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Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score , which is based on 11 key systemic disease domains, at Week 24 versus placebo

Critical patient-reported SjD symptoms including dryness, pain and fatigue trended towards greater improvement in the nipocalimab-treated group compared to placebo-treated patients

Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation (BTD) by U.S. FDA for the treatment of adults living with moderate-to-severe SjD, and the Phase 3 DAFFODIL study is currently enrolling patients

SPRING HOUSE, Pa., Oct. 24, 2025 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced findings from the Phase 2 DAHLIAS study published in The Lancet showing that nipocalimab, an investigational FcRn treatment for Sjögren’s disease (SjD), significantly decreased disease activity and severity in patients with moderate-to-severe disease.¹

The study met its primary endpoint, with statistically significant improvement in ClinESSDAI^a score, a key SjD activity index, at Week 24 in the nipocalimab 15 mg/kg Q2W group compared to placebo^b.¹ Reductions in disease activity were supported by favorable changes in key biomarkers when compared to placebo, including lower levels of rheumatoid factor, fewer circulating immune complexes, and decreased inflammatory markers.¹

This significant reduction in disease activity suggests nipocalimab may lessen the burden of SjD symptoms for patients impacted by the condition.¹ Patients who received nipocalimab reported a decrease in symptoms, with numerical improvements compared with placebo in the hallmark symptoms of SjD including dryness of the mouth, eyes, and/or vagina, as well as fatigue and joint pain.¹ Additionally, an improvement in objective salivary flow (i.e., at least 50% increase from baseline) was observed in more than twice as many patients in the high dose nipocalimab group (15 mg/kg) compared to the placebo group (33% vs. 16%, respectively) at Week 24.¹

“The DAHLIAS Phase 2 study represents an important step forward in the understanding of FcRn inhibition as a potential therapeutic approach in Sjögren’s disease. By demonstrating clinically meaningful improvements in disease activity and reductions in key biological indicators, nipocalimab may offer an avenue for addressing the autoantibody-driven pathology of this complex condition,” said Ghaith Noaiseh, M.D., Associate Professor, Allergy, Clinical Immunology, and Rheumatology, The University of Kansas Medical Center^c. “The ability of nipocalimab to potentially lower IgG autoantibody levels rapidly and reversibly is consistent with the mechanism of FcRn inhibition and does so without broadly suppressing the immune system.”^2,3

Nipocalimab had a tolerable safety profile and no new safety signals were observed during the 24-week treatment period.¹ Immune function was preserved throughout treatment, even among patients who experienced significant reductions in circulating immunoglobulin G (IgG) levels.¹ There was no observed increase in serious infections and no participants required intravenous immunoglobulin (IVIG) or rescue therapy.¹ The DAHLIAS data are consistent with the overall safety profile of IMAAVY^TM (nipocalimab-aahu), which is approved in generalized myasthenia gravis (gMG).⁴

“A significant unmet need exists in the treatment of Sjögren’s disease, a condition in which patients, 9 out of 10 of which are women, live with persistent and often debilitating symptoms, yet there are no approved therapies available,”^5,6 said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Rheumatology and Autoantibody, Johnson & Johnson Innovative Medicine. “These data published in The Lancet add to the growing body of evidence supporting the potential of nipocalimab in Sjögren’s disease. This publication not only underscores the scientific merit of the findings but also reflects our commitment to advancing research in autoantibody-mediated diseases and delivering innovative therapies for patients with few alternatives.”

Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for SjD (November 2024). It also received Fast Track Designation by the U.S. FDA earlier this year in April 2025. Building on the regulatory momentum, the Phase 3 DAFFODIL study is now underway and actively enrolling patients.

IMAAVY™ is approved by the U.S. Food and Drug Administration for adult and pediatric patients (12 years of age and older) with AChR or MuSK antibody positive gMG, in Brazil by ANVISA for anti-AChR, anti-MuSK or anti-LRP4 antibody positive adults and pediatric patients aged 12 and older, and in Japan by the Pharmaceuticals and Medical Devices Agency for the treatment of all patients living with gMG.

