BioAge Labs Inc. Stock Price, News & Analysis

BioAge Labs (BIOA) has announced the discontinuation of its STRIDES Phase 2 clinical trial evaluating azelaprag in combination with tirzepatide for obesity treatment. The decision follows observations of liver transaminitis in some subjects receiving azelaprag, though without clinically significant symptoms. The study, which enrolled 204 subjects, was designed to evaluate two oral doses of azelaprag combined with tirzepatide in individuals aged 55 and older with obesity.

The company will analyze available data from enrolled subjects and plans to share updated plans for azelaprag in Q1 2025. In parallel, BioAge continues advancing its pipeline, including a brain-penetrant NLRP3 inhibitor program targeting neuroinflammation, with IND submission anticipated in second half of 2025.

BioAge Labs (Nasdaq: BIOA), a clinical-stage biopharmaceutical company focused on developing therapeutics for metabolic diseases through aging biology, has announced its participation in the Goldman Sachs Second Annual "Year-Ahead" Catalyst Clinic. The presentation is scheduled for Thursday, December 19, 2024, from 11-12 PM EST.

The event will feature a virtual presentation that will be accessible via webcast. Interested parties can access the live presentation through registration, and replays will be available on the company's investor relations website for 30 days following the event.

BioArctic AB has initiated dosing in the EXIST Phase 2a study of exidavnemab for Parkinson's disease patients. The study is a randomized, double-blind, placebo-controlled trial evaluating safety and tolerability of the monoclonal antibody targeting aggregated α-synuclein. At least 24 patients will be recruited in Europe, divided into two cohorts receiving different doses.

The trial follows successful Phase 1 studies showing exidavnemab is well-tolerated with a 30-day half-life. The drug demonstrates high affinity and selectivity toward pathological aggregated forms of α-synuclein, which is believed to play a role in disease progression. The study will evaluate various biomarkers in plasma, cerebrospinal fluid, and through digital measurements.

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.