Biogen Stock Tumbles After European Regulators Unexpectedly Reject Alzheimer's Drug

Biogen (BIIB) banal tumbled Friday aft European regulators rejected its Eisai (ESAIY)-partnered Alzheimer's treatment, saying the broadside effects are excessively potent.

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Eisai, which is starring the drug's improvement and regulatory submissions, plans to inquire the Committee for Medicinal Products for Human Use to reexamine it decision. But RBC Capital Markets expert Brian Abrahams noted that this inactive delays a imaginable launch.

The drug, Leqembi, is already approved successful the U.S., Japan, China, South Korea, Hong Kong and Israel. It works by removing built-up plaque successful the encephalon known arsenic beta amyloid. But doing truthful tin origin encephalon swelling called amyloid-related imaging abnormalities, oregon ARIA. ARIA is usually asymptomatic and temporary, but it tin beryllium terrible oregon deadly for immoderate patients.

"Practically speaking, Europe is not the largest marketplace for Leqembi fixed pricing considerations," Abrahams said successful a report. "Still, this is apt to somewhat hamper planetary perceptions and momentum for the cause and the class."

In premarket trading connected today's banal market, Biogen banal skidded much than 5% to 215. Eisai shares weren't yet active. Shares of Eli Lilly (LLY), which makes a rival Alzheimer's attraction successful the aforesaid cause class, fell 0.7% to 815.50.

Biogen Stock: Peak Sales In Jeopardy

Specifically, the European regulators said the hazard of ARIA counterbalances the benefits of Leqembi. In the tests that helped triumph U.S. approval, patients who received Leqembi for 18 months had a 27% slower diminution successful cognition vs. placebo recipients.

Abrahams had estimated Leqembi income would deed a highest of $8.3 billion. About 20%, oregon $1.7 cardinal of that, stemmed from Europe.

He kept his outperform standing and 303 terms people connected Biogen stock.

The determination is "somewhat surprising" fixed physicians person go much comfy managing ARIA "and the alternate (no disease-modifying treatment) has invariably precocious morbidity and mortality," helium said.

The quality puts Biogen banal connected platform to undercut its 50-day moving average astatine the open, according to MarketSurge. Shares closed sitting connected apical of that enactment Thursday.

Follow Allison Gatlin connected X, the level formerly known arsenic Twitter, astatine @IBD_AGatlin.

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