bluebird bio will use the funds for the commercialisation and manufacturing of its three FDA-approved gene therapies, as well as general working capital requirements. Credit: Watchara Ritjan via Shutterstock.

is pursuing two avenues to secure up to $250m to address financial challenges exacerbated by the absence of an expected priority review voucher from the FDA.聽

The first involves a proposed public offering, with bluebird working with working with and JP Morgan Securities, aiming to raise $150m. The second is an agreement with speciality finance company Alterna Capital Solutions, providing access to up to $100m.聽

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Under the deal, bluebird will sell Alterna some of its trade accounts receivable, accelerating cash collection compared to the current invoicing process. However, bluebird will receive 90% of the owed amount until Alterna obtains payment, with associated fees.聽

The funds from Alterna will cater to general working capital needs while the proposed offering targets support for the commercialisation and manufacturing of bluebirds three gene therapies, notably Skysona (elivaldogene autotemcel), Zynteglo (betibeglogene autotemcel) and the recently approved sickle cell disease treatment Lyfgenia (lovotibeglogene autotemcel).聽

Bluebird had anticipated the FDA鈥檚 approval of a priority review voucher for Lyfgenia. As per the Priority Review Voucher programme, a company receives a separate voucher that can be used for a different drug when it receives FDA approval for a drug with a priority review designation. The biotech declared in October that had committed to purchasing this voucher for $103m. However, ultimately, the FDA decided against granting the voucher for Lyfgenia. 聽

In the approval letter from the FDA on 8 December, the agency attributed this decision to Lyfgenia鈥檚 active ingredient already being used in bluebird’s Zynteglo. Due to this, despite a high-profile approval coming through that day, bluebird鈥檚 share price fell by nearly 44% and is yet to recover. 

The FDA approval for bluebird鈥檚 sickle cell disease cell therapy Lyfgenia coincided with the approval of Vertex/CRISPR鈥檚 Casgevy (exagamglogene autotemcel). Lyfgenia is derived from a patient鈥檚 blood stem cells, employing cell-based gene therapy to incorporate a novel haemoglobin gene, replacing malfunctioning cells. The therapy initially received a Prescription Drug User Fee Act (PDUFA) date of 20 December, meaning the cell therapy was approved ahead of time. 聽

According to GlobalData鈥檚 Pharma Intelligence Center, Lyfgenia is forecast to generate $1.27bn in sales in 2030.  

GlobalData is the parent company of Pharmaceutical Technology.