BioAge Labs Inc. Stock Price, News & Analysis

BioArctic AB (Nasdaq Stockholm: BIOA B) founders Lars Lannfelt and Pär Gellerfors, along with CEO Gunilla Osswald, have been awarded Uppsala University's Innovation and Entrepreneurship Prize 2025 for their groundbreaking work in Alzheimer's disease treatment.

The recognition stems from Lannfelt's 1990s breakthrough in understanding Alzheimer's disease and developing an antibody-based treatment. The company, founded in 2003, partnered with Japanese pharmaceutical company Eisai to develop lecanemab, which is now approved in eleven countries including the USA, Japan, and China, with pending approvals in 17 additional countries and regions, including Europe.

The founders' vision includes building BioArctic into a fully-fledged pharmaceutical company in Sweden, focusing on both research and product commercialization. Gunilla Osswald, CEO since 2014, has been instrumental in realizing this vision of helping patients worldwide.

BioArctic AB (NASDAQ: BIOA B) announced that Australia's Therapeutic Goods Administration (TGA) has declined to approve lecanemab for early Alzheimer's disease treatment. The TGA rejected both the initial application in October 2024 and a December 2024 reconsideration request that proposed limiting the treatment to ApoE4 noncarriers and heterozygotes.

The TGA suggested a narrower indication for ApoE4 noncarriers only, citing safety concerns for ApoE4 heterozygotes. Despite Eisai's proposal for treating heterozygotes in specialist centers under expert supervision, the TGA maintained its rejection.

This decision affects approximately 411,000 people living with dementia in Australia as of 2023, with this number projected to reach 849,000 by 2058. Lecanemab, which works by clearing toxic Aβ protofibrils and plaques, has already received approval in 11 markets including the US, Japan, China, and the UK, with pending applications in the EU and 17 other regions.

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.