• Kia PV5 Cargo earns the top five-star rating in the 2025 Euro NCAP Commercial Van Safety assessment
• Strong performance across key categories, including Occupant Protection, Safety Assist/Crash Avoidance and Post-Crash Safety
• Standard ADAS technologies — including AEB, Lane Support System and Speed Assistance System — deliver high performance in demanding real-world test scenarios
• Latest recognition follows a series of global accolades, including 2026 International Van of the Year (IVOTY) and 2026 Top Gear Awards

SEOUL, South Korea, Dec. 9, 2025 /PRNewswire/ — Kia today announced that the Kia PV5 Cargo has achieved the highest possible five-star rating in the 2025 Euro NCAP Commercial Van Safety assessment, reaffirming the model’s leadership in delivering safe and practical electric mobility for commercial customers across Europe.

Euro NCAP reported that the PV5 Cargo delivered a consistently strong performance across all major evaluation areas, including occupant protection, safety assist & crash avoidance and post-crash safety.

This result positions the PV5 Cargo among Europe’s safest commercial vans and continues Kia’s track record of top-tier Euro NCAP results following the EV6 (2022), EV9 (2023), and EV3 (2025).

“The PV5 opens a new chapter in practical, electrified mobility, offering generous space and modular versatility for everyday use. Achieving the top Euro NCAP five-star rating is clear validation of its safety performance and will serve as strong momentum as Kia expands its PBV lineup across Europe.” – Sangdae Kim, Executive Vice President and Head of PBV Business Division

Advanced safety technologies as standard across Europe

Euro NCAP highlighted the strong performance of the PV5’s standard Autonomous Emergency Braking (AEB) with Forward Collision Warning (FCW), which detects pedestrians, cyclists, and other vehicles.

• Demonstrated strong responsiveness in vehicle-to-vehicle scenarios, even at higher speeds
• Avoided collisions in most pedestrian and cyclist test cases
• Provides additional protection for pedestrians behind the vehicle

The Lane Support System (LSS) was praised for its gentle steering corrections and more assertive interventions in critical situations to prevent unintended road departure. Euro NCAP noted that overall LSS performance was “good.”

The Speed Assistance System (SAS) uses digital maps and a forward-facing camera to identify local speed limits and present clear information to the driver, enabling appropriate speed management.

A standard seatbelt reminder for both front seats further enhances safety compliance.

For more information, visit the Kia Global Media Center at www.kianewscenter.com

 

ABU DHABI, UAE, Dec. 9, 2025 /PRNewswire/ — Abu Dhabi Finance Week (ADFW) 2025 opened today with some of the world’s most influential financial and business leaders engaging in critical discourse around the capital’s evolving economic landscape and strategic role on the world stage.

This year’s ADFW – hosted by ADGM – is the largest and most significant edition of the region’s flagship financial gathering. This edition also witnessed a landmark pledging moment, convened by the Mohamed bin Zayed (MBZ) Foundation for Humanity. Bill Gates, Chair of the Gates Foundation, joined other international leaders, philanthropists, and global health partners to commit a collective USD 1.9 billion for polio eradication.

The official ADFW Opening Ceremony brought together Abu Dhabi’s economic leadership and international delegates for a high-level assembly to catalyse global collaboration and dialogue. It set an ambitious tone for the day, inviting global decision-makers into a conversation defined by trust, legacy, and future connectivity.

In his opening address, H.E. Ahmed Jasim Al Zaabi, Chairman of Abu Dhabi Department of Economic Development (ADDED) and ADGM, stated, “In only four years, ADFW has become one of the most influential financial gatherings in the world. A reflection of an economy that rises with purpose, thinks with clarity and consistently delivers results that reshape global markets. This year, we welcome leaders from across the world representing more than 60 trillion dollars in assets, representing over half the world’s GDP.”

H.E. added , “For twenty-five years, Abu Dhabi held a double-A credit rating, without a single downgrade, and achieved seventeen consecutive quarters of GDP growth, with 6.6 per cent in the last quarter alone. We are the world’s richest city in sovereign wealth, and the region’s leading and largest international financial centre. Our capital markets have grown for six consecutive years, with foreign investment surging four times and now accounting for more than a third of all activity.”

