On Friday, TD Cowen reaffirmed its confidence in Geron (NASDAQ:GERN) Corporation (NASDAQ:GERN), maintaining a Buy rating and a $10.00 price target for the biopharmaceutical company's stock. The endorsement comes after Geron's drug Rytelo (imetelstat) received approval for the treatment of adults with transfusion-dependent lower-risk myelodysplastic syndromes (LR-MDS), regardless of ring sideroblasts (RS) status.
The approval by the Food and Drug Administration (FDA) was granted one week before the anticipated Prescription Drug User Fee Act (PDUFA) date. This early decision marked a significant milestone for Geron, as Rytelo was cleared with a broad label that notably did not include a black box warning for cytopenias—a concern that can often accompany new drug approvals.
The absence of the black box warning is particularly noteworthy, as it suggests a favorable risk-benefit profile for Rytelo, which is expected to be well-managed within the standard practices for treating patients with this condition. The approval exceeded expectations and is seen as a testament to the company's persistence and the strength of the data supporting the drug's manageability.
TD Cowen anticipates a robust market introduction for Rytelo, indicating a positive outlook for Geron's commercial prospects. The drug's approval and the subsequent endorsement by the analyst underscore the company's potential to make a significant impact in the treatment of LR-MDS. The maintained price target suggests confidence in the company's trajectory following this latest regulatory success.
In other recent news, Geron Corporation has been making significant strides in the pharmaceutical sector. The U.S. Food and Drug Administration (FDA) recently approved Geron's new injectable drug, Rytelo, for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). This marks Geron's first FDA approval, positioning Rytelo as a competitor to Bristol Myers (NYSE:BMY) Squibb's Reblozyl.
Analysts from Baird and B. Riley Securities have projected Rytelo's sales to reach $933 million and $700 million respectively by 2029. In addition, Geron has announced the pricing for Rytelo, with the 188 mg vial priced at $9,884 and the 47 mg vial at $2,471. The company plans to distribute the 188 mg vial by the end of June and expects the 47 mg vial to become available by the summer of 2024.
Furthermore, Geron reported a positive outlook in its Q1 2024 earnings call, focusing on the upcoming U.S. launch of another novel drug, Imetelstat. The company holds $465 million in resources and plans for sustained operations through projected sales until Q2 2026. Geron is also progressing in a Phase 3 trial for Imetelstat in myelofibrosis, with key analyses due in the coming years.
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