Akebia Therapeutics is a fully integrated biopharmaceutical company focused on developing vadadustat, an investigational therapy for anemia in patients on dialysis. The company says vadadustat is under FDA review, with a potential decision noted for March 27, 2024. Akebia secured a $55 million term loan facility to strengthen liquidity around that regulatory milestone. The arrangement provides $37.0 million immediately and an additional $18.0 million contingent on FDA approval of vadadustat. The financing includes an extended interest-only period and deferred principal repayment, which reduces near-term cash outflows. Management frames the facility as enabling the company to navigate pre- and post-approval activities, including potential commercialization efforts. The deal increases financial leverage and creates eventual repayment obligations tied to the company’s future regulatory and commercial outcomes. Akebia Therapeutics is developing AKB-6548, an orally available hypoxia‑inducible factor prolyl hydroxylase (HIF‑PH) inhibitor intended to treat anemias secondary to chronic kidney disease (CKD) and end‑stage renal disease. The compound is positioned as a potentially safer, orally dosed alternative to injectable erythropoiesis stimulating agents (ESAs) by stimulating endogenous EPO via HIF2α stabilization. In a 93‑patient, 42‑day Phase 2a CKD trial AKB-6548 produced a statistically significant, dose‑related increase in hemoglobin with a safety profile comparable to placebo and low iron requirements. Akebia plans a 140‑day Phase 2b CKD trial expected to begin in the third quarter and intends to use new financing over the next 18 months to complete studies and prepare AKB-6548 for Phase 3. The company was spun out of Procter & Gamble Pharmaceuticals in 2007 and is based in Cincinnati, Ohio. No revenue or user metrics were disclosed in the article. Akebia Therapeutics is a discovery and development company focused on treatments for chronic anemia. Its lead program, AKB-6548, is an orally bioavailable HIF-prolyl hydroxylase (HIF-PH) inhibitor currently in Phase 2 clinical trials. AKB-6548 is described as potentially best-in-class, offering potential advantages including an improved safety profile, once-daily oral dosing, and lower cost of goods versus traditional erythropoiesis stimulating agents. The company drew down a $4.1 million tranche of a previously announced Series B financing to enable completion of the Phase 2 study and to continue the process of selecting a partner for Phase 3 pivotal studies. The tranche was provided by a syndicate of life-science investors. Separately, Akebia spun out two programs—AKB-9778 (Tie-2 activator) and AKB-4924 (HIF-1α stabilizer)—to form a new stand-alone company, Aerpio Therapeutics. Akebia Therapeutics is a Cincinnati, OH–based pharmaceutical discovery and development company focused on anemia and vascular disorders. Its lead anemia program is AKB-6548, which the company says offers potential advantages over traditional erythropoiesis-stimulating agents, including an improved safety profile, oral dosing and lower cost of goods. The financing announced enables Akebia to complete two Phase 2b studies of AKB-6548 and to position that program for pivotal studies. Akebia also plans to advance AKB-9778, a novel Tie-2 activator for diabetic macular edema and vascular leak, into the clinic. The company closed a $22m Series B with a $14m first closing and the right to access an additional $8m through the end of 2011, which funds these near-term clinical plans. Akebia Therapeutics was formed by Joseph Gardner and John Rice to commercialize therapies acquired from Procter & Gamble and focuses on small-molecule drug discovery and development. Its lead candidate is AKB-6548, an oral erythropoietin-stimulating drug intended to treat chronic anemia. The company reported positive Phase 1 results in 33 healthy volunteers, showing increased erythropoietin and reticulocytes and good tolerability. Akebia plans to move into Phase 2 clinical trials for AKB-6548 and is evaluating partnering with a large pharmaceutical company or pursuing additional fundraising to complete development. Financially, the company recently completed a second closing that boosted a previously announced financing to $17 million. Management expects market opportunities due to safety concerns with existing injectable ESAs and potential expansion of the treated patient population if oral agents prove safer and easier to use.

Total raised

$148M

Funding rounds

6

Latest round

Debt Financing

Latest activity

Jan 2024