ZBIO

- Safety and efficacy results from the Phase 3 INDIGO trial to be presented by Emanuel Della Torre, M.D., Ph.D., on Thursday June 4, 2026, at 2:45 PM GMT - WALTHAM, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that safety and efficacy outcomes from the Phase 3 INDIGO trial evaluating obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) will be presented in an oral presentation at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, held from June 3-6, 2026, in London, England. INDIGO, the largest randomized, double-blind, placebo-controlled study conducted in IgG4-RD, met the primary endpoint demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (HR 0.443; 95% CI 0.277–0.711; p=0.0005) during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints: time to first investigator-determined flare requiring rescue therapy (p=0.0001), number of investigator- and AC-determined flares requiring rescue therapy (p=0.0008), proportion of patients achieving complete remission (p=0.0049), and cumulative glucocorticoid rescue therapy use (p=0.0042). Obexelimab was well tolerated with no new safety signals observed. Treatment-emergent adverse events (TEAEs) occurred in 97.9% vs 95.9% of participants (obexelimab vs placebo). Incidence of Grade ≥3 TEAEs was less with obexelimab (11.3% vs 23.7%), and the incidence of serious adverse events was 10.3% vs 18.6%. Infections occurred in 53.6% vs 62.9% of participants. Injection-site reactions were reported in 3.5% vs 2.3% of total patient doses. Hypersensitivity occurred in 16.5% vs 11.3% of participants. There were no deaths in the obexelimab group and one death (1.0%) in the placebo group. Details of EULAR Presentation: Title: Obexelimab, a B Cell Inhibitor, in IgG4-Related Disease: Results From the Phase 3 INDIGO Trial Presenting Author: Emanuel Della Torre, M.D., Ph.D., Associate Professor of Rheum...

– Obexelimab marketing applications for the treatment of IgG4-RD on-target for submission to the FDA this quarter and the EMA in H2 2026 based on the Phase 3 INDIGO IgG4-RD trial results – – Obexelimab Phase 3 INDIGO IgG4-RD trial results accepted for oral presentation at EULAR 2026 – – Obexelimab global Phase 2 SunStone SLE trial enrollment complete; topline results expected in Q4 2026 – – First subject dosed in Phase 1 trial of ZB021 (oral IL-17AA/AF inhibitor); initial clinical data expected by year-end – – Orelabrutinib global Phase 3 PriMroSe trial in patients with PPMS and global Phase 3 Monarch trial in patients with naSPMS ongoing – – Completed public offerings and entered into debt financing; cash runway extended into 2029 – WALTHAM, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today reported financial results for the quarter ended March 31, 2026, and provided recent corporate updates. “This quarter we continued to execute across our portfolio and made meaningful progress toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune and chronic inflammatory diseases,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “Over the next three quarters, we expect to achieve important clinical and regulatory milestones, including the presentation of INDIGO study results at EULAR, the filing and acceptance of our marketing applications for obexelimab for IgG4-RD in the U.S. and Europe, topline results from the SunStone trial, and initial clinical data for ZB021, our oral IL-17 AA/AF inhibitor. With our balance sheet strengthened by recent financings, Zenas remains focused on preparing for the potential commercialization of obexelimab while continuing to advance our broader pipeline.” Corporate highlights Obexelimab, a CD-19 and FcgRIIb inhibitor of B cell function Obexelimab marketing applications for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) remain on track: Zenas expects to submit a Biologics License Application (BLA) to the U.S. Foo...

