Menarini Group reports data from the Phase 3 SENTRY trial of selinexor plus ruxolitinib in myelofibrosis at The European Hematology Association (EHA) 2026 Congress. * The combination of selinexor plus ruxolitinib met the first co-primary endpoint demonstrating a statistically significant improvement of spleen volume reduction (SVR35) of 49.8% for the combination arm vs 28% for the control arm at week 24. * Post-hoc analysis from the phase 3 SENTRY trial suggests SVR35 may predict overall survival (OS); new data from the phase 1 SENTRY trial demonstrates a similar finding. * Data selected by EHA's Scientific Program Committee for late-breaking oral presentation. * Data stems from the pivotal study conducted in collaboration with Karyopharm Therapeutics, Inc. FLORENCE, Italy and NEW YORK, June 14, 2026 - The Menarini Group ("Menarini"), a leading international 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 that new data related to the pivotal Phase 3 SENTRY trial will be presented as a late-breaking oral[1] at The European Hematology Association (EHA) 2026 Congress. SENTRY (NCT04562389), a pivotal Phase 3 trial, is a randomized, double-blind, placebo-controlled trial of 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis (MF) (n=353), versus ruxolitinib monotherapy. Conducted by Karyopharm Therapeutics, Inc., in collaboration with the Menarini Group, SENTRY was designed to evaluate two co-primary endpoints: spleen volume reduction of 35% or more (SVR35) and absolute total symptom score (Abs-TSS). The trial met the first co-primary endpoint, demonstrating that patients who were treated with the combination of selinexor plus ruxolitinib achieved a clear and statistically significant improvement in SVR35, compared to patients who received ruxolitinib alone. These results highlight that the combination arm enabled rapid, deep and sustained spleen volume reductions. | / | selinexor plus ruxolitinib (n=235) | placebo + ruxolitinib (n=118) | | SVR35 at week 12 | 49.4% (n=116) | 20.3% (n=24) | | SVR35 at week 24 | 49.8% (n=117) | 28.0% (n=33) | | SVR35 at week 36* | 46.9% (n=97) | 23.0% (n=23) | *Analysis conducted in those patients who completed a spleen assessment or discontinued the study prior to week 36 "Achievement of spleen reduction is the essential goal of myelofibrosis treatment. Importantly, the spleen reduction results seen in SENTRY were rapid, deep and durable, and associated with potential overall survival benefit for the patients receiving the combination," said Dr. Claire Harrison, Professor of Myeloproliferative Neoplasms and Deputy Chief Medical Officer at Guy's and St. Thomas' NHS Foundation Trust. "We are encouraged that these results represent a potential new therapeutic advance for our patients who are in dire need of better options." Other key highlights include: * Absolute Total Symptom Score (Abs-TSS): The combination arm demonstrated a comparable benefit to ruxolitinib alone, with a 9.9 point improvement in Abs-TSS at week 24, in patients who received the combination, compared to a 10.9 point improvement in patients who received ruxolitinib alone. The difference across the two arms was not statistically significant, and the combination arm did not meet this second co-primary endpoint. * Overall Survival (OS): While these data were immature at the time of analysis, a promising early OS signal, a pre-specified secondary endpoint, was observed with the selinexor combination compared to ruxolitinib alone. The study showed a greater than 50% reduction in the risk of death for patients receiving the selinexor combination (HR 0.43). * Spleen Volume Reduction: Consistent SVR35 benefit was observed across prespecified subgroups. Notably, at week 24, superior spleen volume reduction was achieved by the selinexor combination, regardless of the ruxolitinib dose, including by patients receiving less than 15 mg of ruxolitinib per day. * Variant Allele Frequency (VAF) Reduction: This pre-specified exploratory endpoint, which is associated with SVR35, was observed in 32% of patients in the selinexor plus ruxolitinib arm at week 24 versus 23.9% of patients treated with ruxolitinib alone, indicating the combination's potential for disease modification. * Safety and Tolerability: The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed. "The strength of the spleen response and the encouraging early overall survival data observed in the SENTRY study creates hope for a potential new treatment option for patients suffering from this devastating disease with dismal outcomes," said Elcin Barker Ergun, CEO of the Menarini Group. "Our dedication and commitment to bring transformational treatments to patients facing cancer is stronger than ever." About Myelofibrosis (MF) Myelofibrosis (MF) is a type of blood cancer that belongs to a group of diseases called Myeloproliferative Neoplasms (MPNs). These diseases are caused by the overgrowth of abnormal blood-forming cells in the bone marrow, which leads to the formation of scar tissue. This scarring makes it difficult for the body to produce healthy blood cells. The incidence of MF is rare, with only about one or two people diagnosed each year for every 100,000 individuals, and the median survival after diagnosis is six years. Additionally, for people living with MF, their quality of life can be compromised by symptoms including fatigue, an enlarged spleen, and low blood counts, all of which are caused by the disease. 1,[2],[3] To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at [email protected]. All of the relevant information can be found at https://stemline.com/contact/ Please see Summary of Product Characteristics (SmPC) and European Public Assessment Report at www.ec.europa.eu. Please refer to local prescribing information where selinexor is approved for full information. Menarini Group holds licensing rights for selinexor and currently markets it in numerous European countries and global territories. In the U.S., Karyopharm Therapeutics markets selinexor and the full prescribing information is available here. About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 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 www.menarini.com. About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, 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, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. Media Contacts The Menarini Group Valeria Speroni Cardi Email: [email protected] [1] The safety and efficacy of the investigational combinations and unapproved indications discussed in this press release have not been established by the FDA, EMA, or any other regulatory authority.

