MILAN, Italy–(BUSINESS WIRE)–Alfasigma S.p.A, a global pharmaceutical company with a focus on innovation in rare disease and specialty care in areas where there is significant unmet patient need, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), an oral, once-daily JAK1 preferential inhibitor, for the treatment of patients with active axial spondyloarthritis (axSpA), both n
Month: September 2026
LONDON–(BUSINESS WIRE)– FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Qube Research & Technologies Limited (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiari
RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasiv
LITTLE ROCK, Ark., Sept. 18, 2026 (GLOBE NEWSWIRE) — Dillard’s, Inc. (NYSE: DDS) (the “Company” or “Dillard’s”), a Texas corporation headquartered in Little Rock, Arkansas, today announced that it will voluntarily transfer the primary listings of its securities from the New York Stock Exchange (“NYSE”) to the Texas Stock Exchange (“TXSE”).
The transfer applies to both Dillard’s Class A Common Stock (ticker: DDS) and the 7.50% Capital Securities of Dillard’s Capital Trust I (and the Guarantee of the Company with respect thereto) (ticker: DDT). Both securities are expected to cease trading on the NYSE as primary listings at the market close on Friday, October 2, 2026, and commence trading on the TXSE as primary listings at the market open on Monday, October 5, 2026, retaining their existing ticker symbols. No action is required by DDS shareholders or DDT securityholders in connection with the transfer.
The move aligns Dillard’s deep roots and strong retail presence in Texas with TXSE’s technology-driven platform. Dillard’s Texas heritage dates back to 1956, when founder William T. Dillard acquired a store in downtown Tyler. The Lone Star State has since grown into the Company’s largest market, now home to 54 locations. Dillard’s reincorporated from Delaware to Texas in August 2025.
About Dillard’s
Dillard’s was founded by William T. Dillard in 1938 in Nashville, Arkansas with an $8,000 investment in a hometown department store. Today, Dillard’s, Inc. ranks among the nation’s largest fashion retailers – operating 272 Dillard’s stores, including 28 clearance centers, spanning 30 states and an Internet store at dillards.com. The Company focuses on delivering style, quality and value to its customers by offering premium fashion apparel, beauty and home collections from both national and exclusive brand sources. Dillard’s complements this curated merchandise assortment with exceptional, client-focused customer care.
Forward-Looking Statements
Certain matters contained in this press release concerning the listing transfers of DDS and DDT constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s expectations and beliefs concerning future events impacting the Company. Many factors outside the Company’s control, including risks related to delays in the timing for implementing the transfers, potential market disruptions with respect to the trading of the securities and potential impacts on the Company’s business or operations as it implements the transfers, could cause actual results to differ materially from those contemplated by forward-looking statements. Forward-looking statements speak only as of the date they were made, and the Company undertakes no obligation to publicly update them. For a description of other factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended January 31, 2026.
CONTACT:
Dillard’s, Inc.
Julie J. Guymon
501-376-5965
julie.guymon@dillards.com
- Ocrevus addresses a critical need in paediatric neurology as the first high- efficacy anti-CD20 treatment option for people with MS as young as 10 years old
- In the Phase III OPERETTA 2 study, Ocrevus demonstrated non-inferiority in relapse control and superiority over fingolimod in suppressing brain lesions1
- Safety in children and adolescents was aligned with the established safety profile of Ocrevus across more than 525,000 adult patients globally1
Basel, 18 September 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS). The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. A final decision from the European Commission is expected in the near future.
“Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The positive CHMP opinion brings us closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience.”
“Living with a paediatric MS diagnosis means that children and adolescents must navigate a complex condition with unpredictable relapses that require hospital admission and acute therapies, lead to missed days of school and social activities, and face the potential for future disability,” said Dr. Brenda Banwell, MD, Chair of Pediatrics, Johns Hopkins Medicine, Pediatrician-in-Chief and Co-Director, Johns Hopkins Children’s Center. “Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health.”
The CHMP’s positive opinion is based on the Phase III OPERETTA 2 study, which showed that Ocrevus was non-inferior to fingolimod (the current standard treatment in paediatric MS) at controlling relapses, reducing the risk of relapses by 48% compared with fingolimod. In OPERETTA 2, Ocrevus was superior at reducing brain inflammation, showing significant reductions in new or enlarging T2 lesions (-48%) and gadolinium-enhancing active T1 lesions (-87%). Ocrevus demonstrated a consistent safety profile in children and teens similar to that seen in adults, with no patients stopping treatment due to side effects.1
At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe, emphasising the need for early high-efficacy MS treatment.2
About Ocrevus® (ocrelizumab)
Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months.
About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.
Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS. Despite the availability of high-efficacy therapies, over a third of MS patients remain on lower-efficacy therapy today. Slowing or stopping progression while simultaneously stopping relapses remains a high unmet need in MS.
About Roche in Neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.
Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Banwell B, et al. Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Paediatric Relapsing- Remitting MS: Results of the Phase III OPERETTA 2 Study. Presented at the 2025 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); 26 September 2025; Barcelona, Spain.
[2] MS International Federation. The Atlas of MS 2026: A global update on MS prevalence, incidence, and the gaps that remain. September 2026. Available from: http://www.msif.org/wp-content/uploads/2026/09/Atlas-Epidemiology-report-text-core-data-2026-FINAL.pdf
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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LONDON–(BUSINESS WIRE)– FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Qube Research & Technologies Limited (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiari
LONDON–(BUSINESS WIRE)– FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Qube Research & Technologies Limited (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiari
LONDON–(BUSINESS WIRE)– FORM 8.3 PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE Rule 8.3 of the Takeover Code (the “Code”) 1. KEY INFORMATION (a) Full name of discloser: Qube Research & Technologies Limited (b) Owner or controller of interests and short positions disclosed, if different from 1(a): The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiari
NANJING, China & BASILDON, England–(BUSINESS WIRE)–For business and medical media only IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opi
If approved, Sogroya® (somapacitan) would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, providing a much-needed treatment option for children and their families affected by this condition.
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended once-weekly Sogroya® (somapacitan) for children in Europe living with idiopathic short stature (ISS) with persistent growth disturbance.
- ISS is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found, affecting a child’s confidence and well-being1-4. This affects up to 3% of children worldwide1,6,8.
- Positive opinion follows the previous recommendation for Sogroya® in the treatment of short stature in children born Small for Gestational Age (SGA) and with Noonan Syndrome (NS) in Europe5.
Bagsværd, Denmark, 18 September 2026 – Novo Nordisk today welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending once-weekly Sogroya® for children with idiopathic short stature (ISS) with persistent growth disturbance.
“Through our research and relationships with the community, we know that 70% of families raising children with ISS and other growth disorders feel unseen, and that the impact on their child’s daily life simply isn’t recognised,” said Ashley Gilmer, chief executive officer of International Coalition of Organizations Supporting Endocrine Patients (ICOSEP). “This recommendation is a meaningful signal that this may be starting to change. What matters now is that recognition turns into real support of timely diagnosis, clear information, and access to care for every family who needs it.”
ISS affects up to 3% of children worldwide, yet it remains under-recognised and has limited options for managing its treatment1,6-8. As part of the REAL8 clinical trial, Sogroya® has been assessed for the treatment of ISS and acts as a long-acting growth hormone, given as a single injection under the skin once a week9,10. If approved, Sogroya® would be the first and only growth hormone treatment approved for ISS in the EU, providing a much-needed treatment option for children and their families living with this condition.
“For too long, treatment options for many children with growth disorders have been limited. Building on our decades of experience in growth hormone medicines, we’re committed to changing that. Today’s approval recommendation from the CHMP is a very important step forward for children and their families affected by ISS across Europe,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo.
This opinion follows the CHMP recommendation of Sogroya® for the treatment of short stature in children born small for gestational age (SGA) and Noonan Syndrome (NS) in May 20265. The opinion is now passed to the European Commission, whose decision on marketing authorisation, covering all three indications, is expected later this year.
About once-weekly Sogroya® (somapacitan)
Once-weekly Sogroya® (somapacitan) is a long-acting human growth hormone analogue, given as a single injection under the skin once a week. It uses albumin-binding technology, which allows the growth hormone to attach to a protein naturally present in the blood, allowing it to remain in the body for longer11.
In the EU, Sogroya® was authorised for the treatment of growth hormone deficiency in adults on 31 March 2021 and in children aged 3 years and older on 24 July 202312.
The REAL8 clinical trial data that supported this positive CHMP opinion showed that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, born small for gestational age and Noonan Syndrome9.
What is idiopathic short stature?
Idiopathic short stature is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found1. It affects up to 3% of children worldwide, yet it remains under-recognised and often overlooked – in many countries, it is not a recognised condition1,6,7. Children with idiopathic short stature are more likely to face teasing, bullying and social exclusion as a result of their condition – experiences that can affect confidence and wellbeing into adulthood2,3,13.
Why is idiopathic short stature difficult to diagnose and treat?
The path to a diagnosis is often long and emotionally draining for families, as it can only be identified once other causes of short stature have been ruled out14. As many children with idiopathic short stature are not referred for diagnosis until puberty is approaching, the window for effective intervention with growth hormone (GH) therapy is limited15,16. Even after diagnosis, treatment with GH therapy is only approved for idiopathic short stature in some regions and used off-label or not at all in others, leaving many children and families without options14,17,18.
What does it mean to be born small for gestational age?
When a baby is born small for gestational age, it means they are smaller than expected in length, weight, or head circumference19,20. There is not always a clear cause, though being born small for gestational age has been associated with genetic factors, problems with the placenta and maternal health, including malnutrition, chronic high blood pressure and chronic infections21. Most children born small for gestational age reach their expected height by the age of two, but if catch-up growth has not happened by two or three years of age, a referral to a paediatric endocrinologist may be needed22,23.
What is Noonan Syndrome?
Noonan Syndrome is a genetic condition affecting both boys and girls, occurring in around 1 in 1,000 to 2,500 births24,25. Around half of all cases are caused by a mutation on a gene found on chromosome 1225. Noonan Syndrome can have a variety of effects on a child’s health and development, including short stature, heart defects present at birth, and certain distinctive facial features24.
Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.
Contacts for further information
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Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com |
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| Michael Novod +45 3075 6050 nvno@novonordisk.com |
Sina Meyer +45 3079 6656 azey@novonordisk.com |
| Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com |
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| Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com |
Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com |
| Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com |
Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com |
References
1. Wit JM, Clayton PE, Rogol AD, et al. Idiopathic short stature: definition, epidemiology, and diagnostic evaluation. Growth Horm IGF Res. 2008;18:89-110.
2. A Juul, A Linglart, MH Rasmussen, et al. Impact of Idiopathic Short Stature (ISS) on children’s well-being. ESPE Abstracts (2024), 98, P1-68. Paper/Poster presented.
3. Novo Nordisk Data on File. Equips: Evaluating the Quality of Life in People with Short Stature. 2025.
4. The Magic Foundation. Psycological impact of short stature on children and adolescents [online]. Available at: magicfoundation.org/psychologicalimpact. Last accessed: August 2026.
5. Sogroya – opinion on variation to marketing authorisation. European Medicines Agency [online]. Available at: ema.europa.eu/en/medicines/human/variation/sogroya. Last accessed: August 2026.
6. Sharma L, Rani D, Kanchan T, et al. Short Stature StatPearls Treasure Island (FL); 2026.
7. Novo Nordisk Data on File. Investigating the Association between Idiopathic Short Stature and Health and Well-being: a register study. 2025.
8. Romero CJ and Rapaport R. The challenges of optimising the treatment of children diagnosed with idiopathic short stature. Ann Hum Biol. 2026;53:2621718.
9. Once-weekly Sogroya® (somapacitan) is an efficacious and welltolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE 2025. Novo Nordisk [online]. Available at: ml-eu.globenewswire.com/Resource/Download/f899ae3b-aa4e-4ef3-9498-9537d9cc424b. Last accessed: August 2026.
10. Sogroya® (somapacitan): SmPC [online]. Available at: ema.europa.eu/en/documents/product-information/sogroya-epar-product-information_en.pdf. Last accessed: August 2026.
11. Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419.
12. An overview of Sogroya and why it is authorised in the EU. European Medicines Agency [online]. Available at: ema.europa.eu/en/documents/overview/sogroya-epar-medicine-overview_en.pdf. Last accessed: August 2026.
13. Investigating the Association between Idiopathic Short Stature and Health and Well-being: a register study. 2025.
14. Pedicelli S PE, Violi E, et al. Controversies in the definition and treatment of idiopathic short stature (ISS). J Clin Res Pediatr Endocrinol. 2009;1:105-115.
15. Cohen P, Rogol AD, Deal CL, et al. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008;93:4210-7.
16. Novo Nordisk Data on File. Adivo – 2023 US GHT Patient Assessment. 2025.
17. Kemp SF and Frindik JP. Emerging options in growth hormone therapy: an update. Drug Des Devel Ther. 2011;5:411-9.
18. Murano MC. A Disability Bioethics Reading of the FDA and EMA Evaluations on the Marketing Authorisation of Growth Hormone for Idiopathic Short Stature Children. Health Care Anal. 2020;28:266-282.
19. Schlaudecker EP, Munoz FM, Bardaji A, et al. Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data. Vaccine. 2017;35:6518-6528.
20. Lee PA, Chernausek SD, Hokken-Koelega AC, et al. International Small for Gestational Age Advisory Board consensus development conference statement: management of short children born small for gestational age, April 24-October 1, 2001. Pediatrics. 2003;111:1253-61.
21. Liu Q, Yang H, Sun X, et al. Risk factors and complications of small for gestational age. Pak J Med Sci. 2019;35:1199-1203.
22. Finken MJJ, van der Steen M, Smeets CCJ, et al. Children Born Small for Gestational Age: Differential Diagnosis, Molecular Genetic Evaluation, and Implications. Endocr Rev. 2018;39:851-894.
23. Hokken-Koelega ACS, van der Steen M, Boguszewski MCS, et al. International Consensus Guideline on Small for Gestational Age: Etiology and Management From Infancy to Early Adulthood. Endocr Rev. 2023;44:539-565.
24. Sharma L, Winters R and Corado A. Noonan Syndrome StatPearls Treasure Island (FL); 2026.
25. Visser-van Balen H, Sinnema G and Geenen R. Growing up with idiopathic short stature: psychosocial development and hormone treatment; a critical review. Arch Dis Child. 2006;91:433-9.
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