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/C O R R E C T I O N — OHI Group S.A./

LUXEMBOURG, May 30, 2025 /PRNewswire/ — OHI Group S.A., a société anonyme organized under laws of Luxembourg (the “Issuer”), today announced that it intends to confidentially submit a draft registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the “SEC”) relating to a proposed initial public offering of its ordinary shares in the United States.

The timing, number of ordinary shares to be offered and the price range for the proposed offering have not yet been determined. The proposed initial public offering is subject to market and other conditions, including completion of the SEC’s review of the registration statement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations of offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”). This announcement is being issued in accordance with Rule 135 under the Securities Act.

Contact:
Ivan Coyard
Group CFO
Phone: (+351) 910019317
e-mail: ivan.coyard@ohi.pt 

 

Concord Healthcare Announces Official Release of the Proton Therapy Large Model

BEIJING, May 30, 2025 /PRNewswire/ — Concord Healthcare Group Co., Ltd. (“Concord Healthcare”), a subsidiary of Concord Medical Services Holdings Limited (the “Company”) (NYSE: CCM), which subsidiary is listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “HKSE”) under the stock code 2453.HK, announced that Concord Healthcare had made important progress in precise tumor diagnosis and treatment technology. Concord Healthcare’s self-developed large language model (“LLM”) in the vertical field of proton therapy was officially released and successfully deployed in Guangzhou Concord Cancer Hospital. Since the commencement of the proton therapy in Guangzhou Concord Cancer Hospital, the proton therapy has completed a number of high-quality patient treatment cases, demonstrating the outstanding advantages of precise treatment, significant efficacy, and reduced side effects.

Concord Healthcare’s proton LLM is the first LLM focusing on proton therapy in China, and its research and development relies on the tumor diagnosis and treatment technology system and massive data accumulated by Concord Healthcare over the years. It integrates nearly 10,000 high-quality radiotherapy cases to construct multimodal medical data, and also integrates data from Proton China and professional journal literature to achieve enhancement of model training.

The Company previously announced the listing of Concord Healthcare’s H shares on the HKSE on January 9, 2024. The information related to Concord Healthcare’s Transactions on the HKSE is accessible through the HKSE’s website at www.hkexnews.hk.

About Concord Medical

Concord Medical Services Holdings Limited is a healthcare provider featuring a full cycle of premium oncology services including cancer diagnosis, treatment, education and prevention. The Company focuses on providing multidisciplinary cancer care in all aspects of oncology healthcare services in its cancer hospitals and equipping them with technologically advanced equipment such as the state-of-the-art proton therapy system. The Company is striving to improve the quality and accessibility of cancer care through its network of self-owned cancer hospitals and clinics as well as partnered hospitals across China. For more information, please see http://ir.ccm.cn.

About Concord Healthcare

Concord Healthcare is an oncology healthcare provider in China. Concord Healthcare serves both cancer patients through self-owned medical institutions and third-party medical institutions through medical equipment, software and related services. In its self-owned medical institutions, Concord Healthcare provides a full spectrum of oncology healthcare services to cancer patients across the entire care continuum, leveraging its multidisciplinary team specialists and diagnosis and treatment capabilities featuring precision radiation therapy. Through its medical equipment, software and related services, Concord Healthcare serves a widespread network of enterprise customers, primarily hospitals, with integrated oncology-related services, including primarily sales and installing of medical equipment and software, management and technical support, and operating lease.

Safe Harbor Statement

This announcement contains forward-looking statements. These forward-looking statements can be identified by words or phrases such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar expressions. Forward-looking statements are inherently subject to uncertainties and contingencies beyond the Company’s control and based upon premises with respect to future business decisions, which are subject to change. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. The Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

 

New CE Summit Focuses on Veterinary Neurosurgery, Innovation, and Collaboration

BOZEMAN, Mont., May 30, 2025 /PRNewswire/ — Bridger Veterinary Specialists (BVS) proudly announces the inaugural BVS Neurosurgery Summit — a premier, two-and-a-half-day event focused on advancing the field of veterinary neurosurgery. Tailored for specialists and residents within ACVIM (Neurology), ECVN, ACVS, and ECVS, the summit will provide cutting-edge education, collaboration, and hands-on experience. 

