On November 3, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported it will share two presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 6-9, 2025, in Orlando, Florida, including updated clinical data from iMMagine-1, its Phase 2 pivotal study (publication #256) of anitocabtagene autoleucel (anito-cel) in patients with relapsed and/or refractory multiple myeloma (RRMM). Additionally, an abstract (publication #7644) describing the fast off-rate of anito-cel’s D-Domain binder will be published in a supplemental issue of Blood in November 2025. The company will also have a medical affairs booth (#1363) at the Orange County Convention Center.

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"We’re pleased to share that, along with our partners at Kite, we conducted our pre-BLA meeting with the FDA and remain confident in our planned 2026 commercial launch of anito-cel," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "This milestone marks a significant step toward bringing our innovative therapy to the multiple myeloma community. We look forward to sharing updated clinical data from our iMMagine-1 study in an oral presentation at ASH (Free ASH Whitepaper). These are exciting times at Arcellx!"

ASH Presentation Details:

Title: Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine-1
Speaker: Krina K. Patel, MD, MSc, MD Anderson Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma
Session Date: Saturday, December 6, 2025
Session Time: 2:00 p.m. – 3:30 p.m. ET
Presentation Time: 2:45 p.m. ET
Location: OCCC – West Hall E1
Publication Number: 256
Submission ID: abs25-4541

Title: Visualizing geographic variation and systemic inequities of disease burden and CAR T-cell therapy access in multiple myeloma in the US
Speaker: Brandon Blue, MD, Moffitt Cancer Center
Session Name: 907. Outcomes Research: Plasma Cell Disorders: Poster III
Session Date: Monday, December 8, 2025
Session Time: 6:00 p.m. – 8:00 p.m. ET
Location: OCCC – West Halls B3-B4
Publication Number: 6344
Submission ID: abs25-2093

Title: The fast off-rate of anito-cel’s D-Domain binder contributes to its distinctive pharmacology profile in preclinical models of multiple myeloma
Disposition: Online Publication
Publication Number: 7644
Submission ID: abs25-1695

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, NOV 3, 2025, View Source [SID1234659308])

On November 3, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"BioCryst’s excellent performance this quarter was driven by the continued momentum of ORLADEYO, which delivered impressive growth. We’ve recently made two strategic moves that are transformative for our company: the sale of our European ORLADEYO business, which strengthened our margins and financial position and enabled us to pay off our debt, and the proposed acquisition of Astria, which we believe gives us the incredible opportunity to help even more HAE patients and drive sustainable growth and profitability well into the next decade," said Jon Stonehouse, Chief Executive Officer of BioCryst.

"It has been an incredible honor to lead the employees of BioCryst over these past nearly 19 years. I couldn’t be more confident in the exceptional team we have built and am excited to see them take BioCryst forward and continue to deliver innovative treatments for patients living with rare diseases."

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

ORLADEYO net revenue in the third quarter of 2025 was $159.1 million (+37 percent year-over-year (y-o-y)).
New patient prescriptions in the third quarter were strong, slightly beating those in Q3 2024 despite the recent launches of new prophylactic competitors.
The number of new prescribers of ORLADEYO in the U.S. in the third quarter was 64, exceeding our two-year quarterly average.
Patient retention rates remained consistent with long-term trends.
Sales from the U.S. contributed 89 percent of global ORLADEYO net revenues in the third quarter.
"ORLADEYO demand remained strong in the third quarter, with new patient adds and prescriber confidence driving continued growth. Even with the market entry of new prophylactic therapies, ORLADEYO remains the most differentiated option for patients and our commercial results are strong evidence of this. We’re not resting on our success though: we’re excited about the possibility to bring ORLADEYO granules to kids with HAE in the near-term as well as potentially expanding our HAE portfolio with navenibart. Our team’s continuing focus on execution and innovation is improving our ability to help more patients in the HAE community, now and for years to come," said Charlie Gayer, President and Chief Commercial Officer of BioCryst.