Zenas BioPharma, Inc. has reported first-quarter 2026 results, recording a net loss of US$80.99 million, compared with US$33.57 million a year earlier, with basic and diluted loss per share from continuing operations rising to US$1.46 from US$0.80. The widening loss underscores how the company’s cost base or investment spend has grown materially year on year, even as it remains in a loss-making phase. We will now examine how this sharp year-on-year increase in net loss shapes Zenas BioPharma’s investment narrative and risk profile. We've uncovered the 13 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. To own Zenas BioPharma today, you have to believe that obexelimab’s emerging profile across IgG4-RD and relapsing MS can ultimately justify heavy upfront investment and ongoing losses. The latest quarter’s US$80.99 million net loss, sharply higher than a year ago, reinforces that this is still very much a funding and execution story rather than an earnings one. Recent financing moves, including a US$100 million follow-on offering and up to US$250 million in term loans, have bought time for key regulatory and partnering catalysts, but at the cost of dilution and higher financial obligations. Against a share price that has fallen year to date, the bigger loss figure raises the stakes around cash burn and any delay in converting positive trial data into approvals or commercial deals. Unless you think this spending curve is proportionate to the opportunity, the risk side of the equation will loom larger after this update. However, one funding risk now looks even more important to understand in detail. Upon reviewing our latest valuation report, Zenas BioPharma's share price might be too optimistic. One fair value estimate from the Simply Wall St Community sits at US$42 per share, showing just a single, concentrated viewpoint. Set that against rising losses and fresh financing needs, and it becomes clear why different investors may reach very different conclusions about how Zenas’ execution from here could influence future outcomes. Explore another fair value estimate on Zenas BioPharma - why the stock might be worth just $42.00! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Zenas BioPharma research is our anal...

- Obexelimab marketing applications for the treatment of IgG4-RD expected to be submitted to the FDA in Q2 2026 and the EMA in H2 2026 based on the Phase 3 INDIGO trial results - - Topline results of the global Phase 2 SunStone trial of obexelimab in SLE expected in Q4 2026 - - New, half-life extended anti-CD-19 and FcγRIIb mAb (ZB014) progressing toward clinical development - - Global orelabrutinib Phase 3 trial for primary progressive multiple sclerosis (MS) ongoing; global Phase 3 trial for non-active secondary progressive MS expected to be initiated in Q1 2026 - - Oral, IL-17AA/AF inhibitor (ZB021) Phase 1 trial expected to be initiated in 2Q 2026 with initial clinical data by year-end - - Up to $250 million non-dilutive, multi-tranche debt financing secured from Pharmakon - WALTHAM, Mass., March 16, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today reported financial results for the quarter and year ended December 31, 2025, and provided recent corporate updates. "Following the highly positive Phase 3 INDIGO results reported earlier this year, we enter 2026 with strong momentum as we prepare for the potential commercialization of obexelimab for the treatment of IgG4-RD. We are on track to submit obexelimab marketing applications for the treatment of IgG4-RD to the FDA in the second quarter and to the EMA in the second half of the year, both major milestones for the program and patients living with this disease,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We look forward to progressing multiple Zenas pipeline programs this year, including the orelabrutinib progressive MS Phase 3 studies, clinical development of our oral IL-17 inhibitor, ZB021, and the advancement of an exciting new molecule, ZB014, a half-life extended anti-CD-19 and FcγRIIb antibody. In addition, we expect to report topline overall and biomarker population results of the Phase 2 SunStone trial of obexelimab in SLE. Collectively, these programs represent the foundation for compelling franchises across numerous areas of unmet need for patients living with immune mediated diseases. We are also very pleased to announce today a non-d...

- Obexelimab met the primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo over weeks 8 and 12 (p=0.0009) - - Separately announced 24-week data support the robust and durable activity of obexelimab and further validate its unique inhibitory mechanism of action - - Obexelimab was well tolerated, and no new safety signals were observed - WALTHAM, Mass., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS) were presented in a late-breaking oral presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026, which took place from February 5-7, 2026 in San Diego, California. Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo (p=0.0009). Near-complete suppression of new GdE T1 hyperintense lesions, markers of active inflammation, was observed with obexelimab by 8 weeks of treatment and was sustained through week 12. The adjusted mean number of new GdE T1 hyperintense lesions per scan was 0.01 (95% CI: 0.00, 0.06) in the obexelimab group compared to 0.23 (95% CI: 0.11, 0.51) with placebo. Over weeks 8 and 12, only two new GdE T1 lesions were observed in obexelimab-treated patients compared to 19 in placebo-treated patients, with 97.2% of obexelimab treated patients free from T1 lesions over this period. Consistent with the inhibitory mechanism of obexelimab, mean B cell values remained within the normal range for obexelimab-treated patients. The safety profile of obexelimab was consistent with that observed in prior completed trials, including cases of infections and hypersensitivity, most commonly mild injection site reactions. Separately announced 24-week data further confirm the robust and durable activity of obexelimab. The highly statistically significant reductions in total GdE T1 lesions observed with...

