Friday, Geron Corporation’s GERN shares are trading lower with a high session volume of 5.82 million compared to the average 100-day volume of 8.8 million, as per data from Benzinga Pro.
Thursday, the FDA’s Oncologic Drugs Advisory Committee voted in favor of the clinical benefit/risk profile of Geron’s imetelstat for blood cancer.
The company is seeking approval for transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
By a 12-to-2 margin, the panel voted in favor of the benefits of imetelstat, stating that the associated risks and toxicities of the treatment appear to be manageable.
The FDA assigned a Prescription Drug User Fee Act target action date of June 16, 2024.
If approved, Imetelstat will be Geron’s first commercial treatment in the market and compete with Bristol Myers Squibb Co’s BMY Reblozyl (luspatercept-aamt), which received an FDA label expansion last year for the same disease indication.
Citing Baird analyst Reuters notes that imetelstat is expected to generate $933 million in sales by 2029 and estimates the market opportunity to be four times larger than Reblozyl.
The committee viewed the results of the IMerge Phase 3 clinical trial.
The primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo, with median RBC-TI duration approaching one year for imetelstat ≥8-week RBC-TI responders.
28% of imetelstat-treated patients compared to 3% on placebo obtained a statistically significant improvement in the key secondary endpoint of at least 24-week RBC-TI.
A sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients.
In FDA’s briefing documents, staff flagged concerns related to its Phase 3 trial, saying it is not clear that the magnitude and durability of RBC-TI outweigh the risks of treatment with imetelstat for patients with lower-risk MDS.
Price Action: GERN shares are down 0.15% at $3.39 on the last check Friday. During the after-market trading session on Thursday, the stock surged over 80%.
Image by PDPics from Pixabay
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