Business Updates

The company has selected Ron Dullinger to become its next Chief Commercial Officer, effective January 1, 2026. With decades of commercial leadership experience across rare disease, oncology, and vaccine markets, Mr. Dullinger has a proven track record of building and leading high-performing teams and delivering exceptional results. He joined the BioCryst commercial organization in 2019 as Vice President of U.S. Sales and has served most recently as Senior Vice President and General Manager of the Americas region, leading the commercialization of ORLADEYO.
The Prescription Drug User Fee Act goal date for the company’s new drug application for ORLADEYO granules in children with HAE aged 2 to <12 is December 12, 2025. ORLADEYO would be the first targeted oral prophylactic therapy for children with HAE.
In October, the company entered into a definitive agreement to acquire Astria Therapeutics. The proposed transaction will add Astria’s lead product candidate, navenibart, to BioCryst’s HAE portfolio. Navenibart is an injectable, long-acting, monoclonal antibody inhibitor of plasma kallikrein currently in Phase 3 clinical development for HAE prophylaxis. The transaction is expected to close in the first quarter of 2026.
A Phase 1 trial of BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, is enrolling in healthy volunteers and patients. The company expects initial data in patients from this program by the end of the first quarter of 2026.
A Phase 1 trial of avoralstat, an investigational plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME), is enrolling in patients. The company expects initial data from this program by the end of the year and plans to seek a strategic partner for development beyond Phase 1.
Third Quarter 2025 Financial Results

For the three months ended September 30, 2025, total revenues were $159.4 million, compared to $117.1 million in the third quarter of 2024 (+36 percent y-o-y). The increase was primarily due to $159.1 million in ORLADEYO net revenue in the third quarter of 2025, compared to $116.3 million in ORLADEYO net revenue in the third quarter of 2024 (+37 percent y-o-y).

Research and development expenses for the third quarter of 2025 increased to $44.6 million from $41.1 million in the third quarter of 2024 (+9 percent y-o-y), primarily due to advancement of BCX17725 into the clinic and investigational new drug (IND)-enabling activities for pre-clinical programs. These increases were partially offset by the discontinuation and close-out of the Factor D program, a decrease in stock-based compensation, and ORLADEYO-related regulatory, safety, quality, and manufacturing expenses, previously recorded in research and development, that are now recorded in selling, general, and administrative to reflect the program’s commercial progression.

Selling, general and administrative expenses for the third quarter of 2025 increased to $83.0 million, compared to $65.1 million in the third quarter of 2024 (+27 percent y-o-y). Approximately $6.9 million of the increase was driven by transaction-related costs and stock-based compensation. Approximately $4.7 million was driven by ORLADEYO-related regulatory, safety, quality, and manufacturing expenses, previously recorded in research and development, that are now recorded in selling, general, and administrative to reflect the program’s commercial progression. The remainder was driven by the growth of ORLADEYO and general and administrative expenses.

Operating income for the third quarter of 2025 was $29.6 million, compared to $7.7 million for the third quarter of 2024. Non-GAAP operating income, excluding stock-based compensation expense and transaction-related costs, was $51.7 million for the third quarter of 2025, compared to $24.9 million for the third quarter of 2024.

Interest expense was $19.7 million in the third quarter of 2025, compared to $24.8 million in the third quarter of 2024 (-21 percent y-o-y). The decrease was primarily the result of the $125 million in partial prepayments on the outstanding principal amount under the Pharmakon Term Loan made in 2025, and the decrease in the effective interest rate related to the Pharmakon Loan Agreement.

Net income for the third quarter of 2025 was $12.9 million, or $0.06 per share, compared to a net loss of $14.0 million, or $0.07 per share, for the third quarter of 2024. Non-GAAP net income, excluding stock-based compensation expense, transaction-related costs, and loss on extinguishment of debt was $35.6 million, or $0.17 per share, for the third quarter of 2025, compared to $3.2 million, or $0.02 per share, for the third quarter of 2024.

Cash, cash equivalents, restricted cash and investments totaled $269.4 million at September 30, 2025, of which $14.8 million of cash and cash equivalents are held within the company’s European business and is reflected in current assets held for sale, compared to $351.7 million at September 30, 2024. Net cash utilization for the third quarter of 2025 was $17.8 million, which was driven by the $50 million Pharmakon prepayment made in July 2025. Excluding this prepayment, there was $32.2 million of cash generated during the quarter, primarily driven by ORLADEYO sales.

