- Akebia Therapeutics Inc (NASDAQ:AKBA) announced initial findings from an investigator-sponsored study evaluating vadadustat for Acute Respiratory Distress Syndrome (ARDS) with COVID-19 and hypoxemia.
- Akebia said the drug failed the primary endpoint, as measured by the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS).
- While the primary superiority threshold over placebo was 95%, researchers calculated a 94% probability that their drug was better than the placebo.
- The University of Texas Health Science Center conducted the trial and was partially funded by Akebia. It enrolled 449 patients.
- "While the trial missed its prespecified primary endpoint at Day14, we are extremely encouraged by the data and believe they support further developing vadadustat as a treatment for ARDS due to COVID-19 or other causes," CEO John Butler said in a statement. "We will now work to review the full data set more thoroughly, consult with experts in the field and ultimately consult FDA on a potential path forward."
- In April, FDA issued a partial clinical hold on the drug's pediatric studies, triggering layoffs. Then in May, Otsuka Holdings (OTC: OTSKY) called off its licensing and co-development pact.
- Earnings: The company reported Q2 Auryxia (ferric citrate) sales of $43.7 million, +32.4% Y/Y. Akebia increased 2022 net Auryxia product revenue guidance to $170 - $175 million.
- Total revenues increased to $126.8 million compared to $52.9 million a year ago.
- The company ended the quarter with $143.9 million.
- Price Action: AKBA shares are down 2.39% at $0.40 during the market session on the last check Friday.
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