eyeownu
12 months ago
CAMBRIDGE, Mass., Jan. 30, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced it has closed a loan facility with funds and accounts managed by BlackRock. The loan provides Akebia with up to $55.0 million of borrowing capacity available in three tranches.
At the closing, Akebia drew the first tranche of $37.0 million and used the proceeds to pay down $35.0 million of principal outstanding from a loan agreement with Pharmakon Advisors, LP (Pharmakon), the investment manager of the BioPharma Credit funds, plus interest and fees. The new agreement substantially extends the interest-only period in the event of vadadustat approval by the U.S. Food and Drug Administration (FDA) without requiring any principal repayment until December 31, 2025, with an option for Akebia to extend until December 31, 2026.
eyeownu
12 months ago
$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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