Calciphylaxis is a rare but incredibly dangerous condition that causes small blood vessels in the skin to become blocked by calcium buildup and blood clots. This leads to painful skin sores (necrosis) that do not heal easily. Because these open wounds are prone to severe infections, the outlook for patients is often grim; more than half of those diagnosed do not survive past the first year. Currently, there are no Food and Drug Administration (FDA) approved medications specifically designed to stop the progression of this disease. However, recent research has identified a specific culprit: Interleukin-6 (IL-6). The research team is looking at a drug called Tocilizumab to turn off the progression of the disease.
This project aims to investigate whether Tocilizumab can consistently stop the cycle of inflammation and clotting, providing a much-needed lifeline for patients facing this life-threatening diagnosis. Ten participants with calciphylaxis and end-stage kidney disease will be enrolled to receive 3 infusions of Tocilizumab, follow-ups on a weekly basis, during their trip to the dialysis unit, for a total of 16 weeks.

Start Date01 Sep 2027

Sponsor / Collaborator

Boston Medical Center

NCT03787290

/ SuspendedPhase 2IIT

Examining Immune-Based Mechanisms of Action for Mild-Intensity Whole Body Hyperthermia (WBH) in the Treatment of Major Depressive Disorder

Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

Start Date01 Dec 2026

Sponsor / Collaborator

The General Hospital Corp.

[+1]

NCT07629583

/ RecruitingPhase 1

An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).

Start Date31 Oct 2026

Sponsor / Collaborator

Genentech, Inc.

100 Clinical Results associated with Tocilizumab

100 Translational Medicine associated with Tocilizumab

100 Patents (Medical) associated with Tocilizumab

7,074

Literatures (Medical) associated with Tocilizumab

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

Author: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Grajales-Cruz, Ariel F. ; Lee, Hans C. ; Zhang, Xinke ; Wang, Jiamin ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

01 Nov 2026·Biomaterials advances

An antibody-conjugated polymer nanoparticle that targets inflammatory site for abdominal aortic aneurysm antioxidant stress therapy

Article

Author: Zhang, Qin ; Huang, Youjin ; Liu, Jinping ; Wu, Ya ; Liu, Yong ; Yin, Qi''nan

Abdominal aortic aneurysm (AAA) tends to occur in the lower segment of the abdominal aorta in the elderly population. Its continuously growth and rupture risk seriously threaten the life and health of patients. AAA molecular pathomechanism is complex, its core mechanism is a IL-6 mediated immune response regulation and inflammatory mediators release, and b) oxidative stress triggered the programmed death of endothelial cells and vascular smooth muscle cells (VSMCs). Thereby, the damage to the blood vessel walls continues to worsen. The treatment of AAA with traditional drugs often has off-target effect and systemic toxicity. Surgical treatment also has many problems, such as large postoperative wound, significant complications and poor long-term efficacy. Therefore, this study developed an antibody-conjugated sustained-release nanoparticle, which loaded 2-MEthoxyestradiol (2ME) and target AAA inflammatory sites by significantly reducing mitochondrial oxidative stress damage in vascular endothelial cells through surface conjugation with tocilizumab (TCZ). The 2ME/TCZ modified nanomedicine (2MTNP) has long-term drug release ability, achieved oxidative stress inhibition in the AAA region and significantly restored the expression of mitochondrial anti-oxidative stress proteins PGC-1α, MT-CO1, and TFAM. In AAA mouse, the nanomedicine was highly enriched in areas of AAA, effectively slowing the expansion of AAA and the thinning of aortic vessel walls, thereby improving the survival of diseased mice. More importantly, PLGA-PEG nanocarrier-mediated drug delivery did not show significant organ toxicity such as liver and kidney in mice, demonstrating superior biocompatibility. This study reports an antibody-conjugated sustained-release nanodrug for targeted therapy of AAA, which provides a new treatment method for inflammatory vascular aneurysms.

