Eli Lilly (LLY) shares slipped ~5% on Thursday, marking what could be its biggest intraday loss in five months after Reuters reported that a potential FDA nod for the company’s weight loss pill, orforglipron, is now due April 10, a delayed timeline compared to LLY’s initial expectations.
The report highlighted review delays faced by two recipients of FDA Commissioner’s National Priority Review vouchers. Unveiled in June, the pilot program aims to serve companies aligning with U.S. national priorities to expedite the review of their experimental therapies from 10–12 months to just 1–2 months.
When the FDA issued a National Priority Review voucher for Lilly’s (LLY) oral GLP-1 agonist in November, the company’s CEO, David Ricks, said that the once-daily pill could be approved as early as Q1 2026.
However, CFO Lucas Montarce tempered expectations this week, noting that the company is on track for orforglipron’s approval in Q2 2026, a decision that could pave the way for the latest entrant in the promising market of oral obesity drugs.
Last week, rival Novo Nordisk (NVO) launched its Wegovy pill for cash-paying customers in the U.S. at $149 per month after the oral version of its popular injectable semaglutide was approved by the FDA last month.