ADEF: Local Momentum Meets Global Ambition

Earlier in the day, the third edition of ADEF brought together UAE Cabinet ministers, sovereign wealth fund executives, CEOs of Abu Dhabi’s industrial champions and international stakeholders to explore Abu Dhabi’s economic diversification, industrial strategy, infrastructure pipeline, and evolving trade partnerships. It also highlighted the progress of the Falcon Economy – with Q2 2025 GDP reaching AED 306.3 billion and non-oil economic growth at 6.6% YoY.

Opening the forum, H.E. Khaldoon Al Mubarak, Managing Director & Group CEO of Mubadala Investment Company, delivered a visionary message,saying, “Today Abu Dhabi is a global centre of capital, AI, energy, innovation and life sciences. We are engineering a globally connected economy built around the sectors and technologies that will define the next generation of global wealth and global growth. Abu Dhabi and our partners in this room will be central to whatever that future becomes. If you believe the world is changing, invest where you can shape that change.“

USD 1.9 Billion Polio Pledge at ADFW

In the afternoon, the global pledging, ‘Investing in Humanity’ panel, was hosted by the MBZ Foundation for Humanity, in partnership with the Global Polio Eradication Initiative (GPEI). Gates was joined on stage by Her Highness Sheikha Mariam bint Mohamed bin Zayed Al Nahyan, Chair of the Mohamed bin Zayed Foundation for Humanity and H.E. Dr. Mekdes Daba, Minister of Health, Ethiopia.

Pledges were made from a diverse group of donors and countries, including USD 1.2 billion from the Gates Foundation; USD 140 million from the Mohamed bin Zayed Foundation for Humanity; USD 450 million from Rotary International; USD 100 million from Bloomberg Philanthropies; USD 154 million from Pakistan and USD 62 million from Germany; USD 46 million from the United States of America; USD 6 million from Japan; $4 million from the Islamic Food & Nutrition Council of America (IFANCA); and USD 3 million from Luxembourg.

“The fight to end polio shows what is possible when the world invests together in a shared goal. We’re 99.9 per cent of the way there – but the last stretch demands the same determination that got us this far,” said Gates. “This renewed funding will help us cross the finish line and strengthen the systems that protect children from this terrible disease for good.”

Newcomers and Major Collaborations

A number of firms announced setting up in ADGM on the inaugural day of ADFW. The Financial Services Regulatory Authority (FSRA) of ADGM formally approved the authorisation of Binance’s global platform, Binance.com, under a comprehensive regulatory framework. Meanwhile, Cantor, a premier global investment bank and Plenary Group, a global infrastructure developer and investor, have secured an In Principle Approval (IPA) from the FSRA and are expanding their Middle East presence.

In another significant announcement, Mubadala and Aldar committed to an AED 60+ billion expansion of the north side of Al Maryah Island . The development will deliver more than 1.5 million sqm of gross floor area, including Grade A offices, luxury homes, retail and hospitality – seamlessly blending commerce, community and lifestyle.

Breakout Events: Insight-Driven, Sector-Focused Dialogues

The opening day also featured a robust agenda of invite-only and public forums. Highlights included Global Markets Summit, a newly added event examined the macroeconomic undercurrents shaping trade flows, investment strategies and the global capital network realignment, CNBC’s New Energy Finance Forum, which convened energy CEOs and the UAE Minister of Energy to examine the intersection of AI, energy demand, and investment flows in the transition economy; the Greenwich Economic Forum, a closed-door gathering of global CEOs and investment leaders, Private Wealth Dialogues, focused on family office strategy and private banking trends; the CEO Global Growth Forum, which brought together portfolio company leaders and the UBS Investor Forum, which explored emerging capital opportunities and cross-border investment flows.

For more details of ADFW, visit www.adfw.com.

What started as a frustration on site has become a global product. 

PETERBOROUGH, England, Dec. 9, 2025 /PRNewswire/ — EV Blocks is proud to share that founder Trevor Palmer has been named Global Entrepreneur of the Year 2025 at The Allica Bank British Entrepreneur Awards.

The story began with Trevor standing on muddy ground, wrestling with shuttering and waiting for concrete to set. He kept asking the same question installers still ask today: 

Why are we building the future of EV charging with processes that slow us down? 

