Akebia Therapeutics Inc (AKBA)

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$AKBA from stocktwits

MORE GOOD NEWS - FDA Fast Track Designation is process designed to facilitate development & expedite drug review to treat serious conditions & fill UNMET MEDICAL NEED. Determining whether condition is serious enough for designation is matter of judgment … ARDS is life threatening & acute, diffuse, inflammatory form of lung injury in seriously ill patients characterized by poor oxygenation, pulmonary infiltrates, acute onset. Unadjusted hospitalization mortality was reported to be 35% among those w/ mild ARDS, 40% w/ moderate disease, 46% for patients w/ severe ARDS. AKB 9090 is Akebia’s ARDS drug. Filling an unmet need is defined as providing therapy where none exists or which may be potentially better than available therapy. Drug that receives Fast Track is eligible for accelerated approval/priority review. August of 2022, CEO Butler said Vadadustat was in trials for Covid-19/ARDS which was an “unmet medical need.” Butler was signaling intention to go after Fast Track status.
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