Just a day after European approval, Albireo Pharma Inc (NASDAQ: ALBO) has received FDA approval for Bylvay (odevixibat), the first drug approved to treat pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC).
PFIC afflicts children with severe, progressive liver disease.
The FDA approved Bylvay based on phase 3 trials showing that the drug can help ease pruritus and reduce serum bile acids. It isn't yet known whether it can reduce the need for liver transplants.
The approval marks a high point for the company, spun out of AstraZeneca PLC (NASDAQ: AZN) way back in 2008.
Since then, it went public through a reverse merger and was later forced to shed its nonalcoholic steatohepatitis (NASH) candidate. It failed to achieve proof-of-concept for key NASH measures.
FDA issued a Rare Pediatric Disease Priority Review Voucher (PRV), which the company plans to monetize.
It had cash and cash equivalents of $186.3 million as of June 30 and anticipates the 2021 operating cash burn of $130 million to $135 million.
Excluding any proceeds from the planned sale of the PRV, the company believes that its cash balance will fund its expenses into 2023.
Albireo is kicking off an "immediate" launch.
Price Action: ALBO shares are up 3.41% at $35.50 during the premarket session on the last check Wednesday.
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