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      What Is Causing bluebird bio (BLUE) Stock To Rise

      By Fahim Awan

      Published on

      November 1, 2023

      3:13 PM UTC

      Last Updated on

      November 1, 2023

      3:56 PM UTC

      What Is Causing bluebird bio (BLUE) Stock To Rise

      The stock of bluebird bio, Inc. (NASDAQ: BLUE), has demonstrated an upward trajectory on the financial charts during the current trading session. As of the most recent update in the early trading hours, bluebird bio’s stock has surged by 2.54% to reach a price of $3.03. This surge is attributed to a strategic agreement recently entered into by the company.

      This week, bluebird bio (BLUE) finalized a significant accord pertaining to the potential sale of a Rare Pediatric Disease Priority Review Voucher (PRV), contingent upon its reception. This agreement is intricately linked to the anticipated approval of lovotibeglogene autotemcel, often referred to as lovo-cel, for the treatment of sickle cell disease.

      Pursuant to the agreement, the rights to the PRV will be transferred to the purchasing party, with bluebird bio set to receive a sum of $103 million upon the consummation of the sale. It’s essential to note that the execution of this agreement hinges on the approval of the biologics license application (BLA) for lovo-cel by the U.S. Food and Drug Administration (FDA), in addition to the granting of the PRV.

      The BLA for lovo-cel had previously been granted priority review status by the FDA, specifically for patients afflicted with sickle cell disease aged 12 and above, who have a history of vaso-occlusive events (VOEs). Furthermore, the BLA is associated with a Prescription Drug User Fee Act (PDUFA) target date set for December 20, 2023. Importantly, it’s worth noting that bluebird bio may be eligible for a PRV in the event of lovo-cel’s approval for patients below the age of 18.

      The potential sale of a priority review voucher is poised to provide bluebird bio with a significant source of non-dilutive capital, strategically positioned in advance of the forthcoming launch of lovo-cel. Throughout the FDA’s thorough evaluation of lovo-cel, the BLUE team maintains a high level of confidence in the comprehensive and mature nature of its BLA submission designed for individuals aged 12 and above suffering from sickle cell disease.

      The company is eagerly awaiting a regulatory decision expected to be made by the close of this year. The finalization of this transaction is subject to various conditions, including the FDA’s approval of lovo-cel, the receipt of the PRV, and the fulfillment of customary closing requirements.

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