01 Sep 2026·JOURNAL OF CLINICAL EPIDEMIOLOGY

The importance of non-clinical information in updating living recommendations: a case study of the Australian living COVID-19 clinical guidelines

Article

Author: Green, Sally ; Turner, Tari ; Millard, Tanya ; Synnot, Anneliese ; McDonald, Steve ; White, Heath

BACKGROUND AND OBJECTIVE:

Living guidelines facilitate optimized patient care by providing up-to-date, evidence-based recommendations. Although a strong focus has been placed on the updating of living recommendations using clinical evidence from primary studies, the inclusion of contextualizing information from nonclinical sources is equally important in maximizing the applicability, appropriateness, and implementability of living recommendations. We aimed to examine the range and impact of changes to the Australian Living COVID-19 Clinical Guidelines based on information from nonclinical sources.

STUDY DESIGN AND SETTING:

We retrospectively identified and extracted all nonclinical information updates (ie, updates to the guideline based on information other than direct primary studies, approval or supply of therapeutics) to the COVID-19 guidelines. For each update, we recorded the location in the guideline where the change was made (eg, recommendation, evidence-to-decision), source of change (eg, expert consensus, consumer input, and government/policy decision), and reason for change (eg, approval/supply of therapeutics, clarity around population). Additional information was collected for specific high-impact nonclinical evidence updates.

RESULTS:

A total of 302 nonclinical changes were made to the guidelines across a 3-year period. The majority of changes were made to the additional information underpinning recommendations (46%), text of the recommendation (26%), or patient preferences and values (18%), with the most prevalent source of change being expert consensus (50%). Several impactful changes were made in areas such as tocilizumab supply and in vitro evidence regarding reduced activity of monoclonal antibodies against SARS-CoV-2 Omicron subvariants.

CONCLUSION:

Our analysis highlights the significant quantity and diversity of information captured and incorporated within the COVID-19 clinical guidelines from nonclinical sources. Engagement with a broad range of interest holders across living guideline iterations is integral to acquiring this information, and developers should consider a fourth key criterion, based on nonclinical information, to determine whether a living approach is appropriate.

312

News (Medical) associated with Tocilizumab

13 Aug 2026

·www.biospace.com

Allogene Therapeutics Reports Second Quarter 2026 Financial Results and Business Update

