RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Orphan Drug (Australia), Paediatric investigation plan (European Union)

Structure/Sequence

Sequence Code 66437L

Source: *****

Sequence Code 9941502H

Source: *****

Clinical Trials associated with Ravulizumab-CWVZ

NCT07010302

/ Not yet recruitingPhase 4IIT

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.
In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.
Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.
This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.

Start Date01 May 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07399730

/ Not yet recruitingNot Applicable

A Non-interventional Study Evaluating Ravulizumab Treatment Outcomes in Polish Patients With Atypical Hemolytic Uremic Syndrome

This multicenter, observational cohort study uses retrospective collection of past medical history and prospective follow-up to capture longitudinal data on the management and clinical outcomes of patients with atypical hemolytic uremic syndrome (aHUS) treated with ravulizumab as part of routine clinical practice under Poland's National Drug Program (NDP).

Start Date01 Apr 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT06333652

/ RecruitingPhase 2IIT

Clinical Trial on the Use of Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders

The researchers are testing a medication named ravulizumab for the treatment of severe preeclampsia and Hemolysis, Elevated Liver enzymes, Low Platelets (HELLP) syndrome.

Start Date01 Mar 2026

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Ravulizumab-CWVZ

100 Translational Medicine associated with Ravulizumab-CWVZ

100 Patents (Medical) associated with Ravulizumab-CWVZ

320

Literatures (Medical) associated with Ravulizumab-CWVZ

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost per responder analysis of iptacopan versus eculizumab and ravulizumab in treatment of paroxysmal nocturnal hemoglobinuria: implications for decision-making

Article

Author: Shafrin, Jason ; Muthukrishnan, Sanjana ; Kuypers, Nicholas ; Bilano, Ver ; Than, Kyi-Sin ; Paulose, Jincy

OBJECTIVE:

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and debilitating hematological disease with significant economic burden. Despite the availability of multiple therapies, there is a lack of consensus on optimal treatment strategies among physicians and payers in the United States. This study aimed to evaluate the economic value of iptacopan, a novel oral treatment option, compared to terminal complement inhibitors (specifically, complement component C5 inhibitor or C5i)-including eculizumab and ravulizumab-among patients with PNH who are either (i) C5i-experienced or (ii) complement-inhibitor-naïve.

METHODS:

A cost per responder analysis was conducted based on treatment efficacy from clinical trials comparing iptacopan with C5i treatments. Treatment response was defined as the proportion of patients achieving red blood cell transfusion independence. Treatment costs were estimated as pharmaceutical wholesale acquisition cost and treatment administration costs, accounting for discontinuation. Outcomes evaluated included the number needed to treat to achieve a response and the cost per responder over the treatment duration of 24 weeks.

RESULTS:

Over 24 weeks, the number needed to treat to achieve an additional response was lower for iptacopan than all C5i comparators (C5i-experienced: 1.05 with iptacopan vs. 3.86 with C5is; complement-inhibitor-naïve: 1.02 with iptacopan vs. 1.69 with C5is). Cost per responder was lower for iptacopan than C5i comparators for both C5i-experienced ($264,337 for iptacopan vs. $975,298 for ravulizumab, $1,060,511 for eculizumab, and $744,561-$955,194 for eculizumab biosimilar with 10%-30% discount from eculizumab cost) and complement-inhibitor-naïve patients ($256,754, vs. $428,139 for ravulizumab, $465,546 for eculizumab, and $326,849-$419,314 for eculizumab biosimilar).

CONCLUSION:

Among both C5i-experienced and complement-inhibitor-naïve patients, treatment with iptacopan resulted in higher response rates and lower cost per responder compared to C5is.

01 Feb 2026·Kidney Medicine

Real-World Effectiveness of Ravulizumab Among C5 Inhibitor-Naive Patients With Atypical Hemolytic Uremic Syndrome: A Physician Panel-Based Chart Review (aHUS IMPACT Study)

Article

Author: Burdeau, Jordan A ; Wang, Yan ; Nag, Arpita ; Hanna, Ramy Magdy ; Song, Rui ; Huynh, Lynn ; Chaturvedi, Shruti ; Duh, Mei Sheng ; Ong, Moh-Lim

Rationale & Objective:

Atypical hemolytic uremic syndrome (aHUS) is a rare form of thrombotic microangiopathy (TMA) caused by complement dysregulation. Ravulizumab, a complement C5 inhibitor (C5i), is approved for aHUS; however, published evidence in a real-world setting is limited.

