A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid? (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Start Date21 Mar 2026

Sponsor / Collaborator

National Cancer Institute

NCT07095452

/ Not yet recruitingPhase 2/3

Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide
Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date12 Nov 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06461988

/ Not yet recruitingPhase 2IIT

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Start Date01 Nov 2025

Sponsor / Collaborator

Stanford University

[+1]

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

9,456

Literatures (Medical) associated with Lenalidomide

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

31 Dec 2025·Hematology

Review

Author: Kollsete Gjelberg, Hilde ; Dahl Hamnvik, Lars Henrik ; Sefland, Øystein ; Sandnes, Miriam ; Reikvam, Håkon ; Ktoridou-Valen, Irini ; Andersson Tvedt, Tor Henrik ; Brendsdal Forthun, Rakel

OBJECTIVES:

Myeloid neoplasms occurring after cytotoxic therapy (MN-pCT), previously termed therapy-related myelodysplastic neoplasia (MDS) or therapy-related acute myelogenous leukemia (AML), pose significant treatment challenges due to high resistance, poor chemotherapy tolerance, and relapse.

METHODS:

We present a 73-year-old woman with therapy-related AML following treatment for myxofibrosarcoma, characterized by the rare RUNX1::MECOM fusion resulting from a t(3;21)(q26;q22) chromosomal translocation. We also review the current literature regarding cases of this rare translocation.

RESULTS:

The patient, previously treated with chemotherapy and radiotherapy for sarcoma, was diagnosed with pancytopenia and hypoplastic bone marrow with increased blasts. Cytogenetic analysis confirmed RUNX1::MECOM fusion. Furthermore, we discuss the molecular mechanisms underlying MECOM rearrangements, specifically the role of the EVI1 oncogene. AML associated with MECOM rearrangements is associated with poor prognosis and resistance to conventional therapies. While allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potential curative treatment, the high relapse rate limits its efficacy. Recent advancements in understanding the molecular drivers of MECOM-related AML suggest potential therapeutic strategies, including hypomethylating agents and novel combinations such as lenalidomide.

CONCLUSION:

this case and literature review emphasizes the importance of long-term monitoring of cancer survivors treated with cytotoxic therapies, as well as awareness of rare translocations in MN-pCT.

31 Dec 2025·Hematology

Bortezomib, thalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in transplant-eligible newly diagnosed multiple myeloma: a systemic review and meta-analysis

Review

Author: Lin, Cheng-Hsien ; Teng, Chieh-Lin Jerry ; Su, Yu-Chen ; Wang, Yin-Che

BACKGROUND:

The current study aimed to compare treatment responses, the incidence of the need for auto-HSCT, and the occurrence of specific adverse events (AEs) between VTD and velcade, VRD induction regimens in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM).

METHODS:

This systematic review and meta-analysis included 15 studies: six evaluating the VTD regimen and nine evaluating the VRD one. The primary endpoints were response rates after induction therapy and the incidence of a need for autologous hematopoietic stem cell transplantion (auto-HSCT) between the groups. We also examined the occurrence of grade 3 or 4 hematological, infection, and thrombotic AEs in both groups.

RESULTS:

The VTD group showed an overall response rate (ORR) of 93%, while the VRD group had an ORR of 86%. The very good partial response (VGPR) rates were 61% in the VTD group and 60% in the VRD one. The auto-HSCT rate was higher in the VTD group, averaging 93% compared to 70% in the VRD one. The incidence of grade 3 or 4 hematological AEs was 31% for VTD and 33% for VRD. The rates of grade 3 or 4 infection-related AEs were 9% in the VTD group and 14% in the VRD one. The incidence of grade 3 or 4 thrombotic AEs was 4% for VTD and 3% for VRD.

CONCLUSIONS:

With comparable safety profiles, VTD and VRD induction therapies are similarly effective for transplant-eligible NDMM, showing similar ORRs and VGPR rates.

