BioAge Labs Inc. - BIOA STOCK NEWS

BioArctic AB (BIOA B) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab (Leqembi®) in early Alzheimer's disease, originally adopted in November 2024. This follows the European Commission's January 2025 request to review additional safety information and risk minimization measures clarity.

Leqembi, an anti-Aβ monoclonal antibody targeting toxic protofibrils and Aβ plaques, is already approved in the US, Japan, China, and Great Britain. If approved by the EC, the marketing authorization will extend to all 27 EU member states, Iceland, Liechtenstein, and Norway.

BioAge Labs (Nasdaq: BIOA), a clinical-stage biopharmaceutical company focused on developing therapeutic products for metabolic diseases through aging biology, has announced its participation in TD Cowen's 45th Annual Health Care Conference.

The conference is scheduled for March 3-5, 2025, at the Boston Marriott Copley Place in Boston, MA. BioAge will engage in one-on-one meetings during the event, which features presentations, fireside chats, and panel discussions moderated by TD Cowen research team members, covering various healthcare industry aspects.

BioArctic AB announced the completion of its global license agreement with Bristol Myers Squibb after receiving U.S. Federal Trade Commission clearance. The agreement, initially announced on December 19, 2024, grants Bristol Myers Squibb worldwide development and commercialization rights for BAN1503 and BAN2803, part of BioArctic's PyroGlutamate-amyloid-beta antibody program for Alzheimer's disease.

The deal includes a USD 100 million upfront payment to BioArctic, potential milestone payments up to USD 1.25 billion, and tiered low double-digit royalties on global sales. BioArctic retains Nordic region co-commercialization rights and maintains rights to its BrainTransporter platform technology for other applications.

The PyroGlu-Aβ antibody program targets a specific modified form of amyloid-beta that tends to aggregate and cause Alzheimer's symptoms. BAN2803 incorporates BioArctic's BrainTransporter technology, marking the first license agreement utilizing this platform.

BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has achieved the first sales milestone for Leqembi®, reaching €200 million in sales during Eisai's fiscal year 2024 (April 2024 - March 2025). This achievement triggers a €10 million milestone payment to BioArctic.

Leqembi, an antibody developed through collaboration between BioArctic and Eisai, originated from Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease. While Eisai manages clinical development, market approval applications, and global commercialization, BioArctic retains rights to commercialize Leqembi in the Nordic region jointly with Eisai, with preparations for regional commercialization currently underway.

BioArctic AB (BIOA B) announced that the European Commission has requested the Committee for Medicinal Products for Human Use (CHMP) to address two additional questions regarding lecanemab, their early Alzheimer's disease treatment. Despite receiving a positive CHMP opinion in November 2024, the EC needs clarification on safety information that emerged after the opinion and the clarity of risk minimization measures.

The questions will be discussed at the February 2025 CHMP meeting before a final EC decision. Importantly, the safety profile of lecanemab in clinical practice in the US, Japan, and other markets remains consistent with approved labels, with no new safety signals identified. Eisai, BioArctic's partner, believes existing information is sufficient to address the EC's concerns.

Leqembi, developed through collaboration between BioArctic and Eisai, originated from Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease. While Eisai leads clinical development and commercialization, BioArctic maintains Nordic region commercialization rights alongside Eisai.

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.