Canine Vertebral Stabilization
Canine Vertebral Stabilization

The summit will take place September 19–21, 2025, at the Kimpton Armory Hotel in beautiful Bozeman, Montana. An optional hands-on dry lab will also be offered on September 22 at the BVS hospital.

This summit provides a unique opportunity for veterinary neurologists, surgeons, house officers, and students to engage in collaborative learning and professional development.

Event Highlights  

Expert-Led Sessions: Attendees will gain up to 14 hours of RACE-pending Continuing Education (CE) through case-based insights, research-driven lectures, expert-led discussions, and a half-day dry lab

Specialist-Level Lectures & Roundtables: Topics include intracranial surgery, skull reconstruction, minimally invasive neurosurgical techniques, spinal biomechanics, implant decision-making, comparative neurosurgery strategies, and advances in lumbosacral surgery.

Networking Opportunities: The summit fosters collaboration among peers and thought leaders in a picturesque mountain setting conducive to learning and recharging. 

Summit Registration Details

  • Residency-Trained Specialists:
  • $400 early bird pricing until July 1 – $500 thereafter
  • House Officers & Students: Complimentary
  • Meals: Complimentary breakfast and lunch provided

Dry Lab Registration Details:

  • $250 per attendee — space is limited.

For more information and to register, please visit the official summit website: https://bvspets.vet/neuro-summit 

Media Contact:
Marketing Director
marketing@bvspets.com
406-920-0160

 

VEX Robotics and RECF Partner with Saudi Federation to Enhance STEM Education in Saudi Arabia

Advancing STEM Learning with Innovative Robotics and Global Competition Access

RIYADH, Saudi Arabia, May 30, 2025 /PRNewswire/ — VEX Robotics, a global leader in educational robotics, and the Robotics Education & Competition Foundation (RECF) have announced an exciting partnership with the Saudi Federation of Robotics and RC Sports. This collaboration aims to significantly advance STEM (Science, Technology, Engineering, and Mathematics) education across Saudi Arabia by integrating cutting-edge robotics technology into classrooms and competitions.

This strategic partnership represents an important step in equipping Saudi students with world-class educational tools and platforms, aligning with the Kingdom’s technological innovation and youth empowerment vision. By fostering a culture of STEM excellence, this initiative will open new pathways for students to explore robotics, develop critical skills, and engage in global robotics competitions.

“We are thrilled to partner with the Saudi Federation of Robotics and RC Sports to bring the transformative power of robotics to students across Saudi Arabia,” said Tony Norman, CEO and founder of VEX Robotics. “This collaboration is about inspiring the next generation of innovators and problem-solvers by providing them with the tools they need to succeed in a rapidly evolving world.”

VEX Robotics offers a hands-on robotics education solution called the VEX Continuum, designed to engage students from elementary through university levels. The RECF organizes the world’s largest global robotics competition, encouraging students to apply classroom learning, develop hands-on problem-solving skills, and collaborate with peers in dynamic environments.

“We are honored to partner with VEX Robotics and RECF to enhance the robotics landscape in Saudi Arabia,” said Abdullah Alsunaydi, CEO of the Saudi Federation of Robotics and RC Sports. “This partnership supports our mission to cultivate a knowledge-driven society, nurture innovation, and create new opportunities for our youth.”

The collaboration will focus on expanding access to robotics education by providing teacher training and resources and establishing local, regional, and national competitions. These initiatives inspire students to explore STEM and build confidence in science, technology, and engineering careers.

Looking ahead, VEX Robotics, RECF, and the Saudi Federation aim to establish a sustainable ecosystem for robotics education in Saudi Arabia. Through this partnership, students will gain opportunities to compete on the global stage, representing Saudi Arabia in international competitions.

For more information on this groundbreaking initiative or to access exclusive resources from VEX Robotics and RECF, visit vexrobotics.com or recf.org

About VEX Robotics: VEX Robotics is a leading global educational and competition robotics solution provider. With a mission to inspire through hands-on learning, VEX offers a complete ecosystem of robotics hardware and software designed for engagement from elementary through university levels.