Pivotal Phase 2 ALPHA3 Program in 1L Large B-cell Lymphoma (LBCL): Recent Interim Futility Analysis Supports Cemacabtagene Ansegedleucel’s (Cema-Cel) Potential as an Outpatient, MRD-Guided 1L Consolidation Therapy Strong Execution and Increased Investigator Interest Accelerated 2026 Site Activation Target by Six Months; Approximately 100 Sites Now Expected by Year-End, Further Supporting Enrollment Next Update Anticipated in Mid-2027, with Trial Enrollment Expected to Be Completed by Year-End 2027 Following Review of the Interim Futility Analysis, FDA Granted RMAT and Fast Track Designations for Cema-Cel Underscoring MRD Positivity as an Unmet Need in LBCL Phase 1 RESOLUTION Trial in Autoimmune Disease: Brisk Enrollment Continues Across ALLO-329 Dose Escalation and Lymphodepletion Optimization Cohorts Clinical Data Update Expected Q4 2026 Ended the Second Quarter of 2026 with $423.6 Million in Cash, Cash Equivalents and Investments Conference Call and Webcast Scheduled for Today at 2:00 PM PT/5:00 PM ET SOUTH SAN FRANCISCO, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today provided corporate updates and reported financial results for the quarter ended June 30, 2026. “When we reset our strategy in 2024, we started with the patient and focused on where the distinct attributes of allogeneic CAR T could create a clinical advantage,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. “ALPHA3 is the clearest expression of that strategy: identifying patients at high risk of relapse, treating before disease returns clinically, and enabling CAR T delivery where patients already receive care. We took the same patient-first approach with ALLO-329, recognizing early that chemotherapy-based lymphodepletion and treatment interruptions associated with leukapheresis in autologous therapy could create meaningful burdens for patients with autoimmune disease. Together, these programs demonstrate that the value of allogeneic CAR T extends well beyond off-the-shelf availability, offering the flexibility to address clinical and practical barriers other approaches cannot. We believe the scale of that opportunity will become increasingly apparent as our programs continue to advance.” Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL Cemacabtagene ansegedleucel (cema-cel) is being evaluated in ALPHA3, the first pivotal, randomized Phase 2 trial in LBCL designed to assess whether MRD-guided treatment following first-line therapy can delay or prevent clinical relapse. In July, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following review of the interim futility analysis. At the protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity, with the majority clearing MRD by the first post-treatment assessment, compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature and cross-study benchmarks suggest that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This pro favorably with the broader CAR T experience, where hospitalization for toxicity management remains common. Most patients were treated and followed entirely in the outpatient setting. Community cancer centers accounted for approximately one-third of screening activity and cema-cel infusions, including sites with limited or no prior CAR T experience. These findings support ALPHA3’s potential to bring CAR T earlier in the course of disease and closer to where patients receive care. The Company achieved its 2026 goal of activating more than 80 sites approximately six months ahead of schedule, driven by strong execution and increased investigator interest following the interim futility analysis. The Company now expects approximately 100 sites to be active by year-end, with the significant majority in the United States and additional sites in Canada, Australia and South Korea. This expansion is expected to support enrollment momentum, broaden access to the trial, and provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch. ALPHA3 is expected to randomize approximately 220 MRD+ patients to either cema-cel consolidation or close observation, with enrollment anticipated to be completed by year-end 2027. The next program update tied to the interim event-free survival (EFS) analysis is expected in mid-2027. ALLO-329: Purpose-Built Allogeneic CAR T for Autoimmune Disease ALLO-329 is a next-generation, dual-targeting anti-CD19/CD70 AlloCAR T product incorporating the Company’s proprietary Dagger ® technology. The product was designed to address allogeneic rejection by targeting activated CD70-positive host T cells, with the goal of supporting CAR T-cell expansion while reducing or eliminating the need for conventional chemotherapy-based lymphodepletion. The ongoing Phase 1 RESOLUTION trial is a dose-escalation study evaluating cell dose of ALLO-329 and the role played by Dagger with and without lymphodepletion across multiple autoimmune indications, including systemic lupus erythematosus, scleroderma, and inflammatory myositis. Enrollment continues at a brisk pace across cohorts, dose levels and lymphodepletion strategies. The Company remains on track to provide a clinical and translational update in the fourth quarter of 2026. 