emerging desensitization treatments for peanut allergy. The company said, "In its review, ICER fails to incorporate available data on both long-term outcomes and quality-of-life. ICER's analysis and the public meeting discussion discounted patient and community perspectives on the physical, social and psychological benefits of desensitization. The resulting final report is biased against immunotherapy, generally, and fails to specifically capture the full value of AR101. Aimmune joins advocates and clinical experts asking payers and policymakers to engage in more thoughtful, unbiased consideration of available evidence-including patient perspectives on quality-of-life improvements and relief from the stress and fear of accidental exposure-when evaluating emerging treatments for peanut allergy. In clinical trials, AR101, Aimmune's investigational biologic drug for use in oral immunotherapy, has demonstrated the ability to increase the median tolerated dose of peanut protein by 100-fold in each of its two pivotal Phase 3 clinical trials. While the report found AR101 to be cost-effective well below traditional health economic thresholds, ICER failed to acknowledge the availability of the positive long-term efficacy and quality-of-life data from the PALISADE open label follow-on study, as well as the clinical outcomes data from the European Phase 3 ARTEMIS trial. These data were recently presented at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress and shared with ICER in May under its "academic in confidence" policy and throughout the review process including the June 11 public meeting. ICER did not acknowledge or incorporate the existing data in its final evidence report or the associated cost-effectiveness analysis. Additionally, ICER failed to consider the potential for long-term disease modification consistent with allergen immunotherapies and mischaracterized the allergic response associated with immunotherapy as a harm, rather than an expected, well understood and easily managed part of the immunotherapy process. With all immunotherapy, allergic reactions are expected and acceptable in the short term in exchange for long-term desensitization to protect against accidental exposure. In clinical trials, median tolerated dose for AR101-treated patients improved from 10mg at baseline to 1000mg at month 12 to 2000mg at month 18-demonstrating both the potential for long-term disease modification and the potential for significant protection against the average real-world reaction-provoking exposure of 125mg, or half a peanut." The FDA's Allergenic Products Advisory Committee, or APAC, will review Aimmune's biologics license application, or BLA, for AR101 at its meeting scheduled for September 13. The FDA accepted the BLA for AR101 in March and previously informed Aimmune that completion of its review would be targeted by late January 2020.

  • 09

    Sep

  • 13

    Sep

AIMT Aimmune
$19.89

-1.05 (-5.01%)

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.
06/17/19
GSCO
06/17/19
INITIATION
Target $14
GSCO
Buy
DBV Technologies initiated with a Buy at Goldman Sachs
Goldman Sachs analyst Graig Suvannavejh started DBV Technologies (DBVT) with a Buy rating and $14 price target. DBVT is a late-stage specialty biotech company, with a proprietary technology platform that could be used to treat a range of food allergies, Suvannavejh tells investors in a research note. The analyst sees 66% upside from current share levels given the potential catalysts over the next 18 months, which include the Biologics License Applications re-filing in Q3 and FDA acceptance in Q4, a potential panel hearing in mid-2020, and likely final U.S. approval by the end of 2020. Suvannavejh sees an 85% probability of success for DBV's Viaskin Peanut and views the treatment as a more compelling option versus Aimmune's (AIMT) AR101 on overall safety and product presentation profiles.
06/19/19
PIPR
06/19/19
NO CHANGE
Target $60
PIPR
Overweight
Piper views setup for Aimmune shares as 'decidedly positive'
Following a dinner with management which included a review of the Phase 3 Artemis data, Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Aimmune Therapeutics with a $60 price target. The key takeaway from the event was the continued execution by management to successfully position AR101 for approval, Raymond tells investors in a research note. The analyst continues to see the setup on Aimmune as "decidedly positive" and he remains a buyer of the stock.

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