Study Design:

Retrospective, longitudinal, physician panel-based chart review.

Setting & Population:

C5i-naive adults with aHUS in the United States treated with ravulizumab. Physicians randomly selected 1-5 patients who had ≥6 months of follow-up after ravulizumab initiation; patients who died within 6 months of initiation were eligible.

Exposures or Predictors:

Ravulizumab.

Outcomes:

The clinical outcomes evaluated included hematologic and renal outcomes, complete TMA response (a composite hematolgic/renal endpoint), and dialysis use.

Analytical Approach:

Descriptive statistics, Kaplan-Meier estimators, and generalized linear models.

Results:

Overall, 79 C5i-naive adults with aHUS (enrolled by 31 physicians) initiated ravulizumab and were included in the study. Statistically significant improvements from baseline occurred as early as day 4 (lactate dehydrogenase and percent change in serum creatinine; both P < 0.001) and day 8 (platelet count; P < 0.001). The proportions of patients with normalization of platelet counts and lactate dehydrogenase levels, and ≥25% improvement in serum creatinine levels, were 14 out of 67 (21%), 12 out of 58 (21%), and 10 out of 65 (15%) at day 4, and 40 out of 48 (83%), 35 out of 38 (92%), and 42 out of 48 (88%) at 12 months after ravulizumab initiation, respectively. Complete TMA response rates were 60% and 68% within 6 and 12 months after ravulizumab initiation, respectively, and the median (interquartile range) time to complete TMA response was 3.1 (1.0-14.0) months. Of the 20 patients who received any dialysis at baseline, 14 (70.0%) did not have dialysis during follow-up.

Limitations:

The study design relies on available medical record data and has potential responder bias.

Conclusions:

This study supports the immediate and sustained benefits of initiating ravulizumab in patients with aHUS as seen by the early response and continued improvement in clinical outcomes.

01 Feb 2026·PEDIATRIC NEUROLOGY

Inebilizumab: Pediatric Case Series in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorder

Article

Author: Maddox, Denise ; Dinov, Darina ; Greenberg, Benjamin M

BACKGROUND:

Neuromyelitis Optica Spectrum Disorder (NMOSD) is an autoimmune condition which can be diagnosed either based on a constellation of neurological symptoms and/or a positive anti-aquaporin 4 antibody. About 3-5% of all cases occur in pediatric patients, and currently there are no FDA-approved therapies for patients under the age of 18 years for NMOSD. There are currently 4 FDA-approved medications for adults with seropositive NMOSD-eculizumab, inebilizumab, satralizumab, and ravulizumab.

METHODS/RESULTS:

Herein, we present a case series of four patients who have seropositive NMOSD and are on inebilizumab. All four patients have had two courses of this medication and have tolerated it well. There was not a significant burden of side effects, and none of the patients have presented with relapses.

CONCLUSIONS:

This study adds to the literature because it shows that in our cohort inebilizumab was a safe medication for pediatric patients with NMOSD and prevented further relapses.

305

News (Medical) associated with Ravulizumab-CWVZ

09 Mar 2026

·www.biospace.com

NovelMed Therapeutics Announces Regulatory Clearance for Subcutaneous Ruxoprubart and Reports Positive Phase II Intravenous Monotherapy Results in PNH