- Obexelimab Phase 3 INDIGO trial topline results in Immunoglobulin G4-Related Disease (IgG4-RD) expected around year-end 2025 - - Reported highly positive 12-week primary endpoint results from Phase 2 MoonStone trial of obexelimab in Relapsing MS (RMS) - - Secured development and commercialization rights for three autoimmune product candidates, including orelabrutinib, a BTK Inhibitor in Phase 3 development for progressive forms of Multiple Sclerosis (MS) - - Entered into obexelimab funding agreement with Royalty Pharma for up to $300.0 million, including $75M upfront, to support clinical development and potential commercial launch - WALTHAM, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate updates. “Our recent achievements mark a significant step toward our vision of becoming a fully integrated, global development and commercial-stage biopharmaceutical company that brings impactful treatments to patients living with autoimmune diseases,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “The outstanding results from our Phase 2 MoonStone trial in relapsing multiple sclerosis validates the rapid, deep and sustained inhibitory mechanism of obexelimab and provide strong evidence of its potential to broadly address the pathogenic role of B cells in autoimmune conditions. In addition, we significantly expanded our pipeline with the in-licensing of three potentially best-in-class product candidates, including orelabrutinib which we are advancing in a Phase 3 progressive multiple sclerosis program, and recently completed two financing transactions. We look forward to sharing topline results from the obexelimab Phase 3 INDIGO trial in IgG4-RD around year-end.” Recent corporate highlights Poised to report Phase 3 data for Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD): Plan to report topline data from the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news from Incyte and Zenas BioPharma, as well as updates from MapLight Therapeutics, Merck & Co. and GSK that you may have missed. Incyte has paused further development of three prospects as part of an ongoing R&D review that will see the company focus on “high-value programs” to drive its “next phase of growth,” CEO Bill Meury said in a quarterly earnings statement Tuesday. In the pipeline reshuffling, Incyte will no longer work on a drug called povorcitinib in a form of chronic urticarias. It’ll also stop testing two other medicines code-named INCA034460 and INCB57643, which the company was evaluating in vitiligo and myelofibrosis, respectively. The moves come amid a heightened focus on Incyte’s pipeline, as the main patent protecting its top-selling drug Jakafi will expire later this decade. — Ben Fidler Shares of Zenas Biopharma climbed by about a third on Monday after the company reported positive results from a Phase 2 study in people with relapsing forms of multiple sclerosis. Zenas said that, when compared to a placebo, its drug obeleximab was associated with a 95% relative reduction, after 8 or 12 weeks, in the cumulative number of new “T1” brain lesions — a sign of active inflammation in MS. The findings were “best-in-disease” data that matched or surpassed what’s been observed in testing of drugs like Ocrevus and Kesimpta, wrote Jefferies analyst Roger Song. Zenas will report longer-term data from the study next year, by which time the company expects to have revealed Phase 3 results from a study of obeleximab in IgG4-disease, another inflammatory condition. — Ben Fidler MapLight Therapeutics raised $251 million in an initial public offering it priced with the help of a little-used regulatory workaround enabling it to debut on Wall Street during the ongoing federal government shutdown. MapLight, which is developing a rival schizophrenia drug to Bristol Myers Squibb’s Cobenfy, sold 14,750,000 shares at $17 apiece in the offering. It also raised about $8 million in a concurrent private share sale to affiliates of Goldman Sachs. The company’s IPO is the third largest this year, only trailing new stock offerings from Metsera in January and LB Pharmaceuticals in September, according...