958

News (Medical) associated with Lenalidomide

6 hours ago

·www.prnewswire.com

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG SECOND QUARTER 2025 RESULTS

Total Revenue Increased 41% YOY to $326 million and Royalty Revenue Increased 65% YOY to $206 million Net Income Increased 77% YOY to $165 million; Adjusted EBITDA Increased 65% YOY to $226 million; GAAP Diluted EPS Increased 85% YOY to $1.33; Non-GAAP Diluted EPS Increased 69% YOY to $1.541 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,275 - $1,355 million, Representing YOY Growth of 26% - 33%, Adjusted EBITDA to $865 - $915 million, Representing YOY Growth of 37% - 45% and Non-GAAP Diluted EPS to $6.00 - $6.40, Representing YOY Growth of 42% - 51%1 Announcing Third $250 million Share Repurchase Tranche Under $750 million Authorized Plan SAN DIEGO, Aug. 5, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the second quarter ended June 30, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance. "We are very excited to report another quarter of exceptional growth with a 65% increase in royalty revenue driven by our current three blockbuster therapies, DARZALEX SC, Phesgo, and VYVGART Hytrulo. In the second quarter, four notable approvals include RYBREVANT SC in Europe, VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in Europe and the VYVGART Hytrulo pre-filled syringe for gMG and CIDP in the U.S and Europe. Additional regulatory milestones were achieved with ENHANZE, including new indications and geographic expansion for DARZALEX SC, Opdivo SC, HYQVIA and Phesgo, which will further accelerate our future growth trajectory and enhance patient access. Based on the strong performance and growth trends, we are pleased to increase our full-year 2025 financial guidance ranges for the second time this year," said Dr. Helen Torley, President and CEO, Halozyme. "The strong results highlight the momentum and durability across our business, powered by high-margin royalty streams and increasing global demand for our industry-leading ENHANZE drug delivery technology. In the quarter, we completed a total of $303 million in share repurchases, including the $250 million program that we announced in May. Our outperformance and strong cash generation supports a balanced capital allocation strategy, including investing in growth through M&A and returning capital to shareholders," concluded Dr. Torley. Second Quarter and Recent Corporate Highlights: In June 2025, Halozyme initiated the third $250 million share repurchase tranche under the $750 million approved program from February 2024, of which $53.5 million was used to repurchase approximately 1.0 million shares at an average price of $52.40 per share in June 2025 for a total of $303.4 million of share repurchases in the second quarter. In May 2025, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. The second $250 million share repurchase was completed in June 2025, resulting in a total purchase of 4.8 million shares at an average price of $52.09 per share. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous ("SC") drug delivery technology to develop SC Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. Second Quarter and Recent Partner Highlights: In July 2025, Janssen announced the European Commission approved a new indication for DARZALEX® SC as a monotherapy for the treatment of adult patients with smouldering multiple myeloma ("SMM") at high risk of developing multiple myeloma. In June 2025, Takeda announced the Ministry of Health, Labour and Welfare in Japan approved HYQVIA® SC with ENHANZE® for treatment of patients with chronic inflammatory demyelinating polyneuropathy ("CIDP") and multifocal motor neuropathy. In June 2025, argenx announced European Commission approval of VYVGART® SC with ENHANZE® for the treatment of adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins. VYVGART® SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. In May 2025, Bristol Myers Squibb received European Commission approval of Opdivo® SC, the SC formulation of Opdivo® (nivolumab) developed with ENHANZE® for use across multiple adult solid tumors, resulting in the recognition of $12.0 million in milestone revenue. In May 2025, argenx initiated a Phase 1 study to evaluate ARGX-213 with ENHANZE®. In May 2025, Janssen announced the U.S. Food and Drug Administration ("FDA") Oncologic Drug Advisory Committee voted in favor of the benefit-risk profile of DARZALEX Faspro® for the treatment of adult patients with high risk SMM. In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2-positive breast cancer. Administration of Phesgo® outside of a clinical setting (such as in a person's home) by a healthcare professional will be possible, once safely established in a clinical setting. In April 2025, argenx received FDA approval of VYVGART® Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP. In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT® (amivantamab) with ENHANZE®, in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT® (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the tenth partnered product with ENHANZE® to be commercialized. In May 2025, amivantamab was made available to patients in the EU resulting in a $10.0 million milestone payment. In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX® SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility. Second Quarter 2025 Financial Highlights: Revenue was $325.7 million, compared to $231.4 million in the second quarter of 2024. The 41% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenues. Revenue included $205.6 million in royalties, an increase of 65% compared to $124.9 million in the second quarter of 2024, primarily attributable to increases in revenue of DARZALEX® SC, VYVGART® Hytrulo and Phesgo®. Cost of sales was $46.4 million, compared to $39.6 million in the second quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales and labor allocation initiatives. Amortization of intangibles expense remained flat at $17.8 million, compared to the second quarter of 2024. Research and development expense was $17.5 million, compared to $21.0 million in the second quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense was $41.6 million, compared to $35.7 million in the second quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees, including $2.6 million of litigation costs incurred in connection with a patent infringement litigation case, and an increase in compensation expense. Operating income was $202.4 million, compared to $117.2 million in the second quarter of 2024. Net income was $165.2 million, compared to $93.2 million in the second quarter of 2024. EBITDA was $222.9 million, compared to $137.0 million in the second quarter of 2024. Adjusted EBITDA was $225.5 million, compared to $137.0 million in the second quarter of 2024.1 GAAP diluted earnings per share was $1.33, compared to $0.72 in the second quarter of 2024. Non-GAAP diluted earnings per share was $1.54, compared to $0.91 in the second quarter of 2024.1 Cash, cash equivalents and marketable securities were $548.2 million on June 30, 2025, compared to $596.1 million on December 31, 2024. The decrease was primarily a result of share repurchase activities during the year, partially offset by cash generated from operations. Financial Outlook for 2025 The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented. For the full year 2025, the Company expects: Total revenue of $1,275 million to $1,355 million, representing growth of 26% to 33% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $825 million to $860 million, representing growth of 44% to 51% over 2024. Adjusted EBITDA of $865 million to $915 million, representing growth of 37% to 45% over 2024. Non-GAAP diluted earnings per share of $6.00 to $6.40, representing growth of 42% to 51% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Table 1. 2025 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2025 today, Tuesday, August 5, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and intellectual property litigation costs, and certain adjustments to income tax expense. The Company calculates Non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating Non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations and intellectual property litigation costs. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides Non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the GAAP measures may be materially different than the Non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. The Company considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and Non-GAAP diluted earnings-per-share, potential share repurchases under its share repurchase program and potential expansion of the Company's platform through acquisitions. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE® and its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size, demand and growth prospects of our partners' drug franchises, potential new or expanded collaborations (including potential HVAI and SVAI collaborations) and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program or planned platform expansion through acquisitions, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, uncertainties related to tariff, trade and pharmaceutical pricing policies and tax legislation, unexpected adverse events or patient outcomes and competitive conditions. In addition, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 1Financial Statement