In October, the company prepaid the remaining outstanding amount under the Pharmakon term loan of $198.7 million following the closing of the sale of its European ORLADEYO business. The pro forma cash balance at September 30, 2025 was $294 million, which includes the impacts of net proceeds from the European sale and payment of associated expenses, transfer of cash from European entities, and prepayment of the remaining balance of the Pharmakon term loan and associated expenses.

Financial Outlook for 2025
The company is raising its outlook for full year 2025 global net ORLADEYO revenue to between $590 million and $600 million and lowering its outlook for 2025 non-GAAP operating expenses, excluding stock-based compensation expense and transaction-related costs, to between $430 million and $440 million. These figures exclude revenue and expenses associated with the European ORLADEYO business in the fourth quarter of 2025 as the sale of this business has been completed.

The company remains on track to deliver net income and positive cash flows for full year 2025. Positive cash flow refers to the improvement in cash, cash equivalents, restricted cash and investments from year end 2024 to year end 2025, not including the impact of debt prepayments or the sale of the European ORLADEYO business.

Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, NOV 3, 2025, View Source [SID1234659243])

On November 3, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported key research and development (R&D) and business updates presented during its R&D Updates event held on October 31, 2025. The event highlighted HUTCHMED’s progress in advancing innovative cancer and immunology treatments, including the introduction of its next-generation Antibody-Targeted Therapy Conjugate ("ATTC") platform, alongside updates on late-stage pipeline candidates.

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"Our commitment to advancing innovative therapies drives HUTCHMED’s mission to address critical unmet needs in oncology and immunology," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. "The ATTC platform’s potential to redefine precision oncology, combined with our robust pipeline and partnership strategy, positions us to deliver potentially transformative cancer and immunology treatments to patients around the world."

Breakthrough ATTC Platform and Lead Candidate HMPL-A251
The ATTC platform represents potentially a groundbreaking approach to precision oncology, integrating monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. The ATTC platform integrates monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. In contrast to traditional cytotoxin-based antibody-drug conjugates ("ADC"), ATTCs leverage targeted therapies to achieve synergistic anti-tumor activity and durable responses, as demonstrated in preclinical models. These conjugates have shown superior efficacy and safety profiles compared to standalone antibody or small molecule inhibitor components.

Overcoming Cancer Challenges with PAM-Targeting Payload: The first wave of ATTC candidates focuses on payloads targeting the PI3K/AKT/mTOR ("PAM") signaling pathway. The PAM pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant limitations, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery. The ATTC strategy tries to address these challenges by enhancing targeted delivery of PAM inhibitors directly to tumor cells, maximizing therapeutic benefit while minimizing systemic exposure.

HUTCHMED’s Lead ATTC Candidate, HMPL-A251: HMPL-A251 is a PAM-HER2 ATTC consisting of a highly selective and potent PI3K/PIKK inhibitor payload conjugated to a humanized anti-HER2 IgG1 antibody via a cleavable linker. Preclinical data for HMPL-A251 was recently presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In vitro, the PI3K/PIKK inhibitor payload exhibited high selectivity, potency, and robust anti-tumor activity across a diverse panel of tumor cell lines. HMPL-A251 demonstrated HER2-dependent antitumor activity, with potent inhibition of HER2-positive tumor cell growth regardless of PAM pathway alterations, and moderately reduced activity in HER2-low, PAM-altered lines. Notably, HMPL-A251 exhibited a strong bystander effect, impacting HER2-null cells when co-cultured with HER2-positive cells. In vivo evaluations showed superior anti-tumor efficacy and tolerability compared to the naked antibody and payload administered separately. When benchmarked against trastuzumab deruxtecan (T‑­DXd), a leading HER2-directed ADC, HMPL-A251 achieved comparable or superior efficacy at equivalent doses in most models tested. Furthermore, payload-related toxicities are anticipated to be improved, with plasma exposure of the free payload being significantly lower than that of HMPL-A251.

Encouraged by these promising preclinical results in both HER2-positive and HER2-low models, with or without PAM alterations, HUTCHMED plans to advance HMPL-A251 into clinical development starting in late 2025 using a data-driven strategy. Initial studies will evaluate the candidate across various cancer types with diverse HER2 and PAM alteration statuses.