About Robotics Education & Competition Foundation: The RECF seeks to increase student interest in STEM by providing accessible robotics-based programs. It manages the world’s largest robotics competition, the VEX Robotics World Championship, inspiring critical skills development through hands-on experiences.

About the Saudi Federation of Robotics and RC Sports: The Federation promotes technological education within Saudi Arabia through programs encouraging youth participation in robotics that align with the nation’s vision for an innovative society.

VEX Robotics Media Contact
Madeleine Martin
FINN Partners
madeleine.martin@finnpartners.com
224.436.5267

REC Foundation Media Contact
Jenn Goonan
Rocket Social Impact
jenn@rocketsocialimpact.com
617.947.0971

The Saudi Federation for Robotics & RC Sports
The Saudi Federation for Robotics & RC Sports

 

Saudi Arabia at VEX Worlds
Saudi Arabia at VEX Worlds

 

Databricks Grows Operations in Costa Rica with New Office Expansion, Deepens Investment in Latin America

HEREDIA, Costa Rica, May 30, 2025 /PRNewswire/ — Databricks, the Data and AI company, today celebrated the opening of its new office in the America Free Zone (AFZ) in Heredia, Costa Rica, marking a significant milestone in its ongoing investment in Latin America. The company’s Costa Rica team has expanded to approximately 200 employees, reflecting the rapid growth and deep commitment to the country’s exceptional talent pool. Building on this momentum, Databricks plans to create 100 additional jobs in Costa Rica by the end of 2025, further strengthening its local operations and reinforcing Costa Rica’s strategic role in supporting customers and driving adoption of the Databricks Data Intelligence Platform across Latin America.

Since opening its Costa Rica office in 2023, Databricks has achieved over 150% growth in its LATAM business while supporting major regional customers such as BAC Latam, Nubank, Grupo Bimbo, iFood, Bineo and Kueski. As part of its broader strategy for Latin America, the company is expanding its São Paulo office and recently launched a new presence in Mexico City. These investments are fueled by rapidly growing enterprise demand for Databricks solutions across the region.

“Costa Rica plays a critical role in Databricks’ international expansion strategy,” said Rory Patterson, Chief of Staff to the CEO and VP of Corporate Operations at Databricks. “Our teams in Latin America are not only supporting global operations, they’re pioneering new automation and AI-based programs and processes that drive innovation across the company. This is a testament to the exceptional talent in Costa Rica and their ability to help us scale smarter, and not just faster.”

“Databricks has enabled us to realize our vision of a modern, intelligent, and flexible data and analytics strategy, strengthening our approach as a bank, personalizing our customers’ experience, and generating prosperity for the communities we serve,” said Rodrigo Chaverri, Corporate Director of Data & Analytics of BAC Latam.

The Minister of Foreign Trade, Manuel Tovar, commented, “Databricks’ expansion in Costa Rica strengthens the country’s position as a strategic tech hub for Latin America, supported by a highly skilled workforce, a reliable business environment, and robust digital infrastructure. With over 240 multinational companies in the sector and advanced capabilities in software, analytics, and artificial intelligence, Costa Rica offers a thriving ecosystem for digital solutions, nearshoring, and innovation. This new investment reaffirms the global tech sector’s confidence in our ability to lead complex processes from a secure, stable and competitive platform.”

“At Databricks, we believe in building our future with the best talent, and Costa Rica offers exactly that,” said Ariel Vargas, Director of International & LATAM Operations at Databricks. “Our new office will be a cornerstone for our Latin America operations, enabling us to better serve our customers and foster a culture of innovation and excellence. We look forward to welcoming new Bricksters to our growing team and collaborating with local partners and customers to drive innovation across the region.”

“The opening of Databricks’ new office in Costa Rica reinforces the country’s position as a strategic destination for knowledge-intensive services, which already account for 30% of our total exports. This expansion reflects the confidence that leading companies place in our business environment, legal certainty, and — above all — our highly skilled talent that drives digital transformation globally, every day,” said Laura López, CEO of the Trade & Investment Promotion Agency (PROCOMER).

