PRINCETON JUNCTION, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) — MISTRAS Group, Inc. (NYSE: MG) (“MISTRAS” or the “Company”), a global leader in technology-enabled industrial asset integrity and laboratory testing solutions, today announced that it had entered into a definitive agreement to be acquired by affiliates of H.I.G. Capital (“H.I.G.”), a leading global alternative investment firm with $75 billion of capital under management, in an all-cash transaction, representing an enterprise value of approximately $866 million, including outstanding debt.

Under the terms of the agreement, MISTRAS stockholders will receive $20.35 per share in cash for each share of common stock they own. The purchase price represents a premium of approximately 8% and 13% to the Company’s 30 and 90-day volume-weighted average share price, respectively, for the period ended September 17, 2026. In addition, the purchase price is inclusive of 61% price appreciation since December 31, 2025.

“Upon completion of the transaction, the agreement with H.I.G. would deliver immediate and certain cash value to stockholders,” said Manuel N. Stamatakis, Executive Chairman of MISTRAS’ Board of Directors. “Following extensive engagement with H.I.G., the Board is confident that this agreement is in the best interests of our stockholders and our Company. With H.I.G.’s partnership and support, we believe MISTRAS will be even better positioned to build on the momentum our teams have been delivering through their focus on execution and operational excellence.”

“We are pleased to reach this exciting milestone in our company’s journey to become a leading integrated integrity and testing platform,” said Natalia Shuman, President and Chief Executive Officer of MISTRAS. “H.I.G.’s confidence in our business validates the work we have done through our Vision2030 transformation to deepen the ways we serve our existing customers, expand into new, high-growth end markets and drive efficiency across our organization. We have created significant value through strong execution and we are excited to crystallize that value and work with H.I.G. to continue to invest in our people, drive innovation across our portfolio and broaden our reach to help more customers protect and maintain critical assets.”

“We are very excited by the success achieved by Natalia and the MISTRAS team,” said Matt Gullen, Managing Director at H.I.G. “Through our experience partnering with industrial services businesses, we have developed a deep appreciation for the technical expertise, reliability and customer focus required to support mission-critical operations. MISTRAS has built an impressive platform supported by a highly skilled workforce and longstanding customer relationships, and we look forward to bringing H.I.G.’s experience and resources to support the Company’s next phase of growth.”

Transaction Details

The Company’s Board of Directors has unanimously approved the transaction, which is expected to close in late 2026 or early 2027, subject to customary closing conditions, including approval by the Company’s stockholders and the receipt of required regulatory approvals.

H.I.G. affiliates have entered into voting and support agreements with holders of approximately 31% of the Company’s common stock, under which these stockholders have agreed to vote all owned shares in favor of the transaction.

The definitive agreement includes a 40-day “go-shop” period, expiring at 11:59 p.m. Eastern Time on October 27, 2026, during which time the Company’s Board of Directors, with the assistance of its financial advisor Baird, are permitted to actively initiate, solicit and consider alternative acquisition proposals from third parties. The Company will have the right to terminate the H.I.G. agreement to enter into a superior proposal subject to payment of a termination fee to H.I.G. affiliates and other terms and conditions of such agreement. There can be no assurance that this “go-shop” process will result in a superior proposal or that any other transaction will be approved or completed. The Company does not intend to disclose developments with respect to the go-shop process unless and until its Board of Directors determines such disclosure is required or is otherwise appropriate.

Upon completion of the transaction, the Company’s common stock will no longer be listed on the New York Stock Exchange.

Advisors

Baird is serving as financial advisor to the Company, and Morgan, Lewis & Bockius LLP and Troutman Pepper Locke LLP are serving as legal counsel to the Company.

Texas Capital Securities is serving as financial advisor to H.I.G., and Kirkland & Ellis LLP is serving as legal counsel to H.I.G.