--- Precision Bb Targeting, Robust Efficacy, Transfusion Independence, Excellent Safety in Phase II PNH Study, and Subcutaneous Administration Key Highlights: Monotherapy and Clinical Outcomes The 12-16-week open-label study evaluated Ruxoprubart as monotherapy in treatment-naïve PNH patients. Key findings include: Hemoglobin (Hb) Improvement: Hemoglobin levels increased by 1.5–2.7 g/dL, with an average rise of ~2.13 g/dL during weekly dosing, reflecting meaningful correction from the severely depressed baseline common in untreated PNH. Complete Transfusion Independence: Throughout the weekly dosing period, 100% of patients required no blood transfusions, demonstrating effective control of hemolysis and clinically meaningful correction of anemia. PNH Red Blood Cells (RBCs) Survival & Expansion: PNH RBC populations expanded to up to 94% of their maximum level. This is consistent with near-complete suppression of ongoing complement-mediated hemolysis, a core driver of anemia and fatigue. Biochemical Control (LDH): Lactate Dehydrogenase (LDH) levels were significantly reduced, reflecting biochemical control of intravascular hemolysis (IVH). Quality-of-Life (QoL) Gains: Patient‑reported outcomes, including the Functional Assessment of Chronic Illness Therapy (FACIT) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires, showed meaningful improvements across fatigue, pain, and overall functional capacity. Safety and Tolerability: The therapy was well-tolerated with no drug-related Adverse Events (AEs) or Serious Adverse Events (SAEs) observed. Orphan Drug Designation: Ruxoprubart holds U.S. FDA Orphan Drug Designation (ODD) for PNH, highlighting its potential to address this rare and life-threatening condition. CLEVELAND, March 09, 2026 (GLOBE NEWSWIRE) -- NovelMed Therapeutics Inc., a clinical-stage biopharmaceutical company specializing in alternative pathway (AP) complement-mediated therapies, today announced two major milestones in the clinical development of Ruxoprubart (NM8074) for Paroxysmal Nocturnal Hemoglobinuria (PNH). The company has received regulatory clearance to initiate a Phase II study for the subcutaneous (SC) route of administration, designed as a convenient, weekly, self-administered injection. Concurrently, NovelMed reported the full results of its Phase II intravenous (IV) monotherapy study in treatment-naïve adult patients with PNH. The study met all efficacy endpoints, including significant hemoglobin improvement and complete transfusion avoidance, with an exceptional safety profile. “These milestones validate both our clinical progress and our development strategy,” said Dr. Rekha Bansal, Chief Executive Officer of NovelMed. “Regulatory clearance of the SC route represents the next logical step toward a patient-friendly treatment option, while our monotherapy data demonstrate the strong, consistent efficacy and tolerability of targeting Bb. We are now progressing into the next phase of clinical development.” Advancing Two Complementary Tracks in PNH NovelMed is progressing Ruxoprubart through two distinct delivery methods to maximize patient access and convenience: Subcutaneous (SC) Administration: Cleared for Phase II Development The regulatory agency has cleared the SC route of administration, enabling a planned, weekly self-injection regimen at home. SC trials are planned but have not yet been initiated. This approach is expected to reduce patient and caregiver burden by eliminating the need for IV infusions in a clinical setting. Intravenous (IV) Monotherapy: Treatment-Naïve PNH Patients The successful completion of the intravenous Phase II study establishes Ruxoprubart as a potent monotherapy capable of addressing the core drivers of PNH without adjunctive treatment. “Ruxoprubart has proven its potential as a definitive monotherapy, delivering exceptional efficacy without compromise,” said Mr. Alex Kumar, Chief Strategy Advisor. “Coupled with FDA Orphan Drug Designation status and regulatory clearance for SC dosing, we have a clear, accelerated path forward. NovelMed is now uniquely positioned to lead the next generation of precision complement therapeutics on a global scale.” Precision Targeting: The Bb Mechanism and Differentiation PNH is an AP-driven hemolytic disorder. Ruxoprubart (NM8074) is a first-in-class monoclonal antibody engineered for precision targeting of Bb, the proteolytically activated catalytic fragment generated upon AP activation. By binding Bb rather than native Factor B, Ruxoprubart delivers precise AP-selective inhibition while preserving the Classical Pathway (CP), which remains essential for protecting patients from infections. “The Phase II intravenous results demonstrate a clinical efficacy and safety pro aligns well with FDA expectations for monotherapy development in PNH,” said Mr. Robert Bard. “With the SC route now cleared for evaluation under our Phase II program, we are advancing along a well-defined regulatory path. This progress brings us closer to enabling patient-friendly, self-administered treatment options supported by a mechanism designed for pathway-selective precision.” Competitive Landscape at a Glance Ruxoprubart (NovelMed): Targets activated Bb (FDA Orphan Drug Designation Holder). A precision monotherapy that provides selective AP inhibition while