Databricks’ investment in Costa Rica will support a wide range of roles, including Finance, HR, IT, Technical Support, Marketing, Operations and more. The company encourages interested professionals to explore opportunities and join its mission to democratize data and AI through the Data Intelligence Platform. For more information about career opportunities at Databricks Costa Rica, please visit the Databricks Careers page.

About Databricks

Databricks is the Data and AI company. More than 10,000 organizations worldwide — including Block, Comcast, Condé Nast, Rivian, Shell and over 60% of the Fortune 500 — rely on the Databricks Data Intelligence Platform to take control of their data and put it to work with AI. Databricks is headquartered in San Francisco, with offices around the globe, and was founded by the original creators of Lakehouse, Apache Spark™, Delta Lake and MLflow. To learn more, follow Databricks on LinkedIn, X and Facebook.

Contact: Press@databricks.com

Malaysia Gears Up to Lead Regional Drone Innovation with DronTech Asia 2025 Launch

KUALA LUMPUR, Malaysia, May 30, 2025 /PRNewswire/ — Malaysia took a significant step forward in positioning itself as a regional drone technology hub with the official launch of DronTech Asia 2025, held today at Ujana Ilmu, MATRADE. The event was officiated by YB Tuan Liew Chin Tong, Deputy Minister of Investment, Trade and Industry (MITI), alongside YBhg Rear Admiral Fadhil bin Abdul Rahman, Director General, Defence Cyber & Electromagnetic Division, Malaysia Armed Forces, representing the Chief of Defence Force Malaysia, NAICO Malaysia CEO Ts. Shamsul Kamar Abu Samah, Aerosea Exhibitions Chairman YBhg Tan Sri Asmat Kamaludin and Director YBhg Datuk Dr M Gandhi.

Malaysia Gears Up to Lead Regional Drone Innovation with DronTech Asia 2025 Launch
Malaysia Gears Up to Lead Regional Drone Innovation with DronTech Asia 2025 Launch

The soft launch showcased Malaysia’s commitment to advancing drone technology through collaboration, talent development and strategic policy support in line with the Malaysian Aerospace Industry Blueprint 2030 (MAIB 2030) and New Industrial Master Plan 2030 (NIMP 2030).

NAICO Malaysia CEO, Ts. Shamsul Kamar, noted that DronTech Asia 2025 represents a collective ambition to align industry, academia and government in shaping Malaysia’s future mobility landscape. The event will serve as a strategic platform for showcasing technological excellence while catalysing cross-border collaboration in areas such as AI-integrated drones, urban air mobility, counter-UAS and regulatory harmonisation.

Aerosea Exhibitions Sdn Bhd’s Chairman who represents the lead organiser of DronTech Asia 2025 said today “This year’s event holds even greater significance as it aligns with Malaysia’s ASEAN Chairmanship in 2025. It offers a timely platform to foster regional partnerships and spotlight how drone technology is transforming industries and contributing to ASEAN’s digital and economic advancement. The successful inaugural edition in Bangkok last year welcomed 68 exhibitors and 3,482 participants from 41 countries. This year, we’re taking it a step further — hosting over 100 participating companies from 15 countries, expecting around 5,000 trade visitors, across 5,500 square metres of exhibition space. I am proud to say that Malaysia is no longer catching up — we are actively setting the pace and establishing ourselves as a serious player in this fast-moving sector.”

NAICO Malaysia also reaffirms its commitment to talent development, highlighting recent initiatives such as the Pioneer Aerospace Talent Challenge, which featured STEM-based competitions including e-drone racing and aerospace modelling, supported by the Ministry of Youth and Sports and the Ministry of Education.

DronTech Asia 2025, set to take place from 30 September to 2 October 2025 at MITEC Kuala Lumpur, will feature exhibitions, high-level forums and regional networking opportunities to accelerate  drone  adoption,  innovation,  and  investment  across  ASEAN.

