Geron

In 2024, the FDA approved over 130 drugs, including 40 novel ones. Madrigal's Rezdiffra is the first treatment for MASH, X4's Xolremdi for WHIM syndrome, Day One's Ojemda for pediatric low-grade glioma, Geron's Rytelo for MDS, and ImmunityBio's Anktiva for NMIBC. These approvals mark significant milestones for these companies and address high unmet medical needs.

Geron Corp announced CHMP's positive opinion recommending RYTELO (imetelstat) for transfusion-dependent anemia in lower-risk myelodysplastic syndromes, a step towards EU marketing authorization. RYTELO, a telomerase inhibitor, showed reduced transfusion needs in trials but has side effects like thrombocytopenia. The approval could boost Geron's market position and revenue, though risks remain.

New analyses from IMerge Phase 2, 3, and QTc substudy suggest imetelstat provides clinical benefit for LR-MDS patients with transfusion-dependent anemia, regardless of prior treatments. Patient-reported outcomes show sustained improvement in fatigue and maintenance of quality of life with imetelstat.

H.C. Wainwright initiated coverage on Geron Corporation with a Buy rating and a $8.00 price target, driven by the successful launch of Rytelo, an FDA-approved telomerase inhibitor for treating transfusion-dependent anemia due to low-to-intermediate risk myelodysplastic syndromes. The Phase 3 IMerge study showed significant improvement in transfusion independence with Rytelo. Geron anticipates $19 million in third-quarter revenue from Rytelo, with analyst firms maintaining positive ratings. The company's financial position is strong, with $430 million in cash and equivalents.

Goldman Sachs maintains Buy rating on Geron Corp (NASDAQ:GERN) with $6.00 price target, citing CMS's new billing code for Rytelo starting Jan 1, 2025. The code, J0870, facilitates Rytelo's commercial adoption, expected to drive global peak sales to $1.2 billion. Geron's strong financial position, with $430 million in cash, supports its commercial execution and Rytelo's market potential.

Geron Corporation appoints Jim Ziegler as Executive VP, Chief Commercial Officer to lead global commercial strategy and drive growth of RYTELO™, effective September 9, 2024.

Biologics by McKesson selected by Geron Corp. as a specialty pharmacy provider for RYTELO™ (imetelstat), a telomerase inhibitor for treating low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia. RYTELO, approved by the FDA on June 6, 2024, inhibits telomerase activity, preventing telomere binding. Biologics by McKesson is committed to providing innovative, high-touch care for patients.