|GERN, another bump on Monday|
After four abstracts were released highlighting the latest data on its lead drug candidate, imetelstat, shares of Geron ( NASDAQ:GERN) were trading 23.4% higher as of 1:21 p.m. EST on Friday.
So whatPreviously, Geron's prospects were dealt a significant blow when former imetelstat co-developer Johnson & Johnson decided against advancing the drug into phase 3 studies following lackluster mid-stage trial results in myelodysplastic syndromes (MDS) and myelofibrosis. After Geron received the rights to imetelstat back from J&J, it initiated a phase 3 study in MDS and paused development in MF.
At the upcoming European Hematology Association Congress, which will be held virtually from June 11 through June 14, researchers will provide updated mid-stage data regarding imetelstat's effectiveness against MDS in an oral presentation. They will highlight that 32% of patients in the study (12 patients) achieved 24-week independence from red blood cell transfusions, and 29% of them (11 patients), were transfusion free for at least one year, including one patient who was transfusion free for 2.7 years.
Poster presentations at the event will also offer new insights into imetelstat's phase 2 trial in MF. One poster highlights a dose-dependent trend toward longer overall survival in patients who responded to imetelstat. Another poster highlights improved overall survival in triple negative MF patients who are relapsed or refractory to Janus Kinase (JAK) inhibitors, including Incyte's Jakafi, a blockbuster treatment with expected sales of over $1.88 billion in 2020.
Now whatThe oral abstract is encouraging because it suggests Geron's ongoing phase 3 MDS trial could pan out. If it does, Geron believes imetelstat's addressable population could include 85% of lower-risk MDS patients, resulting in potential revenue of $500 million per year.
The poster presentations also offer encouragement because they could tilt the odds in favor of Geron restarting development of the drug as a treatment for MF. Management plans to sit down with the Food and Drug Administration soon to discuss its options in MF, and then make a decision on whether or not to start a phase 3 study.
Although these presentations are sparking optimism, investors might want to remain cautious given J&J's decision to abandon development of imetelstat and Geron's inability to attract a suitor or another collaborator. Until definitive late-stage data becomes available, it may be wiser to focus on other biotech companies with clearer pathways to drug approvals.