Geron's Imetelstat Gets Fast Track Status For Myelofibrosis
Zacks Investment Research | Sep 30, 2019 10:36PM ET
Geron Corporation (NASDAQ:GERN) announced that the FDA has granted Fast Track designation to its sole pipeline candidate, imetelstat, for treating a hematologic myeloid malignancy, myelofibrosis (“MF”). The designation was given for treating adult patients with intermediate-2 or high-risk MF, whose disease has relapsed following treatment by a JAK inhibitor or is refractory to a JAK inhibitor, as well as patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera. The company is evaluating imetelstat in a similar patient population in the phase II IMbark study.
The FDA grants Fast Track designation to help the development and faster review of drugs, which treat serious and unmet medical conditions. With this designation, the drug is expected to be granted priority review once the company files a new drug application.
Shares of Geron rallied 18.1% in after-market trading on Sep 30, following the announcement. So far this year, the stock has gained 33% against the industry ’s 6.2% decrease.
Please note that in December 2018, Geron presented updated median overall survival (“OS”) data from the higher dosage arm (9.4 mg/kg) of the study. The candidate achieved median OS of 29.9 months, which suggests a meaningful survival outcome. The company is planning to conduct an end of phase II meeting related to IMbark study in the first quarter of 2020 to discuss the path forward for the development of imetelstat in relapsed/refractory MF.
Apart from MF, the company is evaluating imetelstat in a phase II/III IMerge study as a treatment for another hematologic myeloid malignancy, myelodysplastic syndromes (“MDS”). Top-line data from the phase II portion of the study is expected by the end of 2019. Preliminary data presented last year had shown that the benefit/risk profile of imetelstat in treated patients, including the expansion arm, supports continued development in lower risk MDS indication. Based on this data, the company initiated the phase III portion of the IMerge study in August.
We remind investors that Geron had a collaboration with Janssen, a subsidiary of J&J (NYSE:JNJ) , related to development of imetelstat, which was terminated by J&J last year. Geron now holds the full responsibility for development of imetelstat. The company has added new leaders to its development team with vast experience in oncology and drug development to support the progress of imetelstat.
Another MDS candidate, luspatercept, is being developed by Acceleron Pharma (NASDAQ:XLRN) and its partner Celgene (NASDAQ:CELG) in a phase III study, which may pose competition for imetelstat.
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