2026 Second Quarter Financial Results Research and development expenses were $30.7 million for the second quarter of 2026, which includes $2.1 million of non-cash stock-based compensation expense. General and administrative expenses were $20.8 million for the second quarter of 2026, which includes $10.3 million of non-cash stock-based compensation expense. Net loss for the second quarter of 2026 was $42.7 million, or $0.13 per share, including non-cash stock-based compensation expense of $12.4 million. The Company had $423.6 million in cash, cash equivalents, and investments as of June 30, 2026. Based on its cash, cash equivalents, and investments as of June 30, 2026, the Company currently projects its cash runway into 2029. Guidance for operating expense in 2026 is expected to be approximately $165 million. GAAP Operating Expenses are expected to be approximately $225 million, including estimated non-cash stock-based compensation expense of approximately $35 million. These estimates exclude any impact from potential business development activities. Conference Call and Webcast Details Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company's website at under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days. About Allogene Therapeutics Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by cell therapy veterans applying proven CAR T experience, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In some cases, forward-looking statements may be identified by words such as “expect,” “believe,” “aim,” “plan,” “intend,” “seek,” “estimate,” “target,” “potential,” “may,” “could,” “will,” “would,” “should,” “anticipate,” “support,” “designed to,” “working to” and similar expressions. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing, design, conduct, and results of Allogene’s clinical trials and analyses (including the interim futility analysis and MRD clearance outcomes from the Phase 2 ALPHA3 trial of cema-cel and updates from the Phase 1 RESOLUTION trial of ALLO-329); the extent to which additional clinical trial sites may support enrollment momentum, broaden access to the ALPHA3 trial, or provide more sites with hands-on experience administering cema-cel ahead of a potential commercial launch; the rate and pace of enrollment in the RESOLUTION trial; the potential benefits and regulatory implications of the RMAT and Fast Track designations for cema-cel; the potential clinical benefits, safety, tolerability, durability, and efficacy of Allogene’s product candidates; the potential for MRD-guided first-line consolidation to improve outcomes in LBCL; the extent to which published literature, cross-study benchmarks, and observed or potential MRD clearance differences of 25-30% may translate into clinically meaningful improvement at study completion; the potential value and advantages of allogeneic CAR T, including its ability to address clinical and practical barriers presented by other therapies; the potential to deliver allogeneic CAR T therapy in outpatient and community care settings and expand access across academic and community care settings and the extent to which interim data and analysis is supportive thereof; the potential to reduce or eliminate conventional lymphodepletion; expectations regarding clinical trial execution and operational performance; and expectations regarding Allogene’s financial position, cash runway, and 2026 operating outlook. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, but not limited to, risks and uncertainties inherent in clinical development (including that interim or early data may not be predictive of later or final results or clinical outcomes), patient enrollment and trial execution risks, uncertainties related to MRD testing and its clinical significance and whether observed differences in MRD clearance will translate into clinically meaningful benefit, the occurrence of adverse safety events, regulatory risks and uncertainties, manufacturing and CMC risks, reliance on third parties and licensors, competitive developments, intellectual property and contractual risks, and financial risks, including the need for additional capital. These and other risks and uncertainties are described more fully in Allogene’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, being filed with the SEC today. All forward-looking statements in this press release speak only as of the date of this press release, and Allogene undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Dagger ® is a trademark of Allogene Therapeutics, Inc. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom. The anti-CD70 AlloCAR T program is licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to this AlloCAR T program. ALLO-329 (CD19/CD70) in autoimmune disease uses CRISPR gene-editing technology. ALLOGENE THERAPEUTICS, INC. SELECTED FINANCIAL DATA (unaudited; in thousands, except share and per share data) STATEMENTS OF OPERATIONS Three Months Ended June 30, 2026 2025 Collaboration revenue - related party $ 4,640 $ — Operating expenses: Research and development $ 30,721 $ 40,156 General and administrative 20,839 14,281 Impairment of long-lived assets — 2,382 Total operating expenses 51,560 56,819 Loss from operations (46,920 ) (56,819 ) Other income (expenses), net: Interest and other income, net 4,647 6,187 Interest expense (343 ) (268 ) Other income (expenses), net (61 ) (43 ) Total other income (expenses), net 4,243 5,876 Net loss $ (42,677 ) $ (50,943 ) Net loss per share, basic and diluted $ (0.13 ) $ (0.23 ) Weighted-average number of shares used in computing net loss per share, basic and diluted 328,930,269 218,929,548 SELECTED BALANCE SHEET DATA As of June 30, 2026 As of December 31, 2025 Cash, cash equivalents and investments $ 423,590 $ 258,253 Total assets 550,091 415,905 Total liabilities 113,916 123,363 Total stockholders’ equity 436,175 292,542 Allogene Media/Investor Contact: Christine Cassiano EVP, Chief Corporate Affairs & Brand Strategy Officer Christine.Cassiano@allogene.com