ADCAN Pharma, Menarini partner to strengthen UAE's pharmaceutical manufacturing industry. WAM 11 Jun 2026, 21:25 GMT+ ABU DHABI, 11th June May, 2026 (WAM) - ADCAN Pharma, a leading UAE-based pharmaceutical manufacturer distinguished as the nation's first producer of oncology and hormone products, has announced a formal partnership with Menarini, an international pharmaceutical company headquartered in Italy. The partnership represents a significant milestone for ADCAN Pharma as it expands its role as a regional pharmaceutical manufacturing hub and preferred localisation partner for multinational pharmaceutical companies operating across the GCC. The partnership was formalised during a signing ceremony held at ADCAN Pharma's state-of-the-art manufacturing facility in Abu Dhabi. Under the agreement, ADCAN Pharma will locally manufacture and facilitate the batch release of selected Menarini pharmaceutical products within the UAE, leveraging its advanced Good Manufacturing Practice (GMP) infrastructure and robust regulatory capabilities. Through the combined expertise of both entities, the collaboration will contribute to enhancing medicine availability, reducing supply chain risks and facilitating faster patient access to critical therapies across the UAE. The signing ceremony was attended by Dr Shaikha Al Mazrouei, Director of the Research and Laboratories Department at the Emirates Drug Establishment, senior representatives from ADCAN Pharma and various healthcare institutions, as well as key industry stakeholders. Dr Fokion Sinis, Chief Executive Officer of ADCAN Pharma, said, "This partnership with Menarini aligns with our long-standing mission to strengthen the UAE's pharmaceutical manufacturing landscape. Moreover, by combining Menarini's global expertise with ADCAN Pharma's advanced manufacturing and batch-release capabilities, we are supporting the national vision to nurture a resilient and sustainable pharmaceutical ecosystem. The collaboration also reinforces our role as a trusted local manufacturing partner for international pharmaceutical companies while facilitating improved access to high-quality medicines across the region." The partnership represents Menarini's first pharmaceutical localisation initiative in the UAE, establishing the foundation for future collaborations supporting the regional healthcare sector. The agreement is expected to enhance ADCAN Pharma's manufacturing portfolio, increase production capacity utilisation and generate new revenue streams, while strengthening the company's technical expertise and standing within the global pharmaceutical industry. Dr. Basel Thaher, Regional Head Middle East & Africa & General Manager of Menarini said, "The UAE continues to set a strong benchmark for healthcare innovation, localisation and long-term sector development. Through our partnership with ADCAN Pharma, we are supporting the country's vision of building sustainable local pharmaceutical capabilities while ensuring patients have timely access to high-quality medicines. This collaboration combines Menarini's global expertise with ADCAN Pharma's excellence to strengthen supply chain resilience, support healthcare self-sufficiency and ultimately deliver better outcomes for patients across the UAE." Through strategic partnerships with global pharmaceutical companies, ADCAN Pharma continues to advance its role as a regional pharma manufacturing and regulatory specialist. Led by its commitment to innovation, quality and affordability, the company continues to deliver world-class healthcare solutions across the GCC and international markets, aligning with 'We the UAE 2031' vision.

