Geron Announces FDA ODAC Votes in Favor of Geron’s Imetelstat Clinical Benefit/Risk Profile for certain Transfusion-Dependent Anemia Patients

March 15, 2024

DENVER, Colo., Mar 15, 2024 (247marketnews.com)- Geron Corporation (NASDAQ:GERN) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat, based on results from the IMerge Phase 3 clinical trial, 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).

“We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer,” said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. “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 as they complete their review of our New Drug Application.”

The move follows the ODAC IMerge Phase 3 clinical trial results review, as the primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching one year for imetelstat ≥8-week RBC-TI responders.

Geron plans to kick off imetelstat’s US commercial launch following potential FDA approval and the FDA’s Prescription Drug User Fee Act (PDUFA) target action date is scheduled for June 16, 2024.

GERN is trading at $3.02, up $1.27 (+72.57%), on 7.7M shares.

Its 52-week range is $1.64 to $3.735. This morning’s premarket high is $3.71.

Gern is trading just above the $3 key inflection point and almost hit a new 52-week high this morning and a new 5 high isn’t out of the question, as long as the volume remains strong.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (GERN)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.