01 Aug 2025

·www.biopharmadive.com

Regeneron cancer bispecific rejected again; Allogene discloses trial death

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenxthat you may have missed.Regeneron said two more of its new drugshit regulatory setbacks because of Food and Drug Administration inspection issues at a third-party manufacturing plant. The company received a complete response letter for its bispecific cancer antibody odronextamabin lymphoma on July 30, due to issues at an Indiana factory that Novo Nordisk recently acquired from Catalent. In addition, the FDA will delay a decision on an application for high-dose Eylea processed at that plant. The odronextamab setback will require Regeneron to refile its application. The FDA previously rejected another Regeneron bispecific antibody, now approved as Lynozyfic, in multiple myeloma because of third-party manufacturing issues. Jonathan GardnerAllogene Therapeutics is stopping use of an experimental immunosuppresive antibody called ALLO-647 following the death of a study participant, the company said Friday. ALLO-647 is part of a regimen meant to prepare patients for treatment with Allogenes donor-derived cell therapy for blood cancer, cema-cel. But the antibody has been associated in rare cases with severe viral infections and, in this instance, was deemed related to an adenovirus infection that triggered liver failure in a participant in Allogenes pivotal trial. Allogene has closed the study arm with ALLO-647 and wont use it in future trials. It will move forward with a standard two-drug immunosuppressive regimen often used in cancer cell therapy. Results from the pivotal trial are still expected next year, the company said.Ben FidlerBristol Myers Squibb boosted its revenue outlook for 2025 by $700 million, driven by higher-than-expected sales of its off-patent cancer drug Revlimid. The company now expects full-year sales to be between $46.5 and $47.5 billion, although that may not flow through to the bottom line because of the $1.5 billion it has spent this year to license a BioNTech cancer drug. The unexpectedly high $838 million in Revlimid sales in the second quarter were part of a broader overperformance by the company, which beat Wall Street consensus for both its old and new drug business lines. Sales of Eliquis, Opdivo and Reblozyl were higher than expected, although cell therapy Abecma and new psoriasis drug Sotyktu were below, according to Leerink Partners analyst David Risinger. Jonathan GardnerBiogen shares rose as much as 7% Thursday after the biotechnology companys latest earnings report surpassed Wall Street expectations. The company recorded $2.6 billion in revenue from April through the end of June, with $160 million coming from Leqembi, its closely watched drug for Alzheimers disease. Biogen also raised its forecasts for 2025 revenue and earnings per share. To Brian Abrahams, an analyst at the investment bank RBC Capital Markets, the results were indicative that Biogens efforts to turn around the business are starting to show. We see considerable room for upside, he wrote in a note to clients. Jacob BellShares of Argenx climbed by double digits following quarterly sales numbers for its autoimmune drug Vyvgart that handily topped investor expectations. According to Argenx, the companys multiple Vyvgart formulations combined to generate nearly $949 million in revenue between April and June, beating consensus estimates by more than $80 million. The blowout performance included impressive numbers across Vyvgarts approved indications and different versions, wrote William Blair analyst Myles Minter on Thursday. Leerink Partners Thomas Smith now projects more than $9 billion in combined peak yearly sales. Argenxs market value rose past $40 billion on the news. Ben Fidler '

