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Bluebird BioIncBLUE 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.
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 IncVRTX and CRISPR Therapeutics AGCRSP 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.
