- Bluebird Bio Inc BLUE shares are plummeting after the company signaled a delay in its sickle cell disease drug application to the FDA in its Q4 earnings release.
- In early March, the company responded to feedback from the FDA on vector and drug product analytical comparability evaluations completed in December 2022.
- Bluebird expects a response from the FDA within weeks and will move quickly to expedite its marketing application submission to the FDA, pending alignment on product comparability.
- In an update in January, the company said that lovo-cel BLA submission was on track for Q1 2023; vector and drug product analytical comparability studies are complete.
- The company plans to request priority review for patients 12 and older with a history of vaso-occlusive events.
- If approved, Bluebird continues to anticipate a commercial launch in early 2024.
- Related: FDA Allows Bluebird Bio To Resume Sickle Cell Disease Studies In Patients Below 18, With Changed Protocol
- Bluebird's application for lovo-cel is written and ready to file, Bloomberg writes. CEO Andrew Obenshain said the additional back-and-forth with the FDA could lead to a smoother review. However, Bluebird has little room to fail.
- The report noted company nearly ran out of cash in 2022 as a series of safety scares related to lovo-cel delayed efforts to seek approval for the drug by more than a year.
- Rival players Vertex Pharmaceuticals Inc VRTX and CRISPR Therapeutics AG CRSP have said they expect to finish an application for a competing sickle cell disease drug by the end of the month.
- The company's cash and equivalents totaled approximately $227 million as of December 31, 2022.
- FY23 cash burn is expected to be $270-$300 million.
- Bluebird expects its cash balance to be sufficient to provide a runway into Q4 2024.
- Price Action: BLUE shares are down 26.89% at $3.16 on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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