Health authority submissions seeking approval for nipocalimab in the treatment of gMG are currently under review with several regulatory authorities worldwide.

ABOUT SJÖGREN’S DISEASE
Sjögren’s disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.⁷ It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.^5,6 SjD is characterized by autoantibody production, chronic inflammation, and lymphocytic infiltration of exocrine glands. Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.⁷ More than 50% of SjD patients have a moderate to severe form of the condition, and disease burden can be as high as that of rheumatoid arthritis or systemic lupus erythematosus.⁵ It is usually associated with impaired quality of life, and in up to approximately half of patients, a loss of functional capacity that can result in an inability to work due to a disability.^5,8,9,10 

ABOUT DAHLIAS
DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized, placebo-controlled double-blind, dose-ranging study to evaluate the effects of nipocalimab in participants with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index) Score at Week 24. 

ABOUT IMAAVY™ (nipocalimab-aahu)
IMAAVY™ is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating IgG antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions. IMAAVY™ is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.⁴ 

Nipocalimab is continuing to be investigated across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.^{11,12,13,14,15,16,17,18,19,20} The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating IgG auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions. 

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:  

• U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia) FNAIT in March 2024 and SjD in March 2025
• U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
• U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren’s disease in November 2024
• U.S. FDA granted Priority Review in gMG in Q4 2024
• EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025

The legal manufacturer for IMAAVY™ is Janssen Biotech, Inc.

WHAT IS IMAAVY™ (nipocalimab-aahu)?

IMAAVY™ is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

It is not known if IMAAVY™ is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMAAVY™?

IMAAVY™ is a prescription medicine that may cause serious side effects, including:

• Infections are a common side effect of IMAAVY™ that can be serious. Receiving IMAAVY™ may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:

• Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY™ infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY™ infusion:

• Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY™ infusion:

Do not receive IMAAVY™ if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY™. Reactions have included angioedema and anaphylaxis.

Before using IMAAVY™, tell your healthcare provider about all of your medical conditions, including if you:

• ever had an allergic reaction to IMAAVY™.
• have or had any recent infections or symptoms of infection.
• have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY™ should not receive live vaccines.
• are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY™ will harm your baby.
  Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY™ if IMAAVY™ is given during pregnancy or you become pregnant while receiving IMAAVY™. Your healthcare provider should report IMAAVY™ exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of IMAAVY™ ?
IMAAVY™  may cause serious side effects. See “What is the most important information I should know about IMAAVY™ ?”

The most common side effects of IMAAVY™  include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

These are not all the possible side effects of IMAAVY™. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

Please see the full Prescribing Information  and Medication Guide  for IMAAVY™ and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY™ is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

ABOUT JOHNSON & JOHNSON 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  

Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ 

Follow us at @JNJInnovMed.

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS 

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY ™ . The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

¹ Noaiseh, G et al., Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren’s disease (DAHLIAS):a randomised, phase 2, placebo-controlled, double-blind trial. The Lancet. Oct 2025; https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01430-8/fulltext
² Seth N, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. mAbs. 2025 Feb; 17(1). https://doi.org/10.1080/19420862.2025.2461191
³ Yu F, et al. Post-hoc analysis of clinically relevant anti-vaccine antibodies in participants treated with nipocalimab. 2024 Sep.
⁴ IMAAVY^TM U.S. Prescribing Information.
⁵ Nat Rev Rheumatol 20, 158–169 (2024). https://doi.org/10.1038/s41584-023-01057-6
⁶ Beydon, M., McCoy, S., Nguyen, Y. et al. Epidemiology of Sjögren syndrome.
⁷ Huang H, Xie W, Geng Y, Fan Y, Zhang Z. Mortality in patients with primary Sjögren’s syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179.
⁸  Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/
⁹ Hackett KL, et al. Arthritis Care Res (Hoboken). 2012;64(11):1760-1764.
¹⁰ Meijer JM, Meiners PM, Huddleston Slater JJ, Spijkervet FK, Kallenberg CG, Vissink A, Bootsma H. Health-related quality of life, employment and disability in patients with Sjogren’s syndrome. Rheumatology (Oxford). 2009 Sep;48(9):1077-82. doi: 10.1093/rheumatology/kep141. Epub 2009 Jun 24. PMID: 19553376.
¹¹ ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622.  Last accessed: July 2025.
¹² ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: July 2025.
¹³ ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: July 2025.
¹⁴ ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: July 2025.
¹⁵ ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: July 2025.
¹⁶ ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: July 2025.
¹⁷ ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: July 2025.
¹⁸ ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: July 2025.
¹⁹ ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: July 2025.
²⁰ ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: July 2025.

