Roth Capital Partners initiated coverage of Allena Pharmaceuticals (NASDAQ: ALNA) with a “buy” rating and a $61 price target. The stock closed at $11.02 on March 29.
Allena is focused on the treatment of enteric hyperoxaluria (EH), a devastating renal disease that is associated with progression to end-stage renal disease (ESRD). Specifically, approximately half of EH patients develop ESRD, with nearly 50% mortality rate.
“Given the void of pharmacological options available, Allena is a leading pioneer in the space with Phase 2 evidence already in hand, with a minimal competitive landscape,” writes analyst Yasmeen Rahimi. “With a Phase 3 asset, we believe that Allena is significantly undervalued, partly due to the lack of disease awareness.”
The company’s lead asset, ALNA-177, is addressing the underlying cause of EH and has consistently demonstrated urinary oxalate lowering across three Phase 2 trials in 113 secondary hyperoxaluria patients and one Phase 1 trial in 30 healthy volunteers, she added.
Although there is no set regulatory pathway given the lack of therapies, Ms. Rahimi said Allena’s consistent interactions with the FDA supports the recent commencement of a global, placebo-controlled Phase 3 study (URIROX-1) in 124 EH subjects.
“While we wait for details on URIROX-2 [with 400 EH patients], we emphasize to any doubters that all current guidance for both URIROX trials has been in-line with previously guided timelines,” she said. “In our eyes, the close engagement between Allena and the FDA is reassurance for prudent navigation through regulatory ground.”
