BioAge Labs Inc. Stock Price, News & Analysis

BioAge (Nasdaq: BIOA) reported positive interim Phase 1 data for BGE-102, a brain-penetrant oral NLRP3 inhibitor, on Dec 4, 2025. In SAD (10–120 mg) and initial MAD (60, 120 mg) cohorts, BGE-102 was well tolerated and showed dose-proportional pharmacokinetics supporting once-daily dosing.

Key results: IL-1β suppression 90–98% at Day 14 (60–120 mg), and CSF concentrations at ≥60 mg exceeded target IC90 after 14 days, indicating high brain penetration. MAD plasma levels at ≥60 mg exceeded IC90 for 24 hours.

The company expanded MAD cohorts to enroll obese participants with elevated hsCRP; data are anticipated in 1H 2026. Phase 2a is planned to start in 1H 2026 with ~100 patients and a 2H26 readout.

BioArctic partner Eisai (NYSE:B) presented CTAD 2025 data showing continued lecanemab (Leqembi) treatment may delay Alzheimer’s progression by up to 8.3 years in a low‑amyloid subgroup who started treatment early. Analysis used Clarity AD OLE and ADNI natural‑history data to estimate 10‑year time savings by CDR‑SB, with overall delays of 2.5–3.5 years vs untreated and larger gains in low‑amyloid patients.

Separately, a subcutaneous autoinjector (SC‑AI) approved for maintenance in the US (Aug 2025) showed bioequivalent exposure to IV dosing (exposure ratio 104%, 90% CI 99.1%–109%), low systemic infusion reactions, ADA 1.4%, and predicted ARIA‑E rates of 12.4% (30.9% in ApoE4 homozygotes). sBLA for initiation completed Nov 2025; Japan SC submission Nov 2025.

BioAge Labs (NASDAQ: BIOA) will present at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2-4, 2025. Company leaders Kristen Fortney, PhD, CEO, and Dov Goldstein, MD, CFO, will participate in a fireside chat on December 4, 2025 from 1:30–1:55 PM ET and will hold one-on-one meetings.

A live webcast will be available with registration, and replays will be archived in the company investor section at https://ir.bioagelabs.com/ for 30 days after the presentations.

BioArctic (Nasdaq: B) announced that partner Eisai will present new data on lecanemab (Leqembi) at the CTAD conference in San Diego, Dec 1–4, 2025.

Presentations cover long‑term treatment analyses, estimated time savings over 10 years, safety and pharmacokinetics for a subcutaneous initiation option, effects on soluble Aβ protofibrils, and real‑world registry findings including ALZ‑NET and a Japanese post‑marketing study.

BioArctic (NASDAQ: B) partner Eisai received MHRA approval in the United Kingdom for Leqembi (lecanemab) as a once-every-four-weeks IV maintenance treatment for early Alzheimer’s disease on November 14, 2025.

After an initial 18-month induction of 10 mg/kg every two weeks, patients may be transitioned to 10 mg/kg every four weeks or remain on the two-week schedule. Leqembi previously received a UK approval in August 2024 for treatment of MCI and mild dementia due to Alzheimer’s in ApoE ε4 heterozygotes and non-carriers. BioArctic and Eisai are preparing joint commercialization in the Nordic region, where BioArctic holds commercialization rights.

BioAge Labs (NASDAQ: BIOA) will present at the Jefferies Global Healthcare Conference in London on November 17–20, 2025. The company said CEO Kristen Fortney, PhD, and CFO Dov Goldstein, MD, will join a fireside chat on Monday, November 17 from 7:30–7:55 AM ET (12:30–1:00 PM GMT) and will hold one-on-one meetings.

Investors can watch a live webcast by registering via the company link and access replays in the investor section at https://ir.bioagelabs.com/; replays will be archived for 30 days after the presentations.

BioAge (NASDAQ: BIOA) reported Q3 2025 results and program updates on Nov 6, 2025. The company dosed the first participant in the Phase 1 trial of BGE-102, an oral CNS-penetrant NLRP3 inhibitor, with initial single ascending dose (SAD) data expected by year-end 2025. BioAge is advancing oral and parenteral APJ agonist programs targeting 2026 IND submissions and continues collaborations with Novartis and Lilly.

Financial highlights: collaboration revenue was $2.1M; R&D expense was $18.5M; G&A expense was $6.7M; net loss was $20.2M or $0.56 per share; cash and marketable securities were $295.9M, sufficient to fund operations through 2029.

BioArctic (Nasdaq Stockholm: B) will publish its third quarter report for July–September 2025 on Thursday, 13 November 2025 at 08:00 CET. An English-language audiocast with teleconference will follow the report on 13 November 2025 at 09:30 CET, where CEO Gunilla Osswald and CFO Anders Martin-Löf with colleagues will present the report and hold a Q&A.

Investors, analysts and media can join via webcast (written questions) or teleconference (verbal questions) after registration. The webcast will be available on demand on BioArctic's investor website. Contact: Oskar Bosson, VP Communications and Investor Relations.

BioArctic (NASDAQ: B) announced that partner Eisai received a Notice of Compliance with Conditions (NOC/c) from Health Canada for Leqembi (lecanemab) on October 27, 2025, authorizing use in adults with early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes and have confirmed amyloid pathology.

Leqembi is described as the first treatment targeting an underlying cause of early AD and shown in the Phase 3 Clarity AD study to slow cognitive and functional decline; it is approved in 51 countries and regions. The Canadian authorization is conditional pending confirmatory trials and Eisai will submit real-world clinical assessment data. BioArctic retains Nordic commercialization rights and plans joint regional commercialization with Eisai.