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Geron's Imetelstat's Safety a Key Focus for FDA's Oncology Drugs Advisory Committee Meeting
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Geron's Imetelstat's Safety a Key Focus for FDA's Oncology Drugs Advisory Committee Meeting
Mar 12, 2024 8:56 AM

11:25 AM EDT, 03/12/2024 (MT Newswires) -- Geron's ( GERN ) imetelstat will be reviewed by the US Food and Drug Administration's Oncology Drugs Advisory Committee on Thursday and the committee will discuss if the drug's benefits outweigh the risks, according to documents released ahead of the meeting.

The US regulator said more treatment-emergent adverse events, serious adverse events and events leading to dose modification were observed in the imetelstat group compared to placebo in a phase 3 study in certain patients with myelodysplastic syndrome.

Geron ( GERN ) is seeking approval for the drug to treat transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes that cannot use erythropoiesis-stimulating agents.

Geron ( GERN ) did not immediately respond to MT Newswires' request for comment.

Geron ( GERN ) shares were nearly 12% lower in recent trading.

Price: 1.96, Change: -0.19, Percent Change: -8.64

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