BioAge Labs Inc. Stock Price, News & Analysis

BioArctic AB's partner Eisai has announced the launch of Leqembi® (lecanemab) in China on June 28, 2024. Approved in January 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD), Leqembi is now available in the United States, Japan, and China. Eisai estimates there are 17 million early AD patients in China. The drug will be available in the private market with a 200 mg vial priced at CNY 2,508. A specialized healthcare insurance plan partially covering the drug cost has been introduced. Leqembi, which reduces amyloid-beta (Aβ) plaques in the brain, is the first treatment shown to slow disease progression. BioArctic will receive milestone payments and a 9% royalty on global sales, with plans to commercialize the drug in the Nordic region pending European approval.

The FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly intravenous (IV) maintenance dosing of Leqembi® (lecanemab-irmb) for early Alzheimer's Disease (AD). A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. Leqembi is designed to treat patients with mild cognitive impairment or mild dementia. The sBLA is based on data from the Phase 2 Study 201, its open-label extension (OLE), and the Clarity AD study. If approved, the monthly dosing regimen would be less burdensome, aiding long-term treatments. Eisai has also initiated a rolling submission to the FDA for a Leqembi subcutaneous autoinjector for weekly dosing. Leqembi is currently approved in several countries, and BioArctic is entitled to payments and royalties from its sales, with rights to commercialize in the Nordic region pending European approval.

BioArctic's partner, Eisai, projects Leqembi® sales to reach JPY 56.5 billion (approx. SEK 4 billion) for FY 2024 (April 2024 - March 2025), generating SEK 360 million in net royalties for BioArctic. For FY 2023, Leqembi sales were JPY 4.3 billion, resulting in SEK 28.2 million in royalties. BioArctic holds commercialization rights for lecanemab in the Nordic region, pending European approval. The first-quarter report for 2024 will be released on May 17, 2024. The disclosed information complies with the EU Market Abuse Regulation.

Eisai has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. FDA for Leqembi® (lecanemab-irmb) subcutaneous maintenance dosing. This follows the FDA granting Fast Track designation to Leqembi for Alzheimer's disease treatment in early AD stages. Currently approved for biweekly intravenous (IV) treatment, Leqembi's subcutaneous autoinjector simplifies home treatment, reducing the need for hospital visits. The BLA relies on Phase 3 Clarity AD open-label extension study data and aims to maintain effective drug concentrations to sustain clearance of toxic protofibrils. Leqembi is already approved in the US, Japan, and China, with additional applications under review globally. Eisai leads the global development and regulatory submissions, while BioArctic holds commercialization rights in the Nordic region pending European approval.