preserving the CP for host defense. Soliris® / Ultomiris® (AstraZeneca): Targets C5. A distal blocker of both AP and CP that fails to prevent C3b deposition, which leads to persistent anemia. Empaveli® / Syfovre® (Apellis): Targets C3. A proximal blocker that provides broad inhibition of both AP and CP, addressing C3b-mediated EVH but impacting overall complement surveillance. Fabhalta® (Novartis): Targets native Factor B. A proximal blocker that lacks precision by targeting the native protein rather than the proteolytically activated Bb fragment. Voydeya® (AstraZeneca): Targets Factor D. A proximal blocker, strictly approved as an add-on therapy to C5 inhibitors rather than a standalone monotherapy. Key Pillars of the Regulatory Strategy Monotherapy Treatment: Ruxoprubart has demonstrated the ability to meet all primary endpoints as a standalone treatment. This allows for a more direct regulatory path, as the drug does not need to be tested or approved alongside existing C5 inhibitors to prove its value. Subcutaneous (SC) Administration: The regulatory clearance for the SC route is a major milestone. Having passed rigorous safety and manufacturing reviews, Ruxoprubart is now cleared for human trials using at-home injections. This shifts the treatment model from clinical IV infusions to a more convenient, patient-controlled approach. Precision Targeting of the Bb: Ruxoprubart selectively targets the AP while keeping the CP intact. This "selective precision" is designed to maintain the body’s natural ability to fight infections, a differentiated safety pro supports the case for expedited regulatory designations like Fast Track or Breakthrough Therapy. Figure. Complement-mediated destruction of red blood cells in paroxysmal nocturnal hemoglobinuria (PNH). About Paroxysmal Nocturnal Hemoglobinuria (PNH) Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare, acquired, and life-threatening hematologic disorder caused by a somatic mutation in the PIGA gene. This mutation results in the deficiency of GPI-anchored complement regulatory proteins, specifically CD55 and CD59, which act as protective shields for RBCs. Without these proteins, RBCs are highly vulnerable to persistent attack by the AP of the complement system, leading to chronic intravascular and extravascular hemolysis. This ongoing destruction manifests clinically as severe anemia, dangerously elevated Lactate Dehydrogenase (LDH) levels, and a significantly increased risk of life-threatening thrombosis and renal impairment. Effective treatment is measured by stabilization of hemoglobin and the expansion of the PNH RBC clone, indicating that these cells are successfully protected from complement-mediated attack. About NovelMed Therapeutics NovelMed Therapeutics Inc. is a clinical-stage biopharmaceutical company dedicated to developing next-generation immunotherapies that selectively target the complement AP. The company has pioneered a site-specific approach by engineering monoclonal antibodies, such as its lead candidates Ruxoprubart (NM8074) and NM5072, to target proteolytically activated fragments, such as Bb, rather than native proteins. This precision enables potent blockade of the disease-driving AP while intentionally preserving the CP’s critical role in host defense and immune surveillance. Supported by a robust portfolio of intellectual property and promising Phase II data, NovelMed is advancing a differentiated pipeline of first-in-class biologics designed to achieve durable clinical outcomes without compromising the patient’s ability to fight infections. Strategic Partnership Opportunity Following the achievement of 100% transfusion avoidance in its Phase II monotherapy study and the recent regulatory clearance for SC administration, NovelMed is actively pursuing a strategic partnership to propel Ruxoprubart through late-stage global development. This program is exceptionally well-positioned for expansion, supported by U.S. FDA Orphan Drug Designation (ODD) and a validated, precision mechanism that addresses significant unmet needs in the PNH market. NovelMed seeks a partner with extensive clinical and commercial expertise to accelerate the regulatory path towards approval and support the global launch of this patient-friendly, self-administered therapy. By combining NovelMed’s innovative science with a partner's scale, the company aims to redefine the treatment landscape for rare complement-mediated diseases. Media Contact: Ya Gao, MS NovelMed Therapeutics, Inc. media@novelmed.com (216) 440 2696 Forward-Looking Statements This press release contains forward-looking statements that reflect NovelMed’s current expectations and projections about future events. Ruxoprubart (NM8074) is an investigational therapy and has not been approved by any regulatory authority for commercial use. The subcutaneous administration route has received regulatory clearance for further study; no subcutaneous clinical trials have been initiated. Forward-looking statements include expectations about clinical development, regulatory interactions, future study plans, and potential outcomes. NovelMed is a privately held, clinical stage biotechnology company which undertakes no obligation to update these statements except as required by law. A photo accompanying this announcement is available at

