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3 days ago
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New analyses reinforce long-term benefit of DARZALEX® (daratumumab) subcutaneous-based quadruplet regimen for patients with newly diagnosed multiple myeloma
Sustained MRD negativity (10-5) rates at 24 months or longer were more than doubled in transplant eligible patients treated with daratumumab-VRd vs VRd alone in the Phase 3 PERSEUS study1 Data from the Phase 3 CEPHEUS study show daratumumab-VRd significantly reduced the risk of progression or death by 49 percent vs VRd alone in transplant-ineligible newly diagnosed patients2 BEERSE, BELGIUM, June 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced data from two studies highlighting that DARZALEX® (daratumumab) subcutaneous (SC) formulation with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd) demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 'Daratumumab-based quadruplet regimens are redefining frontline treatment in multiple myeloma, offering the potential for deeper, more durable responses from the start, bringing patients closer to long-term remission,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'The latest data presented at ASCO further support the role of the PERSEUS and CEPHEUS regimens as a standard of care in patients with newly diagnosed disease, regardless of transplant eligibility.' A new analysis from the Phase 3 PERSEUS study shows the addition of daratumumab-VRd followed by a maintenance regimen of daratumumab SC with lenalidomide (daratumumab-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5) compared to VRd induction and consolidation with R maintenance.1 At a median follow-up of 47.5 months, sustained MRD negativity (10-5) rates were more than doubled with daratumumab-VRd followed by daratumumab-R maintenance compared to VRd and R maintenance at both 12 months or longer (64.8 percent vs 29.7 percent; odds ratio, 4.42; 95 percent confidence interval [CI], 3.22–6.08; p<0.0001) and 24 months or longer (55.8 percent vs 22.6 percent; odds ratio [OR], 4.36, 95 percent CI, 3.15–6.05, p<0.0001).1 Among patients achieving sustained MRD negativity for 12 months or longer, the 48-month PFS rate for daratumumab-VRd followed by daratumumab-R maintenance was 95.3 percent compared to 94.2 percent for VRd and R maintenance (hazard ratio [HR], 0.83; 95 percent CI,0.3–2.3)—reinforcing the importance of achieving sustained MRD negativity for prolonged disease remission.1 'The data show that daratumumab-VRd followed by a daratumumab-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,' said Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author.* 'The depth and durability of MRD negativity observed—paired with high rates of progression-free survival at four years—underscore the long-term benefit the daratumumab SC-based regimen can offer patients early in their treatment journey.' Additional data from Phase 3 CEPHEUS study explore the benefits of daratumumab SC in transplant-ineligible patients across cytogenetic risk status The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding daratumumab SC to VRd significantly deepens response and prolongs PFS compared to VRd alone in this patient population.2 At a median follow-up of 58.7 months, patients receiving daratumumab-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent vs 39.3 percent with VRd (OR, 2.37; 95 percent CI, 1.47–3.80; p=0.0004).2 Furthermore, treatment with daratumumab-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold with 45.8 percent compared to 26.9 percent with VRd (OR, 2.28; 95 percent CI, 1.40–3.73; p=0.0010).2 These deeper responses translated into improved long-term outcomes, with 69.0 percent of patients remaining progression-free at 54-months when treated with daratumumab-VRd vs 48.0 percent with VRd (HR, 0.51; 95 percent CI, 0.35–0.74; p=0.0003).2 Overall survival (OS) numerically favoured daratumumab-VRd (HR, 0.66; 95 percent CI, 0.42–1.03, p=0.0682), with an even greater benefit observed after censoring for COVID-19-related deaths (HR, 0.55; 95 percent CI, 0.34–0.90, p=0.0159).2 Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529).3 At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in daratumumab-VRd vs VRd.3 Although rates of MRD negativity by treatment arm in patients with protocol-defined high-risk were comparable, PFS trended toward improvement with daratumumab-VRd.3 'Across multiple studies, the growing body of data on daratumumab-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high-risk,' Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of daratumumab SC as a cornerstone of frontline therapy.' In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for daratumumab SC.1,2,3 Safety results of daratumumab-VRd in the PERSEUS study were previously reported in The New England Journal of Medicine.4 The most common haematologic adverse reactions (≥20 percent) in patients with multiple myeloma who received daratumumab-VRd vs VRd included neutropenia (69.2 percent vs 58.8 percent), thrombocytopenia (48.4 percent vs 34.3 percent), and anaemia (22.2 percent vs 20.7 percent).4 Similarly, in the CEPHEUS study, daratumumab-VRd showed no additional safety concerns in the transplant-ineligible subgroup compared with the intent to treat population.2 The most common Grade 3/4 haematologic treatment-emergent adverse events (TEAEs) were neutropenia (43.8 percent vs 31.7 percent), thrombocytopenia (30.6 percent vs 23.2 percent) and anaemia (12.5 percent vs 12.7 percent).2 About the PERSEUS and CEPHEUS studiesThe PERSEUS study (NCT03710603) is being conducted in collaboration with the European Myeloma Network as the sponsor.5 PERSEUS is an ongoing, randomised, open-label, Phase 3 study comparing the efficacy and safety of daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) and autologous stem cell transplant (ASCT) followed by D-R maintenance vs standard bortezomib, lenalidomide, and dexamethasone (VRd) and ASCT followed by R maintenance in patients with transplant eligible newly diagnosed multiple myeloma (NDMM) (n=355).4 The primary endpoint is progression-free survival (PFS), and secondary endpoints include overall complete response or better rate, overall minimal residual disease (MRD) negativity (in patients with complete response or better) and overall survival (OS).4 Daratumumab subcutaneous (SC) formulation was discontinued after at least 24 months of D-R maintenance therapy in patients who had a complete response or better and had sustained MRD negative status for at least 12 months.4 The median age is 61.0 (range, 32-70) years for patients in the daratumumab-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm.4 The study is being conducted in 13 countries in Europe and Australia.5 On 23 October 2024, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM who are eligible for ASCT, based on the results of the PERSEUS study.6,7 CEPHEUS (NCT03652064) is an ongoing, randomised, open-label, Phase 3 study comparing SC daratumumab-VRd with standard VRd.8,9 The trial has enrolled 395 patients with NDMM who are either ineligible for stem cell transplantation (SCT) or for whom SCT is not planned.9 The primary endpoint is overall MRD-negativity rate.9 The minimum age for participation is 18 years for patients in both the daratumumab-VRd arm and VRd arm, with a median patient age of 70 (range 31-80).8 The study is being conducted in 13 countries across North America, South America and Europe.9 On 7 April 2025, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM, based on the results of the CEPHEUS study.9,10 About daratumumab and daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.11 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.12 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.12 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.12 Daratumumab may also have an effect on normal cells.12 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.8,13,14,15,16,17,18,19,20 For further information on daratumumab, please see the Summary of Product Characteristics at: About Multiple MyelomaMultiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.22 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.23 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy 24,25 while remissions become progressively shorter.24,25,26 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.27 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. 1 Moreau P, et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.2 Facon T, et al. Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.3 Bahlis N.J, Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): phase 3 CEPHEUS trial cytogenetic subgroup analysis. Poster presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.4 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024; 390:301-313.5 Daratumumab, VELCADE (bortezomib), lenalidomide and dexamethasone compared to VELCADE, lenalidomide and dexamethasone in subjects with previously untreated multiple myeloma (Perseus). NCT03710603. Available at: Last accessed: May 2025.6 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. June 3, 2024.7 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: Last accessed: May 2025.8 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.9 A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy. NCT03652064. Available at: Last accessed: May 2025.10 European Commission approves Johnson & Johnson's subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility. Available at: Last accessed: May 2025.11 Johnson & Johnson [data on file]. RF-430506. Number of patients treated with DARZALEX® worldwide as of 30 June 2024.12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: Last accessed: May 2025.13 Moreau P, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, openlabel, phase 3 study. Lancet 2019;394(10192):29-38.14 Facon T, et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115.15 Mateos MV, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:P132-141.16 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812.17 Palladini G, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80.18 Chari A, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981.19 Bahlis NJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884.20 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518.21 Abdi J, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207.22 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: Last accessed: May 2025.23 ECIS - European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: Last accessed: May 2025.24 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.25 Hernández-Rivas JÁ, et al. The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies. Biomark Res. 2022;10(1):1-23.26 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.27 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: Last accessed: May 2025. CP-520659 May 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@
Yahoo
27-04-2025
- Business
- Yahoo
Perseus Mining Proceeds with Development of Nyanzaga Gold Project
