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bluebird's (BLUE) Lovo-cel to Not Face Advisory Committee
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bluebird bio (BLUE - Free Report) announced that the FDA has conveyed that an advisory committee meeting for its gene therapy, lovotibeglogene autotemcel (lovo-cel), will not take place. This is expected to accelerate the company’s journey toward potential approval.
Lovo-cel is a potentially transformative, one-time gene therapy for individuals aged 12 and older with sickle cell disease (SCD), who have a history of vaso-occlusive events.
Earlier in June, a biologics license application (BLA) was accepted by the FDA for a priority review seeking approval for lovo-cel gene therapy in patients with SCD. The regulatory body had set a target action date of Dec 20, 2023.
The BLA for lovo-cel was based on efficacy results from 36 patients in the HGB-206 study Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up, which is the longest of any gene therapy program for SCD.
The FDA previously granted orphan drug designation, fast track designation, regenerative medicine advanced therapy designation and rare pediatric disease designation to lovo cell.
Shares of BLUE have plunged 48.4% year to date compared with the industry’s 13.7% decline.
Image Source: Zacks Investment Research
The FDA's decision to not schedule an advisory committee meeting indicates a high level of confidence in the strength of the data submitted by bluebird. Now, with no advisory committee, we can expect an earlier approval of the therapy.
If approved, lovo-cel will compete with CRISPR Therapeutics’ (CRSP - Free Report) exagamglogene autotemcel (exa-cel), developed in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) in late-stage studies to treat transfusion-dependent beta-thalassemia (TDT) and SCD. The companies have completed the BLA submissions with the FDA for exa-cel in SCD and TDT indications and a final decision on the same is expected by Dec 8, 2023, and Mar 30, 2024, respectively.
CRSP, along with VRTX, have also filed similar submissions on exa-cel in Europe and the United Kingdom.
A potential approval will make lovo-cel bluebird’s third ex-vivo gene therapy approved by the FDA for a rare genetic disease and its second FDA approval for an inherited hemoglobin disorder.
BLUE has two approved products in its portfolio — Zynteglo and Skysona. While Zynteglo is approved for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions, Skysona is approved for treating early, active cerebral adrenoleukodystrophy.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has moved up from 66 cents per share to 75 cents for 2023. The bottom-line estimate has also improved from 64 cents to 81 cents for 2024 during the same time frame. Shares of the company have rallied 50.5% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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bluebird's (BLUE) Lovo-cel to Not Face Advisory Committee
bluebird bio (BLUE - Free Report) announced that the FDA has conveyed that an advisory committee meeting for its gene therapy, lovotibeglogene autotemcel (lovo-cel), will not take place. This is expected to accelerate the company’s journey toward potential approval.
Lovo-cel is a potentially transformative, one-time gene therapy for individuals aged 12 and older with sickle cell disease (SCD), who have a history of vaso-occlusive events.
Earlier in June, a biologics license application (BLA) was accepted by the FDA for a priority review seeking approval for lovo-cel gene therapy in patients with SCD. The regulatory body had set a target action date of Dec 20, 2023.
The BLA for lovo-cel was based on efficacy results from 36 patients in the HGB-206 study Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up, which is the longest of any gene therapy program for SCD.
The FDA previously granted orphan drug designation, fast track designation, regenerative medicine advanced therapy designation and rare pediatric disease designation to lovo cell.
Shares of BLUE have plunged 48.4% year to date compared with the industry’s 13.7% decline.
Image Source: Zacks Investment Research
The FDA's decision to not schedule an advisory committee meeting indicates a high level of confidence in the strength of the data submitted by bluebird. Now, with no advisory committee, we can expect an earlier approval of the therapy.
If approved, lovo-cel will compete with CRISPR Therapeutics’ (CRSP - Free Report) exagamglogene autotemcel (exa-cel), developed in collaboration with Vertex Pharmaceuticals (VRTX - Free Report) in late-stage studies to treat transfusion-dependent beta-thalassemia (TDT) and SCD. The companies have completed the BLA submissions with the FDA for exa-cel in SCD and TDT indications and a final decision on the same is expected by Dec 8, 2023, and Mar 30, 2024, respectively.
CRSP, along with VRTX, have also filed similar submissions on exa-cel in Europe and the United Kingdom.
A potential approval will make lovo-cel bluebird’s third ex-vivo gene therapy approved by the FDA for a rare genetic disease and its second FDA approval for an inherited hemoglobin disorder.
BLUE has two approved products in its portfolio — Zynteglo and Skysona. While Zynteglo is approved for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusions, Skysona is approved for treating early, active cerebral adrenoleukodystrophy.
bluebird bio, Inc. Price and Consensus
bluebird bio, Inc. price-consensus-chart | bluebird bio, Inc. Quote
Zacks Rank & Stock to Consider
bluebird currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is Corcept Therapeutics (CORT - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has moved up from 66 cents per share to 75 cents for 2023. The bottom-line estimate has also improved from 64 cents to 81 cents for 2024 during the same time frame. Shares of the company have rallied 50.5% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.