BioTuesdays

HCW starts Allena Pharma at buy; PT $10

Allena Pharmaceuticals Logo

H.C. Wainwright launched coverage of Allena Pharmaceuticals (NASDAQ:ALNA) with a “buy” rating and $10 price target. The stock closed at $1.68 on May 29.

Allena is developing reloxaliase, an orally administered enzyme, for the treatment of enteric hyperoxaluria, which often results in kidney stones and end-stage renal disease. Reloxaliase is in the Phase 3 URIROX-2 study that comes on the heels of the Phase 3 URIROX-1 trial. 

The company’s completed 115 patient Phase 3 URIROX-1 trial that evaluated reloxaliase in patients with enteric hyperoxaluria hit the primary endpoint with a statistically significant reduction in urate oxalate, a biomarker that is a good predictor of the long-term benefit of reloxaliase.

“We are unaware of any other companies that trade at a market cap of under $50-million that are in the second of two Phase 3 studies that could lead to an FDA filing in 2022,” writes analyst Edward White. 

While there is a financial overhang on the stock due to the need for a capital raise to progress to Phase 3 completion, “we believe the promise of a commercially successful drug for enteric hyperoxaluria outweighs the risks,” he added. 

Mr. White said URIROX-2 has the same primary endpoint as URIROX-1 and has common enrollment criteria. Topline data from the full 200 patients are expected in the third quarter of 2022, which could lead to a BLA submission and potential approval in the fourth quarter of 2023, he said.

Sign up for the BioTuesdays weekly newsletter

Get the latest news on the healthcare industry’s corporate and clinical developments, executive moves, and market updates. Every Tuesday, in your inbox.