FDA approves Geron’s Rytelo for MDS

The US Food and Drug Administration (FDA) late Thursday announced the approved of Geron Corporation’s (Nasdaq: GERN) Rytelo (imetelstat), an oligonucleotide telomerase inhibitor.

The drug is authorized for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).

The decision was largely expected given a positive FDA advisory panel vote in March this year. The firm’s shares were up almost 14% at $4.43 in pre-market activity today.