BioAge Labs, Inc. - BIOA STOCK NEWS

BioAge Labs announced significant updates to its clinical programs and platform development. The company has discontinued azelaprag development due to liver transaminitis observations in the STRIDES Phase 2 obesity trial, but is advancing next-generation APJ agonists with a development candidate expected by end of 2025.

The company nominated BGE-102, a brain-penetrant NLRP3 inhibitor, as a development candidate for neuroinflammation conditions, with Phase 1 SAD data expected by end of 2025. BioAge also expanded its discovery efforts through collaborations with Novartis (worth up to $550 million) and Lilly ExploR&D for antibody therapeutics development.

Financially, BioAge reported $334.5 million in cash and equivalents as of September 30, 2024, plus $27.6 million from IPO greenshoe exercise, extending runway beyond 2029.

BioArctic AB announced FDA approval for a new maintenance dosing schedule of Leqembi for early Alzheimer's disease treatment. Patients who complete the 18-month biweekly initiation phase can now transition to a once-every-four-weeks 10 mg/kg dosing regimen.

Clinical data demonstrates the importance of continuous treatment, as discontinuation leads to brain amyloid reaccumulation and reversion to placebo-rate decline. Three-year bi-weekly treatment data showed Leqembi reduced cognitive decline by -0.95 compared to a matched natural history cohort, more than double the 18-month result (-0.45).

Leqembi works by clearing amyloid-beta plaque and toxic protofibrils. The drug is already approved in the US, Japan, China, Great Britain, and received CHMP positive opinion for European approval. A subcutaneous autoinjector version is under FDA review with a PDUFA date of August 31, 2025.

BioArctic AB announced that the FDA has accepted their partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. The PDUFA action date is set for August 31, 2025.

Leqembi, indicated for early Alzheimer's disease treatment, could become the only FDA-approved anti-amyloid therapy offering convenient subcutaneous injection with at-home administration. The SC-AI 360 mg weekly maintenance regimen, following the biweekly intravenous initiation phase, is designed to maintain clinical and biomarker benefits with a 15-second injection process.

The treatment is already approved in the US, Japan, China, Great Britain, and received a positive CHMP opinion from EMA in November 2024. This new delivery method could reduce hospital visits and simplify the treatment pathway for Alzheimer's patients.

BioArctic AB has entered into a global exclusive license agreement with Bristol Myers Squibb for its PyroGlutamate-amyloid-beta antibody program, including BAN1503 and BAN2803. The deal includes a $100 million upfront payment and up to $1.25 billion in milestone payments, plus tiered low double-digit royalties on global product sales.

The agreement covers BioArctic's novel antibodies targeting pyroglutamate modified amyloid-beta, which forms harmful aggregates causing Alzheimer's disease symptoms. BAN2803 incorporates BioArctic's BrainTransporter™ technology, designed to enhance brain drug delivery through the blood-brain barrier using the transferrin receptor. BioArctic retains co-commercialization rights in the Nordic region and all other rights for the BrainTransporter platform in different therapy areas.

BioAge Labs has announced a multi-year research collaboration with Novartis to discover novel therapeutic targets for age-related diseases. The partnership combines BioAge's human longevity datasets with Novartis's expertise in exercise biology. Financial terms include up to $20M in upfront payments and research funding, plus potential future milestones of up to $530M.

BioAge's platform leverages longitudinal human aging cohorts tracked for up to 50 years, using advanced analytics and machine learning to identify determinants of healthy lifespan. Both companies will have rights to advance discovered targets and receive reciprocal success milestones and tiered royalties.

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.