Triptorelin Pamoate

Total-sales growth in FY 2023 of 6.7% at CER1 (3.4% as reported) included strong sales from the growth platforms2 and good contributions from the new medicines. A core operating margin of 32.0% (IFRS operating margin of 26.1%), based on further enrichment of the pipeline and accelerated R&D investment, mainly from recent acquisitions Financial guidance for 20243 comprises total-sales growth4 greater than 6.0% at CER1 and a core operating margin5 around 30% of total sales, including the impact of four potential launches and an advancing pipeline A new phase of growth and mid-term financial outlook were outlined at the December 2023 capital-markets day PARIS, FRANCE, 8 February 2024 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, today presents its financial results for the year and final quarter of 2023. Extract of consolidated results for FY 2023 and FY 20226: FY 2023 FY 2022 % change €m €m Actual CER1 Total Sales 3,127.5 3,025.0 3.4% 6.7% Core Operating Income 1,001.0 1,115.4 -10.3% Core operating margin 32.0% 36.9% -4.9% pts Core Consolidated Net Profit 765.5 872.4 -12.3% Core earnings per share (fully diluted) €9.15 €10.51 -13.0% IFRS Operating Income 816.0 729.9 11.8% IFRS operating margin 26.1% 24.1% 2.0% pts IFRS Consolidated Net Profit 647.2 647.5 - IFRS earnings per share (fully diluted) €7.73 €7.81 -1.0% Free Cash Flow 710.9 817.2 -13.0% Closing net cash 65.1 398.8 -83.7% “Solid results in the year have provided an excellent platform for Ipsen in 2024, an exciting period in which we anticipate four launches and further opportunities to expand the pipeline”, commented David Loew, Chief Executive Officer, Ipsen. “As Ipsen transforms, improving execution is supporting consistent sales growth, while the productive pipeline is yielding further encouraging results for patients. “Our external-innovation strategy, underpinned by a strong balance sheet, continues to extend the number of potential medicines across our three therapeutic areas. Following the acquisition of Albireo in 2023 and the successful launch of Bylvay, we look forward to more milestones this year and enriching the pipeline over time through additional external-innovation transactions. I am confident that this strategy will deliver more medicines for patients and ensure the sustainable growth of Ipsen.” 2023 progress Ipsen continued to deliver successfully in 2023 on its strategy, Focus. Together. For patients and society. The growth platforms produced a further double-digit performance, with Cabometyx and Dysport up by 22.9%7 and 14.5%7, respectively. There were contributions from the new medicines, Bylvay® (odevixibat), Sohonos® (palovarotene) and Tazverik® (tazemetostat), while Somatuline® (lanreotide), continuing its gradual erosion (-10.4%7), represented only 34% of total sales (FY 2022: 40%). The decline in the core operating margin to 32.0% (FY 2022: 36.9%) reflected enhanced investment from the acquisitions of Albireo and Epizyme, including a higher level of R&D expenses to fund the new pipeline. Ipsen ended the year with net cash of €65.1m, driven by solid free cash-flow generation of €710.9m. In March 2023, Ipsen enriched its Rare Disease portfolio and pipeline by acquiring Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases. The primary focus of the transaction was Bylvay, a potent, once-daily, oral, non-systemic ileal bile acid transport inhibitor. Favorable pipeline developments in 2023 included positive results from the Phase III trials of elafibranor in primary biliary cholangitis (PBC) and Cabometyx in prostate cancer, respectively. Regulatory submission acceptances were received for Onivyde in first-line pancreatic ductal adenocarcinoma (1L PDAC), as well as for elafibranor. Sohonos and Bylvay were also granted approval during the year by the U.S. Food and Drug Administration (FDA) in fibrodysplasia ossificans progressiva (FOP) and Alagille syndrome, respectively. 2024 priorities and financial guidance Ipsen anticipates four commercial launches in 2024, following regulatory decisions for Onivyde in 1L PDAC in the U.S (H1), elafibranor in second-line PBC in the U.S. (H1) and in the E.U. (H2), as well as odevixibat in Alagille syndrome in the E.U. (H2). Sohonos, in FOP, was recently launched in the U.S. The Company will continue to drive benefits from its global efficiencies program, leveraging its current platform, which provide significant further investment for launches and the pipeline. Ipsen has set the following financial guidance for FY 2024, which excludes any impact from potential late-stage external-innovation transactions: Total-sales growth greater than 6.0%, at constant currency. Based on the average level of exchange rates in January 2024, an adverse impact on total sales of around 1% from currencies is expected Core operating margin around 30% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities Guidance on total sales incorporates expectations for