About MISTRAS Group, Inc.
MISTRAS Group, Inc. (NYSE: MG) is a global leader in technology-enabled industrial asset integrity and laboratory testing solutions, serving critical strategic markets including oil & gas, aerospace & defense, industrials, power generation & transmission, infrastructure, engineering, and research. MISTRAS Group provides a diversified portfolio of products and services, ranging from advanced non-destructive testing and pipeline inspections to real-time condition monitoring, maintenance planning, and specialized engineering, powered by a proprietary management software suite that centralizes integrity data for predictive analytics and benchmark analysis. With a long-standing track record of innovation and deep industry expertise, MISTRAS Group helps clients reduce risk, extend asset life, and optimize operational performance. Learn more at www.mistrasgroup.com

About H.I.G. Capital
H.I.G. is a leading global alternative investment firm with $75 billion of capital under management.* Based in Miami, and with offices in Atlanta, Boston, Chicago, Los Angeles, New York, San Francisco, and Stamford in the United States, as well as international affiliate offices in Hamburg, London, Luxembourg, Madrid, Milan, Paris, Bogotá, Rio de Janeiro, Dubai, and Hong Kong, H.I.G. specializes in providing both debt and equity capital to middle market companies, utilizing a flexible and operationally focused/value-added approach. Since its founding in 1993, H.I.G. has invested in and managed more than 400 companies worldwide. The Firm’s current portfolio includes more than 100 companies with combined sales in excess of $53 billion. For more information, please refer to the H.I.G. website at hig.com.
* Based on total capital raised by H.I.G. Capital and its affiliates.

Additional Information Regarding the Proposed Transaction and Where to Find It

In connection with the proposed transaction between the Company and H.I.G., the Company will file with the Securities and Exchange Commission (the “SEC”) a preliminary proxy statement on Schedule 14A relating to a special meeting of its stockholders, which will be announced as promptly as practicable to seek Company stockholder approval in connection with the proposed transaction. Additionally, the Company expects to file a definitive proxy statement on Schedule 14A and other relevant materials with the SEC in connection with the proposed transaction. INVESTORS AND SECURITYHOLDERS OF THE COMPANY ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND ANY OTHER RELEVANT MATERIALS FILED OR THAT WILL BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE MATERIALS AND DOCUMENTS INCORPORATED BY REFERENCE THEREIN, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS. Following the filing of the definitive proxy statement with the SEC, the Company will mail the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. Any vote in respect of resolutions to be proposed at the Company’s stockholder meeting to approve the proposed transaction or other responses in relation to the proposed transaction should be made only on the basis of the information contained in the proxy statement. Investors and securityholders will be able to obtain free copies of the proxy statement (when available) and other documents filed or that will be filed by the Company with the SEC at http://www.sec.gov, the SEC’s website, or on the Company’s investor relations website (http://www.investors.mistrasgroup.com). In addition, the proxy statement and other documents filed or that will be filed by the Company with the SEC may be obtained from the Company free of charge by requesting them from Investor Relations by email at investors@mistrasgroup.com, or by telephone at 1 (833) MISTRAS.

Participants in the Solicitation

The Company and certain of its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in respect of the proposed transaction and any other matters to be voted on at the special meeting. Information about the Company and its directors and executive officers can be found in (i) the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 11, 2026, (ii) the Company’s proxy statement for its 2026 Annual Shareholders Meeting, which was filed with the SEC on April 7, 2026, and (iii) the Company’s other filings with the SEC, including any statements of beneficial ownership on Form 3, Form 4 or Form 5. Additional information regarding ownership of the Company’s securities by its directors and executive officers is included in such persons’ SEC filings on Forms 3 and 4. These documents may be obtained free of charge at http://www.sec.gov, the SEC’s website, or on the Company’s investor relations website (http://www.investors.mistrasgroup.com). Additional information regarding the interests of participants in the solicitation of proxies in connection with the proposed transaction will be included in the proxy statement that the Company expects to file in connection with the proposed transaction and other relevant materials the Company may file with the SEC.

