Geron Corporation (NASDAQ: GERN) stock surged during intraday trading Friday after the biopharma company received FDA approval for RYTELO, a rare blood cancer treatment.
Geron Corporation recently announced that the U.S. Food and Drug Administration (FDA) has granted approval for RYTELO (imetelstat) as a treatment for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS). This approval extends to patients with transfusion-dependent (TD) anemia who require four or more red blood cell units over eight weeks and have not responded to, lost response to, or are ineligible for erythropoiesis-stimulating agents (ESA).
John Scarlett, the CEO of Geron, highlighted the potential benefits of RYTELO, stating that patients taking the drug could likely go for more than 24 weeks without transfusions and symptomatic anemia. This breakthrough offers new hope for those suffering from this challenging condition.
Dr. Rami Komrokji, a key investigator in the Phase 3 trial of the injectable drug, emphasized the limited treatment options currently available for patients with lower-risk Myelodysplastic Syndromes (MDS) and anemia requiring blood transfusions. He noted that the RYTLEO addition could be “potentially practice-changing” for physicians treating this patient population, indicating its anticipated positive impact on clinical practice.
RYTELO is poised to enter the market as a competitor to Bristol Myers Squibb’s (BMY) Reblozyl, which received FDA approval last summer. Geron plans to ensure broad access to RYTELO for eligible patients, with wholesale costs set at $9,884 for the 188-milligram (mg) vial and $2,471 for the 47-mg size. A typical dosage of RYTELO is 7.1 mg per kilogram of patient weight.
Geron (NASDAQ: GERN) Stock Movement
On Friday, GERN stock soared 17.99%, closing at $4.59, marking a 29.30% increase for the week. The trading volume was 98,937,920 shares, significantly higher than the average daily volume of 14.24 million.