Phase 2Orphan DrugClinical ResultImmunotherapyFast Track

05 Mar 2026

·www.biospace.com

Xencor Announces Change to Ultomiris® Royalty Revenue Forecast

PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today announced that Alexion Pharmaceuticals, Inc. (the “Licensee”) informed Xencor, Inc. (the “Company”) that it has taken the position that the Licensee does not owe any additional royalties for sales of Ultomiris® (ravulizumab-cwvz) in the United States and that the Licensee does not intend to make any future payments for sales in the United States. The Licensee informed the Company that it intends to continue making royalty payments for sales of Ultomiris outside the United States. “Xencor has reasonably assumed that the multiple licensees of our XmAb Fc domains and technologies remit payments in accordance with the terms of their respective agreements. One licensee has expressed disagreement regarding payments for net sales of Ultomiris in the United States, and we plan to work toward a resolution in this matter. Importantly, we have not observed a change in payments related to ex-U.S. sales,” said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. “We have updated our year-end cash guidance and conservatively adjust our operating runway estimate into mid-2028.” The Company previously announced the issuance of U.S. Patent 12,492,253 and its expectation to receive an estimated additional $100 to $120 million in aggregate through 2028 in low single-digit royalties on net sales of Ultomiris in the United States from the Licensee. Ultomiris is a drug being developed and commercialized by the Licensee and is a registered trademark of the Licensee. Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $380 million and $400 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations into mid-2028. About Xencor Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and multiple XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding projected financial resources and financial guidance, including estimated cash, cash equivalents and marketable debt securities at year end and cash runway for research and development programs and operations, expectations for and estimates of future royalty revenues, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics, the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, the risk of loss of key members of management, the risk that the fair value of our marketable equity securities will decline and the risks, uncertainties and other factors described under the heading “Risk Factors” in Xencor's Annual Report on Form 10-K for the year ended December 31, 2025 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Xencor undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. Contacts For Investors: Charles Liles cliles@xencor.com (626) 737-8118 For Media: Cassidy McClain Inizio Evoke cassidy.mcclain@inizioevoke.com (619) 694-6291