That moment sparked an idea: a faster, cleaner, future-proof foundation for EV charger every time. From a rough sketch to a fully engineered system, that idea became EV Blocks.

Today it’s helping standardise installations across the UK, Australia, North America and France. 

Trevor said:
“I didn’t set out to win awards. I just wanted to fix a problem everyone on site was dealing with. The fact EV Blocks is now used around the world…that’s thanks to the installers, partners and clients who backed the idea early. This award is for them.”

EV Blocks is now helping the industry build more consistently and reliably, even in challenging weather, supporting the rapid global expansion of EV charging networks.

Trevor’s award marks a milestone for the business and the wider EV infrastructure community. It shows what’s possible when a practical problem meets a simple scalable solution.  

The journey started on site.
It’s now a global standard.
And we’re only just getting started.  

More at: EVblocks.com

CONTACT: info@evblocks.com

 

 At Goalkeepers Abu Dhabi, global leaders outline a path to improve and save the lives of millions of children through lifesaving innovation and renewed investment

Partners announce $1.9 billion to advance polio eradication

Event held in partnership with the Mohamed bin Zayed Foundation for Humanity highlights urgency, honors leadership, and showcases champions advancing progress despite historic global funding cuts

ABU DHABI, UAE, Dec. 9, 2025 /PRNewswire/ — At Goalkeepers Abu Dhabi, leaders from government, philanthropy, business, and civil society issued a unified call to accelerate progress on child survival and infectious disease eradication. The appeal was anchored by US$1.9 billion in commitments to advance polio eradication announced earlier in the day at Abu Dhabi Finance Week.

The Gates Foundation contributed US$1.2 billion, reflecting its long-term commitment to a future where no mother, baby, or child dies from preventable causes, and where deadly infectious diseases like polio are eliminated forever.

Co-hosted by the Gates Foundation and the Mohamed bin Zayed Foundation for Humanity, Goalkeepers Abu Dhabi brought together more than 500 global leaders. The leaders delivered a clear message: the world must act now to reverse rising child deaths, stop preventable maternal deaths and finish the job of ending preventable diseases, starting with polio.

Held in the Middle East and North Africa region for the first time, the event marks a significant expansion of Goalkeepers to audiences across the region and underscores the UAE’s growing leadership in child health. Together, the leaders delivered a clear message: the world must act now to reverse rising child deaths and finish the job of ending preventable diseases, starting with polio.

New data from the Gates Foundation’s 2025 Goalkeepers Report shows that the number of children dying before age 5 is projected to rise for the first time in a century. Leaders stressed that this turning point demands bold choices, renewed financing, and commitment to scaling innovations that can save millions of lives by 2045.

$1.9 Billion in New Commitments Toward Polio Eradication Announced

Earlier in the day in the pledging event convened by the Mohamed bin Zayed Foundation for Humanity, countries, philanthropic foundations, and development partners announced US$1.9 billion including approximately US$1.2 billion in newly pledged funds that reduce the remaining resource gap for the Global Polio Eradication Initiative’s (GPEI) 2022-2029 Strategy to $440 million. This funding will strengthen global health systems, expand immunization, and accelerate progress toward polio eradication.

“Far too many children are still dying from diseases we know how to prevent,” said Bill Gates, chair of the Gates Foundation. “The tools exist—vaccines, treatments, and proven delivery strategies—and countries are working hard to get them to those who need them most. The support announced today will strengthen those efforts, protect the most vulnerable children, and help the world stay on course to end polio for good.”

The pledges reflect the growing recognition that even in a constrained global fiscal environment, strategic investment in human health delivers unmatched returns.

A significant portion of the funding will support child survival efforts: expanding vaccine access, protecting newborns, and sustaining critical immunization programs in fragile and conflict-affected settings.

With polio now 99.9% eradicated, leaders stressed that closing the final gap is both a moral imperative and proof that coordinated global action can defeat even the toughest diseases.

“Polio eradication is within reach and today’s generous pledges bring us closer than ever to this goal,” said Her Excellency Dr Shamma Khalifa Al Mazrouei, Acting Director General of the Mohamed bin Zayed Foundation for Humanity. “Both Goalkeepers Abu Dhabi and today’s pledging moment underscore what is possible when countries and donors act together: a world free from polio and a healthier, more resilient future for all.”