National Aerospace Industry Corporation Malaysia (NAICO Malaysia) is an agency under the Malaysian Ministry of Investment, Trade and Industry (MITI), with a mandate to develop and position Malaysia as the preferred aerospace economy in Southeast Asia, and an integral part of the global aerospace value chain by 2030. NAICO Malaysia is guided by the Malaysian Aerospace Industry Blueprint 2030 (MAIB 2030) under Rancangan Malaysia Ke-12. The MAIB 2030 is also supported by the New Industrial Master Plan 2030 (NIMP 2030) to bolster the Malaysian aerospace industry towards achieving MAIB goals by 2030.

– END –

Aerosea Exhibitions Sdn Bhd is the lead organiser of DronTech Asia 2025. An award-winning leader in business events organisation, Aerosea was recently honoured with the Best New Home-Grown Event Excellence Award 2022/2023 by the Malaysian Association of Convention & Exhibition Organisers & Suppliers (MACEOS) for their exceptional management of CyberDSA 2023, among other leading events in Malaysia.

 

Moonkie Unveils Hug & Go Toddler Backpack Ahead of International Children’s Day

A Cozy Companion for Young Explorers, Designed for the Needs of Today’s Families


CALIFORNIA, US – Media OutReach Newswire – 30 May 2025 – Ahead of International Children’s Day, Moonkie—the modern baby and toddler brand—proudly introduces the Moonkie Hug & Go™ Toddler Backpack, a thoughtfully designed essential that meets the evolving needs of modern parenting. Known for its minimalist design and everyday functionality, Moonkie continues its mission of nurturing early childhood development with products that blend emotional connection and practical utility.

The Moonkie Hug & Go™ toddler backpack is designed for families seeking age-appropriate gear that empowers toddlers while maintaining emotional reassurance. Featuring a child-sized backpack with a removable plush companion, it encourages independence through everyday routines—while offering comfort during transitions and new experiences.

A Backpack Designed for Growth—and Hugs

Inspired by Montessori principles, the Hug & Go is more than a backpack; it’s a developmental tool. Sized perfectly for small shoulders, it encourages toddlers to carry their own essentials while the attached plush companion provides emotional reassurance during transitions like daycare drop-offs, travel, or new adventures.

Why it matters

  • Emotional resilience: The soft plush buddy helps soothe separation anxiety, turning moments of uncertainty into opportunities for growth.
  • Safety-first design: Padded straps, embroidered details (no choking hazards), and lightweight materials prioritize comfort and security.
  • Confidence-building: Gives toddlers a sense of ownership (“I can do it myself!”) while easing parental worries.

From Insight to Intention

Moonkie’s design team recognized a universal parenting challenge: toddlers crave independence but still need comfort. “The Hug & Go bridges that gap,” says Cindy M., Product Manager at Moonkie. “It’s a backpack that carries both snacks and emotional support—helping kids feel brave as they explore their world.”

Built for Real Life

  • Parent-approved: Lightweight, compact design (even fits under airplane seats!), durable fabric, and easy-to-clean surfaces
  • Gift-ready: Three charming characters—Rosie Hop the Bunny, Babu the Elephant, and Mossy the Reindeer
  • Accessible luxury: Priced at $32.99 / €28.99 / SR 124.00, the Hug & Go is a charming yet practical gift for birthdays, holidays, or “just because”

Celebrate International Children’s Day with a gift that supports growth, sparks joy, and helps toddlers take their first steps into the world with confidence.

For more information, visit moonkieshop.com
Follow Moonkie on:
Instagram: @moonkie_official
TikTok: @moonkie_official
Facebook: Moonkie Official
YouTube: Moonkie

Hashtag: #Moonkie

The issuer is solely responsible for the content of this announcement.