License out/in

26 Feb 2026

·www.biospace.com

Xencor Reports Fourth Quarter and Full Year 2025 Financial Results

-- XmAb819, novel first-in-class ENPP3 x CD3 T-cell engaging bispecific antibody, Phase 1 dose expansion in CRC, NSCLC and pRCC open to enrollment; on track to present clinical data to support a recommended Phase 3 dose in ccRCC in 2H26 -- -- Final results from healthy-volunteer study of Xmb942, Xtend™ TL1A antibody, and preclinical characterization of XmAb412, TL1A x IL23p19 XmAb® bispecific antibody, to be presented at DDW 2026 -- PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025. “Xencor’s lead oncology drug candidate is XmAb819, a novel first-in-class T-cell engager that could offer a much-needed new therapeutic modality for patients with advanced clear cell renal cell carcinoma (ccRCC). Excitement from the clinical community on our initial data from the dose-escalation study presented during ENA 2025 supports achieving our goal of presenting dose-expansion data during a medical meeting in the second half of 2026 and our plans to initiate a pivotal study during 2027,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Building on the early success in ccRCC, we recently opened additional dose expansion cohorts in other tumor types that have high ENPP3 expression: colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma.” “In 2026, we plan to present additional key clinical data and progress updates as we also advance XmAb541 and our ongoing B-cell depleting autoimmune programs, respectively. Our TL1A pipeline in inflammatory bowel disease continues to advance, as well. We are making great progress with enrollment in our Phase 2b XENITH-UC study of XmAb942 and are excited to begin the first-in-human study of XmAb412, our novel TL1A x IL23p19 bispecific antibody in the second half of 2026. We are proud of our execution across an evolved clinical pipeline and of the Xencor team’s focus on designing proteins to deliver novel medicines for patients.” Wholly Owned Pipeline Overview XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb® 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). The dose-expansion portion of the ongoing Phase 1 study is enrolling patients and dose-optimization continues. Tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are now open to enrollment. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and initiate a pivotal study of XmAb819 in ccRCC during 2027. XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in Phase 1 clinical development for patients with advanced gynecologic and germ cell tumors. Xencor plans to present new clinical data to support a recommended Phase 3 dose in 2H26 and evaluate plans for a pivotal study of XmAb541 during 2027. XmAb942 (Xtend™ anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Xencor is on-track to present final results from the Phase 1 study of XmAb942 in healthy volunteers in a poster titled “XmAb942, a Potential Best-in-class, Long-acting Anti-TL1A Antibody for the Treatment of Inflammatory Bowel Disease: Phase 1 Final Results” at Digestive Disease Week® (DDW), being held May 2-5, 2026 in Chicago and online, and to provide an update on progress achieved in the XENITH-UC study around year-end 2026. XmAb412 (TL1A x IL23p19), a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. Xencor is on track to present the preclinical characterization of XmAb412 in a poster titled “Discovery and Characterization of XmAb412: A Novel, High-Affinity, Anti-TL1A x Anti-IL23 Native-like Bispecific Antibody With Extended Half-life for the Treatment of Inflammatory Bowel Disease” at DDW in May 2026 and to initiate a first-in-human study of XmAb412 in 2H26. Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment. Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26. XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 development for patients with idiopathic inflammatory myopathies (IIM). Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26. XmAb808 (B7-H3 x CD28), a bispecific antibody designed to provide conditional co-stimulation of T cells when also bound to tumor cells. Xencor plans to present a poster characterizing preclinical combinations of XmAb808 with multiple CD3 T cell engaging bispecific antibodies at a medical meeting in 1H26. Xtend U.S. Patent Term Extension: In December 2025, Xencor announced the issuance of U.S. Patent 12,492,253 , which covers Xencor’s Xtend Fc domain for extending the half-life of antibodies targeting C5, with a term that extends into December 2028. Xencor anticipates receiving low-single digit royalties on net sales of Ultomiris® (ravulizumab-cwvz), an anti-C5 antibody engineered with a licensed Xtend Fc domain, into December 2028 in the United States. Ultomiris is a drug being developed and commercialized by Alexion Pharmaceuticals, Inc., and is a registered trademark of Alexion. Xencor previously secured regulatory extensions of exclusivity in several EU countries, Japan and Australia. Based upon consensus sales forecasts, Xencor estimates recognizing potential royalty revenue in excess of the caps under its royalty agreement with OMERS in the range of $100 million to $120 million in aggregate for the extended patent term through 2028. Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $400 million and $430 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations through 2028. Financial Results for the Fourth Quarter and Full Year Ended December 31, 2025 Cash, cash equivalents, and marketable debt securities totaled $610.8 million as of December 31, 2025 compared to $706.7 million as of December 31, 2024. Total revenue for the fourth quarter ended December 31, 2025 was $28.2 million compared to $52.8 million for the same period in 2024. Revenue for the full year ended December 31, 2025 was $125.6 million compared to $110.5 million for the same period in 2024. The increase in revenue in 2025 compared to 2024 was primarily driven by revenue recognition associated with Alexion and Incyte license agreements. Research and development (R&D) expenses for the fourth quarter ended December 31, 2025 were $64.8 million compared to $51.1 million for the same period in 2024. R&D expenses for the full year ended December 31, 2025 were $239.4 million compared to $227.7 million for the same period in 2024. Increased R&D expenses in 2025 compared to 2024 were primarily driven by higher external and internal costs associated with pipeline programs, partially offset by lower stock-based compensation expense. General and administrative (G&A) expenses for the fourth quarter ended December 31, 2025 were $17.0 million compared to $14.9 million for the same period in 2024. G&A expenses for the full year ended December 31, 2025 were $63.6 million compared to $61.2 million for the same period in 2024. G&A expenses in 2025 compared to 2024 remained relatively consistent. Other income, net for the fourth quarter ended December 31, 2025 was $49.4 million compared to other expense, net of $31.4 million for the same period in 2024. Other income, net for the full year ended December 31, 2025 was $87.9 million compared to other expense, net of $56.5 million in the same period in 2024. Other income, net, in 2025 compared to other expense, net, in 2024 was primarily driven by a combination of realized and unrealized gains from marketable equity securities. Net loss attributable to Xencor for the fourth quarter ended December 31, 2025 was $6.7 million or $(0.09) on a fully diluted per share basis compared to net loss of $45.6 million or $(0.62) on a fully diluted per share basis, for the same period in 2024. For the full year ended December 31, 2025 net loss attributable to Xencor was $91.9 million or $(1.24) on a fully diluted per share basis compared to net loss of $232.6 million or $(3.58) on a fully diluted per share basis, for the same period in 2024. About Digestive Disease Week® Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting. Digestive Disease Week® is a registered trademark of DDW, LLC. About Xencor Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and multiple XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit . Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding our expectations regarding regulatory and partnership milestone achievements, clinical pipeline advancements , planned receipt and presentations of clinical data, including the expected timing thereof, and planned and ongoing clinical trials, including the expected timing thereof, projected financial resources and financial guidance, including estimated cash, cash equivalents and marketable debt securities at year end and cash runway for research and development programs and operations, expectations for and estimates of future royalty revenues, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics, the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, the risk of loss of key members of management, the risk that the fair value of our marketable equity securities will decline and the risks, uncertainties and other factors described under the heading “Risk Factors” in Xencor's Annual Report on Form 10-K for the year ended December 31, 2025 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Xencor undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. Xencor, Inc. Selected Consolidated Balance Sheet Data (in thousands) December 31, December 31, 2025 2024 Cash, cash equivalents and marketable debt securities - current $ 435,231 $ 449,846 Other current assets 164,590 127,755 Marketable debt securities - long term 175,602 256,833 Other long-term assets 100,072 117,511 Total assets $ 875,495 $ 951,945 Total current liabilities $ 95,907 87,432 Liabilities related to the sales of future royalties - long term 76,482 115,159 Other long-term liabilities 67,519 75,328 Total liabilities 239,908 277,919 Total stockholders' equity 635,587 674,026 Total liabilities and stockholders’ equity $ 875,495 $ 951,945 Xencor, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share amounts) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Revenue Collaborations, milestones, and royalties $ 28,237 $ 52,794 $ 125,576 $ 110,493 Operating expenses: Research and development 64,824 51,056 239,434 227,686 General and administrative 17,041 14,916 63,644 61,215 Total operating expenses 81,865 65,972 303,078 288,901 Operating loss (53,628 ) (13,178 ) (177,502 ) (178,408 ) Total other income (expense) 49,362 (31,404 ) 87,869 (56,515 ) Loss before income tax expense and noncontrolling interest (4,266 ) (44,582 ) (89,633 ) (234,923 ) Income tax expense 2,387 1,617 2,504 1,617 Net loss including noncontrolling interest (6,653 ) (46,199 ) (92,137 ) (236,540 ) Net loss attributable to noncontrolling interest — (647 ) (214 ) (3,922 ) Net loss attributable to Xencor, Inc. $ (6,653 ) $ (45,552 ) $ (91,923 ) $ (232,618 ) Net loss per share attributable to Xencor, Inc. (basic and diluted) $ (0.09 ) $ (0.62 ) $ (1.24 ) $ (3.58 ) Weighted-average shares used in calculating net loss per share (basic and diluted) 74,586 73,176 74,239 65,041 Other comprehensive income (loss), net of tax: Net unrealized gain (loss) on marketable debt securities 418 (2,464 ) 2,239 (1,954 ) Comprehensive loss (6,235 ) (48,663 ) (89,898 ) (238,494 ) Less: comprehensive loss attributable to the noncontrolling interest — (647 ) (214 ) (3,922 ) Comprehensive loss attributable to Xencor, Inc. $ (6,235 ) $ (48,016 ) $ (89,684 ) $ (234,572 ) Contacts For Investors: Charles Liles cliles@xencor.com (626) 737-8118 For Media: Cassidy McClain Inizio Evoke cassidy.mcclain@inizioevoke.com (619) 694-6291

