In a Feb. 3 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that Albireo Pharma Inc. (ALBO:NASDAQ) plans to launch three clinical trials this year in the same number of pediatric liver indications, thus making its 2020 "pivotal" and "catalyst rich."
ROTH's target price on Albireo is $75 per share, and the share price is about $23.47.
Rahimi went on to note what the U.S.-based biopharma's imminent three studies are and when they are likely to start.
Albireo's clinical program with the most imminent readout, expected in mid-2020, is its PEDFIC 1 Phase 3 trial of odevixibat at a low dose and a high dose (40 and 120 micrograms per kilogram per day, respectively) in pediatric patients with progressive familial intrahepatic cholestasis (PFIC) 1 and 2. Only one more patient is needed for enrollment to be completed. Accordingly, "potential approval and launch of odevixibat are within sight, which are anticipated in in H2/21," noted Rahimi.
Another data readout expected in mid-2020 is from the Phase 2 study of a different therapeutic, elobixibat, in nonalcoholic steatohepatitis, or NASH, in adults.
Two, now with U.S. Food and Drug Administration (FDA) approval, Albireo is about to launch a pivotal trial in biliary atresia, a rare pediatric liver disease, in H1/20. The study will be double blind and placebo controlled and enroll 200 patients at 70 locations around the world. Patients will be required to have undergone the Kasai surgical procedure and, thus, be newborns under 90 days old. They will be administered 120 micrograms per kilogram of odevixibat once daily. The trial's primary endpoint will be survival with native liver after two years of odevixibat therapy. Albireo has the funding necessary to conduct this trial that will cost an estimated tens of millions of dollars.
Three, Albireo aims to commence a pivotal trial in Alagille syndrome by year-end 2020. The next step is meeting with the FDA in Q1/20 to finalize the study design.
"Albireo has made it loud and clear that 2020 is the year of execution and advancing all of its assets forward in the clinic," wrote Rahimi.
ROTH has a Buy rating on the biopharmaceutical company.
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Disclosures from ROTH Capital Partners, Albireo Pharma Inc., Company Note, February 3, 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 Albireo Pharma, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Albireo Pharma, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
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.