Under the leadership of His Highness Mohamed bin Zayed Al Nahyan, President of the UAE, the Mohamed bin Zayed Foundation for Humanity works with partners to accelerate progress towards a healthier and more equitable world.

His Highness Sheikh Mohamed bin Zayed Al Nahyan has personally committed US$525 million since 2011 to polio eradication, helping to reach more than 400 million children each year with vaccines.

Goalkeepers Abu Dhabi: Imagine the Possible

This year’s Goalkeepers Abu Dhabi theme, “Imagine the Possible,” spotlighted what the world can achieve with courage, partnership, and innovation.

Key moments included:

• An address by His Highness Sheikh Abdullah bin Zayed Al Nahyan, Deputy Prime Minister and Minister of Foreign Affairs, honoring H.H. Sheikha Fatima bint Mubarak, “Mother of the Nation,” and celebrating decades of progress for women and children
• Host David Oyelowo, acclaimed actor and advocate, guiding the evening with purpose and urgency
• CNN International’s Managing Editor Becky Anderson bringing Bill Gates and Her Excellency Reem Al Hashimy, UAE minister of state for international cooperation, together on stage
• Ramesh Ferris, polio survivor and global champion, delivering a powerful call to achieve eradication
• Storytelling performances from global changemakers sharing lived experiences on child survival and equity
• A standout musical performance by Adekunle Gold that energized the audience with a message of resilience and hope

These voices illustrate that progress is possible when the world commits to it.

About the Gates Foundation

Guided by the belief that every life has equal value, the Gates Foundation works to help all people lead healthy, productive lives. In developing countries, we work with partners to create impactful solutions so that people can take charge of their futures and achieve their full potential. In the United States, we aim to ensure that everyone—especially those with the fewest resources—has access to the opportunities needed to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Bill Gates and our governing board.

About Goalkeepers

Goalkeepers is the foundation’s campaign to accelerate progress toward the Sustainable Development Goals (Global Goals). By sharing stories and data behind the Global Goals through an annual report, the Gates Foundation hopes to inspire a new generation of leaders—Goalkeepers who raise awareness of progress, hold their leaders accountable, and drive action to achieve the Global Goals.

Media Contact: media@gatesfoundation.org

 

 

PROVIDENCE, R.I., Dec. 9, 2025 /PRNewswire/ — EpiVax, Inc., with U.S. Food and Drug Administration (FDA) and CUBRC, Inc. (Buffalo, NY) scientist collaborators, announces the publication of a study titled “Immunogenicity Risk Assessment of Peptide-Related Impurities Identified in Generic Teriparatide Products.” The study uses a series of different tools to evaluate whether peptide-related impurities may influence unwanted immune responses in generic teriparatide (TPT)—an important consideration for ensuring the safety and comparability of generic peptide drugs.

Teriparatide, a recombinant peptide used to treat osteoporosis, is among the peptide products highlighted in a recent FDA guidance that recommends that applicants assess immunogenicity risk for synthetic generics submitted under an abbreviated new drug application (ANDA). While establishing active pharmaceutical ingredient sameness is a key regulatory requirement, impurities arising from manufacturing processes may introduce sequence changes with the potential to generate new “T-cell epitopes”.

The study systematically evaluates teriparatide and several theoretical or observed impurities using the orthogonal methods of EpiVax’s PANDA approach: in silico assessment (leveraging T-cell epitope prediction and characterization tools, EpiMatrix^® and JanusMatrix^®), in vitro HLA binding assays, and human T-cell assays.

The investigators identified multiple impurities with higher predicted immunogenic potential than the reference teriparatide sequence, using the computational tools. Experimental analyses corroborated these predictions, revealing enhanced HLA binding and T-cell responses for several impurities compared to teriparatide itself. Notably, the study revealed a potentially tolerogenic region within the teriparatide sequence that may reduce responses to the drug, but that could be disrupted by sequence changes in the impurities.

