Editas Medicine witnesses a significant rise of nearly 30% in its shares following a crucial regulatory advancement for its primary drug candidate targeting severe sickle-cell disease.
Editas Medicine, based in Cambridge, Massachusetts, saw a surge of 28% in its share value, now standing at $11.36.
Regulatory Milestone Achieved
The company announced that it has achieved alignment with the U.S. Food and Drug Administration (FDA) regarding its "RUBY" study on renizgamglogene autogedtemcel, also known as reni-cel. This study has now transitioned into a Phase 1/2/3 trial, a significant step towards obtaining FDA approval.
Advancements in Clinical Trials
Previously designated as a Phase 1/2 study, the RUBY trial focuses on evaluating the safety and effectiveness of reni-cel, an innovative gene-editing therapy. The company is actively enrolling and treating patients in the adult group while initiating recruitment in the adolescent group.
Future Projections
Editas Medicine is on course to present a substantial dataset on sickle-cell patients with extensive clinical monitoring by mid-2024. Further data is anticipated by the end of the same year.
For updates or inquiries, please contact Editas Medicine directly.
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