Tag Archive for: Bluebird bio

Bluebird CFO Chris Krawtschuk in a statement said that the debt financing agreement with Hercules “underscores the value bluebird offers as a standalone gene therapy leader,” while also extending the biotech’s runway and “bolstering our ability to bring transformative treatments to patients and their families.”

Under the deal disclosed Thursday in an SEC filing, bluebird bio doubled the number of covered U.S. patients for its sickle cell gene therapy to a cumulative total of around 200 million people.

These factors, along with bluebird bio’s failure to receive a priority review voucher, all hurt the company’s stock price following Lyfgenia’s approval.

The agency approved two gene therapies for sickle cell disease, making one of them the first treatment in the United States based on the Nobel Prize-winning CRISPR gene editing technology.

The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.

The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.

The Institute for Clinical and Economic Review raised the cost estimate for two experimental gene therapies, stating that the new price can be cost effective to treat sickle cell disease.

Bluebird bio Inc. said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.

In an earnings call, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.

The FDA put 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced February 2.