Clinical ResultLicense out/inPhase 2Phase 1Cell Therapy

07 Aug 2026

·www.gedeonrichter.com

Richter publishes Q2/H1 2026 results

CER Pharma revenues grew by 8.7%, driven by CNS and BIO and also reflecting improving WHC and GenMed dynamics in Q2. Reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026, implying around 9ppt currency headwind. CER Clean EBIT (pharma) growth was outstanding at 21%, driven by the outperformance of cariprazine and the benefits of our multi-year efficiency initiatives; reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn. Net profit was HUF 103.5bn in H1 2026, down by 14% YoY due to large, HUF 27.1bn FX losses burdening the period. Free Cash Flow generation was up by a solid 24% YoY to HUF 137bn. 2026 Clean EBIT guidance (at constant exchange rates, CER) is upgraded to “double-digit growth” on the back of the strong H1 profitability. Budapest, 7 August 2026 - Gedeon Richter Plc. (“Richter”) announced today its Q2/H1 2026 financial results. CER (constant exchange rate) Pharma revenues grew by 8.7% in H1 2026, in line with the high-single-digit growth guidance for the full year and reflected improving dynamics in Q2. FX remains a major drag on reported revenues and represented around 9ppt headwind in H1 (primarily due to the strong HUF). Hence, reported Pharma revenues declined by 0.5% YoY to HUF 455bn in H1 2026. CNS revenues increased by 7% in H1 2026 YoY, as currency movements partly offset the impressive performance of Vraylar® (AbbVie’s net sales increased by 19% YoY to USD 1.98bn reflecting strong demand growth and market share gains in both bipolar disorder and adjunctive MDD) and jumping Reagila® sales (+25% CER, driven by higher supply revenues and high-performing countries in both Richter and partner territories). Women’s Healthcare sales growth (+7% CER in H1) accelerated in Q2 as Endometriosis and Menopause consistently outperform expectations. Lower Eastern European sales and slower dynamics in traditional OC products continue to affect top-line growth. The underlying strength of the leading products (Drovelis®, Ryeqo®, Lenzetto® and Bemfola®) remains intact. BIO revenues jumped in H1 (+30% CER), driven by biosimilar revenues (very strong teriparatide sales and new product launches). GenMed revenues fell by 5% in H1 YoY (CER) although sales dynamics have incrementally been improving. The lack of flu season (weak OTC), a high base and the ongoing rationalization of distributors’ inventory holding affected top-line. Gross profit (pharma) fell by 2.2% YoY to HUF 314bn in H1 2026; gross margin declined to 69% (-1.2ppt), despite improving trends in Q2. CER Clean EBIT (pharma) growth was outstanding at 21% in H1 2026, driven by the outperformance of cariprazine, improving WHC profitability and also supported by lower opex. Reported Clean EBIT (pharma) grew by only 3% to HUF 151.8bn due to the FX headwind. Reported EBIT stood at HUF 143.5bn in H1 2026, 2.2% higher YoY. Net profit (attributable to the owners of the parent) was HUF 103.5bn in H1 2026, declining by 14% YoY, as a result of large, HUF 27.1bn FX losses (mostly unrealized yet) burdening the period as financial expenses. Free cash flow (before M&A) was at another record-high of HUF 137bn in H1 2026, up 24% YoY, driven by lower Net Working Capital funding need vs. a year ago, and higher operating profits, partly offset by FX losses. The multi-year project to optimize and centralize API (active pharmaceutical ingredient) manufacturing in Hungary was completed. The project reduces duplications, improves efficiency, leads to a more compact site structure in Budapest and makes Dorog the API manufacturing site of Richter. Centralizing API manufacturing not only brought in much improved operational efficiency, but also delivered significant environmental benefits. This includes significantly lower energy consumption, materially less overall wastewater and hazardous waste generation, reduced net operational areas and an improved industrial footprint. Gábor Orbán, CEO commented the results: “Top-line growth accelerated in Q2, fully in line with our high-single-digit (CER) growth target for the year, driven by improving dynamics in both Women’s Healthcare and GenMed alongside sustained strength in CNS and BIO revenues. We are upgrading our profitability guidance for 2026 to double-digit Clean EBIT growth (CER), reflecting the outstanding performance of Vraylar® and visible benefits of our multi-year efficiency initiatives. Reported financial results continue to be affected by currency trends. We successfully launched Fylrevy®, an innovative hormone therapy for menopause, in selected pilot markets in Europe; Tuyory®, our tocilizumab biosimilar is now being commercialized; another CNS molecule (RGH-202) is entering Phase II clinical trials; and we further expand our GLP-1 portfolio through global partnerships.” About Gedeon Richter Plc. Richter aspires to be a global innovator in some key scientific fields, while dedicated to making medicines more accessible worldwide. Founded in 1901, headquartered in Hungary, with a market capitalization of EUR 4.8bn and sales of EUR 2.3bn in 2025, it operates Central Europe's largest R&D hub. Its research drives breakthroughs in Neuropsychiatry and Women's Healthcare, while Biotechnology and General Medicines strengthen its affordable treatment portfolio. Committed to sustainable growth, Richter invests in R&D, manufacturing excellence, and digitalization to advance medical innovation. Learn more at www.gedeonrichter.com For further information: Investors: Róbert Réthy, CFA +36 20 342 2555 Media: Zsuzsa Beke +36 20 916 4507