“This collaboration with FDA scientists underscores the power of combining robust computational and wet-lab methods to better understand and mitigate immunogenicity risks in generic peptide development,” said Dr. Vibha Jawa (CSO, EpiVax). “Our findings offer a practical framework for developers navigating the FDA guidance on impurity assessment and highlight opportunities to strengthen peptide drug safety.”

The study may help generic peptide manufacturers identify impurities of concern that would contribute to immunogenicity and thus should be controlled in the generic drug product.

FDA Funding Statement
The research described was performed by EpiVax in collaboration with CUBRC, Inc. and FDA contributors, supported by FDA contract HHSF223018186C. The contents of this release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Press Contact:
Sarah Moniz
Director, Business Development
SMoniz@EpiVax.com

Logo – https://laotiantimes.com/wp-content/uploads/2025/12/epivax_logo.jpg 

• In addition, the expansive elacestrant clinical development program updates reinforce its potential as a backbone endocrine therapy in combination settings, as well as in both metastatic and early stage breast cancer.

FLORENCE, Italy and NEW YORK, Dec. 8, 2025 /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, will present updated meaningful median progression-free survival (mPFS) efficacy results from two combination regimens of the Phase 2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). The ELEVATE study was designed to evaluate the safety and efficacy of oral-oral combination treatment options to overcome different resistance mechanisms observed in ER+/HER2- mBC with the goal of improving patient outcomes. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS), December 9-12.

“The encouraging progression-free survival data increase our confidence in the role elacestrant could play as an endocrine therapy backbone in the combination setting,” said Virginia Kaklamani, MD, DSc, Professor of Medicine in the Division of Hematology/Oncology at UT Health San Antonio, and Leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center. “The safety profile of elacestrant in combination with everolimus or abemaciclib is consistent with the known safety profiles of each drug. No new safety signals have been observed.”

The ELEVATE data to be presented at SABCS demonstrate that elacestrant in combination with everolimus or with abemaciclib shows a consistent PFS benefit, irrespective of ESR1 mutation status in patients with ER+/HER2- mBC, who experience disease progression on endocrine therapy (ET), with or without prior exposure to CDK4/6 inhibitors. These updated results also show that the safety of the combinations are consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy.

Phase 2 mPFS in months (95% CI) in all patients and subgroups

 

“The extensive evidence for elacestrant spans the monotherapy setting in our pivotal EMERALD study, now backed by two recent real-world data publications^{[1], [2]}, and in its growing potential in combination regimens, as highlighted by the data presented at SABCS,” said Elcin Barker Ergun, CEO of the Menarini Group. “We remain deeply committed to fully exploring elacestrant’s potential benefit across multiple ongoing trials in both early stage and metastatic breast cancer.”

Additionally, other elacestrant updates will be presented at SABCS, investigating its potential across the spectrum of breast cancer:

Presentation Title: Elacestrant in combination with everolimus or abemaciclib in patients with ER+/HER2-locally advanced or metastatic breast cancer (mBC): phase 2 results from ELEVATE, an open-label, umbrella study
Abstract Number: 1255
Presentation Date & Time: Thursday, December 11, 2025, 1:00 – 2:00 PM
Location: Hemisfair1-2
Presenting Author: Hope S. Rugo

Presentation Title: Elacestrant alone or in combination with triptorelin in premenopausal women with ER+/HER2-early breast cancer: primary analysis from the phase 2 SOLTI-2104-PremiÈRe trial
Abstract Number: 1123
Presentation Date & Time: Friday, December 12, 2025, 7:30 – 7:33 AM
Location: 301 ABC
Presenting Author: Mertixell Bellet

Presentation Title: ELEGANT: Elacestrant Versus Standard Endocrine Therapy (ET) in Women and Men With Node-positive, Estrogen Receptor-positive (ER+), HER2-negative (HER2-), Early Breast Cancer (eBC) With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-label Phase 3 Study.
Abstract Number: 1276
Presentation Date & Time: Thursday, December 11, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Aditya Bardia

Presentation Title: The ADELA study: A Double-blind, Placebo-controlled, Randomized Phase 3 Trial of Elacestrant (ELA)+ Everolimus (EVE) Versus ELA + Placebo (PBO) in ER+/HER2-Advanced Breast Cancer (aBC) Patients with ESR1-mutated Tumors Progressing on Endocrine Therapy (ET) + CDK4/6i
Abstract Number: 1141
Presentation Date & Time: Wednesday, December 10, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Antonio Llombart-Cussac

