In a Jan. 2 research note, analyst Yasmeen Rahimi reported that Allena Pharmaceuticals Inc. (ALNA:NASDAQ) recently initiated its URIROX-2 trial evaluating reloxaliase (ALLN-177) in patients with enteric hyperoxaluria after it reached agreement with the FDA on the study design and the biologics license application submission plan.
"Especially with the full Phase 3 program underway and shares undervalued in our opinion, we believe this is a buying opportunity" for Allena, Rahimi added. In fact, ROTH's $61 per share price target on this company reflects a potential nearly tenbagger return as the stock is currently trading at around $6.46 per share.
ROTH anticipates 2019 will be transformative for Allena, with numerous catalysts expected to occur, each of which should present a buying opportunity. These events include interim clinical data in H1/19 from the Phase 2 basket trial study; topline results in H2/19 from URIROX-1 and from study 206; and filing of an investigational new drug application for ALLN-346 in gout, which presents in chronic kidney disease patients, sometime this year.
In its discussions with the FDA on URIROX-2, Allena "got what it wanted" in terms of trial design, Rahimi noted. The primary endpoint will be the percent difference from the baseline reading in 24-hour urate oxidase measured during weeks one through four and 16 to 24.
"We believe this morning's announcement of the FDA's agreement with these key design and approval strategy elements represent a big win for Allena," wrote the analyst.[NLINSERT]
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Disclosures from ROTH Capital Partners, Allena Pharmaceuticals Inc., Company Note, January 2, 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 Allena 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.