- Bluebird Bio Inc BLUE has agreed to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $102 million.
- Bluebird was granted two PRVs upon the FDA approvals of Zynteglo (betibeglogene autotemcel) for beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions and Skysona (elivaldogene autotemcel) for early, active cerebral adrenoleukodystrophy.
- "As momentum builds across our business, this non-dilutive capital further bolsters the ongoing launches of our two recently approved gene therapies and the execution of near-term, value-creating milestones, including the planned submission and subsequent FDA review of our biologics licensing application for lovo-cel for sickle cell disease," said Andrew Obenshain, CEO, Bluebird bio.
- Bluebird continues exploring additional financing opportunities, including monetizing its second PRV, and anticipates providing full 2023 guidance early next year.
- Earlier today, Argenx SE ARGX agreed to acquire an FDA Priority Review Voucher for $102 million.
- A PRV entitles the holder to FDA priority review of a single Biologics License Application (BLA), which reduces the target review period and may lead to an expedited approval.
- Also Read: Argenx's Flagship Neuromuscular Treatment For Subcutaneous Injection Goes Under Priority FDA Review.
- Price Action: BLUE shares are up 1.52% at $7.77 on the last check Wednesday.
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