No Offer or Solicitation

This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Forward-Looking and Cautionary Statements

Certain statements contained in this press release, including statements regarding the proposed transaction, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally use words such as “future,” “possible,” “potential,” “targeted,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict,” “project,” “will,” “may,” “should,” “could,” “would” and other similar words and phrases. These forward-looking statements are based on the beliefs and assumptions of management at the time that these statements were prepared and are inherently uncertain. Such statements are not guarantees of future events or results and may not accurately indicate the timing of, or the date by which, such events or results will be consummated or achieved, if at all. These statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. Such risks, uncertainties and contingencies include, among others: uncertainties as to the timing of the proposed transaction; uncertainties as to how many of the Company’s stockholders will vote in favor of the proposed transaction including the possibility that the Company’s stockholders may not approve the proposed transaction; the possibility that competing offers will be made, whether through the “go-shop” process or otherwise; the ability to receive the required consents and regulatory approvals for the proposed transaction and to satisfy the other closing conditions of the proposed transaction on a timely basis or at all; the risk that, prior to the completion of the proposed transaction, the Company’s business and its relationships with employees, collaborators, vendors and other business partners could experience significant disruption due to transaction-related uncertainty; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; negative effects of the announcement of the proposed transaction on the market price of the Company’s common stock and/or on the Company’s business, financial condition, results of operations and financial performance; the ability of the Company to retain and hire key personnel; and the risks and uncertainties pertaining to the Company’s business, including those detailed under “Risk Factors” and elsewhere in the Company’s public periodic filings with the SEC. There can be no assurance that the proposed transaction or any other transaction described above will in fact be consummated in the manner described or at all. Stockholders, potential investors and other readers are urged to consider these risks and uncertainties in evaluating forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. It is not possible to anticipate or foresee all risks and uncertainties, and investors should not consider any list of risks and uncertainties to be exhaustive or complete. For additional information on identifying factors that may cause actual results to vary from those stated in forward-looking statements, please see the Company’s statements and reports on Forms 10-K, 10-Q and 8-K filed with the SEC and other written statements made by the Company from time to time. Forward-looking statements speak only as of the date of this communication, and, except as required by applicable law, the Company does not undertake any obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

MISTRAS Media Contact:

Theresa Feraren
Senior Vice President & Chief Marketing Officer
MISTRAS Group, Inc.
marcom@mistrasgroup.com

Aaron Palash / Tim Lynch
Joele Frank, Wilkinson Brimmer Katcher
+1 (212) 355-4449

MISTRAS Investors Contact:

Edward J. Prajzner
Senior Executive Vice President & Chief Financial Officer
+1 (833) MISTRAS | investors@mistrasgroup.com

H.I.G. Contact:

Media Relations
media@hig.com

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

Tristan Schmitz
Phone: +41 79 529 70 35
Lorena Corfas
Phone: +41 79 568 24 95

 

Simon Goldsborough
Phone: +44 797 32 72 915
Karsten Kleine
Phone: +41 79 461 86 83

 

Kirti Pandey
Phone: +41 79 398 38 53
Yvette Petillon
Phone: +41 79 961 92 50

 

Irène Stephan
Phone:  +41 79 377 83 75
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Phone: +41 79 775 66 12

Attachment

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

Novo Media:  
Ambre James-Brown
+45 3079 9289
globalmedia@novonordisk.com

Liz Skrbkova (US)
+1 609 917 0632
USMediaRelations@novonordisk.com

Novo Investors:  
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

 
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.

Attachment

These Relevant Opportunities Are Valued in the Hundreds of Millions of Dollars

Newport Beach, CA, Sept. 18, 2026 (GLOBE NEWSWIRE) — Bimergen Energy Corporation (NYSE American: BESS), a developer, owner, and operator of utility-scale and distributed battery energy storage systems, today announced that its wholly owned subsidiary, Emergen Energy, LLC, has completed its System for Award Management (SAM.gov) registration and received its Commercial and Government Entity (CAGE) code 23R51. Emergen’s registration is active for “All Awards,” establishing the registration foundation to compete for federal contracts and pursue eligible federal assistance opportunities, subject to individual solicitation and program requirements.

The milestone supports Bimergen’s strategy of expanding the commercial reach of its energy storage development capabilities and building relationships that advance energy infrastructure projects. With an active federal registration, Emergen is positioned to pursue opportunities with government agencies and explore collaboration with prime contractors and other industry partners.

