European Medicines Agency (EMA) announcements

FDA Approves Geron's Rytelo for Lower-Risk MDS; Shares Surge 30%, Including 22.4% Pre-Market

Jun 7, 2024, 12:10 PM

The U.S. Food and Drug Administration (FDA) has approved Geron's drug Rytelo (imetelstat) for the treatment of patients with lower-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia. This marks the first FDA approval for Geron, a biotech company founded in 1990 by Mike West and Alex Barkas. Following the approval, Geron's shares surged, rising by as much as 30% on Friday, including a 22.4% pre-market increase. The drug, an oligonucleotide telomerase inhibitor, represents a significant advancement in the treatment of blood disorders. The approval has been widely praised by the medical community, with notable endorsements from experts involved in the trial's steering committee, including Mikkael Sekeres from SylvesterCancer.