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FDA Approval of Peanut Allergy Treatment Expected Next Year
Research Report

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The current status, catalysts and outlook for the immunotherapy are discussed in a ROTH Capital Partners report.

In a Nov. 7 research note, ROTH Capital Partners analyst Zegbeh Jallah reported that with respect to Aimmune Therapeutics Inc. (AIMT:NASDAQ), "all eyes remain 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 positive vote from the U.S. Food and Drug Administration's (FDA) allergy products advisory committee, in support of the approval," Jallah noted. The FDA is scheduled to make a decision on Palforzia by January 2020, and approval is expected. ROTH models Q1/20 revenue from U.S. sales of Palforzia at about $4 million.

Jallah highlighted that ROTH does not expect any surprises from the FDA concerning the labeling of Palforzia. This is because the FDA and Aimmune continue to work together to finalize the risk evaluation and mitigation strategy (REMS) associated with the expected black box warning on Palforzia. "No surprises to the label or REMS for Palforzia upon approval will certainly be a positive for the stock," she added.

The analyst indicated that an annual price for Palforzia of around $7,000 is reasonable given it is a specialty drug and will save insurers costs related to allergic reactions that do not receive immediate treatment. Pricing and a "very accommodative REMS" could be near-term catalysts for Aimmune prior to the FDA's decision on Palforzia.

Another near-term catalyst for Aimmune could be the outcome of the advisory committee meeting concerning DBV Technologies SA's (DBVT:NASDAQ) Viaskin, a peanut allergy patch for children ages 4–11. "If DBV is unable to get a majority advisory committee vote in favor of Viaskin, this would be a positive catalyst for Aimmune," Jallah indicated.

With respect to Aimmune's financial status, the biopharma ended Q3/19 with about $200 million in cash.

ROTH has a Buy rating and a $45 per share 12-month target price on Aimmune, whose stock is currently trading at around $27.64 per share.


1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from ROTH Capital Partners, Aimmune Therapeutics Inc., Company Note, November 7, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of Aimmune Therapeutics, Inc. and as such, buys and sells from customers on a principal basis.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

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