NEW THERAPY FOR CHILDREN WITH GROWTH HORMONE DEFICIENCY APPROVED IN AUSTRALIA

SKYTROFA® (lonapegsomatropin) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of paediatric growth hormone deficiency.[1]

SINGAPORE, May 30, 2025 /PRNewswire/ — Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce the Australian registration of SKYTROFA® (lonapegsomatropin) as a new once-weekly injectable therapy for paediatric growth hormone deficiency (GHD).[2] The Therapeutic Goods Administration (TGA) has approved SKYTROFA as a treatment for “growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion”.[1,2]

GHD is a rare disease affecting around 2-3/10,000 Australians, with approximately 2,000 children thought to be living with the condition.[3] It occurs when the pituitary gland, located at the base of the brain, does not produce an adequate level of growth hormone, which is essential for promoting healthy growth in children.[3] In children, GHD is typically characterised by slow height growth, resulting in short stature, and may also include delayed puberty, impaired hair growth and headaches.[3] The goal of treatment for GHD is to restore normal levels of growth hormone in the body, reduce physical symptoms, enhance metabolic health and improve quality of life.[3]

ST Chief Executive Officer, Mr Carlo Montagner, said the TGA approval of SKYTROFA demonstrated the company’s ongoing mission to support patients with rare diseases in Australia and the Asia-Pacific region.

“We are delighted to have secured TGA registration of SKYTROFA for eligible Australian children with growth hormone deficiency. Beyond short stature, children and adolescents with the condition may experience considerable physical and psychosocial impacts on their daily life, such as poor concentration, decreased strength or muscle development, fatigue, and reduced quality of life.[4]

“This announcement also represents a significant milestone for Specialised Therapeutics, marking the second endocrinology therapy we have successfully registered in Australia, following the approval of YORVIPATH® (palopegteriparatide) earlier this year,” said Mr Montagner.

SKYTROFA is being registered in Australia by ST, under an exclusive distribution agreement with biopharmaceutical company Ascendis Pharma A/S that covers Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam. The Australian registration of SKYTROFA follows approvals issued to Ascendis Pharma by the United States Food and Drug Administration (US FDA)[5] in August 2021 and the European Medicines Agency (EMA)[6] in January 2022.

Developed using Ascendis Pharma’s proprietary TransConTM platform, SKYTROFA is delivered as a subcutaneous injection, available in various strengths.[2] The starting dose depends on the patient’s body weight and is then adjusted individually by the treating endocrinologist based on the patient’s response to treatment.[2]

Ascendis Pharma’s innovative TransConTM technology platform is designed to create new therapies with the potential to optimise therapeutic effect, including improving treatment efficacy, safety and dosing frequency.[7] TransConTM molecules have three components: an unmodified parent drug, an inert TransCon™ carrier that protects it, and a TransConTM linker that temporarily binds the two.[7]

SKYTROFA is a prodrug of somatropin administered once weekly, designed to provide sustained release of active, unmodified somatropin.[6] This allows the medicine to slowly release unmodified growth hormone into the body over the course of one week, removing the need for daily injections.

SKYTROFA consists of three components: the parent drug somatropin, an inert methyloxypolyethlene glycol carrier (mPEG), and a proprietary TransConTM linker that transiently binds the other two elements.[8,9] While bound, the carrier inactivates the somatropin and shields it from renal excretion and receptor-mediated clearance.[10] Following injection, autocleavage of the linker occurs under physiologic conditions, and SKYTROFA releases fully active, unmodified somatropin in a predictable manner.[10]

The TGA registration of SKYTROFA was based on the results of Ascendis Pharma’s three pivotal Phase 3 clinical trials, heiGHt, fliGHt and enliGHten, which collectively treated more than 300 paediatric patients diagnosed with GHD, including from Australia.[2,8,11,12]

SKYTROFA was generally well-tolerated across all three clinical trials. The most commonly reported adverse events include viral infections, fever, cough, nausea and vomiting, haemorrhage, diarrhoea, abdominal pain, arthralgia, arthritis, and increased blood phosphate levels.

PBS Information: SKYTROFA is not listed on the Pharmaceutical Benefits Scheme (PBS).

About Specialised Therapeutics

Founded in 2007, Specialised Therapeutics is the region’s largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company’s broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA).

Additional information can be found at www.stbiopharma.com

About Ascendis Pharma

Ascendis Pharma is a global biopharmaceutical company focused on applying its innovative TransConTM technology platform to make a meaningful difference for patients. Guided by core values of Patients, Science, and Passion, and following its algorithm for product innovation, Ascendis Pharma applies TransConTM to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit: ascendispharma.com to learn more.

About Paediatric Growth Hormone Deficiency

Paediatric growth hormone deficiency (GHD) is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone. Physiological levels of growth hormone are required for overall endocrine health and development of healthy bone, muscle, and adipose tissue. Children with GHD are characterised by short stature and may also experience metabolic abnormalities, psychosocial challenges, and an overall poor quality of life. For decades, the standard of care for GHD has been a daily subcutaneous injection of human growth hormone (hGH) to improve growth and overall endocrine health.

About SKYTROFA (lonapegsomatropin)

Once-weekly SKYTROFA is a prodrug of somatropin, designed to provide sustained release of unmodified somatropin. The unmodified, unbound somatropin released from lonapegsomatropin has the same 191 amino acid sequence and size as endogenous growth hormone.[8]

SKYTROFA single-use, prefilled cartridges are manufactured in nine dosage strengths, allowing for convenient dosing flexibility. They are designed for use only with the SKYTROFA Auto-Injector and may be stored at room temperature for up to six months. The recommended dose of SKYTROFA for treatment-naïve children with growth hormone deficiency and those switching from daily somatropin is 0.24 mg/kg body weight, administered once weekly.[2] The dose may be adjusted based on the child’s weight and insulin-like growth factor-1 standard deviation score (IGF-1 SDS).[2]

SKYTROFA was studied in over 300 children with GHD across the Phase 3 program, which consisted of the HeiGHt Trial[8] (for treatment-naïve patients), the FliGHt Trial[11] (for treatment-experienced patients), and the EnliGHten Trial[12] (a long-term extension trial). Patients who completed the HeiGHt or FliGHt Trials were able to continue in EnliGHten, with some on lonapegsomatropin treatment for over four years. Ascendis Pharma is also conducting the ongoing open-label portion of the global Phase 3 ForesiGHt Trial of SKYTROFA in adults with GHD.

Ascendis®, TransConTM and SKYTROFA®  are trademarks owned by the Ascendis Pharma group (NASDAQ: ASND).

About TransConTM Technologies

TransCon refers to “transient conjugation”. Ascendis Pharma’s innovative technology platform to create new therapies designed to potentially optimise therapeutic effect, including improving efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert TransCon carrier that protects it, and a TransCon linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g. pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied to a broad variety of therapeutics, such as antibodies, antibody fragments, proteins, peptides, or small molecules, and can be designed for systemic or local administration.

References:

[1] Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG). Available at: https://www.tga.gov.au/resources/artg?keywords=skytrofa. [Accessed May 2025].
[2] SKYTROFA (lonapegsomatropin) Product Information, Australia.
[3] Australian Pituitary Foundation. Factsheet: A Guide To Growth Hormone Deficiency, 2023. Available at: https://pituitary.asn.au/wp-content/uploads/2023/09/APF-Growth-Hormone-Deficiency-Fact-Sheet-2023_Digital-Final.pdf [Accessed May 2025].
[4] Brod M et al. Qual Life Res. 2017 Jul;26(7):1673-1686.
[5] US Food and Drug Administration (FDA). Drug Approval Package: SKYTROFA. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761177Orig1s000TOC.cfm [Accessed May 2025].
[6] European Medicines Agency (EMA). Skytrofa (previously Lonapegsomatropin Ascendis Pharma), January 2022. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/skytrofa [Accessed May 2025].
[7] Ascendis Pharma A/S. TransCon: A powerful technology platform central to our innovative approach. Available at: https://ascendispharma.com/technology/ [Accessed May 2025].
[8] Thornton PS, et al. J Clin Endocrinol Metab. 2021 Oct;106(11):3184-3195.
[9] SKYTROFA® [package insert]. Palo Alto, CA: Ascendis Pharma, Inc.
[10] Sprogøe K, et al. Endocr Connect. 2017;6(8):R171-r181.
[11] Maniatis AK, et al. Horm Res Paediatr. 2022 Mar;95(3):233-243.
[12] Maniatis AK, et al. J Clin Endocrinol Metab. 2022 Jun;107(7):e2680-e2689.