ESALF - Biogen up as Guggenheim upgrades citing full approval for Leqembi

2023-05-01 08:47:05 ET

After three straight sessions of gains, Biogen ( NASDAQ: BIIB ) shares continued to rise in the pre-market Monday as Guggenheim upgraded the biotech citing full FDA approval for its Alzheimer's therapy Leqembi developed with Eisai ( OTCPK:ESALF )( OTCPK:ESAIY ).

Last week, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure said that her agency would cover the anti-amyloid agent in the event of a full U.S. FDA approval.

In January, the FDA granted accelerated approval for Leqembi (lecanemab) for Alzheimer's, and the agency is expected to decide on its full approval by July 6.

"We expect Leqembi to receive full approval in AD (PDUFA on 07/06/23) and broad CMS coverage," Guggenheim analysts wrote, upgrading BIIB to Buy from Neutral and raising its price target to $350 from $270 per share.

Citing a potential launch of depression therapy zuranolone, the company developed with Sage Therapeutics ( SAGE ), Guggenheim expects the oral once-daily therapy "will Mark BIIB's footprint in psychiatry and represents a large commercial opportunity in the long run."

Zuranolone is currently under the FDA priority review, with a decision expected by Aug. 05.

Guggenheim also highlights Biogen's ( BIIB ) deal-making ability noting, "CEO's bold business development vision and strong cash position bode well for new deals and expansion in therapeutic "hot" areas like immunology."

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