bluebird bio BLUE announced that the FDA has extended the review period of biologics licensing applications (BLAs) for betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel) as treatments for β-thalassemia and cerebral adrenoleukodystrophy (CALD), respectively, by three months.

The new PDUFA action dates for both of bluebird’s lentiviral vector gene therapies are Aug 19, 2022 for beti-cel and Sep 16, 2022 for eli-cel. The previous action dates set by the FDA for beti-cel and eli-cel were May 20, 2022 and Jun 17, 2022, respectively.

The delay is on account of the additional data submitted by the company upon FDA’s request during the ongoing review of both beti-cel and eli-cel. The information submitted by bluebird constitutes major amendments to the information filed by bluebird in its earlier BLAs. The extension by the FDA is not connected with any safety concerns in either of the two applications.

Following this announcement, shares of bluebird fell 9.4%. The decline was likely because investors were not happy with the extension of the review period. Although both beti-cel and eli-cel are approved in the European Union (beti-cel is marketed as Zynteglo while eli-cel is marketed as Skysona), bluebird’s decision to wind down European operations to focus on the U.S. market marks an urgent need for an FDA approval to either or both the therapies.

bluebird has plunged 83.5% in the trailing 12 months compared with the industry’s 35.1% decline.

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The BLA for beti-cel seeks approval for treating adult, adolescent and pediatric patients with β-thalassemia across all genotypes requiring regular red blood cell transfusions. Conversely, the BLA for eli-cel seeks approval for treating CALD in patients aged less than 18 years who do not have a matched donor sibling.

Both the BLAs were earlier granted priority review by the FDA. While the BLA for beti-cel was accepted for priority review last November, the BLA for eli-cel was granted priority review by the FDA last month.

The extension in the review of both BLAs will not affect the priority review status granted by the FDA to both the therapies.

Both beti-cel and eli-cel gene-therapies had also been earlier granted orphan drug, rare pediatric disease and breakthrough therapy designations by the FDA.

Currently, bluebird has no FDA-approved drug. An FDA approval to either or both eli-cel and beti-cel will provide bluebird with its first approved/marketed drug.

Following FDA approval to both its BLAs, bluebird expects to secure priority review vouchers. The company expects to sell these priority review vouchers for approximately $150-200 million to extend cash resources to 2023.

bluebird also announced that it has received written queries from the FDA with regard to the partial clinical hold placed by the regulatory agency on lovotibeglogene autotemcel (lovo-cel) gene therapy in patients under the age of 18 with sickle cell disease (SCD). While bluebird is assessing the impact of this clinical hold on potential FDA filing for lovo-cel in SCD in first-quarter 2023, the company plans to provide an update on the same alongside its Q4 earnings call next month.

bluebird bio, Inc. Price

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Zacks Rank & Key Picks

bluebird bio carries a Zacks Rank #3 (Hold) at present. Some better-ranked stocks in the same sector include Alkermes ALKS, BioNTech BNTX and Vir Biotechnology VIR, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates for 2022 have increased from $0.70 to $0.71 in the past 60 days. Shares of Alkermes have risen 13.1% in the past year.

Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 147%, on average.

BioNTech’s earnings per share estimates for 2022 have increased from $31.14 to $32.52 in the past 60 days. Shares of BioNTech have risen 63.9% in the past year.

Earnings of BioNTech beat estimates in all the last four quarters, delivering a surprise of 132.4%, on average.

Vir Biotechnology’s bottom-line estimates for 2022 have been revised from a loss of $0.47 per share to earnings of $6.82 in the past 60 days.

Earnings of Vir Biotechnology beat estimates in two of the last four quarters while missing on the other two occasions, with an average surprise of 13%.

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