Perth, April 28, 2025 (GLOBE NEWSWIRE) -- PERSEUS MINING PROCEEDS WITH DEVELOPMENT OF THE NYANZAGA GOLD PROJECT overview Perth, Western Australia/ April 28, 2025/ Perseus Mining Limited (ASX/TSX: PRU) is pleased to announce that a Final Investment Decision (FID) has been taken to develop the Nyanzaga Gold Project (NGP) in Tanzania, following an update of the NGP Feasibility Study (FS). Perseus has committed to invest approximately US$523 million (including contingency) to develop and prepare for the operation of the mine that is expected to produce first gold in Q1 2027. The NGP development will be solely financed via interest free, intercompany loans provided by Perseus from its existing cash and bullion balance of US$801 million as of 31 March 2025. In anticipation of an affirmative FID, Perseus has spent approximately US$27.5 million to date to build project team capacity and commence early works that include site establishment, installation of temporary construction accommodation, and bulk earthworks as well as implementing the Relocation Action Plan (RAP) to construct new dwellings for people impacted by future construction and operating activities. The updated FS incorporates findings and recommendations from a range of comprehensive technical assessments made by Perseus's technical team. Notably, Perseus has opted for a large scale, wholly open-pit mining operation, for the first phase of development, in preference to a smaller scale, combined open pit - underground option contemplated by the previous owners. Key metrics associated with the NGP include the following: Production & Cost Metrics (100% basis): Total gold production over an 11-year, Phase 1 mine life is currently estimated to be 2.01 Moz based on a JORC 2012 Probable Ore Reserve of 52.0 Mt @ 1.40 g/t gold for 2.3 Moz. Gold production averages over 200,000 ounces of gold per annum from FY28 to FY35, with peak production of 246,000 ounces in FY28. Over the life of the mine, the estimated average All-In Site Cost (AISC) is US$1,211/oz. Capital cost for the plant and site infrastructure is estimated at US$472 million inclusive of US$49 million of contingency, and pre-production capital of US$51 million, giving a total capital cost to first gold pour of US$523 million. Investment Metrics (100% basis)1: Applying Perseus's assumed long-term gold price of US$2,100/oz, the NGP's investment metrics include: Undiscounted free cashflow pre-tax of US$1,133 million and post-tax of US$706 million, (or US$2,252 million pre-tax and US$1,471 million post-tax at a gold price of US$2,700/oz.) Net Present Value (NPV10%) of US$404 million pre-tax and US$202 million post-tax, (or US$1,010 million pre-tax and US$617 million post-tax at a gold price of US$2,700/oz). Internal Rate of Return (IRR) of 26% pre-tax and 19% post-tax (or 45% pre-tax and 34% post-tax at a gold price of US$2,700/oz). The FID to proceed with developing the NGP builds upon Perseus's demonstrated capacity to successfully develop and efficiently operate modern gold mines on the African continent. Perseus has previously successfully developed, and is now operating three gold mines including Edikan, Sissingué, and most recently, the Yaouré gold mine that was delivered ahead of schedule and under budget in 2020, using many of the same team that will be deployed on the NGP development. The FID also comes following constructive engagement with the Government of Tanzania to clarify terms of an existing Framework Agreement that sets out the basis on which the NGP will be developed and operated, as well as the Shareholder's Agreement between the Tanzanian Government and Perseus.1 A second phase of resource definition drilling is currently underway at the NGP with the aim of converting Inferred Mineral Resources into Indicated Mineral Resources, which would potentially enable the Ore Reserve to be materially expanded and the life of the NGP operation extended during the second phase of the Project, beyond the currently projected 11-year mine life. 1 Note: Perseus owns an 80% contributing interest in the NGP together with the Government of Tanzania who owns a 20% non-contributing interest. This announcement was approved for release by the Managing Director & CEO, Jeff Quartermaine. Technical Disclosure: All Ore Reserves and Mineral Resources were calculated as of 28 April 2025 and have been prepared in accordance with the standards set out in the Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves dated December 2012 (the JORC Code) and in accordance with National Instrument 43-101 of the Canadian Securities Administrators (NI 43-101). The JORC Code is the accepted reporting standard for the Australian Stock Exchange Limited (ASX). The definitions of Ore Reserves and Mineral Resources as set forth in the JORC Code (2012) have been reconciled to the definitions set forth in the CIM Definition Standards. If the Mineral Reserves and Mineral Resources were estimated in accordance with the definitions in the JORC Code, there would be no substantive difference in such Mineral Reserves and Mineral Resources. Competent Person Statement: All production targets referred to in this report are underpinned by estimated Ore Reserves which have been prepared by Competent Persons in accordance with the requirements of the JORC Code. The information in this report that relate to Mineral Resources for the Nyanzaga Gold Project is based on, and fairly represents, information and supporting documentation prepared by Mr Daniel Saunders, a Competent Person, a full-time employee of Perseus Mining and Fellow of The Australasian Institute of Mining and Metallurgy. Mr Saunders, has sufficient experience, which is relevant to the style of mineralisation and type of deposit under consideration and to the activity being undertaken, to qualify as a Competent Person as defined in the 2012 Edition of the 'Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves' and to qualify as a Qualified Person under National Instrument 43-101 – Standards of Disclosure for Mineral Projects (NI 43-101). Mr Saunders consents to the inclusion in the report of the matters based on his information in the form and context in which it appears. The information in this report that relates to Ore Reserves for the Nyanzaga Gold Project is based on information compiled