Geron surges after winning first US FDA approval for blood disorder drug
By Christy Santhosh and Pratik Jain
(Reuters) -Shares of Geron surged more than 20% on Friday, a day after the company gained its first approval from the U.S. 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 FDA's expanded approval last year to treat the same disease indication.
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.
A typical dose of Rytelo consists of 7.1 mg of the drug per kilogram of the patient's weight. Geron said a 188 mg vial would be available by the end of June, and a 47 mg vial is expected to be available later in the summer.
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.
In March, a panel of FDA advisers voted in favor of the drug, stating that the treatment's associated risks and toxicities appear manageable.
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 20.6% at $4.7 after surging more than 30% in early trading.
(Reporting by Sriparna Roy and Christy Santhosh and Pratik Jain in Bengaluru; Editing by Nivedita Bhattacharjee and Tasim Zahid)