Phase 1Phase 2Financial Statement

100 Deals associated with Ravulizumab-CWVZ

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ravulizumab-CWVZ	L04AA43	DB11580

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuromyelitis Optica	European Union	Alexion Europe SAS	12 Jul 2023
Neuromyelitis Optica	Iceland	Alexion Europe SAS	12 Jul 2023
Neuromyelitis Optica	Liechtenstein	Alexion Europe SAS	12 Jul 2023
Neuromyelitis Optica	Norway	Alexion Europe SAS	12 Jul 2023
Thrombotic Microangiopathies	South Korea	Astrazeneca Korea Ltd.	21 May 2020
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Australia	Alexion Pharmaceuticals Australasia Pty Ltd.	17 Oct 2019
Myasthenia Gravis	Australia	Alexion Pharmaceuticals Australasia Pty Ltd.	17 Oct 2019
Atypical Hemolytic Uremic Syndrome	European Union	Alexion Europe SAS	02 Jul 2019
Atypical Hemolytic Uremic Syndrome	Iceland	Alexion Europe SAS	02 Jul 2019
Atypical Hemolytic Uremic Syndrome	Liechtenstein	Alexion Europe SAS	02 Jul 2019
Atypical Hemolytic Uremic Syndrome	Norway	Alexion Europe SAS	02 Jul 2019
Hemoglobinuria, Paroxysmal	United States	Alexion Pharmaceuticals, Inc.	21 Dec 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Henoch-Schonlein Purpura Nephritis	Phase 3	United States	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	China	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	Japan	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	Italy	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	South Korea	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	Spain	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Henoch-Schonlein Purpura Nephritis	Phase 3	Taiwan Province	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Purpura, Schoenlein-Henoch	Phase 3	United States	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Purpura, Schoenlein-Henoch	Phase 3	China	Alexion Pharmaceuticals, Inc.	14 Jun 2025
Purpura, Schoenlein-Henoch	Phase 3	Japan	Alexion Pharmaceuticals, Inc.	14 Jun 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04557735 (ALXN1210-TMA-314, Tandem Meetings ASTCT and CIBMTR2026)	Phase 3	Thrombotic Microangiopathies	41	Ravulizumab	sjfkatpnue(rimmxyavza) = ddonxwsifn mpxrfoegsz (vshjgaxtiu ) View more	Positive	04 Feb 2026
NCT04557735 (ALXN1210-TMA-314, CTgov)	Phase 3	Thrombotic Microangiopathies \| Hematopoietic stem cell transplantation	41	Ravulizumab (Ravulizumab)	loknvqenvz = ikpdujzfrm fssmfgmvqv (xncdtnhycu, aijbenuthe - micmqvtiid) View more	-	12 Jan 2026
				Ravulizumab (Treatment Period: Ravulizumab)	uwzckddymd(xysmsnnjeg) = oieqjwowut tvxcylcxqn (jzvcixnszs, yyqsdpwztp - pxgroflhqp) View more
NCT04557735 (ASH2025)	Phase 3	Hematopoietic stem cell transplantation	41	Ravulizumab	uzrykkvghk(uysnaspbrr) = oeczbjcofm tnvkzhxaph (jarvxjcugb ) View more	Positive	06 Dec 2025
NCT04557735 (ASH2025)	Phase 3	-	41	Ravulizumab	zmlopeabrn(wunxhuqnsy) = uxwneqdjnu ssjscisqhw (ndymimzsti ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Hemoglobinuria, Paroxysmal	87	eculizumab	oarzoumznk(ytjnosfgss) = grdvwlxpqz rtvzvnliah (grgxuuvane ) View more	Positive	06 Dec 2025
				ravulizumab	oarzoumznk(ytjnosfgss) = ormjhrdoxt rtvzvnliah (grgxuuvane ) View more
ASH2025	Not Applicable	Hemoglobinuria, Paroxysmal \| Myeloproliferative Disorders	11	Eculizumab	furpaykqwq(itdrjxecwx) = Sepsis as the cause of death in 3 cases mntoyoiyyo (fepmoeparv )	Negative	06 Dec 2025
NCT02949128 (ASN2025)	Phase 3	Atypical Hemolytic Uremic Syndrome	56	Ravulizumab (≤7 days)	ejkvlxqqpw(rvjbjtaumw) = eimjduinlg txoaldxqit (iaxssdfinb ) View more	Positive	08 Nov 2025
				Ravulizumab (>7 days)	ejkvlxqqpw(rvjbjtaumw) = asyxnadkxh txoaldxqit (iaxssdfinb ) View more
NCT02949128 (ASN2025)	Phase 3	Atypical Hemolytic Uremic Syndrome	56	Ravulizumab ≤7 days	caieqtjlvn(snvrycuqce) = nfvonulght gpwzhkwxua (gdfpxtcyvl )	Positive	08 Nov 2025
				Ravulizumab >7 days	caieqtjlvn(snvrycuqce) = rotslirdwq gpwzhkwxua (gdfpxtcyvl )
NCT05966467 (NMO SPOTLIGHT Registry, ECTRIMS2025 \| Company_Website) Manual	Not Applicable	AQP4-IgG positive Neuromyelitis optica spectrum disorder AQP4-IgG	56	ALXN-C5IT (eculizumab or ravulizumab)	kaqwttegwl(ittuckzeug) = qyfxdbyhlj fhqrwgqstq (rvjiijhqcw, 0.00 - 0.05) View more	Positive	09 Sep 2025
				ALXN-C5IT (eculizumab or ravulizumab) (switched from rituximab)	kaqwttegwl(ittuckzeug) = npexoxivhi fhqrwgqstq (rvjiijhqcw ) View more
ECTRIMS2025 \| Company_Website Manual	Not Applicable	AQP4-IgG positive Neuromyelitis optica spectrum disorder AQP4-IgG	11	Ravulizumab + satralizumabssive drugs (switched from satralizumab)	bgqsqauess(fdxjoabdjw) = bsylokowgd oaiftahsdl (zcugxuabtp ) View more	Positive	09 Sep 2025

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