Author: Cha, Minjeong ; Cuellar, Carlos ; Wang, Amy ; O’Connor, Kelly ; Ott, Nicole ; Kim, Soo ; Rajan, Neeraja Sundar ; Williams, Ambrose ; Sengupta, Rituparna ; Maier, Andrew ; Neyyan, Josephine ; Burgess, Sean

In early-stage development of therapeutic monoclonal antibodies, assessment of the viability and ease of their purification typically requires extensive experimentation. However, the work required for upstream protein expression and downstream purification development often conflicts with timeline pressures and material constraints, limiting the number of molecules and process conditions that can reasonably be assessed. Recently, high-throughput batch-binding screen data along with improved molecular descriptors have enabled development of robust quantitative structure-property relationship (QSPR) models that predict monoclonal antibody chromatographic binding behavior from the amino acid sequence. Here, we describe a QSPR strategy for in silico monoclonal antibody purification process fit assessment. Principal Component Analysis is applied to extract a one-dimensional basis for comparison of molecular chromatographic binding behavior from multi-dimensional high-throughput batch-binding screen data. Kernel Ridge Regression is used to predict the first principal component for new molecular sequences. This workflow is demonstrated with a set of 97 monoclonal antibodies for five chromatography resins in two salt types across a range of pH and salt concentrations. Model development benchmarks four descriptor sets from biophysical structural models and protein language models. The investigation illustrates the value QSPR models can provide to purification process fit assessment, and selection of resins and operating conditions from sequence alone.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Application of monoclonal antibodies in diabetes: A bibliometric analysis from 2004–2024

Article

Author: Jia, Bochao ; Sun, Ning ; Zhang, Xuexue ; Li, Qiuyan ; Zheng, Shuang ; Wang, Miaoran ; Zhang, Rui ; Wei, Rui

Monoclonal antibodies (mAbs) have shown significant promise in diabetes treatment through immunobiological mechanisms. To comprehensively understand the current development status and future trends of this research field, this study used bibliometric methods to retrieve literature data from the Web of Science Core Collection database from 2004 to 2024 and conducted a comprehensive analysis using R software and VOSviewer. A total of 900 papers were published by 4,678 authors from 56 countries, with global publication volume and average citation frequency peaking in 2019, after which the field entered a stable development phase. The United States emerged as the leading contributor in terms of total publications, citations, and national collaborations. The journal Diabetes had the highest publication output. Herold KC from Yale University ranked highest in publication count, citation frequency, and Hirsch index. Four key research focuses were identified in T1D: the multifaceted roles of mAbs in clinical trials (a hot mature topic), developing therapeutic targets through animal models (a centralized, declining topic), inducing immune tolerance in transplantation using mAbs (a mature, declining topic), and assessing the safety, risk, and efficacy of mAbs in diabetes treatment (a niche and well-developed topic). Substantial clinical progress has already been achieved with mAbs targeting autoimmune destruction in T1D, while therapeutic strategies for metabolic dysregulation in T2D are primarily in the preclinical stage yet show promising potential. Advancing combination therapies, personalizing treatments, and enhancing mechanistic research will improve the safety and efficacy of mAbs in diabetes management, providing valuable insights for future research in this field.

31 Dec 2025·ANNALS OF MEDICINE

Early combination of sotrovimab with nirmatrelvir/ritonavir or remdesivir is associated with low rate of persisting SARS CoV-2 infection in immunocompromised outpatients with mild-to-moderate COVID-19: a prospective single-centre study

Article

Author: Cuccurullo, F. ; Buonomo, A. R. ; Scotto, R. ; D’Agostino, A. ; Palmieri, S. ; Viceconte, G. ; Silvitelli, M. ; Grimaldi, F. ; Moccia, M. ; Mercinelli, S. ; Gentile, I. ; Pietroluongo, D. ; Gravetti, A. ; Trastulli, F.

BACKGROUND:

Immunocompromised patients are at high risk of developing persisting/prolonged COVID-19. Data on the early combined use of antivirals and monoclonal antibodies in this population are scarce.

RESEARCH DESIGN AND METHODS:

We performed an observational, prospective study, enrolling immunocompromised outpatients with mild-to-moderate COVID-19, treated with a combination of sotrovimab plus one antiviral (remdesivir or nirmatrelvir/ritonavir) within 7 days from symptom onset. Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.

RESULTS:

We enrolled 52 patients. No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.

CONCLUSIONS:

Early administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.

News (Medical) associated with Monoclonal antibodies (Amgen/Medarex)

