Bluebird Bio Sells Priority Review Voucher For $102M, Strengthening Its Financial Position

  • 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.
Loading...
Loading...
ARGX Logo
ARGXargenx SE
$551.22-4.62%

Stock Score Locked: Edge Members Only

Benzinga Rankings give you vital metrics on any stock – anytime.

Unlock Rankings
Edge Rankings
Momentum
84.13
Growth
Not Available
Quality
Not Available
Value
16.18
Price Trend
Short
Medium
Long
Market News and Data brought to you by Benzinga APIs

Comments
Loading...