Welcome to our dedicated page for Zenas BioPharma news (Ticker: ZBIO), a resource for investors and traders seeking the latest updates and insights on Zenas BioPharma stock.
Zenas BioPharma, Inc. (Nasdaq: ZBIO) is a clinical-stage global biopharmaceutical company focused on autoimmune diseases, and its news flow reflects active development across multiple programs. Company announcements frequently highlight progress with its lead product candidate, obexelimab, a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb across the B cell lineage to inhibit cells implicated in autoimmune disease without depleting them. News items include updates on the Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease (IgG4-RD), Phase 2 MoonStone trial in Relapsing Multiple Sclerosis (RMS), and Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE), including reports of statistically significant efficacy results and safety findings.
Investors following ZBIO news can also track developments related to orelabrutinib, a late-stage, highly selective CNS-penetrant, oral BTK inhibitor licensed from InnoCare Pharma. Press releases cover Phase 3 trials in Primary Progressive Multiple Sclerosis (PPMS) and planned trials in Secondary Progressive Multiple Sclerosis (SPMS), as well as partner-reported data in SLE. Additional news covers earlier-stage programs ZB021 and ZB022, described as potentially best-in-class oral IL-17AA/AF and TYK2 inhibitors in IND-enabling or preclinical stages.
Regulatory, financing and corporate updates are another key component of Zenas BioPharma’s news. The company issues releases on revenue participation and funding agreements, such as its obexelimab funding arrangement with Royalty Pharma, private placement financings, and material license agreements with InnoCare. Earnings-related press releases and Form 8-K–linked announcements provide context on cash runway, research and development spending, and strategic priorities.
This ZBIO news page aggregates these disclosures so readers can follow clinical milestones, regulatory plans, licensing transactions and capital raises associated with Zenas’ autoimmune pipeline. For investors, analysts and healthcare professionals, it offers a single view into how obexelimab, orelabrutinib, ZB021 and ZB022 are progressing through development and how the company is structuring partnerships and funding to support its programs.
Zenas BioPharma (Nasdaq: ZBIO) announced an inducement grant under Nasdaq Listing Rule 5635(c)(4) dated Jan 15, 2026. The Compensation Committee granted a non-qualified stock option to a newly hired employee to purchase 100,000 shares of common stock.
The option has a 10-year term, an exercise price of $19.93 per share (equal to the closing price on the grant date), and vests over 4 years (25% after one year, then 36 equal monthly installments), subject to continued service and the terms of the 2026 Inducement Plan and the related option agreement.
Zenas BioPharma (Nasdaq: ZBIO) announced positive Phase 3 INDIGO results for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint with a 56% reduction in risk of IgG4-RD flare versus placebo (Hazard Ratio 0.44, p=0.0005) over 52 weeks and achieved statistically significant results on all four key secondary endpoints. The drug was well tolerated with no new safety signals, similar injection site reaction rates, and lower infection rates versus placebo. Zenas plans to submit a BLA to FDA in Q2 2026 and an MAA to EMA in H2 2026. Full INDIGO data will be presented at a future medical meeting and a conference call was scheduled for January 5, 2026.
Zenas BioPharma (Nasdaq: ZBIO) announced inducement option grants on December 15, 2025 to two newly hired employees totaling 300,000 non-qualified stock options. The options have a 10-year term and an exercise price of $32.59, equal to the closing price on the grant date. Vesting is over four years: 25% on the one-year anniversary of each employee's start date, then the remainder in 36 equal monthly installments, subject to continued service. Grants are governed by an Inducement Option Award Agreement and were approved by the Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4).
Zenas BioPharma (Nasdaq: ZBIO) highlighted that partner InnoCare achieved the primary endpoint in a Phase 2b study of orelabrutinib for Systemic Lupus Erythematosus (SLE) on Dec 15, 2025. In a 187‑patient, randomized (1:1:1) trial, orelabrutinib 75 mg QD produced an SRI‑4 response rate of 57.1% vs 34.4% for placebo at week 48 (p < 0.05). The 75 mg dose showed dose‑dependent benefit versus 50 mg and achieved higher SRI‑6 and BICLA response rates (p < 0.05). Orelabrutinib was reported as well tolerated. Separately, China’s CDE approved a Phase 3 registrational trial in SLE, and Zenas retains commercial/development rights for MS and certain non‑oncology territories per an Oct 2025 license.