Somatuline of further generic lanreotide products in the U.S and E.U. Capital-markets day and mid-term financial outlook Ipsen outlined its next phase of growth at its capital-market day, held in December 2023. Several current and potential near-term launches are set to be complemented by many pipeline milestones over the mid-term to build a strengthened and diversified business, including a combination of seven anticipated and current medicines, each with expected peak sales of at least €500m. This will be augmented by an active external-innovation strategy, designed to provide a platform to drive sustainable pipeline growth. The Company outlined the following mid-term financial outlook8: Total-sales average growth of at least 7% per year for the period 2023-2027 at constant exchange rates A core operating margin in 2027 of at least 32% of total sales Environment, Social and Governance: Generation Ipsen Ipsen presented an ambitious sustainability roadmap at the aforementioned capital-markets day, based on Generation Ipsen, the strategy focused on four pillars: Environment, Patients, People and Governance. Good progress was made in 2023. Ipsen is committed to science-based reductions in greenhouse-gas emissions across the entire value chain. The Company achieved a 36% reduction in Scope 1 & 2 emissions in 2023 vs the 2019 baseline. Scope 3 reductions in 2023, against the same baseline year, amounted to 29%. Ipsen has the ambition to be carbon-neutral by the end of 2025 and reach net-zero emissions by 2045. With a key focus on patients, the Company has made progress to reduce the length of time between clinical-trial readouts and non-FDA/EMA9 regulatory submissions by 25%. In 2023, 53% of the GLT was comprised of women versus 48% in 2022, while 43% of colleagues were engaged in healthcare or environmental projects in 2023. Finally, ISO37001 certification for anti-corruption management was renewed in the year. Consolidated financial statements The Board of Directors approved the consolidated financial statements on 7 February 2024. The consolidated financial statements have been audited and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available in due course on ipsen.com (regulated-information section). Conference call A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here. Calendar Ipsen intends to publish its first-quarter sales update on 25 April 2024. Notes All financial figures are in € millions (€m). The performance shown in this announcement covers the twelve-month period to 31 December 2023 (FY 2023) and the three-month period to 31 December 2023 (Q4 2023), compared to the twelve-month period to 31 December 2022 (FY 2022) and the three-month period to 31 December 2022 (Q4 2022), respectively, unless stated otherwise. Commentary is based on the performance in FY 2023, unless stated otherwise. About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. Ipsen contacts Investors Craig Marks +44 (0)7584 349 193 Nicolas Bogler +33 6 52 19 98 92 Media Amy Wolf +41 79 576 07 23 Ioana Piscociu +33 6 69 09 12 96 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. 1 At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 2 Dysport® (abobotulinumtoxinA), Decapeptyl® (triptorelin), Cabometyx® (cabozantinib) and Onivyde® (irinotecan). 3 Excludes any impact from potential late-stage external-innovation transactions. 4 Incorporates expectations for Somatuline of further generic-lanreotide products in the U.S and E.U. and excluding, based on the average level of exchange rates in January 2024, an adverse expected impact on total sales of around 1% from currencies. 5 Includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities. 6 Extract of consolidated results. The Company’s auditors performed an audit of the consolidated financial statements. 7 At CER, which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period. 8 Excluding the impact of any potential additional late-stage (Phase III clinical development or later) external-innovation opportunities. 9 European Medicines Agency. Attachment FY 2023 - results announcement

Data spans eleven presentations across both solid tumors and hematologic malignancies, providing added understanding of the potential benefit these therapies bring to patients ORSERDU data reinforce its key role in the treatment of ER+, HER2- advanced or metastatic breast cancer (mBC) tumors that harbor ESR1 mutations, while showing initial data from combination trials ELZONRIS presentation includes updated real-world data from patients with Blastic Plasmacytoid Dendritic Cell Neoplasm FLORENCE, Italy & NEW YORK--(BUSINESS WIRE)-- The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, announced today that they will present new data related to ORSERDU® (elacestrant) and ELZONRIS® (tagraxofusp-erzs) in two upcoming congresses. This press release features multimedia. View the full release here: ORSERDU, a once-daily oral endocrine