SOURCE Johnson & Johnson

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Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.

X’s advertising chief, once touted as a potential successor to Linda Yaccarino as chief executive, has left Elon Musk’s social media platform after only 10 months, marking the latest departure from the billionaire’s executive ranks.

John Nitti, who joined X in January as its global head of revenue operations and advertising innovation, left the company on Friday, according to people familiar with the matter.

Yaccarino, who was chief executive for two years, resigned in July. Since then, her duties have been split between several leaders including Angela Zepeda, global head of marketing, and Nitti, who was considered a contender for the CEO position by industry insiders.

His departure comes as Musk contends with an ongoing wave of senior exits across the business, which was taken over by his artificial intelligence start-up xAI in March.

Mike Liberatore, who was xAI’s chief financial officer, also quit over the summer after three months in the role, soon followed by its general counsel Robert Keele.

In early October, X’s chief financial officer Mahmoud Reza Banki, announced that he was leaving after less than a year in the role, a departure first reported by the Financial Times.

The churn reflects frustration among some executives with Musk’s sudden changes of strategy, and difficulty executing their own objectives given the hands-on approach of their billionaire boss.

X’s advertising leaders have long faced demands from Musk to boost revenues. That pressure has increased as he spends billions of dollars on infrastructure and chips in the race to develop superhuman AI to compete with the likes of OpenAI and Google’s DeepMind.

At the same time, advertisers have been put off by Musk’s decision to relax content moderation standards, citing his “free speech” ideals, and his response to marketers who disagreed with his approach to “go fuck” themselves.

Certain brands have been persuaded to return, while xAI has recently clinched media partnerships with companies such as Disney. The company has also told brands that its advertising metrics are improving due to its use of xAI’s AI technology, according to an email seen by the FT.

However, some advertisers have complained in private that they felt pressured to spend on X after it sued several brands such as Shell and Pinterest for allegedly undertaking “illegal boycott” of the platform, which they deny.

Nitti, a former Verizon executive, was among the sales leaders who had become frustrated with Musk’s approach to the advertising business, according to one insider.

In the first half of the year, Musk had been distracted by his role in Donald Trump’s administration, which ended over the summer in a falling out with the US president.

Since then, he began making unilateral decisions around advertising without consulting the advertising leadership, according to two people familiar with the matter. This included banning hashtags from advertising on X, one of the people said, which frustrated some advertisers.

xAI and X have also appointed new leadership recently. Earlier this month, Anthony Armstrong, a former Morgan Stanley banker who advised on Musk’s $44bn takeover of X, was named xAI CFO.

X did not respond to a request for comment.

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RIO DE JANEIRO, Oct 24 (Reuters) – Brazilian state-run oil firm Petrobras reported on Friday a total oil, gas and gas liquids production of 3.14 million barrels of oil equivalent per day (boed) in the third quarter, up some 17% from a year earlier.

Petrobras produced 2.52 million barrels of oil per day (bpd) in Brazil, an increase of more than 18%, as 11 wells began production in the third quarter, according to a securities filing.

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Total sales of oil, gas and derivatives rose nearly 10% in the period to 3.26 million bpd, while exports reached 1.04 million bpd, up 29%.

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Columbia University plans to rely more heavily on its endowment to finance operations next year, following sweeping research funding cuts imposed by President Donald Trump.

In its annual financial statement released late on Thursday, the New York Ivy League school said it had taken the rare step of drawing directly from its endowment to create a “research stabilisation fund” to offset $400mn in funding cuts by the White House. The fund has issued more than 500 internal research grants.

