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bluebird (BLUE) Up 101% in the Past Three Months: Here's Why
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Shares of bluebird bio (BLUE - Free Report) are flying high for the past three months after the company received a slew of positive news over the aforementioned time period.
The stock has surged 101% in the year-to-date period compared with the industry’s rise of 2.5%.
One of the main reasons for the surge in stock price is the recent FDA approval of bluebird’s one-time gene therapy, Zynteglo (betibeglogene autotemcel/ beti-cel), for treating beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions across all genotypes.
Zynteglo is now the first and only FDA-approved ex-vivo lentiviral vector gene therapy for transfusion dependent beta-thalassemia (TDT) patients.
The company’s decision to commercialize Zynteglo in the United States, after its FDA approval, to provide access to the drug as soon as possible, also contributed to the rise in bluebird’s stock price.
In June alone, bluebird’s stock soared approximately 39.4% after the announcement of unanimous votes from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) in favor of BLUE’s candidate gene therapies, eli-cel and beti-cel for the treatment of cerebral adrenoleukodystrophy (CALD) and beta-thalassemia, respectively. The regulatory body voted that the gene therapies outweigh the risks for patients with CALD and beta-thalassemia, and are effective enough to justify their use in patients.
Eli-cel is another gene therapy candidate in bluebird’s product pipeline, being evaluated for the treatment of CALD. A BLA filing for the candidate for the aforementioned indication is currently under review with the FDA and a decision is expected by September 2022. A potential approval will be another boost for the company
The company is also evaluating lovotibeglogene autotemcel (lovo-cel, formerly LentiGlobin for SCD) for the treatment of adult and pediatric patients with sickle cell disease (SCD). bluebird expects to seek approval for lovo-cel in SCD under an accelerated pathway in the United States on the basis of data from Group C of the ongoing phase I/II HGB-206 study. The company is expected to file a BLA for lovo-cel with the FDA in first-quarter 2023. bluebird has also completed enrolment in the phase III HGB-210 study, which will serve as a confirmatory study to seek full approval for lovo-cel in SCD
However, shares were down post Zynteglo’s FDA approval.
Zynteglo approval is a significant boost for the company, bluebird still has a long way to go, given the targeted market.
Inozyme’s loss per share estimates for 2022 have narrowed from $2.08 to $1.84 in the past 30 days. The same for 2023 has narrowed from $1.95 to $1.82 in the same time frame.
Earnings of Inozyme missed estimates in three of the trailing four quarters and beat the same on the remaining one occasion. The average earnings surprise for INZY is 6.65%.
Rhythm’s loss per share estimates for 2022 widened from $3.74 to $3.82 in the past 30 days. The same for 2023 has narrowed from $3.40 to $3.08 in the same time frame.
Earnings of Rhythm missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for RYTM is 2.97%.
Pliant’s loss per share estimates for 2022 have improved from $3.28 to $3.01 in the past 30 days. The same for 2023 has narrowed from $3.68 to $3.29 in the same time frame.
Earnings of Pliant beat estimates in two of the trailing four quarters, were in line in one and missed the same on the remaining occasion. The average earnings surprise for PLRX is 0.90%.
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bluebird (BLUE) Up 101% in the Past Three Months: Here's Why
Shares of bluebird bio (BLUE - Free Report) are flying high for the past three months after the company received a slew of positive news over the aforementioned time period.
The stock has surged 101% in the year-to-date period compared with the industry’s rise of 2.5%.
One of the main reasons for the surge in stock price is the recent FDA approval of bluebird’s one-time gene therapy, Zynteglo (betibeglogene autotemcel/ beti-cel), for treating beta-thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions across all genotypes.
Zynteglo is now the first and only FDA-approved ex-vivo lentiviral vector gene therapy for transfusion dependent beta-thalassemia (TDT) patients.
The company’s decision to commercialize Zynteglo in the United States, after its FDA approval, to provide access to the drug as soon as possible, also contributed to the rise in bluebird’s stock price.
In June alone, bluebird’s stock soared approximately 39.4% after the announcement of unanimous votes from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) in favor of BLUE’s candidate gene therapies, eli-cel and beti-cel for the treatment of cerebral adrenoleukodystrophy (CALD) and beta-thalassemia, respectively. The regulatory body voted that the gene therapies outweigh the risks for patients with CALD and beta-thalassemia, and are effective enough to justify their use in patients.
Eli-cel is another gene therapy candidate in bluebird’s product pipeline, being evaluated for the treatment of CALD. A BLA filing for the candidate for the aforementioned indication is currently under review with the FDA and a decision is expected by September 2022. A potential approval will be another boost for the company
The company is also evaluating lovotibeglogene autotemcel (lovo-cel, formerly LentiGlobin for SCD) for the treatment of adult and pediatric patients with sickle cell disease (SCD). bluebird expects to seek approval for lovo-cel in SCD under an accelerated pathway in the United States on the basis of data from Group C of the ongoing phase I/II HGB-206 study. The company is expected to file a BLA for lovo-cel with the FDA in first-quarter 2023. bluebird has also completed enrolment in the phase III HGB-210 study, which will serve as a confirmatory study to seek full approval for lovo-cel in SCD
However, shares were down post Zynteglo’s FDA approval.
Zynteglo approval is a significant boost for the company, bluebird still has a long way to go, given the targeted market.
Zacks Rank and Stocks to Consider
Currently, BLUE has a Zacks Rank #3 (Hold).
Some better stocks in the same sector are Inozyme Pharma (INZY - Free Report) , Rhythm Pharmaceuticals (RYTM - Free Report) and Pliant Therapeutics (PLRX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Inozyme’s loss per share estimates for 2022 have narrowed from $2.08 to $1.84 in the past 30 days. The same for 2023 has narrowed from $1.95 to $1.82 in the same time frame.
Earnings of Inozyme missed estimates in three of the trailing four quarters and beat the same on the remaining one occasion. The average earnings surprise for INZY is 6.65%.
Rhythm’s loss per share estimates for 2022 widened from $3.74 to $3.82 in the past 30 days. The same for 2023 has narrowed from $3.40 to $3.08 in the same time frame.
Earnings of Rhythm missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions. The average earnings surprise for RYTM is 2.97%.
Pliant’s loss per share estimates for 2022 have improved from $3.28 to $3.01 in the past 30 days. The same for 2023 has narrowed from $3.68 to $3.29 in the same time frame.
Earnings of Pliant beat estimates in two of the trailing four quarters, were in line in one and missed the same on the remaining occasion. The average earnings surprise for PLRX is 0.90%.