Presentation Title: ERADICATE: A phase Ib/II study of elacestrant plus trastuzumab deruxtecan in patients with CDK4/6 inhibitor and endocrine-resistant HR+/HER2-low or HER2-ultralow metastatic breast cancer
Abstract Number: 2119
Presentation Date & Time: Friday, December 12, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Sara L. Sammons

Presentation Title: Hormonal receptor (HR)-positive HER2 negative breast cancer patients treated with preoperative Elacestrant and PULSAR adaptive radiotherapy: a phase II study (HELP Trial)
Abstract Number: 1071
Presentation Date & Time: Friday, December 12, 2025, 12:30 – 2:00 PM
Location: Henry B. Convention Center
Presenting Author: Luca Visani

About The Elacestrant Clinical Development Program

Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. 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. 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. 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.

About ORSERDU (elacestrant)
U.S. Indication: ORSERDU (elacestrant), 345 mg tablets, is 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.

Full prescribing information for the U.S. can be found at www.orserdu.com.

Important Safety Information
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 profile prior 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 www.fda.gov/medwatch.

About The Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of $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.

[1] Lloyd et al. Clinical and genomic factors associated with elacestrant outcomes in ESR1-mutant metastatic breast cancer. Clin Cancer Res (2025). https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-3033/768341/Clinical-and-Genomic-Factors-Associated-with

[2] Rugo et al. Real-World Outcomes of Elacestrant in ER+, HER2-, ESR1-mutant Metastatic Breast Cancer. Clin Cancer Res, 2025. CCR-25-3040R1. https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-3040/768340/Real-World-Outcomes-of-Elacestrant-in-ER-HER2-ESR1

AUSTIN, Texas, Dec. 9, 2025 /PRNewswire/ — Abracon, a leading provider of timing, frequency control, power, magnetics, RF, and antenna solutions, has announced significant enhancements to its global operations to meet the rising demand for its MEMS (Micro-Electro-Mechanical Systems) oscillator portfolio.

The company has expanded manufacturing capacity, increased global production redundancy, and introduced a new Quick-Turn Service, delivering faster, more reliable access to high-performance timing components. These improvements bolster Abracon’s ability to serve customers in IoT, industrial, communications, and automotive markets requiring dependable timing solutions.

Expanding Supply Resilience and Speed
To strengthen product availability and minimize disruptions, Abracon has increased both domestic and international supply chain redundancy and boosted on-hand inventory of high-demand MEMS oscillator part numbers. This expanded logistics network supports consistent, timely delivery worldwide.

A key element of this initiative, Abracon’s in-house Quick-Turn Service, enables customers to receive custom MEMS oscillators programmed to any frequency within five business days. Ideal for prototypes and low-volume production, this service leverages in-house programming and inventory to accelerate development cycles. For larger-scale needs, Abracon maintains extensive stocked options through its global distribution partners.

Reliable, Configurable MEMS Timing Solutions
With over 6,500 part numbers, Abracon’s MEMS oscillators deliver low-power operation, tight stability, wide temperature ranges, compact packaging, and multiple output options, ensuring easy integration across diverse applications.

“Abracon is recognized as one of the most responsive and reliable timing partners in the industry, and we’re committed to building on that operational excellence,” said Kevin Lemon, Global VP of Product and Marketing. “By investing in scalable MEMS infrastructure and accelerating customer-customizable quick-turn options, we’re giving engineers greater flexibility and confidence to move from concept to production and get their products to market faster.”

These enhancements reaffirm Abracon’s commitment to delivering dependable MEMS timing solutions supported by a robust, responsive, and globally resilient supply chain.

About Abracon, LLC | Innovation For Tomorrow’s Designs

Headquartered outside of Austin, Texas, Abracon is a trusted supplier of leading-edge and innovative electronic components including Frequency Control, Timing, Power, Magnetics, RF and Antenna solutions. Servicing world-class companies across data communication, transportation, industrial, medical, consumer, aerospace, and defense industries, Abracon accelerates customers’ time-to-market by providing unmatched product solutions, technical expertise, and service excellence.