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Show: Allena Pharmaceuticals, Inc (NASDAQ: ALNA)
Receives Fast Track Designation from FDA for the Development of ALLN-346
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Allena Pharmaceuticals, Inc (NASDAQ: ALNA)
surged over 20% in premarket trading after the company announced that its novel oral therapeutic candidate ALLN-346 received the Fast Track designation from the U.S. FDA.
ALLN-346 is in Phase 2 development for the treatment of hyperuricemia in gout patients with advanced chronic kidney disease with currently available therapies either dose-limited or contraindicated due to safety and tolerability concerns.
Allena Pharmaceuticals, Inc. is a late-stage biopharmaceutical company leveraging its novel oral biologic platform to discover, develop and commercialize first-in-class, oral enzyme therapeutics for difficult-to-treat metabolic diseases. Allena’s lead product candidate, reloxaliase, is currently being evaluated in a pivotal Phase 3 clinical program for the treatment of enteric hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, CKD and other serious kidney disorders. Allena is also developing ALLN-346 for the treatment of hyperuricemia and gout in the setting of advanced CKD, with a Phase 1 multiple ascending dose study recently completed and a Phase 2a program underway.
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Allena Pharmaceuticals, Inc.
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“The Buzz” Show: Allena Pharmaceuticals, Inc (NASDAQ: ALNA) Development of ALLN-346