- Obexelimab met primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo, p=0.0009 - WALTHAM, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS). Obexelimab met the primary endpoint, demonstrating a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (Gd)-enhancing (GdE) T1 hyperintense lesions over week 8 and week 12 compared with placebo (p=0.0009). “These profound MoonStone trial results, including the near elimination of new GdE T1 lesions, provide strong evidence of the deep and sustained inhibitory mechanism of obexelimab and further validate the potential for obexelimab to become a meaningful therapy across multiple autoimmune diseases, including Immunoglobulin G4-Related Disease and Systemic Lupus Erythematosus, which are currently being evaluated by Zenas in Phase 3 and Phase 2 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. Near-complete suppression of new GdE T1 hyperintense lesions, which are markers of active inflammation, was observed with obexelimab by 8 weeks of treatment and was sustained through week 12. The adjusted mean number of new GdE T1 hyperintense lesions per scan in the obexelimab group was 0.01 (95% CI: 0.00, 0.06) compared to 0.23 (95% CI: 0.11, 0.51) with placebo. Additionally, over weeks 8 and 12 of treatment, obexelimab significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions compared to placebo, which represent the amount of disease burden or chronic lesion load. The safety profile of obexelimab was consistent with that observed in prior completed trials, including cases of infections and hypersensitivity, most commonly mild injection site reactions. “The observed clinical activity in the MoonStone trial, combined with obexelimab’s unique inhibitory mechanism of action, subcutaneous self-administration and tolerability profile, position obexelimab as a potential opti...

- Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 - - Completed enrollment of Phase 2 MoonStone trial in Relapsing Multiple Sclerosis; results expected early in the fourth quarter 2025 - - Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 - - Cash, cash equivalents and investments of $274.9 million as of June 30, 2025, expected to provide cash runway into the fourth quarter of 2026 - WALTHAM, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for autoimmune diseases, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. “We are very pleased with the rapid advancement of our broad obexelimab development program, including the completion of enrollment for the Phase 2 MoonStone trial in patients with Relapsing Multiple Sclerosis this past quarter. We look forward to reporting the results from the primary analysis of the trial, and importantly, the topline results from the Phase 3 INDIGO trial of obexelimab in patients with IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “Given the differentiated profile of obexelimab, along with our extensive development capabilities and commercialization experience, we are well positioned to execute on the significant opportunity ahead to potentially impact the lives of patients living with autoimmune diseases worldwide.” Recent corporate highlights Obexelimab, a CD-19 x FcγRIIb inhibitor of B cell function Immunoglobulin G4-Related Disease (IgG4-RD): Advanced the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. Target enrollment of the INDIGO trial concluded in November 2024, and Zenas expects to report topline results around year-end 2025. Relapsing Multiple Sclerosis (RMS): Completed enrollment of the Phase 2 MoonStone trial, a multicenter, rand...

- Topline results from pivotal Phase 3 INDIGO trial in Immunoglobulin G4-Related Disease expected around year-end 2025 - - Phase 2 MoonStone trial in Relapsing Multiple Sclerosis enrollment concluding; topline results expected early in the fourth quarter 2025 - - Enrollment of Phase 2 SunStone trial in Systemic Lupus Erythematosus expected to be completed by year-end 2025; topline results expected mid-2026 - - Strengthened leadership team with appointments of Lisa von Moltke, M.D., Head of Research and Development and Chief Medical Officer, and Haley Laken, Ph.D., Chief Scientific Officer - - Cash, cash equivalents and investments of $314.2 million as of March 31, 2025, expected to provide financial runway into the fourth quarter of 2026 - WALTHAM, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates. “We are pleased with the continued momentum of our obexelimab program across ongoing Phase 2 and Phase 3 clinical trials, for which we expect to report topline results later this year from trials in patients with relapsing multiple sclerosis and IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “With a strengthened team following the recent additions of Lisa and Haley, we are well positioned to execute on our clinical trials and advance obexelimab as a differentiated B cell inhibitor with a potentially safer, more potent and convenient profile for patients.” Recent corporate highlights Obexelimab, a CD-19 x FcγRIIb inhibitor of B cell function Immunoglobulin G4-Related Disease (IgG4-RD): Advanced the Phase 3 INDIGO trial, a global registration-directed, multicenter, randomized, double-blind, placebo-controlled trial, to evaluate the efficacy and safety of obexelimab in patients with IgG4-RD. INDIGO is the largest clinical trial conducted in patients living with IgG4-RD to date. In the fourth quarter of 2024, Zenas completed the target enrollment of the INDIGO trial and expects to report topline results from the INDIGO trial around year-end 2025. Relapsing Multiple Sclerosis (RMS): Patient screening concluding with th...