06 Mar 2025

·www.businesswire.com

Stevanato Group Reports Record Revenue of €1,104 Million for Fiscal Year 2024

PIOMBINO DESE, Italy--(BUSINESS WIRE)--Stevanato Group S.p.A. (NYSE: STVN), a leading global provider of drug containment, drug delivery, and diagnostic solutions to the pharmaceutical, biotechnology, and life sciences industries, today announced its financial results for the fourth quarter and fiscal year 2024. Fourth Quarter and Full-Year 2024 Highlights (comparisons to prior-year period) Revenue for the fourth quarter of 2024 increased 3% to €330.6 million, and high-value solutions represented 40% of total revenue, in line with Company expectations. For the fourth quarter, diluted earnings per share were €0.18, and adjusted diluted earnings per share were €0.19. Adjusted EBITDA margin increased 50 basis points to 27.5% for the fourth quarter. For fiscal year 2024, revenue increased 2% to €1,104 million, and high-value solutions represented 38% of total revenue. For fiscal year 2024, diluted earnings per share were €0.43, and adjusted diluted earnings per share were €0.48. Adjusted EBITDA margin for fiscal year 2024 was 23.5%. The Company is establishing fiscal year 2025 guidance and expects revenue in the range of €1,160 million to €1,190 million, adjusted EBITDA in the range of €293.0 million to €306.3 million, and adjusted diluted EPS between €0.51 and €0.55. Fourth Quarter 2024 Results For the fourth quarter of 2024, revenue increased 3% (3% on a constant currency basis) compared with the same period last year, to €330.6 million, driven by a 7% increase in the Company's Biopharmaceutical and Diagnostic Solutions (BDS) Segment, which offset the expected 16% decline in its Engineering Segment. Revenue from high-value solutions increased to a record €131 million and represented 40% of total revenue for the fourth quarter of 2024, compared with 37% for the same period last year, driven primarily by increased customer demand for high-performance syringes. As expected, lower revenue from EZ-fill® vials unfavorably impacted the mix within high-value solutions for the fourth quarter of 2024. Gross profit margin for the fourth quarter of 2024 decreased by 210 basis points to 29.7%, compared with the same period last year, primarily due to the effects of vial destocking, and lower gross profit from the Engineering Segment. This was partially offset by a strong quarter in high-value solutions and year-over-year improvements in the Company's Fishers and Latina manufacturing facilities. For the fourth quarter of 2024, operating profit margin increased 20 basis points to 20.2%, due to cost management initiatives. Adjusted operating profit margin increased 70 basis points to 21.5% Full Year 2024 Results Revenue for the full year increased 2% (2% on a constant currency basis) to €1,104 million, compared with the same period last year, driven by 6% growth in the BDS Segment, which was offset by a 17% decline from the Engineering Segment. Revenue from high-value solutions increased 15% to €422.3 million for fiscal year 2024, and represented 38% of total Company revenue compared with 34% last year. As expected, gross profit margin for fiscal 2024 decreased to 27.4%, compared with 31.3% in 2023, mainly due to (i) lower bulk and EZ-fill® vial volumes related to vial destocking, (ii) lower gross profit from the Engineering Segment, and (iii) short-term inefficiencies tied to the start-up of the Company's new manufacturing facilities. As a result, operating profit margin was 14.6% and adjusted operating profit was 16.2% for fiscal 2024. Franco Stevanato, Chairman and Chief Executive Officer, stated, "We finished the year with positive fourth quarter results, which were in line with our expectations. The increase in high-value solutions was driven by strong customer demand for high-performance syringes. We believe our growth investments are aligned to satisfy market needs to capitalize on the growing patient demand for biologics such as GLP1s and monoclonal antibodies. In 2024, revenue from biologics increased to 34% of BDS Segment revenue, compared with 30% in the same period last year. We continue to make meaningful progress on our Engineering optimization plan and are on track to complete the majority of the previously delayed projects by mid-year 2025." Biopharmaceutical and Diagnostic Solutions Segment (BDS) Revenue grew 7% (8% on a constant currency basis) to €279.4 million for the fourth quarter, and increased 6% (7% on a constant currency basis) to €933.7 million for fiscal 2024, compared with the same periods last year, driven primarily by growth in high-value syringes, which was partially offset by the expected revenue declines from bulk and EZ-fill® vials. The declines were more pronounced in EZ-fill® vials. Revenue from high-value solutions increased to 47% and 45% of Segment revenue in the fourth quarter and full year, respectively. For the fourth quarter of 2024, gross profit margin decreased to 31.1%, mostly due to the expected temporary effects from vial destocking, which was partially offset by a strong quarter in high-value solutions and improvements in Fishers and Latina as the Company continues to scale its manufacturing operations. For fiscal year 2024, gross profit margin decreased to 28.7% driven by: (i) vial destocking, and (ii) short term inefficiencies tied to the start-up phase of the Company's new manufacturing facilities. Engineering Segment Revenue from the Engineering Segment decreased 16% to €51.2 million for the fourth quarter, and 17% to €170.3 million for fiscal year 2024, compared with the same periods last year. The Company remains focused on executing its business optimization plan and expects to complete all the previously delayed projects in 2025. The plan is designed to address current challenges, improve the overall health of the business and return the business to profitable growth. As expected, gross profit margin decreased to 18.6% and 15.7% for the fourth quarter and full year of 2024, respectively. Balance Sheet and Cash Flow At December 31, 2024, the Company had cash and cash equivalents of €98.3 million and net debt of €335.0 million. The Company believes that it has available liquidity to fund its strategic priorities over the next twelve months through a combination of cash on hand, available credit, cash generated from operations, and the ability to access additional financing. Capital expenditures totaled €80.0 million and €286.6 million for the fourth quarter and fiscal year 2024, respectively, as the Company continues to ramp-up capacity in response to customer demand for high-value solutions in Fishers, Indiana and Latina, Italy. For fiscal 2024, cash flow from operating activities was €155.8 million. For the full year 2024, cash flow used for the purchase of property, plant, and equipment, and intangible assets totaled €313.6 million, driven primarily by capital expenditures supporting strategic initiatives. The combination of increased cash flow from operations and lower capex helped drive a significant year-over-year improvement in free cash flow. As result, negative free cash flow improved to €148.5 million for fiscal 2024, compared with negative free cash flow of €333.9 million for fiscal 2023. 2025 Guidance The Company is introducing full year 2025 guidance and expects: Revenue in the range of €1,160 million to €1,190 million; Adjusted EBITDA in the range of €293.0 million to €306.3 million; and Adjusted diluted EPS in the range of €0.51 to €0.55. Franco Stevanato concluded, "Looking to 2025, we remain focused on executing our key priorities and achieving our long-term objectives. The fundamentals of our business are strong, as we operate in growing end markets with favorable secular tailwinds. We continue to deliver organic growth driven by solid demand for high value solutions, and we expect to increasingly benefit from our ongoing capacity expansion projects as they continue to scale and mature. We enjoy an enviable market position and our unique value proposition makes us a partner of choice for customers. Above all, we are committed to putting the business on the right path to return to double-digit growth, expand margins and build long-term shareholder value." Conference call: The Company will host a conference call and webcast at 8:30 a.m. (ET) on Thursday, March 6, 2025, to discuss financial results. During the call, management will refer to a slide presentation which will be available on the morning of the call on the “Financial Results” page under the Investor Relations section of the Company's website. Pre-registration: Participants who pre-register will be given a conference passcode and unique PIN to gain immediate access to the call and bypass the live operator. We encourage participants to pre-register for the conference call using the following link: STVN conference call pre-registration. Webcast: A live, listen-only webcast of the call will be available at the following link: STVN webcast. Dial in: Those who are unable to pre-register may dial in by calling: Italy: +39 02 802 09 11 United Kingdom: +44 1 212 818004 United States: +1 718 705 8796 United States Toll Free: +1 855 265 6958 Questions during the call: Participants who wish to ask questions during the call should use the HD webphone link: https://hditalia.choruscall.com/?$Y2FsbHR5cGU9MiZpbmZvPWNvbXBhbnk=. Replay: The webcast will be archived for three months on the Company’s Investor Relations section of its website. Forward-Looking Statements This press release may include forward-looking statements. The words "establishing," "expects," "believe," "growing," "continue," "remains," "improve," "return," "growth," "increasingly," "believes," "continues," "remaining," "are strong," "solid," "ongoing," "enjoy," "are committed," "expand," "build," and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the Company's future financial performance, including revenue, operating expenses and ability to maintain profitability and operational and commercial capabilities; the Company's expectations regarding the development of the industry and the competitive environment in which it operates; the expansion of the Company's plants and its expectations to increase production capacity; the global supply chain and the Company's committed orders; customer demand and customers' ability to destock higher inventories accumulated during the COVID-19 pandemic; the success of the Company's initiatives to optimize the industrial footprint, harmonize processes and enhance supply chain and logistics strategies; the Company's geographical and industrial footprint; and the Company's goals, strategies and investment plans. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as conditions in the U.S. capital markets, negative global economic conditions, inflation, the impact of the conflict between Russia and the Ukraine, the evolving events in Israel and Gaza, supply chain and logistical challenges and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the geopolitical, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. For a description of the risks that could cause the Company’s future results to differ from those expressed in any such forward looking statements, refer to the risk factors discussed in our most recent annual report on Form 20-F filed and our most recent filings with the U.S. Securities and Exchange Commission. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements. Non-GAAP Financial Information This press release contains non-GAAP financial measures. Please refer to the tables included in this press release for a reconciliation of non-GAAP financial measures. Management monitors and evaluates our operating and financial performance using several non-GAAP financial measures, including Constant Currency Revenue, EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin, Adjusted Operating Profit, Adjusted Operating Profit Margin, Adjusted Income Taxes, Adjusted Net Profit, Adjusted Diluted EPS, Capital Employed, Net Cash/Net Debt, Free Cash Flow, and CAPEX. The Company believes that these non-GAAP financial measures provide useful and relevant information regarding its performance and improve its ability to assess our financial condition. While similar measures are widely used in the industry in which the Company operates, the financial measures it uses may not be comparable to other similarly titled measures used by other companies, nor are they intended to be substitutes for measures of financial performance or financial position as prepared in accordance with IFRS. About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes, and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation, and its engineering excellence are central to its ability to offer value added solutions to clients. To learn more, visit: www.stevanatogroup.com. Consolidated Income Statement (Amounts in € millions, except per share data) For the three months For the years ended December 31, ended December 31, 2024 % 2023 % 2024 % 2023 % Revenue 330.6 100.0 % 320.6 100.0 % 1,104.0 100.0 % 1,085.4 100.0 % Costs of Sales 232.4 70.3 % 218.8 68.2 % 801.7 72.6 % 745.5 68.7 % Gross Profit 98.2 29.7 % 101.8 31.8 % 302.3 27.4 % 339.9 31.3 % Other Operating Income 5.5 1.7 % 3.0 0.9 % 9.1 0.8 % 10.4 1.0 % Selling and Marketing Expenses 5.9 1.8 % 7.1 2.2 % 24.9 2.3 % 25.0 2.3 % Research and Development Expenses 5.6 1.7 % 10.1 3.1 % 31.7 2.9 % 35.7 3.3 % General and Administrative Expenses 25.4 7.7 % 23.6 7.4 % 93.7 8.5 % 88.9 8.2 % Operating Profit 66.8 20.2 % 64.0 20.0 % 161.1 14.6 % 200.7 18.5 % Finance Income 8.7 2.6 % 4.3 1.4 % 22.3 2.0 % 20.3 1.9 % Finance Expense 10.9 3.3 % 9.5 3.0 % 23.2 2.1 % 31.4 2.9 % Profit Before Tax 64.6 19.6 % 58.8 18.3 % 160.3 14.5 % 189.6 17.5 % Income Taxes 16.3 4.9 % 13.6 4.2 % 42.5 3.9 % 43.9 4.0 % Net Profit 48.3 14.6 % 45.2 14.1 % 117.8 10.7 % 145.7 13.4 % Earnings per share Basic earnings per common share 0.18 0.17 0.43 0.55 Diluted earnings per common share 0.18 0.17 0.43 0.55 Average common shares outstanding 272.9 265.5 271.1 265.0 Average shares assuming dilution 272.9 265.5 271.2 265.0 Reported Segment Information (Amounts in € millions) For the three months ended December 31, 2024 Biopharmaceutical and Diagnostic Solutions Engineering Adjustments, eliminations and unallocated items Consolidated External Customers 279.4 51.2 — 330.6 Inter-Segment 1.1 56.1 (57.2 ) — Revenue 280.5 107.3 (57.2 ) 330.6 Gross Profit 87.2 20.0 (9.0 ) 98.2 Gross Profit Margin 31.1 % 18.6 % 29.7 % Operating Profit 65.5 16.4 (15.0 ) 66.9 Operating Profit Margin 23.3 % 15.3 % 20.2 % For the three months ended December 31, 2023 Biopharmaceutical and Diagnostic Solutions Engineering Adjustments, eliminations and unallocated items Consolidated External Customers 260.0 60.6 — 320.6 Inter-Segment 0.6 40.6 (41.2 ) — Revenue 260.6 101.2 (41.2 ) 320.6 Gross Profit 87.5 21.4 (7.1 ) 101.8 Gross Profit Margin 33.6 % 21.1 % 31.8 % Operating Profit 61.7 15.5 (13.2 ) 64.0 Operating Profit Margin 23.7 % 15.3 % 20.0 % For the year ended December 31, 2024 Biopharmaceutical and Diagnostic Solutions Engineering Adjustments, eliminations and unallocated items Consolidated External Customers 933.7 170.3 — 1,104.0 Inter-Segment 4.0 187.3 (191.4 ) — Revenue 937.8 357.6 (191.4 ) 1,104.0 Gross Profit 268.8 56.2 (22.6 ) 302.3 Gross Profit Margin 28.7 % 15.7 % 27.4 % Operating Profit 165.6 33.1 (37.6 ) 161.1 Operating Profit Margin 17.7 % 9.3 % 14.6 % For the year ended December 31, 2023 Biopharmaceutical and Diagnostic Solutions Engineering Adjustments, eliminations and unallocated items Consolidated External Customers 879.3 206.1 — 1,085.4 Inter-Segment 2.0 166.7 (168.7 ) — Revenue 881.3 372.8 (168.7 ) 1,085.4 Gross Profit 290.2 78.3 (28.6 ) 339.9 Gross Profit Margin 32.9 % 21.0 % 31.3 % Operating Profit 187.6 53.6 (40.5 ) 200.7 Operating Profit Margin 21.3 % 14.4 % 18.5 % Cash Flow (Amounts in € millions) For the three months ended December 31, For the years ended December 31, 2024 2023 2024 2023 Cash flow from operating activities 43.6 10.2 155.8 105.2 Cash flow used in investing activities (91.0 ) (92.3 ) (310.2 ) (421.2 ) Cash flow from financing activities 66.3 87.7 183.2 158.0 Net change in cash and cash equivalents 18.9 5.6 28.8 (158.0 ) Non GAAP Financial Information This press release contains non-GAAP financial measures. Please refer to "Non-GAAP Financial Information" on page 4 and the tables included in this press release for a reconciliation of non-GAAP financial measures. Reconciliation of Revenue to Constant Currency Revenue (Amounts in € millions) Three months ended December 31, 2024 Biopharmaceutical and Diagnostic Solutions Engineering Consolidated Reported Revenue (IFRS GAAP) 279.4 51.2 330.6 Effect of changes in currency translation rates 1.1 — 1.1 Organic Revenue (Non-IFRS GAAP) 280.5 51.2 331.7 Year ended December 31, 2024 Biopharmaceutical and Diagnostic Solutions Engineering Consolidated Reported Revenue (IFRS GAAP) 933.7 170.3 1,104.0 Effect of changes in currency translation rates 3.8 0.1 3.9 Organic Revenue (Non-IFRS GAAP) 937.5 170.4 1,107.9 Reconciliation of EBITDA (Amounts in € millions) For the three months ended December 31, Change For the years ended December 31, Change 2024 2023 % 2024 2023 % Net Profit 48.3 45.2 6.8 % 117.8 145.7 (19.2 )% Income Taxes 16.3 13.6 20.5 % 42.5 43.9 (3.1 )% Finance Income (8.7 ) (4.3 ) 101.6 % (22.3 ) (20.3 ) 10.3 % Finance Expenses 10.9 9.5 13.9 % 23.2 31.4 (26.2 )% Operating Profit 66.8 64.0 4.4 % 161.1 200.7 (19.7 )% Depreciation and amortization and impairment of PPE 19.8 20.1 (1.6 )% 80.7 78.5 2.8 % EBITDA 86.6 84.1 3.0 % 241.8 279.2 (13.4 )% Calculation of Net Profit margin, Operating Profit Margin, Adjusted EBITDA Margin and Adjusted Operating Profit Margin (Amounts in € millions) For the three months ended December 31, For the year ended December 31, 2024 2023 2024 2023 Revenue 330.6 320.6 1,104.0 1,085.4 Net Profit Margin (Net Profit/ Revenue) 14.6 % 14.1 % 10.7 % 13.4 % Operating Profit Margin (Operating Profit/ Revenue) 20.2 % 20.0 % 14.6 % 18.5 % Adjusted EBITDA Margin (Adjusted EBITDA/ Revenue) 27.5 % 27.0 % 23.5 % 26.9 % Adjusted Operating Profit Margin (Adjusted Operating Profit/ Revenue) 21.5 % 20.8 % 16.2 % 19.6 % Reconciliation of Reported and Adjusted EBITDA, Operating Profit, Income Taxes, Net Profit, and Diluted EPS (Amounts in € millions, except per share data) Three months ended December 31, 2024 EBITDA Operating Profit Income Taxes (4) Net Profit Diluted EPS Reported 86.6 66.8 16.3 48.3 0.18 Adjusting items: Start-up costs new plants (1) 3.8 3.8 1.0 2.8 0.01 Restructuring and related charges (2) 0.4 0.4 0.1 0.3 0.00 Other severance costs (3) 0.2 0.2 0.0 0.1 0.00 Adjusted 90.9 71.2 17.5 51.5 0.19 Adjusted Margin 27.5 % 21.5 % — — — Three months ended December 31, 2023 EBITDA Operating Profit Income Taxes (4) Net Profit Diluted EPS Reported 84.1 64.0 13.6 45.2 0.17 Adjusting items: Start-up costs new plants (1) 2.6 2.6 0.7 1.9 0.01 Adjusted 86.7 66.6 14.3 47.1 0.18 Adjusted Margin 27.0 % 20.8 % — — — Year ended December 31, 2024 EBITDA Operating Profit Income Taxes (4) Net Profit Diluted EPS Reported 241.8 161.1 42.5 117.8 0.43 Adjusting items: Start-up costs new plants (1) 13.0 13.0 3.5 9.5 0.04 Restructuring and related charges (2) 4.0 4.0 1.0 3.0 0.01 Other severance costs (3) 0.4 0.4 0.1 0.3 0.00 Adjusted 259.2 178.5 47.1 130.6 0.48 Adjusted Margin 23.5 % 16.2 % — — — Year ended December 31, 2023 EBITDA Operating Profit Income Taxes (4) Net Profit Diluted EPS Reported 279.2 200.7 43.9 145.7 0.55 Adjusting items: — — — — — Start-up costs new plants (1) 12.0 12.0 3.2 8.8 0.03 Restructuring and related charges (2) 0.3 0.3 0.1 0.2 0.00 Adjusted 291.5 213.0 47.2 154.7 0.58 Adjusted Margin 26.9 % 19.6 % — — — (1) During the three months and the year ended December 31, 2024, the Group recorded €3.8 million and €13.0 million, respectively, of start-up costs for the new plants in Fishers, Indiana, United States, and in Latina, Italy. During the three months and the year ended December 31, 2023, the Group recorded €2.6 million and €12.0 million, respectively, of start-up costs for the new plants in Fishers, Indiana, United States, and in Latina, Italy. These costs are primarily related to labor costs incurred prior to the commencement of commercial operations that are associated with recruiting, hiring, training and travel expenses of personnel. (2) During the three months and the year ended December 31, 2024, the Group recorded €0.4 million and €4.0 million, respectively, of restructuring and related charges among cost of sales, research and development, and general and administrative expenses. During the year ended December 31, 2023, the Group recorded €0.3 million of restructuring and related charges among general and administrative expenses. These charges are mainly employee costs related to the reorganization of certain business functions. (3) During the three months and the year ended December 31, 2024, the Group recorded €0.2 million and €0.4 million, respectively, related to personnel expenses, including other severance costs. (4) The income tax adjustment is calculated by multiplying the applicable nominal tax rate to the adjusting items. Capital Employed (Amounts in € millions) As of December 31, 2024 As of December 31, 2023 - Goodwill and Other intangible assets 83.6 81.0 - Right of Use assets 15.7 18.2 - Property, plant and equipment 1,248.4 1,028.5 - Financial assets - investments FVTPL 0.2 0.7 - Other non-current financial assets 5.4 4.5 - Deferred tax assets 95.3 76.3 Non-current assets excluding FV of derivative financial instruments 1,448.7 1,209.2 - Inventories 245.2 255.3 - Contract Assets 168.5 172.6 - Trade receivables 296.0 301.8 - Trade payables (231.0 ) (277.8 ) - Advances from customers (16.6 ) (22.9 ) - Non-current advances from customers (44.0 ) (39.4 ) - Contract Liabilities (16.5 ) (22.3 ) Trade working capital 401.6 367.2 - Tax receivables and Other receivables 70.6 58.2 - Non-current assets held for sale 0.2 — - Tax payables and Other liabilities (92.2 ) (107.0 ) - Current Provisions (4.1 ) (1.1 ) Net working capital 376.1 317.4 - Deferred tax liabilities (12.6 ) (9.6 ) - Employees benefits (7.2 ) (7.4 ) - Non-Current Provisions (2.8 ) (4.0 ) - Other non-current liabilities (62.7 ) (48.5 ) Total non-current liabilities and provisions (85.3 ) (69.5 ) Capital employed 1,739.4 1,457.1 Net (debt)/ net cash (335.0 ) (324.4 ) Equity (1,404.4 ) (1,132.6 ) Total equity and net debt (1,739.4 ) (1,457.1 ) Free Cash Flow (Amounts in € millions) For the three months ended December 31, For the years ended December 31, 2024 2023 2024 2023 Cash Flow from Operating Activities 43.6 10.2 155.8 105.2 Interest paid 3.6 0.7 7.4 3.1 Interest received (0.4 ) (0.3 ) (1.3 ) (0.9 ) Purchase of property, plant and equipment (88.9 ) (82.0 ) (302.6 ) (433.2 ) Proceeds from sale of property, plant and equipment — 0.5 3.2 0.6 Purchase of intangible assets (2.3 ) (5.1 ) (11.0 ) (8.7 ) Free Cash Flow (44.3 ) (76.0 ) (148.5 ) (333.9 ) Net (Debt) / Net Cash (Amounts in € millions) As of December 31, As of December 31, 2024 2023 Non-current financial liabilities (317.7 ) (255.6 ) Current financial liabilities (116.9 ) (143.3 ) Other non-current financial assets - Fair value of derivatives financial instruments — 0.6 Other current financial assets 1.3 4.4 Cash and cash equivalents 98.3 69.6 Net (Debt)/ Net Cash (335.0 ) (324.4 ) CAPEX (Amounts in € millions) For the three months ended December 31, Change For the year ended December 31, Change 2024 2023 € 2024 2023 € Addition to Property, plants and equipment (1) 77.7 89.6 (11.9 ) 275.6 444.6 (169.0 ) Addition to Intangible Assets 2.3 5.1 (2.9 ) 11.0 8.7 2.3 CAPEX 80.0 94.7 (14.7 ) 286.6 453.3 (166.7 ) (1) For the year ended December 31, 2023 the addition related to the grant of land by the city of Fishers amounting to €8.3 million is excluded Reconciliation of 2025 Guidance* Reported and Adjusted EBITDA, Operating Profit, Net Profit, Diluted EPS (Amounts in € millions, except per share data) Revenue EBITDA Operating Profit Net Profit Diluted EPS Reported 1,160-0-1,190.0 284.8-298.1 180.9-194.2 132.0-142.2 0.48-0.52 Adjusting items: Start-up costs new plants 8.2 8.2 6.3 0.03 Adjusted 1,160.0-1,190.0 293.0-306.3 189.1-202.3 138.3-148.5 0.51-0.55 *Amounts may not add due to rounding

Financial Statement

10 Jan 2025

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Serna Bio Announces Scientific Advisory Board

Seasoned advisory group including RNA, translation and commercialisation luminaries. LONDON, Jan. 10, 2025 /PRNewswire/ -- Serna Bio, an AI drug discovery company pioneering RNA-targeting small molecules, today announced the members of its Scientific Advisory Board (SAB). Established in 2021, Serna Bio is a preclinical drug discovery company with lead programs in neuro metabolism and obesity. The company is backed by leading investors including but not limited to, Y-combinator, Hummingbird Ventures, and 50Years. "We have established a truly differentiated platform to discover a novel class of small molecules - translational enhancers - and are using this to advance the development of therapies for diseases with no existing treatments, with a focus on genetically validated targets. The strength of our platform and IP has enabled us to surround ourselves with industry veterans with expertise in RNA Biology, preclinical RNA-small molecule research, clinical development and drug commercialisation. I am honoured to work with such an exceptional Scientific Advisory Board. They will be a force amplifier as we progress our lead assets toward the clinic and strengthen our pipeline," said Dr. Khan, MBA PhD. founder and CEO of Serna Bio The Scientific Advisory Board includes leading academics such as Dr. Nahum Sonenberg, who identified and characterized various translation factors involved in translation initiation; Dr. Matthew Hayes, a world leader in obesity drug discovery; and Dr. Jay Schneekloth, an expert in RNA small molecule development. It also includes industry leaders, including Jeff Ajer, the former Chief Commercial Officer at BioMarin. The advisors will draw on their considerable expertise and depth of experience to advise the company and its leadership team on scientific and strategic matters at the intersection of machine learning, RNA biology and drug discovery to help Serna Bio design next-generation small molecules to enhance translation for diseases caused by insufficient protein expression. "Serna Bio has developed a unique approach to biological translation via a large library of next-generation small molecules targeting RNA, with the potential to improve outcomes for patients with a range of diseases otherwise not addressed by present therapies." said Giorgio Massimini, MD, "I am excited to work closely with Dr. Khan and her leadership team as the company builds on its discoveries and pursues its clinical aspirations." "Many patients with rare genetic diseases continue to lack treatment options. With Serna Bio's ability to enhance translation, the company is opening up a new mechanism of action, enabling the development of much-needed medicines for the treatment of previously intractable diseases" said Nick France, MD The full SAB comprises: Jay Schneekloth Senior Investigator at National Cancer Institute (NCI). A pioneer in the identification of selective RNA and DNA binding small molecules. His work has led to the discovery that RNA targeting, druglike compounds are suitable starting points for inhibitor discovery efforts while driving fundamental advances in understanding RNA-small molecule recognition. Giorgio Massimini formerly Vice President Merck KGaA. Over 30 years of experience in leading clinical research & development projects. He contributed to the development of MEK inhibitors, c-Met inhibitors, IDO/TDO inhibitors, MetAP2 inhibitors, DNA repair inhibitors, monoclonal antibodies and other tyrosine kinase inhibitors in the Merck Biopharma pipeline. Nahum Sonenberg James McGill professor of biochemistry at McGill University in Montreal, Quebec, Canada. He is best known for his seminal contributions to our understanding of translation and is notable for the discovery of the mRNA 5' cap-binding protein, eIF4E, the rate-limiting component of the eukaryotic translation apparatus. Nick France Vice President, Global Therapeutic Area Head for Genomic Medicines and Neurology at Alexion. A physician-scientist and rare disease drug development leader. He has worked across the biopharma ecosystem developing diverse therapies for rare disease. Jeff Ajer formerly Executive Vice President and Chief Commercial Officer at BioMarin. Mr. Ajer has more than 25 years of experience driving commercialisation for rare diseases and speciality medicines. He was integral in establishing BioMarin's commercial infrastructure and global footprint and played a leadership role in the launches and growth strategies for BioMarin's commercial brands. Emily Freeman Senior Director, Global Medical Affairs, Patient Focused Implementation Science at Gilead Sciences. She is interested in the development of evidence-based communication tools to facilitate shared decision-making for patients. She has experience at Bristol-Myers Squibb, Pfizer, Eli Lilly, AbbVie, and most recently Sanofi. Matthew Hayes Albert J Stunkard Professor in Psychiatry at the University of Pennsylvania and Vice Chair for Basic and Translational Neuroscience Research in the Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania. Dr. Hayes is considered a leading expert on the neuroendocrine systems that regulate energy balance. About Serna Bio Serna Bio is an AI-enabled drug discovery company developing the next generation of small molecules to enhance translation. By targeting functional RNA structures, the company's proprietary discovery platform enables selective upregulation of the production of a protein of interest, using orally bio-available small molecules. Serna Bio's approach is a paradigm shift in drug discovery, moving from classical "inhibition" of protein function to protein enhancement. This novel approach unlocks the potential to treat a range of diseases intractable by classical drug discovery. The company's programs are powered by a Generative AI discovery platform trained on proprietary RNA-small molecule datasets, enabling Serna Bio to generate molecules in novel chemical space, outperforming state-of-the-art methods such as NVIDIA MolMIMM for small molecules targeting RNA. For more information about Serna Bio, please visit the company website at serna.bio or follow us on LinkedIn. Logo - SOURCE Serna Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

23 Oct 2024

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Anti-CD38 mAb Market to Accelerate Substantially During the Study Period (2020-2034) Owing to a Strong Uptake of DARZALEX in Multiple Myeloma and Expected Entry of anti-CD38 mAbs in Autoimmune Diseases | DelveInsight

The anti-CD38 mAb market is projected to experience substantial growth in the coming years owing to strong uptake of DARZALEX (along with DARZALEX FASPRO), the expected entry of subcutaneous formulation of SARCLISA in Multiple Myeloma. This growth is also driven by a rising number of cancer and autoimmune disorder diagnoses, as well as an increasing number of Anti-CD38 mAbs undergoing clinical trials and seeking approval. LAS VEGAS, Oct. 23, 2024 /PRNewswire/ -- DelveInsight's Anti-CD38 mAb Market Insights report includes a comprehensive understanding of current treatment practices, emerging anti-CD38 mAb, market share of individual therapies, and current and forecasted anti-CD38 mAb market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Anti-CD38 mAb Market Report As per DelveInsight's analysis, the total market size of anti-CD38 mAb in the 7MM is expected to surge significantly by 2034. Multiple Myeloma is the only indication for which anti-CD38 therapies, Johnson&Johnson's (J&J) DARZALEX and Sanofi's SARCLISA have been approved until now. Around 50% of DARZALEX usage comes from second-line treatment in Multiple Myeloma. Additionally, in the frontline multiple myeloma clinical trials, DARZALEX has emerged triumphant, surpassing all expectations and solidifying its position as the gold standard of therapy. Its unparalleled effectiveness and exceptional safety profile have exceeded rivals' predictions and soon positioned DARZALEX to dominate the multiple myeloma market. The filing submission of SARCLISA subcutaneous in 3L R/R MM (IRAKLIA) is anticipated in 2025 and beyond. Somehow, SARCLISA is way behind DARZALEX in terms of market expansion, and DARZALEX has also got an early mover advantage of over 4 years. Multiple Myeloma is the leading indication, other emerging indications with commercial opportunity include Systemic Lupus Erythematosus (SLE), Chronic Kidney Disease (CKD), and IgA Nephropathy Leading emerging anti-CD38 mAb companies such as Takeda Pharmaceuticals, HI-Bio, Genmab, CASI Pharmaceuticals, and others are developing novel anti-CD38 mAb that can be available in the market in the coming years. Some of the key anti-CD38 mAb in the pipeline include Mezagitamab (TAK-079), Felzartamab, GEN3014, CID-103 , and others. In June 2024, data from the IMROZ Phase III study by Sanofi demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed transplant-ineligible multiple myeloma. In May 2024, Biogen and Human Immunology Biosciences (HI-Bio), announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for USD 1.15 billion upfront and up to USD 650 million in potential milestone payments. Discover which therapies are expected to grab the anti-CD38 mAb market share @ Anti-CD38 mAb Market Report Anti-CD38 mAb Market Dynamics The market for anti-CD38 mAbs has undergone significant growth and transformation in recent years, driven primarily by the increasing prevalence of multiple myeloma and the d emand for more effective treatment options. The market dynamics are further influenced by ongoing research into the broader application of anti-CD38 mAbs beyond multiple myeloma. There is growing interest in exploring their efficacy in other CD38-expressing malignancies, such as chronic lymphocytic leukemia and certain solid tumors. Additionally, research into combination therapies, where anti-CD38 mAbs are paired with immune checkpoint inhibitors, CAR-T cells, or other novel agents, is expanding the horizon for these treatments. Such advancements are likely to further propel the market, attracting substantial investment and fueling innovation. However, challenges such as biosimilar competition, pricing pressures, and the need for differentiation in a crowded market pose potential hurdles. The entrance of biosimilars could reduce costs but also threaten market share for existing products. Companies must navigate these challenges through strategic pricing, market access strategies, and continuous innovation to maintain their competitive edge. The anti-CD38 mAb market is poised for continued expansion, with a promising pipeline of new therapies and combinations on the horizon, making it a dynamic and evolving sector within oncology. Anti-CD38 mAb Treatment Market Monoclonal antibodies targeting CD38 are crucial in the treatment of newly diagnosed and refractory multiple myeloma. Currently, DARZALEX and SARCLISA are the two approved anti-CD38 therapies. SARCLISA is a prescription medication used to treat multiple myeloma in adults. It is administered alongside pomalidomide and dexamethasone for patients who have undergone at least two previous treatments, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is used with carfilzomib and dexamethasone for patients who have received one to three prior therapies that were either ineffective or have stopped working. In March 2020, the US FDA approved SARCLISA in combination with pomalidomide and dexamethasone for multiple myeloma patients who had at least two prior therapies, including lenalidomide and a proteasome inhibitor. Later, in May 2020, the European Commission approved SARCLISA. By March 2021, the US FDA also approved SARCLISA with carfilzomib and dexamethasone for those with relapsed or refractory multiple myeloma who had received one to three previous treatments. DARZALEX is an innovative monoclonal antibody that the US FDA approved for treating multiple myeloma in patients with at least one prior treatment. It works by inducing tumor cell death through several mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis. In November 2015, the FDA granted DARZALEX accelerated approval as a monotherapy for multiple myeloma patients who had undergone at least three prior treatments. By November 2016, it was also approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who had received at least one prior therapy. From 2015 to 2021, DARZALEX gained further approvals for use in various drug combinations. Their effectiveness in managing multiple myeloma and plasma cell disorders has been confirmed by numerous Phase III clinical trials. Moreover, CD38-targeted therapies are being explored for other conditions such as primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematologic cancers. Learn more about the FDA-approved anti-CD38 mAb @ Anti-CD38 mAb Drugs Key Emerging Anti-CD38 mAb and Companies Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Mezagitamab is a fully human IgG1 monoclonal antibody that targets CD38 and is being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, the FDA granted Fast Track designation and Orphan Drug status to mezagitamab for idiopathic thrombocytopenic purpura (ITP). Takeda also revealed plans to begin a global Phase III trial for mezagitamab in ITP later in 2024. The drug is currently in Phase II of clinical development. HI-Bio's leading candidate, felzartamab, is a fully human anti-CD38 monoclonal antibody. Clinical studies have demonstrated its ability to selectively target and deplete CD38+ cells, including plasma cells and NK cells, potentially enabling broader therapeutic applications and enhanced clinical outcomes across various immune-mediated diseases. Felzartamab has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for primary membranous nephropathy and also received Orphan Drug Designation for treating antibody-mediated kidney transplant recipients. Phase II trials have been completed for primary membranous nephropathy and antibody-mediated transplant rejection, with ongoing studies in IgA nephropathy. HI-Bio intends to progress each of these indications to Phase III. The anticipated launch of these emerging therapies are poised to transform the anti-CD38 mAb market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anti-CD38 mAb market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about anti-CD38 mAb clinical trials, visit @ Anti-CD38 mAb Treatment Drugs Anti-CD38 mAb Overview Anti-CD38 monoclonal antibodies (mAbs) are a class of therapeutic agents that target CD38, a surface protein widely expressed on plasma cells, including malignant ones in multiple myeloma. By binding to CD38, these mAbs can induce direct cytotoxicity, promote antibody-dependent cellular cytotoxicity (ADCC), and facilitate complement-dependent cytotoxicity (CDC) to destroy the targeted cells. Beyond their role in multiple myeloma, anti-CD38 mAbs are being explored for their potential in treating other hematologic malignancies and autoimmune diseases. CD38 is not only a marker for plasma cells but also involved in processes like calcium signaling and NAD+ metabolism, which are crucial for cell survival and proliferation. By targeting CD38, these antibodies can modulate the immune microenvironment, making them a promising tool for both oncology and immunology. The ongoing research is focused on optimizing their efficacy, managing resistance, and exploring their use in combination with other immunotherapies to enhance patient outcomes. Anti-CD38 mAb Epidemiology Segmentation Epidemiology assessed for multiple myeloma showed that the United States, in 2023, accounted for 36,800 incident cases of multiple myeloma. The anti-CD38 mAb market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Indication for Anti-CD38 mAb Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication Total Treatable Cases of Selected Indications for Anti-CD38 mAb Scope of the Anti-CD38 mAb Market Report Anti-CD38 mAb Therapeutic Assessment: Anti-CD38 mAb current marketed and emerging therapies Anti-CD38 mAb Market Dynamics: Conjoint Analysis of Emerging Anti-CD38 mAb Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Anti-CD38 mAb Market Access and Reimbursement Discover more about anti-CD38 mAb in development @ Anti-CD38 mAb Clinical Trials Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insight, Epidemiology and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including Janssen, Pharmacyclics, Novartis, Incyte Corporation, Gracell Biotechnology, SpringWorks Therapeutics, Sana Biotechnology, Cytovia Therapeutics, Pfizer, MorphoSys, Biokine Therapeutics, Arcellx, Rapa Therapeutics, iTeos Therapeutics, Sorrento Therapeutics, CARsgen, Ascentage Pharma, Cartesian Therapeutics, Bristol-Myers Squibb, Juno Therapeutics, Nanjing IASO Biotherapeutics, Arch Oncology, Oncoceutics, TeneoBio, Nerviano Medical Sciences, among others. Relapse/Refractory Multiple Myeloma Market Relapse/Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R multiple myeloma companies, including NexImmune, Amgen, AbbVie, Allogene Therapeutics, Precision Biosciences, Takeda Oncology, ORIC Pharmaceuticals, Ionis Pharmaceuticals, Cellectis S.A., YZY Biopharma, Janssen Research & Development, Bristol Myers Squibb, Lava Therapeutics, Prelude Therapeutics, among others. Relapse/Refractory Multiple Myeloma Pipeline Relapse/Refractory Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key R/R multiple myeloma companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugFast TrackPhase 3Immunotherapy

100 Deals associated with Monoclonal antibodies (Amgen/Medarex)

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	-	Medarex, Inc.	-
Neoplasms	Phase 2	-	Amgen, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	Metastatic Colorectal Carcinoma RAS	674	Combination Chemotherapy	qrtddfadir(zcwdiegdzq): HR = 1.05 (95% CI, 0.88 - 1.26)	Negative	30 May 2025
				Combination Chemotherapy + Monoclonal Antibodies
ATS2023	Not Applicable	Asthma	-	Omalizumab	jyxdgfgdxq(nowwczsxke) = A safety signal was observed for all biologicals, except for reslizumab (due to lack of power), with the strongest signal attributed to benralizumab and the most frequently reported drug being omalizumab rhozlokquo (acynbuhwrd )	-	21 May 2023
				Mepolizumab
ASN2022	Not Applicable	COVID-19	-	Bamlanivimab or Casirivimab/Imdevimab	xcpeemxwlj(crbjeysyca) = There was no serious adverse event related to the mAb infusion aqnylmkrbm (lhstqwtavw )	-	03 Nov 2022
				Sotrovimab
ECTRIMS2022	Not Applicable	COVID-19 \| Multiple Sclerosis	461	Anti-SARS-CoV-2 monoclonal antibodies (mAb)	barczpkxpj(ahbpqdloge) = ybaifqafuk otzmboxpwi (ingytjmcbg )	-	26 Oct 2022
				Antiviral therapies (AVT)	barczpkxpj(ahbpqdloge) = rejdlczcqj otzmboxpwi (ingytjmcbg )
ASCO2022	Phase 3	Advanced breast cancer	-	Margetuximab	vmvcsxduzt(akjwwbqozr) = these therapies are generally well tolerated with manageable side effects as listed in the table. ctehxflamj (ozbmvitpgy ) View more	Positive	02 Jun 2022
				Trastuzumab
ATS2022	Not Applicable	Post Acute COVID 19 Syndrome	-	Rituximab	nywxbdipjd(carhjtwwtq) = noqmgvzgag nnittdgnnx (dgfgrxswjt ) View more	-	15 May 2022
				Venetoclax/Obinutuzumab	nywxbdipjd(carhjtwwtq) = vnlwgnfhrz nnittdgnnx (dgfgrxswjt ) View more
Tandem Meetings ASTCT and CIBMTR2022	Phase 2/3	Adult Acute Lymphocytic Leukemia CD 22 \| CD 20 \| CD 19 ... View more	1,330	Inotuzumab	pixeygzvlp(zsldphdqne) = tltxhkogrk puivweemas (rlqeasdien ) View more	Positive	01 Mar 2022
				Epratuzumab	pixeygzvlp(zsldphdqne) = wrrzlvbqkc puivweemas (rlqeasdien )
ASCO2019	Not Applicable	Multiple Myeloma	1,917	Isatuximab	mqcskqbshg(oznwvlxcfu) = mndkwpenut tockyutxrf (hdjfndptas ) View more	-	26 May 2019
				F50067	piknuraxaq(lrtwwumoqx) = vxemaliosw olnkflvlhy (zqydmnagek )
ASCO2019	Not Applicable	Systemic amyloidosis	19	Daratumumab+NEOD001	pbidgpglgu(nfqjpyahgh) = ihtydqbyxd unkfbkqwrd (lyufzwuqca ) View more	Positive	26 May 2019
ESMO2018	Not Applicable	Metastatic Triple-Negative Breast Carcinoma	-	Immune Checkpoint Targeted Monoclonal Antibodies (Good LIPI risk group)	dhhmqiglxj(zlrrorgyqn) = Metastatic cutaneous lesions were also associated with poor PFS with ICT mAbs in our cohort, HR 3.189, P = 0.0028. isombvvkjq (qozbbwbsey )	Positive	22 Oct 2018
				Immune Checkpoint Targeted Monoclonal Antibodies (Intermediate LIPI risk group)

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