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U.S. Biopharma Expands Into ALS, Doses First Patient in 'Potentially Pivotal' Trial
Research Report

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The design of Apellis Pharmaceuticals and its partner's clinical study is presented in a ROTH Capital Partners report.

In a Nov. 19 research note, ROTH Capital Partners analyst Elemer Piros reported that Apellis Pharmaceuticals Inc. (APLS:NASDAQ) and collaborator Swedish Orphan Biovitrum dosed the first patient "in a potentially pivotal amyotrophic lateral sclerosis (ALS) trial" and did so within a month of announcing the study.

Piros briefly described the trial. It will evaluate the safety and efficacy of pegcetacoplan versus placebo, randomized on a 2:1 basis, in 200 patients treated over 52 weeks. The primary endpoint is change in scores on the combined assessment of function and survival. Secondary endpoints include changes in lung function, muscle strength and quality of life.

The analyst highlighted that about 225,000 people in the world have ALS, "a relatively large orphan condition."

In other news, Piros relayed, Apellis recently received a PDUFA date of May 14, 2021 from the U.S. Food and Drug Administration for its new drug application in paroxysmal nocturnal hemoglobinuria.

ROTH has a Buy rating and a $50 per share price target on Apellis Pharmaceuticals, the stock of which is trading now at about $47.40 per share.


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Disclosures from ROTH Capital Partners, Apellis Pharmaceuticals Inc., Flash Note, November 19, 2020

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 Apellis Pharmaceuticals, 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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