Menarini Group Announces New Data at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. EQS-News: Menarini Industrie Farmaceutiche Riunite / Key word(s): Miscellaneous/Miscellaneous Menarini Group Announces New Data at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting 25.05.2026 / 12:50 CET/CEST The issuer is solely responsible for the content of this announcement. * Data spans seven presentations across both solid tumors and hematologic malignancies, providing updates on the potential benefit these therapies may bring to patients. * Data from the elacestrant plus capivasertib regimen of the ELEVATE study will be presented underscoring its potential in combination settings in mBC, along with updates from the elacestrant clinical development program, including its potential role as a monotherapy option in adjuvant breast cancer. * Stemline's partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in myelofibrosis "FOR MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY" FLORENCE, Italy and NEW YORK, May 25, 2026 /PRNewswire/ - The Menarini Group ("Menarini"), a leading international 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 that new data related to elacestrant and tagraxofusp will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. New data exploring the safety and preliminary efficacy of elacestrant in combination with capivasertib in patients with ER+/HER2- PI3K/AKT/PTEN- pathway altered metastatic breast cancer (mBC) from the phase 1/2 ELEVATE study will be presented. Additional details on ongoing studies of elacestrant in combination, in the advanced setting, will be shared: ADELA (pivotal phase 3 combination with everolimus); ELECTRA (phase 1b/2 combination with abemaciclib in patients with brain metastases); and CAPELA (phase 2 combination with capecitabine). Lastly, an update from the ELEGANT study, exploring elacestrant as adjuvant treatment in node-positive early breast cancer with high risk of recurrence, will be presented at the congress. Also accepted for presentation is new phase 2 tagraxofusp combination data in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), which will be presented by Naveen Pemmaraju, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Additionally, Stemline's partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in JAKi naïve patients with myelofibrosis (MF). Selinexor is marketed in the U.S. by Karyopharm Therapeutics, and in the EU by Stemline. "The extensive oncology data that will be presented, encompassing both solid tumors and hematologic malignancies, highlights our dedication to tackling the most difficult-to-treat cancers with high unmet needs," said Elcin Barker Ergun, CEO of the Menarini Group. "Our focus remains on accelerating innovation to provide transformational, targeted therapies that offer meaningful advances to patients and the healthcare communities dedicated to their care." See below for full details of upcoming presentations: | 2026 American Society of Clinical Oncology (ASCO) Annual Meeting | | Lead Author | Abstract Title and ID | Presentation Details | | Elacestrant | | Wassim McHayleh | Elacestrant in combination with capivasertib in patients with ER+/HER2- advanced breast cancer: Update from ELEVATE, a phase 1b/2 open-label, umbrella study Abstract: 1098 | June 1, 2026; 1:30 - 4:30 PM CT Poster Board 212 | | Aditya Bardia | ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study Abstract: TPS1153 | June 1, 2026; 1:30 - 4:30 PM CT Poster Board 262a | | Antonio Llombart- Cussac | ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant + everolimus versus elacestrant + placebo in ER+/HER2- advanced breast cancer patients with ESR1-mutated tumors progressing on endocrine therapy + CDK4/6i*[#] Abstract: TPS1154 | June 1, 2026; 1:30 - 4:30 PM CT Poster Board 262b | | Nuhad Ibrahim | ELECTRA: An open-label multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis from ER+/HER2- breast cancer Abstract: TPS1155 | June 1, 2026; 1:30 - 4:30 PM CT Poster Board 263a | | Kristina Fanucci | CAPELA: A phase II multicenter open-label randomized study of capecitabine in combination with elacestrant versus capecitabine alone in advanced estrogen receptor (ER)-positive breast cancer (TBCRC 070)* Abstract: TPS1156 | June 1, 2026; 1:30 - 4:30 PM CT Poster Board 263b | | Tagraxofusp | | Naveen Pemmaraju | A Phase II Trial of Tagraxofusp, Hyper-CVAD, and Venetoclax for Patients with Newly Diagnosed or Relapsed/Refractory BPDCN* Abstract: 6502 | Oral Presentation June 2, 2026; 10:09 - 10:21 am CT | | Selinexor | | John Mascarenhas | Selinexor plus ruxolitinib in JAK inhibitor-naïve myelofibrosis: Phase 3 SENTRY trial* Abstract: LBA6500 | Oral Presentation June 2, 2026; 9:45 am - 12:45 pm CT | | *Denotes investigator sponsored research or collaborative research #The ADELA study is a pivotal study co-sponsored with MEDSIR | About The Elacestrant Clinical Development Program Elacestrant is also being investigated in several company-sponsored clinical trials in breast cancer disease, alone or in combination with other therapies. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease. To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at [email protected]. All of the relevant information can be found at https://stemline.com/contact/ About The Menarini Group The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $5.5 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 www.menarini.com. About Stemline Therapeutics Inc. Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, 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, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers. 25.05.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. The issuer is solely responsible for the content of this announcement. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. View original content: EQS News 2332886 25.05.2026 CET/CEST