Adaptable Payload and Antibody Design Unlocks Versatile Mechanisms: Beyond HER2-targeted antibodies, HUTCHMED aims to explore a broader range of antibody selections that synergize with the payload’s signaling pathways, leveraging the antibody as a delivery vehicle to enhance combination effects. Payload options are also adaptive, targeting a wide array of signaling pathways, positioning ATTCs as a versatile tool in overcoming resistance and improving treatment outcomes. Additionally, ATTC shows potential for combination with chemotherapy-based frontline standard-of-care treatments or as a chemotherapy-free adjuvant for long-term use, enhancing its possible application as combination therapy in early-line settings. Successful development of multiple ATTC molecules is expected to lead to collaboration and licensing opportunities in the future. Initial responses from potential partners are very positive.

Significant Progress from Late-stage Programs
In addition to the ATTC platform, the R&D Updates featured updates on some of the late-stage programs:

Fruquintinib FRUSICA-2 Study: Data from the Phase III trial of fruquintinib in combination with sintilimab for second-line renal cell carcinoma was presented at ESMO (Free ESMO Whitepaper) Congress 2025. The combination achieved a progression-free survival (PFS) of 22.2 months versus 6.9 months with standard-of-care axitinib or everolimus (hazard ratio [HR]: 0.37; p<0.0001). The objective response rate more than doubled to 60.5% versus 24.3%, with a median duration of response of 23.7 months compared to 11.3 months.
Savolitinib Registration Studies: Recruitment has been completed for the SANOVO China Phase III study in first-line EGFR-mutated non-small cell lung cancer ("NSCLC") with MET overexpression. Recruitment for the SAFFRON global Phase III study for second-line EGFR-mutated NSCLC patients with MET amplification or overexpression is progressing well, with enrollment completion expected in late 2025.
Surufatinib for Pancreatic Cancer: The Phase II/III study of surufatinib combined with Hengrui’s camrelizumab (a PD-1 antibody), nab-paclitaxel, and gemcitabine for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) remains on track. Results from the Phase II portion will be presented at an upcoming scientific conference.
Sovleplenib for ITP and wAIHA: Preparations for the resubmission of the new drug application for second-line immune thrombocytopenia (ITP) are progressing as outlined in the 2025 interim report, with resubmission planned for the second quarter of 2026. The ESLIM-02 study in second-line warm autoimmune hemolytic anemia (wAIHA) has completed enrollment, with topline results expected in early 2026.
Fanregratinib in China: Recruitment for the registrational Phase II study in patients with advanced intrahepatic cholangiocarcinoma (IHCC) in China has been completed, with new drug application submission preparation underway for the first half of 2026.

(Press release, Hutchison China MediTech, NOV 3, 2025, View Source [SID1234659259])

On November 3, 2025 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"Throughout the third quarter, we made strong progress across our gene editing pipeline and reported compelling Phase 1 safety and efficacy data for PBGENE-HBV at the International Coalition to Eliminate HBV Cure Symposium. We’re also eagerly awaiting a late-breaking oral presentation at AASLD on November 10th," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "The PBGENE-HBV data presented so far this year has shown proof of durable activity and a safety profile that allows us to continue dose escalation in pursuit of achieving a complete cure for hepatitis B patients. With great excitement, in 2026 we anticipate starting the first-in-human clinical trial with our second program, PBGENE-DMD for DMD patients, following our targeted IND submission by the end of 2025. We are highly encouraged by the unique preclinical data showing the potential to restore a nearly full length dystrophin gene which is native to the human body with the goal of improving function over time."

Wholly-Owned Portfolio:

PBGENE-HBV (Hepatitis B Viral Elimination Program):

On October 14th, Precision announced that it had been selected to deliver a late-breaking oral presentation at the upcoming Liver Meeting 2025 during the 75th American Association for the Study of Liver Diseases. The oral presentation will feature new data from the multiple cohorts of the ongoing Phase 1 ELIMINATE-B Trial.

On October 7th, Precision announced that the first clinical trial sites in the U.S. for the ELIMINATE-B trial had officially been activated. The site at Massachusetts General Hospital in Boston, Massachusetts, is now actively recruiting chronic hepatitis B patients along with multiple global clinical trial sites.

On September 12th, the Company presented data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV at the 6th International Coalition to Eliminate HBV Cure Symposium in Berlin, Germany. To date, PBGENE-HBV has shown to be well-tolerated by patients in both Cohort 1 and Cohort 2, who received multiple doses of 0.2 mg/kg of PBGENE-HBV and 0.4 mg/kg, respectively. In addition, PBGENE-HBV has demonstrated a substantial HBsAg reduction in all patients across Cohort 1 with one patient in Cohort 1 achieving a durable HBsAg reduction of approximately 50% from baseline that was ongoing seven months following initial dose administration. Given the favorable safety profile of Cohorts 1 and 2, the Data Monitoring Committee recommended the Company to proceed with dosing Cohort 3 which occurred during the third quarter of 2025.

On September 8th, Precision announced the issuance of a U.S. Patent (No. 12,410,418) by the U.S. Patent and Trademark Office (USPTO) titled "Optimized engineered meganucleases having specificity for a recognition sequence in the Hepatitis B Virus genome." The composition of matter claims in the patent encompass the PBGENE-HBV ARCUS nuclease which has an expiration date in March 2042. Patents in Europe and Hong Kong granted earlier this year included similar composition of matter claims.

PBGENE-DMD (Muscle Targeted Excision Program):

On October 10th, the Company presented a late-breaking poster presentation at the 30th Annual International Congress of the World Muscle Society meeting highlighting durable improvements in muscle function over time through increased dystrophin expression and dystrophin-positive cells for PBGENE-DMD. The data from a DMD mouse model demonstrated that dystrophin protein was detected in all muscles evaluated following the administration of PBGENE-DMD at doses up to 1×1014 vg/kg, with increased expression observed at nine months versus prior timepoints in the quadriceps, gastrocnemius, heart, and diaphragm, resulting in substantial and sustained functional muscle improvement. An increase in dystrophin-positive muscle cells were observed in all muscles. The maximum force output was significantly improved over untreated DMD mice at three, six and nine months post-treatment, highlighting strong durability of PBGENE-DMD outcomes.

Precision has completed final toxicology studies and is manufacturing clinical supplies, with an anticipated IND filing by the end of 2025. Pending IND clearance, Phase 1 initiation in DMD patients is anticipated in the first half of 2026 with initial data expected to follow in the second half of 2026.

Partnered In Vivo Gene Editing Programs:

iECURE-OTC (Gene Insertion Program)

Led by partner, iECURE, ECUR-506 is an ARCUS-mediated in vivo targeted gene insertion program currently in a first-in-human trial (OTC-HOPE) evaluating ECUR-506 as a potential treatment for neonatal onset ornithine transcarbamylase (OTC) deficiency.

Several recent medical conference presentations with updated ECUR-506 clinical data include:

The 6th International Symposium on Urea Cycle Disorders and the 15th International Congress of Inborn Errors of Metabolism, both held in early September in Kyoto, Japan. In October, presentations at medical conferences included the European Society of Gene & Cell Therapy Annual Congress held in Sevilla, Spain, and the American Society of Human Genetics Annual Meeting in Boston, Massachusetts.

These data presentations build upon previously reported clinical results demonstrating complete clinical response in the first participant at the lowest dose level (1.3×1013 GC/kg) of ECUR-506, as defined by the study protocol. The OTC-HOPE study is ongoing in the U.K., the U.S., Australia, and Spain with data from the trial expected in the first half of 2026.

Non-Core Ex Vivo Programs:

Azer-Cel (azercabtagene zapreleucel allogeneic CAR T treatment for cancer)

Imugene Limited, Precision’s clinical stage partner developing azer-cel for oncology indications, announced on September 17th, additional efficacy data from its Phase 1b clinical trial evaluating azer-cel in patients with relapsed/refractory diffuse large B-cell lymphoma. The updated data showcased an overall response rate of 81% in patients treated with azer-cel and IL-2 with seven complete responses and six partial responses including several patients remaining in durable remission beyond one year.

On October 28th, Imugene announced the first efficacy results from the CAR T-naïve indication cohort of its ongoing Phase 1b trial of azer-cel. Of the six evaluable CAR T-naïve patients, five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending. A total of ten patients have been treated in this CAR T-naïve cohort thus far, with additional results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably Waldenström Macroglobulinemia (WM), Marginal Zone Lymphoma (MZL) and Primary Central Nervous System Lymphoma (PCNSL).

Imugene is actively enrolling patients in the Phase 1b azer-cel trial at ten U.S. sites and five sites in Australia. Imugene has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss potential pivotal study design options for azer-cel. The decision to proceed to a meeting with the FDA to discuss a pivotal trial reflects the positive, durable clinical data that has been generated to date and adds to the growing clinical data set supporting the ARCUS platform. On October 31, 2025, Precision received an $8 million milestone payment in cash and stock from Imugene.

Corporate Updates:

Mark Sulkowski, M.D. Appointed Head Clinical Development Advisor

In August, Mark Sulkowski, Professor of Medicine at the Johns Hopkins University School of Medicine and renowned expert in hepatic and infectious diseases has expanded his advisory role with Precision. In the newly created role, Head Clinical Development Advisor, Dr. Sulkowski will work closely with Precision’s leadership and cross-functional teams to support clinical strategy across the development lifecycle for the Company’s on-going PBGENE-HBV Phase 1 clinical trial as well as initiation of later stage trials. His advisory role will focus on optimizing clinical trials, including translational integration, and aligning scientific rationale with regulatory objectives.

Quarter Ended September 30, 2025 Financial Results

In July 2025, the Company implemented operating efficiencies, including employment related and other expense reductions, to reduce annual operating expenses and extend its expected cash runway. In the third quarter of 2025, the Company realized reductions in early research and general & administrative expenses which reduced the Company’s operating expenses compared to both the second quarter of 2025 and third quarter of 2024.

Cash, Cash Equivalents, and Restricted Cash: As of September 30, 2025, Precision had approximately $71.2 million in cash, cash equivalents and restricted cash. Based on its expected cash runway, Precision believes it is sufficiently capitalized to reach important milestones for PBGENE-HBV and PBGENE-DMD. The Company expects existing cash and cash equivalents, potential near-term cash from CAR T transactions, along with expected operating efficiencies, operational receipts, and availability of Precision’s at-the-market (ATM) facility to extend Precision’s cash runway into the second half of 2027.

Revenues: Total revenues for the quarter ended September 30, 2025, were less than $0.1 million as compared to $0.6 million for the quarter ended September 30, 2024. The decrease was primarily the result of less billable effort under the Novartis Agreement.

Research and Development Expenses: Research and development expenses were $13.4 million for the quarter ended September 30, 2025, as compared to $13.1 million for the quarter ended September 30, 2024. The increase was primarily the result of an increase in the PBGENE-DMD program partially offset by decreases in the PBGENE-HBV program as it transitioned to the clinic at the end of 2024 and the PBGENE-3243 program which has been paused.

General and Administrative Expenses: General and administrative expenses were $7.3 million for the quarter ended September 30, 2025, as compared to $8.8 million for the quarter ended September 30, 2024. The decrease was primarily the result of employee-related costs and other general and administrative expenses.

Net Loss: Net loss was $21.8 million, or ($1.84) per share (basic and diluted), for the quarter ended September 30, 2025. Net loss was $16.4 million or $(2.25) per share (basic and diluted) for the quarter ended September 30, 2024.

About PBGENE-HBV, A Viral Elimination Program

PBGENE-HBV is Precision’s wholly owned in vivo gene editing program under investigation in a global first-in-human clinical trial, which is designed to be a potentially curative treatment for chronic Hepatitis B infection. PBGENE-HBV is the first and only potentially curative gene editing program to enter the clinic that is specifically designed to eliminate the root cause of chronic Hepatitis B, cccDNA, while inactivating integrated HBV DNA. The ELIMINATE-B trial is investigating PBGENE-HBV at multiple ascending dose levels with three dose administrations per dose level in patients with chronic Hepatitis B. PBGENE-HBV has been granted Breakthrough Therapy designation by the FDA.

