01:32 PM EDT, 03/12/2024 (MT Newswires) -- (Updates with comment from Geron's ( GERN ) in the fourth paragraph, stock price movement in the headline and fifth paragraph)

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 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.

"We feel well-prepared for the scheduled ODAC and believe imetelstat could be an important and compelling new medicine for transfusion-dependent anemia in adult patients with lower-risk MDS," A Geron ( GERN ) spokesperson told MT Newswires in an email.

Geron ( GERN ) shares were nearly 18% lower in recent trading.

Price: 1.77, Change: -0.38, Percent Change: -17.52