Zenas BioPharma (Nasdaq: ZBIO) reported Q3 2025 results and a corporate update highlighting clinical progress, pipeline expansion, and financing. Key items include Phase 2 MoonStone obexelimab data in relapsing MS showing a 95% relative reduction in new GdE T1 lesions (p=0.0009), an expected topline readout from the Phase 3 INDIGO trial in IgG4-RD around year-end 2025, and a transformational license for orelabrutinib with Phase 3 programs for PPMS initiated Q3 2025 and SPMS planned Q1 2026.
Financing highlights: up to $300M from Royalty Pharma (including $75M upfront) and a $120M private placement. Cash and investments were $301.6M at Sept 30, 2025.
Zenas BioPharma (Nasdaq: ZBIO) announced management will present at two investor conferences: the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025 at 11:00 a.m. GMT, and the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 2025 at 7:55 a.m. ET.
Live webcasts and archived replays will be available under Events and Presentations in the company’s Investor & Media Relations website.
Zenas BioPharma (Nasdaq: ZBIO) announced positive Phase 2 MoonStone results for obexelimab in relapsing multiple sclerosis on October 27, 2025. Obexelimab met the primary endpoint with a 95% relative reduction in new gadolinium-enhancing T1 lesions versus placebo over weeks 8 and 12 (p=0.0009), with adjusted mean new GdE T1 lesions per scan of 0.01 vs 0.23. The drug also significantly reduced new/enlarging T2 lesions. Safety was consistent with prior trials, including infections and hypersensitivity, most commonly mild injection-site reactions. Zenas expects 24-week MoonStone data in Q1 2026 and additional toplines from INDIGO (IgG4-RD) and SunStone (SLE) in late 2025–mid 2026.
Zenas BioPharma (Nasdaq: ZBIO) announced a license agreement with InnoCare granting Zenas global MS and non-oncology rights to orelabrutinib plus rights to an oral IL-17AA/AF inhibitor and an oral, brain-penetrant TYK2 inhibitor. A global Phase 3 trial in PPMS has been initiated and a SPMS Phase 3 is expected to start in 1Q 2026. The two early candidates aim for IND/Phase 1 starts in 2026. Financial terms include up to $100M in upfront/near-term cash, up to 7.0M Zenas shares, total deal value exceeding $2B, and tiered royalties up to high‑teens. Zenas also announced a $120M private placement expected to close ~October 9, 2025, which it says funds operations into Q4 2026 (into Q1 2027 assuming a $75M milestone).
Zenas BioPharma (Nasdaq: ZBIO) has secured a funding agreement with Royalty Pharma (Nasdaq: RPRX) for up to $300 million to support the development and commercialization of obexelimab. The agreement includes an initial $75 million payment and three additional $75 million milestone payments tied to Phase 3 trial success, FDA approval for IgG4-RD, and FDA approval for SLE.
Obexelimab, a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, is currently in Phase 3 development for IgG4-Related Disease with results expected by year-end, and Phase 2 trials for Relapsing Multiple Sclerosis and Systemic Lupus Erythematosus. In exchange for funding, Royalty Pharma will receive a 5.5% royalty on worldwide net sales.
[ "Secured up to $300 million in funding for obexelimab development and commercialization", "Initial $75 million payment extends cash runway through Q1 2027", "Multiple near-term catalysts with Phase 3 IgG4-RD results expected year-end 2025", "Potential blockbuster opportunity in IgG4-RD market" ]Zenas BioPharma (NASDAQ:ZBIO), a clinical-stage biopharmaceutical company focused on autoimmune disease therapies, has announced its participation in three major healthcare investor conferences in September 2025.
The company will present at the Citi's 2025 Biopharma Back to School Conference (September 2), the Cantor Global Healthcare Conference (September 3), and the Morgan Stanley 23rd Annual Global Healthcare Conference (September 10). All presentations will be accessible via webcast on the company's website.
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