Phase 2Financial Statement

29 Jul 2026

·www.biospace.com

Allogene Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Cemacabtagene Ansegedleucel (Cema-Cel) as First-Line Consolidation Therapy for Large B-Cell Lymphoma

FDA Granted RMAT Designation Based on ALPHA3 Trial Futility Analysis, Highlighting Cema-Cel’s Potential to Transform Disease Treatment in First-Line LBCL Consolidation Cema-Cel Induced Rapid and Substantial MRD Clearance of 58.3%, with a 97.7% Median Decrease in Plasma ctDNA at Day 45, Compared With a 26.6% Median Increase in the Observation Arm Cema-Cel Was Well-Tolerated, With Most Patients Managed in the Outpatient Setting and No Hospitalizations for Treatment-Related Adverse Events FDA Also Granted Fast Track Designation to Cema-Cel for the ALPHA3 Development Program RMAT and Fast Track Status Enable Enhanced FDA Engagement and Support Potential Expedited Development and Review Pathways SOUTH SAN FRANCISCO, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who, at the completion of first-line (1L) therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease (MRD). Together, the designations enable more frequent FDA engagement and support an efficient development and review process. Cema-cel is an investigational allogeneic CAR T product being studied in the pivotal ALPHA3 trial as part of 1L treatment for patients with LBCL who are at high risk of relapse. The ALPHA3 trial uses Natera's CLARITY ™ MRD assay, which is powered by its phased variant MRD technology, to identify patients in remission but who are likely to experience disease recurrence following completion of 1L chemoimmunotherapy. Patients who test positive for MRD are enrolled and assigned to receive either a single dose of cema-cel or close observation, the current standard of care, with outcomes compared between the two groups. “The FDA’s decision to grant both RMAT and Fast Track designations provides additional validation for the strategy we defined with the ALPHA3 trial and strengthens our ability to work closely with the agency on an efficient path to advance cema-cel as a first-line consolidation therapy for large B-cell lymphoma,” said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene Therapeutics. “There is a shared goal across the treatment community to reach patients earlier in their disease course and reduce the barriers that limit access to CAR T therapy. The interim ALPHA3 findings, which showed rapid and substantial MRD reduction, with most patients treated in the outpatient setting, support cema-cel’s potential as an off-the-shelf therapy that can be delivered at scale in community settings where approximately 80% of first-line patients receive their care.” The FDA granted RMAT designation for cema-cel as 1L consolidation therapy for patients with high-risk LBCL following full review of the interim futility analysis from the ongoing ALPHA3 trial, underscoring the continued need for new treatment options. At the protocol-defined data cutoff, triggered when the 24 th patient enrolled in the ongoing study arms completed the Day 45 MRD assessment, 58.3% (7/12) of patients in the cema-cel arm achieved MRD negativity compared to 16.7% (2/12) in the observation arm. This represents a 41.6% absolute difference in MRD clearance between the two arms. Published literature and cross-study benchmarks suggest that MRD clearance differences of 25-30% may lead to clinically meaningful improvement at study completion. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Cema-cel was well-tolerated as of the data cutoff with no treatment-related serious adverse events. There were no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease (GvHD) or high-grade infections. No tocilizumab or steroids were administered for toxicity prophylaxis or treatment, and no patients were hospitalized for treatment-related adverse events. This pro favorably with the broader CAR T experience, where hospitalization for toxicity management remains common. Regenerative Medicine Advanced Therapy (RMAT) designation is intended to expedite the development and review of regenerative medicine therapies intended to treat, modify, or cure a serious or life-threatening disease or conditions when preliminary clinical evidence indicates the therapy has the potential to address an unmet medical need for that disease or condition. Fast Track designation further supports expedited development and review, including potential eligibility for rolling review