The university also said its trustees approved a limited-term increase in its use of endowment returns to fund operations for fiscal year 2026 as part of its “financial stabilisation efforts”.

Columbia’s struggle to maintain its financial health highlights the growing pressure on US universities resulting from the Trump administration’s use of funding cuts as leverage for greater federal control of higher education.

Columbia is among the US universities hit hardest by federal research-funding cuts since the president returned to office, after the administration made the school — home to one of the country’s largest student protests over Israel’s war in Gaza — a target of greater political scrutiny.

Columbia’s operating surplus fell to $113mn this year from $305mn in 2024 — a result Anne Sullivan, the university’s executive vice-president for finance, described as “modest” and “below our historical average” after the government suspended hundreds of research grants earlier this year.

Sullivan said the university experienced a “major destabilising event” after the government terminated more than 350 grants, worth over $1.3bn, in March. The situation has eased since July, when the Trump administration reinstated 260 research grants to Columbia after the university agreed to a $221mn settlement resolving federal investigations into its handling of antisemitism on campus.

While Columbia’s financial statement reported a mere 1 per cent decline in government grants and contracts this year from 2024, Sullivan said the figure “does not adequately capture the level of strain experienced by the research enterprise” in the third and fourth quarters.

She said: “Because tapping endowment for one-time purposes erodes our future capacity to provide support for programmes dependent on the annual distribution, utilising endowment assets in this way, beyond our annual distribution, is a rare and multi-faceted decision which we do not make lightly.”

Columbia’s finances have also benefited from a 12.4 per cent gain on its endowment in the year to June — the highest annual return in seven years. Kim Lew, chief executive of Columbia Investment Management Company, said the result was driven by gains in stocks and an improvement in private investment returns.

LAS VEGAS, Oct. 24, 2025 (GLOBE NEWSWIRE) — GBank Financial Holdings Inc. (the “Company”) (Nasdaq: GBFH), the parent company for GBank (the “Bank”), today announced it has updated the date for the release its third quarter 2025 financial results from after the market closes on Monday, October 27, 2025 to after the market closes on Tuesday, October 28, 2025.  The timing of the quarterly earnings call remains unchanged on Wednesday, October 29, 2025, at 10:00 a.m., PST. Interested parties can participate remotely via Internet connectivity. There will be no physical location for attendance.

Interested parties may join online, via the ZOOM app on their smartphones, or by telephone:

• ZOOM Webinar ID 873 1389 3095
• Passcode: 468468

Joining by ZOOM Webinar:

Log in on your computer at
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Joining by Telephone

Dial (408) 638-0968. The conference ID is 873 1389 3095. Passcode: 468468.

About GBank Financial Holdings Inc.

GBank Financial Holdings Inc. is a bank holding company headquartered in Las Vegas, Nevada and is listed on the Nasdaq Capital Market under the symbol “GBFH.” Our national payment and Gaming FinTech business lines serve gaming clients across the U.S. and feature the GBank Visa Signature® Card—a tailored product for the gaming and sports entertainment markets. The Bank is also a top national SBA lender, now operating across 40 states. Through our wholly owned bank subsidiary, GBank, we operate two full-service commercial branches in Las Vegas, Nevada to provide a broad range of business, commercial and retail banking products and services to small businesses, middle-market enterprises, public entities and affluent individuals in Nevada, California, Utah, and Arizona. Please visit www.gbankfinancialholdings.com for more information.

Available Information

The Company routinely posts important information for investors on its web site (under www.gbankfinancialholdings.com and, more specifically, under the News & Media tab at www.gbankfinancialholdings.com/press-releases). The Company intends to use its web site as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD (Fair Disclosure) promulgated by the U.S. Securities and Exchange Commission (the “SEC”). Accordingly, investors should monitor the Company’s web site, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations and webcasts.

The information contained on, or that may be accessed through, the Company’s web site is not incorporated by reference into, and is not a part of, this document.

For Further Information, Contact:

GBank Financial Holdings Inc.
Edward M. Nigro
Chairman and CEO
702-851-4200
enigro@g.bank

Source: GBank Financial Holdings Inc.