Lilly’s Foundayo Pill Gets European Regulatory Backing – LLY Stock Heads For Best Week In Nearly Four Months

European Medicines Agency’s advisory committee recommended approval of its once-daily weight-loss pill, Foundayo.

• The EMA’s advisory committee recommended approving Foundayo for adults with obesity or those who are overweight and have related health conditions.
• The committee also backed its use in adults with type 2 diabetes.
• Foundayo generated $98 million in Q2 revenue.

Eli Lilly (LLY) received a boost to its European business after the European Medicines Agency’s (EMA) advisory committee recommended approval of its once-daily weight-loss pill, Foundayo, on Friday.

The recommendation comes as Lilly looks to build on the success of its blockbuster weight-loss treatments, Mounjaro and Zepbound.

LLY shares were up 1.8% at the time of writing. The stock has gained about 7.8% so far this week, heading for its best weekly gain in nearly four months.

Foundayo Moves Closer To European Launch

The EMA’s Committee for Medicinal Products for Human Use recommended approving Foundayo for adults with obesity or those who are overweight and have related health conditions. The committee also backed its use in adults with type 2 diabetes.

Foundayo contains Orforglipron, which helps control blood sugar and reduce appetite. Unlike some oral GLP-1 treatments, it can be taken without food or water restrictions.

The pill is already available in the U.S., the U.K. and the United Arab Emirates. In the U.S., it received FDA approval in April for weight management, while in the U.K., it received approval in August for both weight management and type 2 diabetes.

What Happens Next?

Foundayo still requires final authorization from the European Commission, which generally issues a decision within 67 days of EMA’s recommendation. While the timeline puts a potential decision around late December, Lilly has not confirmed when commercial sales would begin.

Foundayo generated $98 million in second-quarter (Q2) revenue. However, Lilly's two blockbuster drugs generated far more. In Q2, Mounjaro generated $9.94 billion in sales, up 91% year over year, while Zepbound brought in $4.93 billion, up 46%.

Retail Says LLY Is Breaking Out

Retail sentiment surrounding LLY on Stocktwits turned ‘neutral’ from ‘bearish’ over the past 24 hours, though message volumes remained ‘normal.’

One user noted that LLY stock is breaking out.

View this Stocktwits post

LLY shares have gained more than 18% so far this year, significantly outperforming rival Novo Nordisk (NVO), whose shares have slumped more than 25% over the same period.

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