and priority review, if relevant criteria are met. About Allogene Therapeutics Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by cell therapy veterans applying proven CAR T experience, Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit , and follow Allogene Therapeutics on X and LinkedIn. Cautionary Note on Forward-Looking Statements for Allogene This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “anticipate,” “expect,” “believe,” “aim,” “plan,” “goal,” “intend,” “seek,” “estimate,” “target,” “potential,” “may,” “could,” “will,” “would,” “should,” “designed to,” “suggest,” “support,” “enable,” “possible” and similar expressions to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential benefits and regulatory implications of the RMAT and Fast Track designations for cema-cel, including enhanced FDA engagement, an efficient or expedited development and review process, and potential eligibility for rolling review or priority review; the ongoing pivotal Phase 2 ALPHA3 trial and the potential for the trial or its results to support the advancement or regulatory approval of cema-cel; the potential clinical benefits, safety, tolerability, durability and efficacy of cema-cel, including its potential to transform treatment and enable earlier intervention for patients with LBCL who are at high risk of relapse; the interpretation and predictive value of the interim futility analysis and the reported MRD clearance and plasma ctDNA results, including whether the observed differences or literature-based benchmarks will translate into clinically meaningful improvement or improved clinical outcomes at study completion; the ability of Natera’s CLARITY™ MRD assay to identify patients who are likely to experience disease recurrence following first-line treatment; cema-cel’s potential as an off-the-shelf therapy that can be delivered at scale in outpatient and community settings and broaden patient access to CAR T therapy; comparisons of cema-cel’s safety, tolerability and outpatient administration pro the broader CAR T experience; and Allogene’s ability to develop and deliver readily available allogeneic CAR T products on-demand, more reliably and at greater scale to more patients. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, but not limited to: risks and uncertainties inherent in clinical development, including that interim or early data from a small number of patients may not be predictive of later or final results and may change as additional patients are enrolled and followed; uncertainties related to MRD and ctDNA testing and their clinical significance, reliability and ability to predict clinical outcomes, including whether MRD clearance will translate into improvements in event-free survival or other clinical endpoints; limitations of comparisons to published literature, cross-study benchmarks or other CAR T therapies; the occurrence of adverse safety events; patient enrollment and trial execution risks; regulatory risks and uncertainties, including that RMAT or Fast Track designation does not ensure expedited development or review or regulatory approval and that the FDA may disagree with Allogene’s clinical or regulatory plans, interpretation of results or proposed development pathway or may require additional data or trials; risks related to the development, regulatory approval and performance of the CLARITY™ MRD assay; manufacturing and CMC risks; reliance on third parties and licensors; competitive developments; intellectual property and contractual risks; and financial risks, including the need for additional capital. These and other risks and uncertainties are described more fully in Allogene’s filings with the SEC, including under the heading “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 13, 2026, and other filings that Allogene may make from time to time with the SEC. All forward-looking statements in this press release speak only as of the date of this press release, and Allogene undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Allogene’s investigational AlloCAR T oncology products utilize Cellectis technologies. Cemacabtagene ansegedleucel (cema-cel) was developed based on an exclusive license granted by Cellectis to Servier. Servier has granted Allogene exclusive rights to cema-cel in the U.S., all EU Member States and the United Kingdom. Allogene Media/Investor Contact: Christine Cassiano EVP, Chief Corporate Affairs & Brand Strategy Officer Christine.Cassiano@allogene.com

