BioAge Labs Inc. - BIOA STOCK NEWS

BioArctic AB (NASDAQ Stockholm: BIOA B) presented significant findings on lecanemab, an antibody for Alzheimer's disease, at the 2023 AD/PD conference. The Phase 3 Clarity AD study involving 1,795 participants confirmed the efficacy of lecanemab, achieving its primary and all key secondary endpoints with strong statistical significance. Presentations highlighted the unique mechanism of action of lecanemab, ARIA incidences, and quality of life improvements for patients and caregivers. BioArctic, partnered with Eisai, is preparing for the joint commercialization of lecanemab in the Nordic region, where BioArctic holds the rights to market the drug.

On March 31, 2023, BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner, Eisai, published detailed analyses from the phase 2b clinical study of lecanemab for treating mild cognitive impairment and early Alzheimer's disease. The multicenter study enrolled 856 patients, showing a consistent reduction in clinical decline over 18 months and demonstrating the potential for disease modification. Lecanemab exhibited a low incidence of amyloid-related imaging abnormalities (ARIA), with manageable side effects. BioArctic retains commercialization rights for lecanemab in the Nordic region, and both companies are preparing for joint commercialization.

BioArctic's partner, Eisai, has published new research on the societal value of the anti-amyloid-beta antibody, lecanemab (LEQEMBI™), in Alzheimer's disease. This study utilized data from the Phase 3 Clarity AD trial, revealing a gain of 0.61 quality-adjusted life-years (QALYs) from a healthcare payer perspective and a reduction in costs by $6,263 per person. For the societal perspective, the QALY gain is 0.64 and costs decrease by $7,451. Lecanemab, which received accelerated FDA approval on January 18, 2023, could significantly improve quality of life and lessen the economic burden of Alzheimer's disease.

BioArctic AB (NASDAQ Stockholm: BIOA B) announced that the U.S. Veterans Health Administration (VHA) will cover LEQEMBI™ (lecanemab-irmb) for veterans with early-stage Alzheimer's disease. This decision comes two months post-FDA approval under the accelerated pathway. Healthcare professionals can prescribe LEQEMBI following VHA and FDA guidelines. The ongoing clinical trials aim to verify LEQEMBI's benefits, and further data is anticipated as Eisai prepares for traditional FDA approval. BioArctic has no development costs for lecanemab and is entitled to royalties and milestone payments from its commercialization.

BioArctic's partner, Eisai, announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for LEQEMBI (lecanemab-irmb) for traditional approval, prioritizing the review. This follows its accelerated approval on January 6, 2023. The sBLA is based on the Phase 3 Clarity AD trial, which met its primary endpoint and key secondary endpoints. Eisai has a Prescription Drug User Fee Act (PDUFA) action date set for July 6, 2023. BioArctic is preparing for commercialization of LEQEMBI in the Nordics, having no development costs and receiving milestone payments and royalties on global sales.

BioArctic AB announced the recruitment of Anders Martin-Löf as the new CFO, effective June 1, 2023. Martin-Löf, who has over 20 years of experience in the Life Science sector, previously held roles at companies like Oncopeptides and A3P Biomedical. The current CFO, Jan Mattsson, will transition to a new role as VP Finance after Martin-Löf's arrival. Gunilla Osswald, the CEO, expressed confidence in Martin-Löf's capabilities to aid in the company's development during this exciting phase, particularly in treatments for neurodegenerative diseases. This change comes as BioArctic continues its partnership with Eisai on Alzheimer's therapies.

BioArctic AB announced that its partner Eisai's Biologics License Application (BLA) for lecanemab (LEQEMBI™) has been granted Priority Review by the National Medical Products Administration (NMPA) in China. This designation, aimed at expediting the approval process for clinically significant drugs, follows Eisai's submission of data, including results from the Phase 2b trial and the Phase III Clarity AD study on Alzheimer's disease. Lecanemab targets amyloid beta aggregates to potentially slow disease progression. BioArctic has no development costs for lecanemab and is entitled to milestone payments and royalties on global sales.

On January 30, 2023, BioArctic AB announced that its partner, Eisai, received Priority Review designation from the Japanese Ministry of Health for the marketing application of lecanemab (LEQEMBI™), an antibody for Alzheimer's disease (AD). The application, submitted on January 16, 2023, is based on results from the Phase 3 Clarity AD study, which demonstrated a significant reduction in clinical decline in early AD. Lecanemab has also received accelerated FDA approval in the U.S. for AD treatment. BioArctic is entitled to payments and royalties from lecanemab's sales, having no development costs associated with the drug.

BioArctic AB announced that its partner Eisai received acceptance from the European Medicines Agency (EMA) for a marketing authorization application (MAA) for lecanemab (brand name LEQEMBI) targeting early Alzheimer's disease.

This approval allows BioArctic to receive a milestone payment of MEUR 5. In the U.S., the drug received accelerated approval by the FDA on January 6, 2023, and Eisai is pursuing traditional approval based on positive Phase III results.

BioArctic has no developmental costs for lecanemab and is entitled to royalties on global sales and milestone payments.