monotherapy, for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, was approved by the U.S. Food and Drug Administration in January 2023 under its priority review and fast track designation. In September 2023, ORSERDU was approved by the European Commission. Updated data, including a spotlight discussion on additional biomarker and clinical subgroup analyses from the Phase 3 EMERALD trial, along with new safety updates evaluating elacestrant in multiple combination settings, will be presented at the San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023. ELZONRIS was approved by the FDA in December 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. In January 2021, ELZONRIS was approved by the European Commission. Updated data, including an oral presentation of updated real-world results in treatment-naïve patients with BPDCN demonstrating durable outcomes and a manageable safety pro to prolonged survival, will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 9-12, 2023. “The breadth of data on our novel oncology therapies, spanning solid tumors and hematologic malignancies, underscore our commitment to addressing significant unmet medical needs in difficult-to-treat cancers,” said Elcin Barker Ergun, CEO of the Menarini Group. “At Menarini Stemline, we are dedicated to driving innovation in oncology to deliver targeted therapies that bring value to people living with cancer and to the healthcare providers who care for them.” See below for full details of the Menarini Group/Stemline Therapeutics' upcoming presentations: San Antonio Breast Cancer Symposium 2023 Lead Author​ Abstract Title and ID​ Presentation Details​ Bardia, A​ Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial​ 1576519/PS17-02 December 8, 2023​ 7-8am CT Poster Spotlight Discussion Hemisfair Ballroom 1-2 Rugo, H​ ELEVATE: A phase 1b/2, open-label, umbrella study evaluating elacestrant in various combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC)​ 1576517/PO2-05-04 December 6, 2023 5-7pm CT​ Poster Halls 2-3 Ibrahim, N​ ELECTRA: An open-label, multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis (mets) from estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer (BC) 1576518​/PO2-05-05 December 6, 2023​ 5-7pm CT​ Poster Halls 2-3 Patnaik, A​ SUMIT-ELA: Phase 1b/2 combination of cyclin-dependent kinase 7 inhibitor (CDK7i) samuraciclib and selective estrogen receptor degrader (SERD) elacestrant in advanced hormone receptor positive (HR+) breast cancer after CDK4/6i* NA/PO3-04-13 December 7, 2023 12-2pm CT​ Poster Halls 2-3 Bellet, M​ A phase 2 randomized pre-operative, window of opportunity trial investigating the effect of elacestrant with/without triptorelin in premenopausal patients with HR+/HER2- breast cancer – SOLTI-2104-PremiÈRe trial*​ 1580190/PO3-19-08 December 7, 2023​ 12-2pm CT​ Poster Halls 2-3 *Denotes investigator sponsored research or collaborative research 65th American Society of Hematology (ASH) Annual Meeting 2023 Lead Author Title and Publication Number Session Name Presentation Details Angelucci et al. Durable Outcomes with Manageable Safety Leading to Prolonged Survival with Tagraxofusp for Treatment-Naive Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm: Updated Results from a European Named Patient Program Publication Number: 547 906. Outcomes Research – Myeloid Malignancies: Real-World Treatment Patterns and Outcomes Oral Presentation December 10, 2023 12:00 PM Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13 Minetto et al. Single Agent Tagraxofusp in Relapsed/Refractory CD123-Positive Acute Myeloid Leukemia: An Interim Analysis of Italian GIMEMA AML2020 Trial* Publication Number: 2918 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II Poster Presentation December 10, 2023 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Lane et al. Tagraxofusp in Combination with Azacitidine and Venetoclax in Newly Diagnosed CD123+ Acute Myeloid Leukemia, Expansion Cohort of a Phase 1b Multicenter Trial* Publication Number: 4277 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III Poster Presentation December 11, 2023 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Boichut et al. Analysis of tagraxofusp activity in AML-PDC as a single agent and in combination with BCL2 inhibitors* Publication Number: 2783 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Poster II Poster Presentation December 10, 2023 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H Navarro Vicente et al. Clinical Features and Treatment in Patients Diagnosed with Blastic Plasmacytoid Dendritic Cell Neoplasm: Interim Analysis from the Pethema Epidemiologic Registry (EPI-BLAS study)* Publication Number: 4234 613. Acute Myeloid Leukemias: Clinical and Epidemiological: Poster III Poster Presentation December 11, 2023 6:00 PM - 8:00 PM San Diego Convention Center, Halls G-H *Denotes investigator sponsored research or collaborative research About the EMERALD Phase 3 Study (NCT03778931) The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/mBC patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator's choice of an approved hormonal agent. The primary endpoints of the study were progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. In the group of patients whose tumors had ESR1 mutations, elacestrant achieved a median PFS of 3.8 months vs 1.9 months on the SOC, and reduced the risk of progression or death by 45% (PFS HR=0.55, 95% CI: 0.39, 0.77) vs SOC. About ORSERDU® (elacestrant) U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is approved by the U.S. Food & Drug Administration (FDA) for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Full prescribing information for the U.S. can be found at Important Safety Information, ORSERDU® Warning and Precautions Dyslipidemia: Hypercholesterolemia and hypertriglyceridemia occurred in patients taking ORSERDU at an incidence of 30% and 27%, respectively. The incidence of Grade 3 and 4 hypercholesterolemia and hypertriglyceridemia were 0.9% and 2.2%, respectively. Monitor lipid pro to starting and periodically while taking ORSERDU. Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, ORSERDU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ORSERDU and for 1 week after the final dose. Adverse Reactions Serious adverse reactions occurred in 12% of patients who received ORSERDU. Serious adverse reactions in >1% of patients who received ORSERDU were musculoskeletal pain (1.7%) and nausea (1.3%). Fatal adverse reactions occurred in 1.7% of patients who received ORSERDU, including cardiac arrest, septic shock, diverticulitis, and unknown cause (one patient each). The most common adverse reactions (>10%), including laboratory abnormalities, of ORSERDU were musculoskeletal pain (41%), nausea (35%), increased cholesterol (30%), increased AST (29%), increased triglycerides (27%), fatigue (26%), decreased hemoglobin (26%), vomiting (19%), increased ALT (17%), decreased sodium (16%), increased creatinine (16%), decreased appetite (15%), diarrhea (13%), headache (12%), constipation (12%), abdominal pain (11%), hot flush (11%), and dyspepsia (10%). Drug interactions Concomitant use with CYP3A4 Inducers and/or inhibitors: Avoid concomitant use of strong or moderate CYP3A4 inhibitors with ORSERDU. Avoid concomitant use of strong or moderate CYP3A4 inducers with ORSERDU. Use in specific populations Lactation: Advise lactating women to not breastfeed during treatment with ORSERDU and for 1 week after the last dose. Hepatic Impairment: Avoid use of ORSERDU in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of ORSERDU in patients with moderate hepatic impairment (Child-Pugh B). The safety and effectiveness of ORSERDU in pediatric patients have not been established. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or . Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); and ELCIN (NCT05596409). Elacestrant is also being evaluated in early breast cancer disease. About ELZONRIS® (tagraxofusp-erzs) U.S. Indication: ELZONRIS (tagraxofusp-erzs) is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older. Full prescribing information for the U.S. can be found at IMPORTANT SAFETY INFORMATION, ELZONRIS® Boxed WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended. Warnings and Precautions Capillary Leak Syndrome Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range - 1 to 46 days), and all but 5 patients experienced an event in Cycle 1. Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability. Hypersensitivity Reactions ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur. Hepatotoxicity Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved. Adverse Reactions Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST. Please see full Prescribing Information, including Boxed WARNING. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or contact the FDA at 1-800-FDA-1088 or . About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini’s products are available in 140 countries worldwide. For further information, please visit . About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. (“Stemline”) a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes ORSERDU® (elacestrant) in the U.S. and E.U., an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline also commercializes ELZONRIS® (tagraxofusp-erzs), a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States and Europe, which is the only approved treatment for BPDCN in the U.S. and E.U. to date. Stemline also commercializes NEXPOVIO® (selinexor) in Europe, an XPO1 inhibitor for multiple myeloma. Stemline also has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. View source version on businesswire.com: Contacts Media The Menarini Group Valeria Speroni Cardi Email: pressoffice@menarini.com Stemline Therapeutics, Inc. Cheya Pope Email: cpope@menarinistemline.com Source: The Menarini Group and its subsidiary Stemline Therapeutics, Inc. View this news release online at: