Shares of Geron surged more than 30% on Friday, a day after the company gained its first approval from the US Food and Drug Administration for its blood disorder drug.
The health regulator's nod allows the injectable drug, branded as Rytelo, to be used for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS), a group of blood cancers.
Rytelo is set to compete with Bristol Myers Squibb's Reblozyl, which received a green light for label expansion from the FDA last year for the same disease indication, Reuters reported.
The California-based company said it had set wholesale prices at $9,884 for the 188 mg vial and $2,471 for the 47 mg vial of Rytelo.
Baird analyst Joel Beatty estimates Rytelo's sales at $933 million in 2029, while B. Riley Securities analyst Kalpit Patel sees $700 million in peak sales.
The 188 mg vial will be available in the distribution channels by the end of June, with 47 mg vial expected to be available by summer 2024.
In March, the FDA's independent panel of advisers overwhelmingly voted in favor of the drug, stating that the treatment's associated risks and toxicities appear manageable.
FDA staff had previously flagged a high rate of low red blood cell count in trial patients.
The biggest victory is the absence of a black box warning or a drug safety program requirement, Patel said, adding that the broad label relieves some investors who were worried about population restrictions.
In a late-stage trial, nearly 40% of the drug-treated patients showed independence from transfusion for eight weeks, compared with 15% of patients on placebo.
MDS are a group of cancers in which blood cells in the bone marrow do not mature or become healthy blood cells, and patients require frequent blood transfusions to manage their anemia.
Geron shares were up about up 31.8% at $5.12 in early trading.