About PBGENE-DMD, A Muscle-Targeted Excision Program

PBGENE-DMD is Precision’s development program for the treatment of DMD. DMD is a genetic disease caused by mutations in the dystrophin gene that prevent production of the dystrophin protein and affects approximately 15,000 patients in the U.S. alone. There are currently no approved therapies that can drive durable and significant functional improvements over time. PBGENE-DMD is designed to improve function for more than 60% of patients afflicted with DMD by employing two complementary ARCUS nucleases delivered in a single AAV to excise exons 45-55 of the dystrophin gene. The aim of this approach is to restore a near-full length functional dystrophin protein within the body that more closely resembles normal dystrophin as opposed to synthetic, truncated dystrophin approaches with minimal functional benefit. PBGENE-DMD has received both Rare Pediatric Disease and Orphan Drug designations from the U.S. FDA.

(Press release, Precision Biosciences, NOV 3, 2025, View Source [SID1234659275])

On November 3, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that it will present 21 abstracts, including 5 oral presentations, during the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (December 6-9). These data showcase Kite’s continued progress in transforming blood cancer care and expanding the reach and impact of CAR T-cell therapy.

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"Kite is dedicated to advancing cell therapy as a path to cures, and our data at ASH (Free ASH Whitepaper) will reflect meaningful progress toward this goal," said Cindy Perettie, Executive Vice President of Kite. "Together with our partner Arcellx, we’ll unveil the updated results from the pivotal Phase 2 iMMagine-1 study. These findings will lay the foundation for our aspiration with anito-cel to deliver a differentiated treatment for relapsed/refractory multiple myeloma with strong potential for community oncology access and reduced burden on patients and caregivers."

Anito-cel Data Updates

Key presentations for anitocabtagene autoleucel (anito-cel) include updated results from the fully enrolled, ongoing iMMagine-1 Phase 2 pivotal study. No delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome, and no immune-mediated enterocolitis, have been observed to date.

Data on Next-Generation Pipeline

Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753. These therapies are designed to target two antigens (CD19 and CD20) found on cancer cells and use two co-stimulatory domains (CD28 and 4-1 BB) to help the immune system fight cancer more effectively. This dual-targeting approach may lower the chance of the cancer escaping treatment and could also improve safety, making it possible to treat patients outside of a hospital setting.

Survival Outcomes with Yescarta Based on ASCT Eligibility

A key presentation for Yescarta (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible. Efficacy, safety, and health-related quality of life patterns were observed to be consistent across both ZUMA-7 and ALYCANTE populations, supporting the use of Yescarta regardless of transplant eligibility and effectively broadening eligibility to this potentially curative, one-time treatment.

Dates and times are listed in ET for the following accepted abstracts and presentations:

Oral Presentations

Abstract Details

Titles

Axicabtagene Ciloleucel Clinical Data

Abstract #671

Sunday, December 7, 2025

5:30 PM – 5:45 PM

OCCC – Tangerine Ballroom F3-4

Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) for Second-Line High-Risk Large B-Cell Lymphoma (LBCL): Interim Results from a Phase 1b Study​

Brexucabtagene Autoleucel Clinical Data

Abstract #569

Sunday, December 7, 2025

1:00 PM – 1:15 PM

OCCC – Tangerine Ballroom F3-4

ZUMA-25 Preliminary Analysis: A Phase 2 Study of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Burkitt Lymphoma (BL), Substudy C

Anitocabtagene Autoleucel Clinical Data

Abstract #256

Saturday, December 6, 2025

2:45 PM – 3:00 PM

OCCC – West Halls D1

Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Updated Results from iMMagine-1

Kite Next Generation CAR T Clinical Data

Abstract #265

Saturday, December 6, 2025

2:00 PM – 2:15 PM

OCCC – West Halls D2

A Phase 1 Study of KITE-753 or KITE-363 in Patients with Relapsed/Refractory B-Cell Lymphoma: Initial Safety and Preliminary Efficacy of KITE-753 and Updated Results of KITE-363

Translational Medicine

Abstract #805

Monday, December 8, 2025

10:30 AM – 10:45 AM

OCCC – W331

Blood and CSF Metabolomics Identifies Tryptophan Catabolism and Polyamine Synthesis as Drivers of CAR T-Cell-Associated Neurotoxicity

Poster Presentations

Axicabtagene Ciloleucel

Abstract #1799

Saturday, December 6, 2025

5:30 PM – 7:30 PM

OCCC – West Halls B3-B4

Patient Journey with Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma in Canada: Manufacturing experience and Impact of Patient Location to Treatment Centre​

Abstract #3714

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Axi-Cel Delivers Similar Outcomes Regardless of ASCT-Eligibility in Second Line R/R LBCL: Combined Data from ZUMA-7 and ALYCANTE

Abstract #1894

Saturday, December 6, 2025

5:30 PM – 7:30 PM

OCCC – West Halls B3-B4

Diffuse Large B Cell Lymphoma in Brazil: Understanding the Patient Journey to Improve Healthcare Assistance​

Abstract #4510

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Estimating the Survival Impact of Not Receiving CAR T-cell (CAR T) Therapy When Eligible in Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the United States (US)​

Abstract #6194

Monday, December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

US Cost Consequence and Time Toxicity Model for Advanced Therapies in the Treatment for Relapsed/Refractory Third-line or Later Diffuse Large B-cell Lymphoma: A Comparison of Axicabtagene Ciloleucel with Bispecific Antibodies

Abstract #5356

Monday, December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Real-World Effectiveness and Safety Outcomes by Age, Comorbidity, Frailty, and Treatments Prior to Infusion in Relapsed or Refractory (R/R) Follicular Lymphoma Patients Treated with Axicabtagene Ciloleucel​

Abstract #3717

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Surrogate Endpoints as Prognostic Factors for Long-Term Outcomes Among Patients Receiving Axicabtagene Ciloleucel in Frontline High-risk Large B Cell Lymphoma​

Abstract #4503

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Real-World Treatment Patterns and Survival Outcomes in Second and Third Line Settings in Large B-cell Lymphoma (LBCL)​

Brexucabtagene Autoleucel

Abstract #1588

Saturday, December 6, 2025

5:30 PM – 7:30 PM

OCCC – West Halls B3-B4

Endogenous Regulation of Inflammatory Response as a Determinant of Durable Remission Without Stem Cell Transplant Following Brexucabtagene Autoleucel (Brexu-Cel) Therapy in ALL

Abstract #1799

Saturday, December 6, 2025

5:30 PM – 7:30 PM

OCCC – West Halls B3-B4

Two-year Update of ZUMA-2 Cohort 3: Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Who Had Not Received Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Therapy​

Abstract #3606

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Real-world Effectiveness and Safety Outcomes by Age, Comorbidities, and Frailty Among Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients Treated with Brexucabtagene Autoleucel (Brexu-Cel)​

Above Brand

Abstract #5882

Monday, December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Pre-Treatment CD19 Antigen Density and Multi-Antigen Profiling by Calibrated Quantitative Flow Cytometry Correlates with CAR T Efficacy in LBCL​

Multiple Myeloma Unmet Clinical Need

Abstract #6344

Monday, December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Visualizing Geographic Variation and Systemic Inequities of Disease Burden and CAR T-Cell Therapy Access in Multiple Myeloma in the US​

Abstract #6284

Monday, December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Outcomes of Inpatient and Outpatient Chimeric Antigen Receptor T-cell Therapy (CAR T) in Newly Authorized Treatment Centers (ATCs) in the United States (US)​

Abstract #4411

Sunday, December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Real-world Healthcare Resource Utilization (HCRU) Following CAR T-Cell Therapy in US Patients Treated in Newly Authorized Treatment Centers​

Publication Only: Anitocabtagene Autoleucel Pre-Clinical Data

Abstract #7644

The Fast Off-Rate of Anito-cel’s D-Domain Binder Contributes to Its Distinctive Pharmacology Profile in Preclinical Models of Multiple Myeloma​

Investigator-Sponsored / Collaboration: Anitocabtagene Autoleucel Pre-Clinical Data*

Oral

Abstract #203

Sunday, December 7, 2025

10:30 AM – 10:45 AM

OCCC – Sunburst Room (W340)

Single-cell Transcriptomics Reveal Mechanisms of Efficacy and Toxicity in Anti-BCMA CAR-T Cell Therapies for Multiple Myeloma

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

*Presentations independently led and sponsored feature Kite CAR T-cell therapies but are not included in total number of Kite accepted abstracts.

About Yescarta

INDICATIONS

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
U.S. IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.
CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including ≥ Grade 3 CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include, cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

HYPERSENSITIVITY REACTIONS

Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes.

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) in:

patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.
patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.
patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

(Press release, Gilead Sciences, NOV 3, 2025, View Source [SID1234659293])