Bluebird Bio's Gene Therapies Face Revenue Setbacks
Slowed Patient Enrollment Dampens Revenue Projections
Shares of gene therapy company Bluebird Bio (BLUEO) have plummeted 15% to $9.09, their steepest-ever decline, following tempered forecasts on patient enrollment for its gene therapies.
FDA Approval with Caveats Limits Revenue
The company's recently FDA-approved gene therapy for sickle cell disease, SKYSONA, faces caveats that could restrict revenue. The FDA has mandated additional data collection and patient monitoring, potentially delaying widespread use.
Patient Enrollments Fall Short of Expectations
Bluebird Bio's overall patient enrollment stands at 27 this year, below initial projections. The company has enrolled 19 patients for ZYNTEGLO, its gene therapy for transfusion-dependent beta-thalassemia, and 4 patients for SKYSONA.
For 2024, Bluebird Bio estimates patient starts between 85 and 105 for its three gene therapies, but this forecast is significantly lower than previous estimates.
Multiple Myeloma Trial Faces Enrollment Challenges
The company's ongoing Phase 2/3 study for its gene therapy for multiple myeloma, LYFGENIA, faces enrollment difficulties. Despite enrolling multiple patients, the study's progress has been slower than anticipated.
Financial Concerns and Future Viability
Bluebird Bio acknowledges substantial doubt about its financial viability as it faces challenges in advancing its gene therapies to market. The company's ability to generate revenue and secure additional funding may be impacted by these setbacks.
Source: FierceBiotech
Comments