[ad_1]
Geron Co. (NASDAQ:GERN) stock price rose as the company announced that the U.S. Food and Drug Administration’s (FDA) Oncology Drug Advisory Committee (ODAC) voted in favor of the clinical benefit/risk profile of Imetelstat in treatment. As a result, the stock soared in after-hours trading on Thursday. Transfusion-dependent anemia.
what happened: After market close on Thursday, Geron voted 12-2 to support the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplasia ODAC. announced. syndrome. Patients must either be unresponsive to erythropoiesis-stimulating agents, have lost their response, or be ineligible for erythropoiesis-stimulating agents.
Imetelstat is a novel, first-in-class, investigational telomerase inhibitor exclusively owned by Geron that is being developed by Geron for hematologic malignancies.
ODAC reviewed the results of the late-stage clinical biopharmaceutical company’s Merge Phase 3 trial and found that the primary endpoint, red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks, was higher for imetelstat compared to placebo. found that it was significantly higher.
“There are few treatment options, and there remains a significant unmet medical need for these patients, especially those in this difficult-to-treat subtype of blood cancer,” he said. Fay FerrerExecutive Vice President and Chief Medical Officer of Geron.
“We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA to complete its review of the new drug application.”
The FDA has assigned a Prescription Drug User Fee Act target action date of June 16, 2024 for Geron’s new drug application for imetelstat.
Related item: Analyst says Robinhood stock is undervalued due to crypto influence: “Crypto market cap expected to reach $7.5 trillion, $2.6 trillion today.”
GERN price action: Earlier this week, Geron’s stock price fell after reports that an FDA staff reviewer had raised multiple safety concerns about Geron’s anemia drug.
At the time of publication, Geron stock was up 88.6% to $3.31, according to data from Benzinga Pro.
This illustration was generated using artificial intelligence through MidJourney.
“The Active Investor’s Secret Weapon” Step up your stock market game with the #1 News & Everything else trading tool: Benzinga Pro – Click here to start your 14-day trial now!
Want the latest stock analysis from Benzinga?
The article Geron stock soars after hours: What’s going on? originally appeared on Benzinga.com
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
[ad_2]
Source link
