Update: Market Chatter: Eli Lilly Could Get FDA Decision for Weight-Loss Pill Orforglipron by March 2026

MT Newswires Live
2025/12/15

(Updates with Novo Nordisk's response in the fifth paragraph.)

Eli Lilly's (LLY) experimental weight-loss pill orforglipron may receive US Food and Drug Administration decision by late March 2026 as officials are pressing reviewers to speed up evaluation of the drug, Reuters reported Friday, citing documents.

The FDA is seeking to reduce the time it takes to assess a filing under its expedited voucher program to one week from the current 60 days, but later settled on a timeline of two or three weeks, Reuters reported.

A speedier timeline could mean an approval of the pill by late March rather than mid-May as previously scheduled, the report said.

Eli Lilly's Danish rival Novo Nordisk (NVO) expects approval for its weight-loss pill in December or January, Reuters said.

Novo Nordisk declined to comment. Eli Lilly and the FDA did not reply to MT Newswires' request for comment.

Eli Lilly shares were up 1% in recent premarket activity Friday.

(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

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