Ladenburg Thalmann initiated coverage of Allena Pharmaceuticals (NASDAQ:ALNA) with a “buy” rating and $23 price target. The stock closed at $10.49 on August 1.
Allena’s developmental program is focused on the reduction of excess metabolite accumulations, such as oxalate, that lead to severe metabolic and kidney disorders. Allena’s lead product is ALLN-177, a form of the enzyme oxalate decarboxylase, which is in late-stage development as a treatment for hyperoxaluria.
“Our investment thesis focuses on ALLN-177 as a potential treatment of enteric hyperoxaluria (EH) and we do not include any of the other forms of hyperoxaluria in our estimates,” writes analyst Matthew Kaplan.
Allena has already initiated its first ALLN-177 Phase 3 trial (URIROX-1), with top-line data in the second half of 2019.
Mr. Kaplan said Allena is currently in discussions with the FDA to finalize the design of the URIROX-2 Phase 3 study and the potential to pursue an accelerated approval pathway for the program. He expects top-line results from Allena’s second Phase 3 study (URIROX-2) in the second half of 2020.
“Based on the above clinical development timeline, we estimate the approval of ALLN-177 for treatment of EH to occur in first half of 2022,” he added. “We expect ALNA to launch the product during 2022.”