100 Deals associated with Tocilizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D02596	Tocilizumab	L04AC07	DB06273

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Interstitial lung disease due to systemic disease	United States	Genentech, Inc.	04 Mar 2021
Still's Disease, Adult-Onset	Japan	Chugai Pharmaceutical Co., Ltd.	22 May 2019
Takayasu Arteritis	Japan	Chugai Pharmaceutical Co., Ltd.	25 Aug 2017
COVID-19	European Union	Roche Registration GmbH	16 Jan 2009
COVID-19	Iceland	Roche Registration GmbH	16 Jan 2009
COVID-19	Liechtenstein	Roche Registration GmbH	16 Jan 2009
COVID-19	Norway	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	European Union	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Iceland	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Norway	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	European Union	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Iceland	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Norway	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	European Union	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Iceland	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Norway	Roche Registration GmbH	16 Jan 2009
Oligoarticular Arthritis	European Union	Roche Registration GmbH	16 Jan 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypoxic respiratory failure	Phase 3	United States	Genentech, Inc.	20 Apr 2020
Polymyalgia Rheumatica	Phase 3	France	-	06 Oct 2017
Osteoarthritis	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Pain	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Inflammation	Phase 3	Denmark	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Finland	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Norway	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Sweden	Hoffmann-La Roche, Inc.	28 May 2014
Scleroderma, Systemic	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Mar 2012
Scleroderma, Systemic	Phase 3	Canada	Hoffmann-La Roche, Inc.	01 Mar 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04375228 (CTgov)	Phase 2	Advanced Malignant Solid Neoplasm	7	Tocilizumab	krvaukwzbb = tywodileao hqjjyzyvgc (dmgxcdqbkr, qjftmfinir - zguldyditl) View more	-	03 Aug 2026
NCT03863015 (IMICA, Pubmed \| Eur Heart J Acute Cardiovasc Care)	Phase 2	Out-Of-Hospital Cardiac Arrest PECAM-1 \| syndecan-1 \| sTM	80	Tocilizumab	zdtxxlumbs(ndrtcctcew) = unhrbpxsds nlsvhvqcyd (romlnwytff ) View more	Positive	08 Jul 2026
NCT03863015 (IMICA, Pubmed \| Resusc Plus)	Phase 2	Out-Of-Hospital Cardiac Arrest	80	Tocilizumab	krilemnejt(uokvlufevi) = jkhhmzygft jakudgrzhq (fyziyydvgj ) View more	Positive	01 Jul 2026
EULAR2026	Not Applicable	Giant Cell Arteritis	150	Glucocorticoids (GCs) alone	upyrrsctde(ixfthfowlb) = eneaojsnnb dczahtaapw (xtjohyybsc ) View more	Positive	11 Jun 2026
				Tocilizumab (TCZ)	bkpzrvzaxz(herxamhagn) = bdmrzrtqck rtyhwyavki (jbvgllyces, 44 - 100) View more
EULAR2026	Not Applicable	Giant Cell Arteritis	2,457	Methotrexate	xtkfnfajpo(wuihrshess) = citcgvgzif pefkpcsnnu (apnlpggbto, 2.33 - 2.61) View more	Positive	11 Jun 2026
				Tocilizumab	xtkfnfajpo(wuihrshess) = csnzncufsg pefkpcsnnu (apnlpggbto, 1.65 - 1.96) View more
EULAR2026	Not Applicable	Giant Cell Arteritis	471	Tocilizumab (Newly Diagnosed)	qynuyyetiq(ogikyezsgq) = hwhsgdugil idrxnrimlp (yvxkcfiuoi )	Positive	11 Jun 2026
NCT03892785 (METOGiA, EULAR2026)	Phase 3	Giant Cell Arteritis	230	Tocilizumab 162 mg/week	pmgynvokwv(bjwwskzofe) = soqttzpnvg iblloypufi (ocfnoereyp )	Negative	11 Jun 2026
				Methotrexate 0.3 mg/Kg/week	zhdwglwuay(kbfznytdzl) = wbneqgtxld wopemjivvc (hmwoqcmsdk )
EULAR2026	Not Applicable	Scleroderma, Systemic \| Lung Diseases, Interstitial	507	Tocilizumab	qzjhaeuatx(fjrrldbrwd) = yzmqxhyhrr jnmrvddozj (pvzmrrrdnj, 6.09 - 8.06) View more	Positive	11 Jun 2026
EULAR2026	Not Applicable	Rheumatoid Arthritis	347	Tapering of b-/tsDMARDs	ybfprjbmoy(txnabpakcv) = llsfcicedj chfyravwks (ucrzfpfrnd )	Positive	11 Jun 2026
				Continuation of stable b-/tsDMARDs	ybfprjbmoy(txnabpakcv) = gvotkusczg chfyravwks (ucrzfpfrnd )
EULAR2026	Not Applicable	Rheumatoid Arthritis	72,000	Tocilizumab	sooviuyudx(xyhimulpkf) = jksduheahd swjhkcgjtm (ozkjgviznj )	Positive	11 Jun 2026
				Rituximab	sooviuyudx(xyhimulpkf) = bdzjmhorcy swjhkcgjtm (ozkjgviznj )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis