Dermatomyositis

THOUSAND OAKS, Calif., May 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2025. "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," said Robert A. Bradway, chairman and chief executive officer. Key results include: For the first quarter, total revenues increased 9% to $8.1 billion in comparison to the first quarter of 2024. Product sales grew 11%, primarily driven by 14% volume growth, partially offset by 6% lower net selling price. U.S. sales grew 14%. Fourteen products delivered at least double-digit sales growth in the first quarter, including Repatha® (evolocumab), BLINCYTO® (blinatumomab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg), TAVNEOS® (avacopan) and UPLIZNA® (inebilizumab-cdon). Our launch of IMDELLTRA ® (tarlatamab-dlle) generated $81 million of sales in the quarter and the Phase 3 confirmatory study demonstrated improved overall survival compared to chemotherapy. IMDELLTRA ® launched in Japan in April 2025. GAAP earnings per share (EPS) were $3.20 for the first quarter of 2025 compared with a GAAP loss per share of $0.21 for the first quarter of 2024, resulting from an unrealized gain on our BeiGene, Ltd. equity investment during the first quarter of 2025 compared to an unrealized loss during the prior year period, partially offset by an Otezla® intangible asset impairment charge of $800 million recorded during the first quarter of 2025. GAAP operating income increased from $1.0 billion to $1.2 billion, and GAAP operating margin increased 1.1 percentage points to 15.0%. Non-GAAP EPS increased 24% from $3.96 to $4.90, driven by higher revenues, partially offset by higher operating expenses. Non-GAAP operating income increased from $3.1 billion to $3.6 billion and non-GAAP operating margin increased 2.5 percentage points to 45.7%. The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Repatha® (evolocumab) sales increased 27% year-over-year to $656 million in the first quarter, primarily driven by 41% volume growth, partially offset by 9% lower net selling price. EVENITY® (romosozumab-aqqg) sales increased 29% year-over-year to $442 million in the first quarter, driven by volume growth. Prolia® (denosumab) sales increased 10% year-over-year to $1.1 billion in the first quarter, primarily driven by 13% volume growth, partially offset by 5% lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Rare Disease TEPEZZA® (teprotumumab-trbw) sales decreased 10% year-over-year to $381 million in the first quarter, primarily driven by 9% lower volume and 8% from a decrease in inventory levels, partially offset by higher net selling price. KRYSTEXXA® (pegloticase) sales were flat year-over-year at $236 million in the first quarter, as 11% volume growth was offset by 10% from a decrease in inventory levels. UPLIZNA® (inebilizumab-cdon) sales increased 14% year-over-year to $91 million in the first quarter, primarily driven by volume growth. TAVNEOS® (avacopan) sales increased 76% year-over-year to $90 million in the first quarter, primarily driven by volume growth. Ultra-Rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), BUPHENYL® (sodium phenylbutyrate) and QUINSAIR® (levofloxacin), generated $179 million of sales in the first quarter. Sales increased 6% year-over-year for the first quarter, driven by volume growth. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 65% year-over-year to $285 million in the first quarter, driven by volume growth. Otezla® (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price. Enbrel® (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth. The year-over-year impact on net selling price is expected to be less pronounced in future quarters. AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth. WEZLANA™ (ustekinumab-auub)/WEZENLA™ (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025 and is the first FDA-approved biosimilar for the treatment of adult and pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. PAVBLU® (aflibercept-ayyh) generated $99 million of sales in the first quarter. PAVBLU launched in the U.S. in the fourth quarter of 2024 and is the first available aflibercept biosimilar for the treatment of retinal conditions, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Oncology BLINCYTO® (blinatumomab) sales increased 52% year-over-year to $370 million in the first quarter, primarily driven by volume growth. Vectibix® (panitumumab) sales increased 8% year-over-year to $267 million in the first quarter, driven by volume growth. KYPROLIS® (carfilzomib) sales decreased 14% year-over-year to $324 million in the first quarter, driven by lower volumes due to increased competition. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 4% year-over-year to $85 million in the first quarter, driven by volume growth, partially offset by lower net selling price. XGEVA® (denosumab) sales increased 1% year-over-year to $566 million in the first quarter. For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year. Nplate® (romiplostim) sales decreased 1% year-over-year to $313 million in the first quarter as volume growth was more than offset by unfavorable changes to estimated sales deductions and foreign exchange impact. IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) generated $81 million of sales in the first quarter. Sales increased 21% quarter-over-quarter driven by volume growth. MVASI® (bevacizumab-awwb) sales decreased 11% year-over-year to $179 million in the first quarter, primarily driven by lower volume. Going forward, we expect continued sales erosion driven by competition. Established Products Our established products, which consist of Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $557 million of sales in the first quarter. Sales decreased 3% year-over-year for the first quarter, driven by 10% lower net selling price and 3% unfavorable foreign exchange impact, partially offset by favorable changes to estimated sales deductions. Product Sales Detail by Product and Geographic Region Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: Total Operating Expenses increased 8% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 7.3 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by changes in our sales mix. Research & Development (R&D) expenses increased 11% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. Selling, General & Administrative (SG&A) expenses decreased 7% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses. Other operating expenses consisted primarily of the Otezla® intangible asset impairment charge of $800 million. Operating Margin as a percentage of product sales increased 1.1 percentage points in the first quarter to 15.0%. Tax Rate increased 78.5 percentage points in the first quarter due to the change in earnings mix as a result of the first quarter 2025 unrealized gains compared to the first quarter 2024 unrealized losses on our equity investments, primarily BeiGene. On a non-GAAP basis: Total Operating Expenses increased 4% year-over-year for the first quarter. Cost of Sales as a percentage of product sales decreased 0.8 percentage points driven by lower manufacturing costs, partially offset by changes in our sales mix. R&D expenses increased 12% driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline. SG&A expenses decreased 3% driven by lower commercial product-related expenses, partially offset by higher general and administrative expenses. Operating Margin as a percentage of product sales increased 2.5 percentage points in the first quarter to 45.7%. Tax Rate decreased 0.8 percentage points in the first quarter due to the change in earnings mix and net favorable items as compared to the prior year. Cash Flow and Balance Sheet The Company generated $1.0 billion of free cash flow in the first quarter of 2025 versus $0.5 billion in the first quarter of 2024. This increase reflects an $800 million tax deposit made in the first quarter of 2024 and current quarter business performance, partially offset by timing of working capital items and higher capital expenditures. The Company declared a first quarter 2025 dividend on December 10, 2024 of $2.38 that was paid on March 7, 2025 to all stockholders of record as of February 14, 2025, representing a 6% increase from the same period in 2024. During the first quarter of 2025, the Company reduced principal debt outstanding by $2.8 billion. During the first quarter, there were no repurchases of shares of common stock. Cash and cash equivalents totaled $8.8 billion and debt outstanding totaled $57.4 billion as of March 31, 2025. 2025 Guidance For the full year 2025, the Company expects: Total revenues in the range of $34.3 billion to $35.7 billion. On a GAAP basis, EPS in the range of $12.21 to $13.46, and a tax rate in the range of 11.0% to 12.5%. On a non-GAAP basis, EPS in the range of $20.00 to $21.20, and a tax rate in the range of 14.5% to 16.0%. Capital expenditures to be approximately $2.3 billion. Share repurchases not to exceed $500 million. This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. First Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide, AMG 133) MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the gastric inhibitory polypeptide receptor (GIPR). MARITIME-1, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, without Type 2 diabetes mellitus. MARITIME-2, a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of maridebart cafraglutide is enrolling adults living with overweight or obesity, with Type 2 diabetes mellitus. Planning for additional MARITIME Phase 3 studies across multiple indications remains on track, with additional studies expected to initiate throughout 2025. Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025. A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus has completed enrollment of adults living with and without obesity. Data readout is anticipated in H2 2025. AMG 513 A Phase 1 study of AMG 513 is enrolling people living with obesity following removal of the clinical hold by the U.S. Food and Drug Administration (FDA). Repatha VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025. EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing. Olpasiran (AMG 890) Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. The OCEAN(a)-outcomes trial, a Phase 3 secondary prevention cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a). A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a first CV event is expected to be initiated in H2 2025/H1 2026. Rare Disease TAVNEOS A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)). TEPEZZA Regulatory review is underway in multiple additional geographies, including with the European Medicines Agency (EMA), where approval is anticipated in H2 2025. A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score thyroid eye disease (TED). A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED. UPLIZNA In April, the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) in adult patients. In April, data from the UPLIZNA Phase 3 MINT study in patients with generalized myasthenia gravis (gMG) were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated durable and sustained efficacy of UPLIZNA treatment compared to placebo (adjusted difference, -1.8 at week 26; −2.8 at week 52) as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the acetylcholine receptor autoantibody-positive (AChR+) subpopulation through week 52. Among the AChR+ patients in the UPLIZNA group, 72% had a ≥3 point improvement in the MG-ADL score, compared to 45% in placebo at week 52. No new safety signals were identified. The FDA has accepted the regulatory submission of the MINT Phase 3 data with a PDUFA date of December 14, 2025. Dazodalibep Dazodalibep is a fusion protein that inhibits CD40L. Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity. Daxdilimab Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care. A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis. Inflammation TEZSPIRE Two Phase 3 studies of TEZSPIRE were initiated and are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. In March, data from the Phase 3 WAYPOINT study of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) were presented and simultaneously published in the New England Journal of Medicine demonstrating that treatment with TEZSPIRE: significantly reduced Nasal Polyp Score (NPS) by -2.065 at week 52. significantly reduced nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 at week 52. Improvements in NPS were observed as early as week four, and NCS as early as week two, and were sustained through week 52. significantly reduced the need for nasal polyp surgery by 98%. significantly reduced the need for systemic corticosteroid treatment by 88%. had a safety profile consistent with its approved severe asthma indication. The FDA has accepted the regulatory submission of the WAYPOINT Phase 3 data with a PDUFA date of October 19, 2025. A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells. The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies. In March, detailed data were presented from the ROCKET HORIZON Phase 3 study, which met its co-primary and all key secondary endpoints. In March, data were announced from three additional ROCKET program Phase 3 studies: The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints at week 24: 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo. In the lower dose group, 36.3% of patients achieved EASI-75, a 23.4% difference vs. placebo. 23.6% of patients in the higher dose group achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1), a 14.9% difference vs. placebo. In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo. 22.7% of patients in the higher dose group achieved a revised Investigator's Global Assessment (rIGA™) score of 0/1 with a ≥2-point reduction from baseline (a more stringent measure of efficacy than vIGA-AD 0/1), a 14.4% difference vs. placebo. In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo. The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI), met its co-primary endpoints and all key secondary endpoints at week 24. The VOYAGER study, which successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations. Across ROCKET program results to date, safety findings were generally consistent with the previously observed safety profile of rocatinlimab. The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache. A higher number of patients receiving rocatinlimab vs. placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%. Key upcoming milestones from the ROCKET Phase 3 program: ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma. A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis (PN). Blinatumomab Blinatumomab is a bispecific T-cell engager (BiTE ®) molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE). Inebilizumab Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease was initiated in adults with SLE. AMG 104 (AZD8630) AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab). A Phase 2 study is enrolling patients with asthma. Oncology BLINCYTO / blinatumomab In April, the FDA granted Breakthrough Therapy Designation for subcutaneous blinatumomab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Philadelphia chromosome (Ph)-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Ph-negative B-ALL. IMDELLTRA / tarlatamab IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE® molecule. In April, the Company announced that the global Phase 3 DeLLphi-304 study met its primary endpoint of improved overall survival at a planned interim analysis. This study evaluated IMDELLTRA compared to local standard-of-care chemotherapy as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy. The safety profile for IMDELLTRA was consistent with its known profile. Together these randomized data have the potential to establish IMDELLTRA as a new standard of care in second-line SCLC. Detailed data from DeLLphi-304 will be presented at the American Society of Clinical Oncology meeting (ASCO) in June. The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage SCLC: DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is enrolling patients with first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC. DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC. DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, is enrolling patients. DeLLphi-310, a Phase 1b study, was initiated in patients with ES-SCLC evaluating IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without anti-PD-L1. DeLLphi-312, a Phase 3 study of first-line IMDELLTRA with carboplatin, etoposide and durvalumab is planned to initiate in patients with ES-SCLC by mid-2025. Xaluritamig (AMG 509) Xaluritamig is a first-in-class BiTE® targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1). A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. A Phase 1 study of xaluritamig monotherapy has completed enrollment of patients with mCRPC who have not yet received taxane-based chemotherapy and has also completed enrollment of patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone. A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer. A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy. AMG 193 AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC). A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study. A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies. A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract and pancreatic cancers. A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, will be discontinued following a wind-down period. Bemarituzumab Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody. FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in Q2 2025. FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression. LUMAKRAS/LUMYKRAS CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC. CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC. Nplate The final analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. Data from this study will be presented at ASCO in June. Biosimilars A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) has completed enrollment of patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025. A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment. A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer. A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis. TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. OCREVUS is a registered trademark of Genentech, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the first quarters of 2025 and 2024, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2025 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the first quarters of 2025 and 2024. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow us on X (formerly known as Twitter), LinkedIn, Instagram, YouTube and Threads. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. 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CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. The stated guidance also includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. SOURCE Amgen WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in MG-ADL at Month 12 Deepest and most compelling sustained responses observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12 Safety profile consistent with previously reported data and continues to support outpatient administration Phase 3 AURORA trial on track to dose first patient in 2Q25 FREDERICK, Md., April 08, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG). Participants dosed with a single six-week course of treatment of Descartes-08 were observed to continue to experience a sustained benefit in symptoms of MG at the 12-month assessment. The data will be discussed by management at the 24th Annual Needham Virtual Healthcare Conference today, April 8, 2025, and presented tomorrow, April 9, 2025, by Tuan Vu, M.D., Professor of Neurology at the University of South Florida Morsani College of Medicine, at the 2025 American Academy of Neurology Annual Meeting being held in San Diego. Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors. 12-Month Phase 2b Trial Results In the Phase 2b double-blind, placebo-controlled, crossover trial, a total of 36 heavily pretreated, highly symptomatic participants with MG were randomized 1:1 to receive either Descartes-08 or placebo administered as six weekly outpatient infusions without preconditioning chemotherapy. As previously announced, the trial met its primary endpoint and demonstrated a safety profile supporting outpatient administration of Descartes-08. In December 2024, the Company reported updated efficacy and safety data from the trial in which deepening responses were observed over time and some participants were observed to have durable responses through to Month 12. The primary efficacy dataset for the follow-up portion of the trial consisted of a modified intent-to-treat (mITT) population of all subjects enrolled at academic medical centers who received at least one dose of Descartes-08 and completed at least one post-Month 3 MG Activities of Daily Living (MG-ADL) score follow-up assessment. As of a March 31, 2025 cutoff date, 12 out of 15 participants who received Descartes-08 in the primary efficacy dataset completed their Month 12 follow-up assessments. Three participants, two of whom were MG Composite (MGC) responders at Month 3, were lost to follow-up after their Month 3 assessments. 12-Month Efficacy Results Deep and sustained responses observed through Month 12 (n=12). Participants treated with Descartes-08 were observed to have deep responses following initial treatment and sustained symptom improvement, with an average MG-ADL reduction of 5.5 (±1.1) at Month 4 and 4.8 (±1.4) at Month 12. Participants treated with Descartes-08 were observed to have an average Quantitative Myasthenia Gravis Score (QMG) reduction of 4.8 (±1.7) points at Month 4, which deepened through Month 12 (6.0±2.1). 33% (4/12) of participants achieved minimum symptom expression (MSE), defined as an MG-ADL score of 0 or 1, at Month 6, all of whom maintained MSE through Month 12. 83% (10/12) of evaluable participants maintained a clinically meaningful response through Month 12. Clinically meaningful response is defined as a reduction in MG-ADL score of at least 2 points. Deepest and most compelling sustained responses observed in participants without prior biologic therapies (n=7). The subset of participants who did not have exposure to prior biologic therapies, including complement or neonatal fragment crystallizable receptor (FcRn) inhibitors, were observed to exhibit a deepening of responses throughout the year, with an average MG-ADL reduction of 6.6 (±1.5) at Month 4 and 7.1 (±1.9) at Month 12. The participants treated with Descartes-08 without exposure to prior biologic therapies were observed to have an average QMG reduction of 5.9 (±2.4) points at Month 4, which deepened through Month 12 (9.4±2.6). 57% (4/7) of these participants were observed to achieve MSE at Month 6 which was maintained through Month 12. 100% (7/7) of these participants were observed to maintain at least a clinically meaningful response through Month 12. Participants treated with Descartes-08 were observed to have deep responses following initial treatment and sustained symptom improvement, with an average MG-ADL reduction of 5.5 (±1.1) at Month 4 and 4.8 (±1.4) at Month 12. Participants treated with Descartes-08 were observed to have an average Quantitative Myasthenia Gravis Score (QMG) reduction of 4.8 (±1.7) points at Month 4, which deepened through Month 12 (6.0±2.1). 33% (4/12) of participants achieved minimum symptom expression (MSE), defined as an MG-ADL score of 0 or 1, at Month 6, all of whom maintained MSE through Month 12. 83% (10/12) of evaluable participants maintained a clinically meaningful response through Month 12. Clinically meaningful response is defined as a reduction in MG-ADL score of at least 2 points. The subset of participants who did not have exposure to prior biologic therapies, including complement or neonatal fragment crystallizable receptor (FcRn) inhibitors, were observed to exhibit a deepening of responses throughout the year, with an average MG-ADL reduction of 6.6 (±1.5) at Month 4 and 7.1 (±1.9) at Month 12. The participants treated with Descartes-08 without exposure to prior biologic therapies were observed to have an average QMG reduction of 5.9 (±2.4) points at Month 4, which deepened through Month 12 (9.4±2.6). 57% (4/7) of these participants were observed to achieve MSE at Month 6 which was maintained through Month 12. 100% (7/7) of these participants were observed to maintain at least a clinically meaningful response through Month 12. Safety Well-tolerated safety profile supports outpatient administration without the need for lymphodepleting chemotherapy. Consistent with previously reported data, Descartes-08 was observed to be well-tolerated across the safety dataset through Month 12 (n=12), and adverse events were transient and mostly mild, with no new adverse events reported in the 12-month follow-up data. Notably, there were no cases of cytokine release syndrome (CRS), and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). In addition, treatment with Descartes-08 was not observed to lead to a decrease in vaccine titers for common viruses and was not associated with increased rates of infection or hypogammaglobulinemia. There were no Descartes-08-related adverse events reported in Month 4 through Month 12 follow-up. As previously reported, common side effects through the Month 3 primary endpoint observed in participants who received any dose of Descartes-08 were infusion-related reactions manifesting as fever (60% of participants receiving Descartes-08), chills (60% of participants receiving Descartes-08), headache (55% of participants receiving Descartes-08) and nausea (45% of participants receiving Descartes-08), all of which typically resolved within 24 hours of infusion. Consistent with previously reported data, Descartes-08 was observed to be well-tolerated across the safety dataset through Month 12 (n=12), and adverse events were transient and mostly mild, with no new adverse events reported in the 12-month follow-up data. Notably, there were no cases of cytokine release syndrome (CRS), and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). In addition, treatment with Descartes-08 was not observed to lead to a decrease in vaccine titers for common viruses and was not associated with increased rates of infection or hypogammaglobulinemia. There were no Descartes-08-related adverse events reported in Month 4 through Month 12 follow-up. As previously reported, common side effects through the Month 3 primary endpoint observed in participants who received any dose of Descartes-08 were infusion-related reactions manifesting as fever (60% of participants receiving Descartes-08), chills (60% of participants receiving Descartes-08), headache (55% of participants receiving Descartes-08) and nausea (45% of participants receiving Descartes-08), all of which typically resolved within 24 hours of infusion. "This impressive data highlights the potential of Descartes-08 to serve as an important therapeutic option to deliver deep and sustained reductions in MG-ADL for patients with myasthenia gravis,” said Tuan Vu, M.D., Professor of Neurology at the University of South Florida Morsani College of Medicine, Division Director for Neuromuscular Medicine and EMG and investigator in the Phase 2b trial. “The data in participants who had not received prior biologic therapy is particularly striking as this population is most comparable to the patient populations in trials of standard-of-care biologics. Participants in this subgroup who were randomized to Descartes-08 were observed to experience a profound average 7.1-point reduction in MG-ADL and 57% these patients were observed to maintain MSE out to Month 12. I look forward to following the continued development of Descartes-08 in MG as it moves into the Phase 3 AURORA trial.” “The remarkable results presented today underscore the potential of utilizing our cell therapy to deliver deep and durable responses in MG patients one year after receiving a single course of therapy in a convenient outpatient setting with no preconditioning chemotherapy,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “The impressive strength and duration of response shown in the data reinforce our confidence in the potential of Descartes-08 to transform the current treatment landscape in MG, offering patients a safe, flexible, and durable treatment option. We look forward to dosing the first patient in our Phase 3 AURORA trial in the second quarter of this year.” Descartes-08 was previously granted Regenerative Medicine Advanced Therapy (RMAT) Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG. Cartesian received written agreement from the FDA under the Special Protocol Assessment (SPA) process indicating the overall design of the planned Phase 3 AURORA trial of Descartes-08 is acceptable to support a future Biologics License Application in MG, subject to the ultimate outcome of the trial. Cartesian remains on track to commence the Phase 3 AURORA trial of Descartes-08 in MG in the second quarter of 2025. About Myasthenia Gravis Myasthenia gravis (MG) is a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. For most people with MG, the disease is characterized by the presence of antibodies against the acetylcholine receptor, a protein found on the surface of nerve cells that plays a key role in muscle contraction. There is currently no cure for MG, and treatment typically requires chronic immunosuppressive medicines, with their attendant risks and side effects. About Descartes-08 Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous chimeric antigen receptor T-cell therapy (CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, Cartesian’s CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis. About Cartesian Therapeutics Cartesian Therapeutics is a clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a CAR-T entering Phase 3 clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. A Phase 3 trial of Descartes-08 in patients with generalized myasthenia gravis has received written agreement from the FDA under the Special Protocol Assessment process. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA CAR-T currently being evaluated in a Phase 1 trial in patients with multiple myeloma. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter. Forward Looking Statements Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding observations and data from the Company’s clinical trials of Descartes-08 in myasthenia gravis, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, juvenile dermatomyositis, or any other disease, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial, whether results of early clinical trials will be indicative of the results of later clinical trials, and whether results observed in certain patient subgroups will be indicative of the results in such subgroups in later clinical trials or are reflective of a product candidate’s overall characteristics, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward looking statements included in this press release, except as required by law. Investor Contact Megan LeDuc Associate Director of Investor Relations megan.leduc@cartesiantx.com Media Contact David Rosen Argot Partners david.rosen@argotpartners.com Source: Cartesian Therapeutics, Inc.

Bispecific antibodies first reached patients as cancer treatments, but a growing number of companies are working to expand these therapies to autoimmune diseases. Sanofi is adding a new contender, agreeing to pay $600 million for a bispecific drug with an approach that could be first in class. The sum announced Thursday is an upfront payment for Dren Bio’s drug candidate, DR-0201. The privately held biotech, which is based in Foster City, California, could receive up to $1.3 billion more if the drug achieves development and product launch milestones. Bispecific antibodies work by simultaneously binding to two targets, one on an immune cell and the other on the target cell. These drugs were initially developed to treat blood cancers by depleting cancer-driving B cells. But B cells also drive certain autoimmune disorders, making these rogue immune cells attractive for bispecific drug R&D. presented by Artificial Intelligence Why Your Patients Are Leaving and How to Stop It Patient expectations continue to evolve, and healthcare practices that fail to adapt risk more than just revenue—they risk losing trust. By Bryan Sequeira, Director, Product Management Greenway Health On B cells, DR-0201 targets a protein called CD20. The drug leads to depletion of these cells via phagocytosis, a process in which an immune cell engulfs a pathogen, eliminating it. DR-0201 prompts this action by activating a specific phagocytic receptor on myeloid cells, a type of immune cell. Dren Bio contends this approach may offer safety and dosing advantages. The phagocytic receptor is activated only in the presence of the targeted antigen, so DR-0201 may be able to offer wider therapeutic index and a superior safety profile compared to other targeted antibody therapies, such as T cell engagers (TCEs) and antibody drug conjugates (ADCs). The Dren Bio drug is currently being evaluated in two Phase 1 studies, one in healthy volunteers and the other in a range of autoimmune diseases, such as lupus, Sjogren’s syndrome, dermatomyositis, and scleroderma. Dren Bio has not formally reported results from these studies, but Sanofi said recent data in the autoimmune disease study “suggest that deep B-cell depletion might have the potential to reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell mediated autoimmune diseases such as lupus, where significant unmet medical needs remain.” In a prepared statement, Houman Ashrafian, Sanofi’s head of research and development, said DR-0201 has the potential to elevate the treatment effect for patients, particularly those who do not respond to existing therapies. Safety could be another key advantage. Leerink Partners analyst David Risinger said in a research note that clinicians have told the firm that safety is particularly critical for lupus patients. While B cells can be addressed by drugs that go after targets such as CD19 and BCMA, those therapies also affect plasma cells, which secrete antibodies important for immunity. Targeting CD20 spares plasma cells, so a CD20-targeting bispecific drug, such as DR-0201, should preserve a patient’s immunity and lower the risk of developing infections. Sanofi’s DR-0201 acquisition is the latest in a line of deals for bispecific drugs for potential applications in autoimmune disease. Last summer, Merck agreed to pay $700 million up front for rights to a Curon Biopharmaceutical bispecific antibody with potential applications in oncology and immunology. Soon after, startup Candid Therapeutics launched with $370 million in financing and two in-licensed TCEs. Last October, GSK paid $300 million up front for rights to a TCE developed by Chimagen Biosciences. GSK was also involved in the formation of Ouro Medicines, a startup that launched in January with $120 million to reach the clinic with an in-licensed TCE. presented by Sponsored Post How PDPM Optimization Improves Facility Financial Performance Transitioning to PDPM models significantly shifted the healthcare industry. By replacing the RUG system, healthcare providers cut waste and more accurately reflect the care each patient received. By Medrina The Sanofi pipeline currently lists one bispecific antibody, SAR446422. This drug, which is designed to target CD28 and the OX4O receptor, is in Phase 1 testing for potential applications in inflammation. Sanofi said it will finance the DR-0201 acquisition with its available cash. The deal, which is still subject to regulatory approvals, is expected to close in the second quarter of this year.