1. Scrip
  2. >>Advanced Therapies
  3. >>Gene Therapies

Bluebird Expects Three Filings In 2020, But US Zynteglo Submission Pushed Back

 
• By Mandy Jackson

A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.

Close up of old English dictionary page with word behind schedule
While delayed, Zynteglo will be one of three US filings for bluebird in 2020 • Source: Shutterstock

bluebird bio Inc. will have an eventful 2020, including the submission of three different products for regulatory approvals, but at least one milestone will be reached a little later than previously expected.

The company launched its gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) in the EU, where it was approved for transfusion-dependent beta-thalassemia (TDT) in June, and will treat its first commercial patient in the first half of 2020, bluebird said in its fourth quarter and

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Gene Therapies

More from Advanced Therapies

Gilead Pipeline Progress Offsets Oncology Sales Slowdown

 
• By Alaric DeArment

Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

Verve Moves Toward Lilly Opt-In For PCSK9 Program With Phase Ib Results

 
• By Alaric DeArment

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.