Cell TherapyImmunotherapyDrug ApprovalClinical ResultFinancial Statement

01 Aug 2025

·pmlive.com

Sanofi’s Sarclisa approved by EC to treat newly diagnosed multiple myeloma

Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat newly diagnosed multiple myeloma (MM). The drug has been authorised for use in combination with bortezomib, lenalidomide and dexamethasone (VRd) as an induction treatment for adults with newly diagnosed MM who are eligible for autologous stem cell transplant. MM is the second most common blood cancer after non-Hodgkin lymphoma, with approximately 46,000 cases of the disease expected to be diagnosed in Europe this year. Sarclisa is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity. The drug is already approved in the EU across three other MM indications, including in combination VRd to treat newly diagnosed MM in adults who are not eligible for autologous stem cell transplant. The EC’s latest decision means that Sarclisa is now approved in the EU across all lines of therapy, regardless of transplant eligibility, and follows a recent recommendation from the European Medicines Agency’s human medicines committee. The new authorisation was based on results from part one of the phase 3 German-speaking Myeloma Multicenter Group (GMMG)-HD7 study, in which Sarclisa-VRd was associated with a statistically significant minimal residual disease (MRD) negativity benefit at the end of the 18-week induction period. There was also a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Sarclisa-VRd during induction, regardless of the maintenance therapy received, and 53.1% of patients receiving Sarclisa-VRd and 38% in the study’s control arm experienced continued MRD negativity, defined as MRD negativity persisting from post-induction to post-transplant. Commenting on the latest authorisation, Olivier Nataf, global head of oncology at Sanofi, said: “We have been on a mission to accelerate Sarclisa’s clinical development programme with the hope to bring this important medicine to as many people as possible living with MM. “[This] decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”

Clinical ResultPhase 3Drug ApprovalCell TherapyImmunotherapy

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	United States	Seagen, Inc.	11 Feb 2025
Marginal Zone B-Cell Lymphoma	United States	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	Japan	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	United States	Bristol Myers Squibb Co.	29 Jun 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	United States	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Japan	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Argentina	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Australia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Austria	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Canada	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Colombia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Czechia	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	France	Incyte Corp.	11 May 2021
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Germany	Incyte Corp.	11 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05222555 (MINDway, CTgov)	Phase 1/2	Diffuse large B-cell lymphoma recurrent	53	Lenalidomide+Tafasitamab (Tafasitamab Dose Level 1 + 25 mg Lenalidomide)	nxdgkbpxxh = jelhlduvbr ccwpwccsth (jjdndczdvq, xifrfuidsp - rpddmivadn) View more	-	28 Jul 2025
				Lenalidomide+Tafasitamab (Tafasitamab Dose Level 2 + 25 mg Lenalidomide)	nxdgkbpxxh = cimlaxlztm ccwpwccsth (jjdndczdvq, figeanqhnd - umkcdpyqdi) View more
NCT02765854 (CTgov)	Phase 2	Recurrent Multiple Myeloma \| Refractory Multiple Myeloma	70	Ixazomib+Dexamethasone (Arm B (Ixazomib and Dexamethasone))	wdnoqrubor = akkeejsecf fqxlwpwhyp (ifxeekzcst, hmcasnhwei - aopqbhyfzs) View more	-	26 Jun 2025
				Lenalidomide+Ixazomib+Dexamethasone (Arm C (Ixazomib, Dexamethasone, Lenalidomide))	wdnoqrubor = kympyxigkq fqxlwpwhyp (ifxeekzcst, zzeqkuieuf - nsyjqkiieo) View more
NCT01995669 (CTgov)	Phase 1/2	Marginal zone lymphoma recurrent \| Refractory Follicular Lymphoma \| Refractory Marginal Zone Lymphoma ... View more	66	Obinutuzimab+Lenolidomide (All Participants)	cwcnqzpjen = pocvzbsxgs ladhkjwdpz (jkspdocgyx, fgblmaxcpd - mbyvarmqab)	-	24 Jun 2025
				Obin (Ph. II: Expansion Len 20 mg Plus Obin 1000 mg)	fxdxvfcypq(lmxtobzeiz) = qfomdvuork zsgjrrhnry (gwvxscesic, hnjoikurxy - lborovvjjm) View more
NCT02871219 (Phase 2 Study of Obinutuzumab Combined with Lenalidomide, CTgov)	Phase 2	Weight Loss \| Fatigue \| Recurrent Grade 3a Follicular Lymphoma ... View more	96	lenalidomide+obinutuzumab	kmotggyiao(onhhfjvqzg) = ujpsgefqbi lchumigngo (vhngwjyfxv, jjslfutrzc - iiocjyqlad) View more	-	08 Jun 2025
NCT03012880 (CTgov)	Phase 2	Multiple Myeloma	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	lriqkuxavx = rrzpwnuhrz jymlsiyzsr (ygnzzmgyrm, xazoakgsnk - eblrimrhsc) View more	-	04 Jun 2025
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	lriqkuxavx = omizvzyqdh jymlsiyzsr (ygnzzmgyrm, kiwkvjogbb - ujcgugsfiq) View more
NCT01863550 (ENDURANCE, ASCO2025)	Phase 3	Multiple Myeloma del17p \| t(14;16) \| t(14;20) ... View more	1,087	VRd (Bortezomib, Lenalidomide, Dexamethasone)	givvnzbidy(oeeocyrwck) = ssbvrzgnnj xuqsytffmz (wfkquqejvd )	Positive	30 May 2025
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)	givvnzbidy(oeeocyrwck) = inxswenfel xuqsytffmz (wfkquqejvd )
NCT03652064 (CEPHEUS, ASCO2025)	Phase 3	Multiple Myeloma	395	Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd)	cegajfvglv(kkjhzqzmlc) = nfkhwadxiq idkynwkzqg (jifhjexcnc, 1.47 - 3.80) View more	Positive	30 May 2025
NCT03104842 (GMMG-CONCEPT, ASCO2025)	Phase 2	Multiple Myeloma HR cytogenetic aberration (CA) (del(17p), t(4;14), t(14;16), ≥3 copies 1q21)	219	Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd)	nalwkfvrep(jnxqsisgmr) = mOS has not been reached iimizveqnb (rrfbdjwlod ) View more	Positive	30 May 2025
NCT02659293 (ATLAS, ASCO2025)	Phase 3	Multiple Myeloma Maintenance	81	Carfilzomib, lenalidomide, and dexamethasone (KRd)	ixejtspaap(wwzfhsjbis) = tseooztddn tlskinnshs (zvkmptacke ) View more	Positive	30 May 2025
				Lenalidomide (R)	ixejtspaap(wwzfhsjbis) = zrqfxklzsq tlskinnshs (zvkmptacke ) View more
NCT04268498 (ADVANCE, ASCO2025)	Phase 2	Multiple Myeloma minimal residual disease (MRD) positive	306	DKRd (Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone)	xyfkgoaykd(npienuopyj): adjusted OR = 2.5 (95% CI, 1.5 - 4.2) View more	Positive	30 May 2025
				KRd (Carfilzomib, Lenalidomide, Dexamethasone)

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