FDA Approval of Peanut Allergy Remedy Anticipated Subsequent Year – InvestorIdeas.com


November 14, 2019 (Investorideas.com Newswire) The existing status, catalysts and outlook for the immunotherapy are discussed in a ROTH Capital Partners report.

In a Nov. 7 analysis note, ROTH Capital Partners analyst Zegbeh Jallah reported that with respect to Aimmune Therapeutics Inc. (AIMT:NASDAQ), “all eyes stay on Palforzia’s U.S. approval and launch in 2020.” Palforzia is Aimmune’s lead candidate, an oral therapy for peanut allergy in youths aged 4–17.

In Q3/19, Palforzia received an “overwhelmingly good vote from the U.S. Meals and Drug Administration’s (FDA) allergy solutions advisory committee, in help of the approval,” Jallah noted. The FDA is scheduled to make a choice on Palforzia by January 2020, and approval is anticipated. ROTH models Q1/20 income from U.S. sales of Palforzia at about $four million.

Jallah highlighted that ROTH does not anticipate any surprises from the FDA regarding the labeling of Palforzia. This is due to the fact the FDA and Aimmune continue to function with each other to finalize the threat evaluation and mitigation tactic (REMS) linked with the anticipated black box warning on Palforzia. “No surprises to the label or REMS for Palforzia upon approval will undoubtedly be a good for the stock,” she added.

The analyst indicated that an annual cost for Palforzia of about $7,000 is affordable provided it is a specialty drug and will save insurers charges associated to allergic reactions that do not acquire quick remedy. Pricing and a “very accommodative REMS” could be close to-term catalysts for Aimmune prior to the FDA’s choice on Palforzia.

A different close to-term catalyst for Aimmune could be the outcome of the advisory committee meeting regarding DBV Technologies SA’s (DBVT:NASDAQ) Viaskin, a peanut allergy patch for kids ages 4–11. “If DBV is unable to get a majority advisory committee vote in favor of Viaskin, this would be a good catalyst for Aimmune,” Jallah indicated.

With respect to Aimmune’s monetary status, the biopharma ended Q3/19 with about $200 million in money.

ROTH has a Invest in rating and a $45 per share 12-month target cost on Aimmune, whose stock is presently trading at about $27.64 per share.


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Disclosures from ROTH Capital Partners, Aimmune Therapeutics Inc., Enterprise Note, November 7, 2019

Regulation Analyst Certification (“Reg AC”): The analysis analyst mostly accountable for the content material of this report certifies the following beneath Reg AC: I hereby certify that all views expressed in this report accurately reflect my private views about the topic organization or organizations and its or their securities. I also certify that no element of my compensation was, is or will be, straight or indirectly, associated to the precise suggestions or views expressed in this report.

ROTH tends to make a marketplace in shares of Aimmune Therapeutics, Inc. and as such, buys and sells from buyers on a principal basis.

ROTH Capital Partners, LLC expects to acquire or intends to seek compensation for investment banking or other small business relationships with the covered organizations described in this report in the subsequent 3 months.

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