by Mr Adrian Ralph, a Competent Person who is a Fellow of The Australasian Institute of Mining and Metallurgy. Mr Ralph is a full-time employee of Perseus Mining. Mr Ralph has sufficient experience which is relevant to the style of mineralisation and type of deposit under consideration and to the activities which he is undertaking to qualify as a Competent Person as defined in the 2012 Edition of the 'Australasian Code for Reporting of Exploration Results, Mineral Resources and Ore Reserves' and a Qualified Person as defined in NI 43-101. Mr Ralph consents to the inclusion in this report of the matters based on his information in the form and context in which it appears. Caution Regarding Forward Looking Information: This report contains forward-looking information which is based on the assumptions, estimates, analysis and opinions of management made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors that management of the Company believes to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Assumptions have been made by the Company regarding, among other things: the price of gold, continuing commercial production at the Yaouré Gold Mine, the Edikan Gold Mine and the Sissingué Gold Mine without any major disruption, development of a mine at Nyanzaga, the receipt of required governmental approvals, the accuracy of capital and operating cost estimates, the ability of the Company to operate in a safe, efficient and effective manner and the ability of the Company to obtain financing as and when required and on reasonable terms. Readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used by the Company. Although management believes that the assumptions made by the Company and the expectations represented by such information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. Forward-looking information involves known and unknown risks, uncertainties, and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any anticipated future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, the actual market price of gold, the actual results of current exploration, the actual results of future exploration, changes in project parameters as plans continue to be evaluated, as well as those factors disclosed in the Company's publicly filed documents. Readers should not place undue reliance on forward-looking information. Perseus does not undertake to update any forward-looking information, except in accordance with applicable securities laws. ASX/TSX CODE: PRUCAPITAL STRUCTURE:Ordinary shares: 1,365,414,823Performance rights: 10,056,681REGISTERED OFFICE:Level 2437 Roberts RoadSubiaco WA 6008Telephone: +61 8 6144 DIRECTORS:Rick MenellNon-Executive ChairmanJeff QuartermaineManaging Director & CEO Amber BanfieldNon-Executive DirectorElissa CorneliusNon-Executive DirectorDan LougherNon-Executive DirectorJohn McGloinNon-Executive Director CONTACTS:Jeff QuartermaineManaging Director & FormanInvestor Relations+61 484 036 RyanMedia Relations+61 420 582 Attachment 20250428 TSX Nyanzaga_FS_Release finalSign in to access your portfolio
Yahoo
13-04-2025
- Business
- Yahoo
EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
13-04-2025
- Business
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EC approves extension of indication for Janssen-Cilag's Darzalex
The European Commission (EC) has approved the extension of indication for Janssen-Cilag International's Darzalex (daratumumab) subcutaneous (SC) formulation to be used in the frontline setting for treating newly diagnosed multiple myeloma (NDMM) in adults. Janssen-Cilag is a Johnson & Johnson (J&J) company. The approval allows for the use of daratumumab SC in conjunction with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd). The therapy currently holds nine indications approved for multiple myeloma (MM) with five for frontline treatment, including regimens for patients both eligible and ineligible for autologous stem-cell transplant (ASCT). The latest approval follows October 2024's indication extension for daratumumab-VRd to treat newly diagnosed patients eligible for ASCT, supported by the Phase III PERSEUS trial results. The trial focused on assessing the therapy's SC-based quadruplet regimen for consolidation and induction therapy with daratumumab SC and lenalidomide maintenance. The trial assessed the safety and efficacy of daratumumab-VRd against VRd in NDMM subjects who were either transplant ineligible or for whom ASCT was not intended as initial treatment. Daratumumab-VRd's overall safety profile was consistent with the known profiles of daratumumab SC and VRd. Johnson & Johnson innovative medicine EMEA therapeutic area haematology lead Edmond Chan stated: 'Daratumumab has become a cornerstone of multiple myeloma treatment over the past decade and is now the only anti-cluster of differentiation 38 (CD38) antibody approved to treat all patient types in the frontline setting, regardless of transplant eligibility. 'This latest approval confirms the enhanced benefit of daratumumab SC-based quadruplet regimens and its versatility and effectiveness in addressing the diverse needs of those affected by this complex disease.' J&J also filed a supplemental biologics licence application with the US Food and Drug Administration in September 2024 for a new indication for daratumumab SC with VRd to treat adults with NDMM who are either ineligible for ASCT or for whom ASCT is deferred. In 2024, the company announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex-based quadruplet therapy for MM. In 2012, J&J's Janssen Biotech and Genmab entered a global agreement granting J&J exclusive development, manufacturing and commercialisation rights for daratumumab. "EC approves extension of indication for Janssen-Cilag's Darzalex" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
