BioAge Labs Inc. Stock Price, News & Analysis

BioArctic AB's partner Eisai has received approval from Mexico's COFEPRIS for Leqembi (lecanemab) to treat early Alzheimer's disease. The drug, which selectively binds to amyloid-beta aggregates, is the first approved treatment proven to reduce disease progression and slow cognitive decline through this mechanism.

The approval is supported by successful results from the Phase 3 Clarity AD clinical trial, where Leqembi met its primary and key secondary endpoints. The drug is already approved in multiple countries including the U.S., Japan, China, and others. In Mexico, approximately 1.3 million people suffer from Alzheimer's disease.

Leqembi was developed through collaboration between BioArctic and Eisai, with BioArctic retaining rights to jointly commercialize in the Nordic region pending European approval.

Eisai has launched Leqembi® in South Korea following its approval in May 2024 for treating early Alzheimer's disease (AD). The drug targets approximately 900,000 dementia patients in South Korea, where about 70% have Alzheimer's dementia. Leqembi, developed through collaboration between BioArctic and Eisai, is the first approved treatment that reduces disease progression by targeting amyloid-beta aggregates. The initial launch will be in the private market, with BioArctic retaining rights for joint commercialization in the Nordic region pending European approval.

BioAge Labs (Nasdaq: BIOA), a clinical-stage biopharmaceutical company focused on developing therapeutics for metabolic diseases through aging biology, has announced its participation in two major healthcare conferences. Kristen Fortney, CEO and co-founder, will present at the Piper Sandler 36th Annual Healthcare Conference in New York on December 3, 2024 (1:30-1:55 PM EST) and the Citi 2024 Global Healthcare Conference in Miami on December 4, 2024 (3:15-3:55 PM EST). Both presentations will be available via webcast and archived for 30 days on the company's investor relations website.

BioArctic AB announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lecanemab as an Alzheimer's disease treatment in the EU. The recommendation applies to adult patients with early Alzheimer's who are apolipoprotein E ε4 heterozygotes or non-carriers. This follows a re-examination of CHMP's earlier negative recommendation, with European Commission's decision expected within 67 days. Lecanemab is already approved in multiple countries including the US, Japan, and China. BioArctic holds Nordic region commercialization rights, while partner Eisai handles development and commercialization elsewhere.

BioArctic AB announced that its partner Eisai has revised down its revenue forecast for Leqembi for fiscal year 2024 (April 2024-March 2025) to JPY 42.5 billion from JPY 56.5 billion previously announced in May. This adjustment would generate approximately SEK 300M in royalty for BioArctic. First-half FY2024 Leqembi sales reached JPY 16.3 billion, resulting in SEK 112.4M royalty to BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Biogen co-commercializing the product. BioArctic maintains Nordic region commercialization rights, pending European approval.

BioAge Labs reported Q3 2024 financial results and business updates. Key highlights include the initiation of Phase 2 STRIDES trial testing azelaprag with tirzepatide for obesity, and completion of a $238.3M IPO. The company reported R&D expenses of $20.0M (up from $6.5M in Q3 2023), G&A expenses of $4.7M, and a net loss of $23.4M. With approximately $334.5M in cash and cash equivalents, BioAge expects to fund operations into 2029. The company also appointed former GSK CEO Jean-Pierre Garnier as Board Chair.

BioArctic AB has unveiled its proprietary BrainTransporter (BT) platform at the PEGS conference in Barcelona. The technology demonstrates up to 70-fold higher penetration of antibodies across the blood-brain barrier using Transferrin Receptor-mediated transport, without negative effects on hematological safety. The platform shows rapid, broad, and deep distribution of amyloid-beta antibodies across the brain in preclinical models. In April 2024, BioArctic and Eisai entered a research evaluation agreement for BAN2802, combining BT technology with an Alzheimer drug candidate.

BioArctic AB (NASDAQ STOCKHOLM: BIOA B) has announced it will release its Q3 2024 report for July-September on November 14, 2024, at 08:00 CET. The company will host an audiocast with teleconference in English at 09:30 CET where CEO Gunilla Osswald and CFO Anders Martin-Löf will present the quarterly results and conduct a Q&A session. Participants can join via webcast or teleconference, with both options requiring pre-registration. The presentation will be available on-demand afterward on BioArctic's corporate website.

BioAge Labs announced new preclinical data presentations for azelaprag, their oral APJ agonist, at ObesityWeek 2024. The studies demonstrated that azelaprag enhanced weight loss when combined with various appetite suppressants in obese mice on high-fat diets. As a monotherapy, azelaprag showed protection against excess weight gain, improved body composition, and increased physical activity and energy expenditure. The data supports azelaprag's potential as a novel obesity treatment, both as a standalone therapy and in combination with other medications like semaglutide, tirzepatide, danuglipron, and rimonabant.