Geron (NASDAQ:GERN) announces
the FDA granted fast-track designation to imetelstat for the treatment
of adult patients with Intermediate-2 or High-risk myelofibrosis (MF)
whose disease has relapsed after or is refractory to janus kinase (JAK)
inhibitor treatment, or relapsed/refractory MF.
The designation includes patients with primary MF and MF developed after essential thrombocythemia.
The same patient population was studied in the IMbark Phase 2 clinical trial.
Geron intends to conduct an end of Phase 2 meeting
with the FDA by the end of Q1 to see if there’s a regulatory path
forward for imetelstat in relapsed/refractory MF.
GERN shares are up 12.7% after hours to $1.50.
https://seekingalpha.com/news/3502725-geron-plus-12_7-percent-fast-track-designation
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