Geron (GERN) Gets ODAC Votes for Blood Disorder Drug, Shares Up
Geron Corporation GERN announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of the clinical benefit/risk profile of pipeline candidate, imetelstat, for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs).
The ODAC voted 12:2 in favor of imetelstat’s benefits over risks.
Consequently, shares of this late-stage clinical biopharmaceutical company have risen in pre-market trading.
Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and is being developed for hematologic malignancies.
The favorable decision by the ODAC was based on results from the phase III IMerge clinical trial.
The primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat as compared to placebo. Additionally, 28% of imetelstat-treated patients experienced a statistically significant improvement in the key secondary endpoint of at least 24-week RBC-TI as compared to 3% on placebo. The median duration was 80 weeks for those achieving ≥24-week RBC-TI.
In August 2023, the FDA accepted the new drug application (NDA) seeking approval for imetelstat for the treatment of TD anemia in adult patients with low to intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for ESAs. The regulatory body set a target action date of Jun 16, 2024, for the NDA.
On Jan 30, 2024, the FDA provided notice in the Federal Register that it has scheduled a public ODAC on Mar 14, 2024, as part of the review of imetelstat’s NDA.
While the FDA takes into account ODAC’s decision when reviewing an NDA, it isn’t bound by it.
Nevertheless, a favorable decision by the ODAC definitely increases the possibility of a potential FDA approval for the drug.
Shares of GERN have lost 33.9% in the past year compared with the industry’s 6.1% decline.
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Geron is currently gearing up for a prospective launch of the drug in the United States. A potential approval and successful commercialization of the drug will be a significant boost for GERN.
The drug is also under review in the EU for the same proposed indication.
The review is expected to be completed in early 2025.
Geron is also evaluating imetelstat in relapsed/refractory myelofibrosis (R/R MF) in an ongoing phase III study.
Zacks Rank and Stocks to Consider
GERN currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics ADMA, GSK plc GSK and FibroGen FGEN. While ADMA and GSK sport a Zacks Rank #1 (Strong Buy) each, FGEN carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the consensus estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. Over the past year, ADMA’s shares have surged 92.3%.
In the past 30 days, the Zacks Consensus Estimate for GSK’s EPS has increased 4 cents to $4.03. During the same period, the estimate for GSK’s 2025 EPS has increased from $4.35 to $4.39.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the consensus mark for the company’s 2025 loss per share is pegged at 6 cents.
FGEN beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 2.26%.
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