Allena Pharmaceuticals Inc. (NASDAQ:ALNA) was up 17% after the company announced that ALLN-346, its oral, urate-degrading enzyme, has been awarded Fast track Designation by the US FDA.
Trading Data
On Wednesday, ALNA stock soared 17% at $1 with more than 131.49 million shares, compared to its average volume of 952k shares. The stock has moved within a range of $0.9300 – 1.1700 after opening the trade at $1.04.
Fast Track Designation from FDA
ALLN-346 is currently in the second phase of development for hyperuricemia in gout for patients with CKD. Allena Chief Medical Officer David Clark said they are delighted to receive the Fast Track designation.
ALLN-346 has a proprietary action mechanism for the indication since it can exert its impact on the intestinal tract. Clark said they believe that the oral biologic represents a new way of treating gout patients with advanced CKD once approved.
Currently, there are around 500,000 patients in the US suffering from both disorders, and it is an area of unmet medical need. The intestinal tract in gout patients having advanced CKD is the main route of elimination for urate. ALLN-346 has been designed to leverage that physiological adaption by improving urate secretion and breakdown in the intestinal tract. So, ALNA is worth watching.
Key Quote
“We are delighted to have received Fast Track designation for ALLN-346,” commented, David J. Clark, M.D., Chief Medical Officer of Allena. ” ALLN-346 has a novel mechanism of action for this indication as it is designed to exert its effect in the intestinal tract, leading us to believe that this oral biologic may represent a meaningful new approach to treat gout patients with advanced chronic kidney disease, if approved. With approximately 500,000 patients in the U.S. affected by both disorders, this is an area of high unmet medical need. The timing of this news is also fortuitous with many of our advisors in the nephrology and rheumatology communities gathering virtually for the American Society of Nephrology and American College of Rheumatology meetings this week.”
Traders Corner
ALNA stock is trading above the 20-Day and 50-Day Moving averages of $0.88 and $0.93 respectively. However, the stock is trading below 200-Day moving average of $1.22. The stock is down 9% in the past month.