Assigned by the Defense Logistics Agency, the CAGE code identifies Emergen within federal procurement systems. The combination of active SAM.gov registration and CAGE code assignment completes a foundational step in the Company’s preparation to participate in the federal marketplace.

“Completing our federal registration is a meaningful step in expanding the opportunities available to Bimergen,” said Cole Johnson, Co-CEO of Bimergen Energy. “Our focus is on developing energy storage infrastructure that strengthens grid reliability and delivers flexible power when needed. We now have the registration foundation to pursue federal opportunities aligned with those capabilities and build relationships with government customers and industry partners.”

Bimergen’s growth strategy combines battery energy storage development with technology and capital partnerships designed to advance projects toward construction and operation. Participation in the federal marketplace offers a potential additional customer channel that complements the Company’s activities across U.S. power markets and its focus on reliable, resilient energy infrastructure.

“Our strategy is to convert development capabilities and strong partnerships into long-term shareholder value,” said Bob Brilon, Co-CEO of Bimergen Energy. “Active SAM.gov registration broadens the opportunities related to hundreds of millions of government contract dollars that we can pursue as we grow our business. We see federal contracting as a potential extension of our commercial strategy, with an emphasis on opportunities that fit our capabilities and support disciplined growth.”

The registration milestone builds on Bimergen’s ongoing efforts to expand its market presence, advance its energy storage portfolio, and establish partnerships that support project execution. The Company remains focused on matching development opportunities with the technology, capital, and operational resources needed to create lasting value.

About Bimergen Energy Corporation

Bimergen Energy Corporation (NYSE American: BESS) is a U.S.-based energy infrastructure developer, asset owner, and operator focused on utility-scale and distributed battery energy storage systems (BESS). The Company develops projects designed to enhance grid reliability, support renewable energy integration, and provide flexible energy solutions across key U.S. power markets. Bimergen works with technology providers and capital partners to advance projects through development, construction, and long-term operation.

For more information about Bimergen Energy, please visit www.bimergen.com.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. These statements include expectations regarding federal contracting and assistance opportunities, potential customer and market expansion, project development, strategic partnerships, and long-term shareholder value. Forward-looking statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “seek,” and similar expressions.

Forward-looking statements are based on Bimergen Energy Corporation’s current expectations and assumptions. Actual results may differ materially due to factors including procurement requirements and award decisions, competition, financing availability, regulatory approvals, project execution, and other risks described in the Company’s Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this announcement. Bimergen Energy Corporation undertakes no obligation to update these statements except as required by applicable law.

Media Contact:
Dave Gentry
RedChip Companies Inc.
1-407-644-4256 | 1-800-REDCHIP (733-2447)
BESS@redchip.com

NAPLES, Fla. and CAMBRIDGE, United Kingdom, Sept. 18, 2026 (GLOBE NEWSWIRE) — CDT Equity Inc. (Nasdaq: CDT) (“CDT” or the “Company”), today announced that it has entered into a partnership with QIMA Life Sciences, a world leading preclinical dermatology CRO, to explore the potential of several of CDT’s assets in autoimmune skin diseases.

CDT plans to leverage QIMA’s unique access to human skin from both healthy donors and patients. The use of patient tissue offers the most clinically relevant data possible, providing rapid translation to clinic and providing potential license partners the highest level of confidence possible for clinical success.

Initial studies will be centred around tapinarof (VTAMA®), a drug currently approved for plaque psoriasis and atopic dermatitis in the US and Japan. CDT has created a robust intellectual property portfolio around tapinarof, including solid form and method-of-use patents in combination with other known drugs. QIMA will explore the potential of these novel combinations in psoriatic patient skin, with the aim of working towards a second generation tapinarof product with increased efficacy and patient benefits. VTAMA® is currently the number one branded topical treatment in the US, and CDT believe that developing a combination therapy could both expand, and extend, its market to further patient groups.

CDT also plans to investigate the potential of its proprietary tapinarof combinations in vitiligo, an autoimmune disease often associated with significant emotional and psychological distress for sufferers. Vitiligo is a common chronic autoimmune disorder affecting approximately 0.5%–2.0% of the global population, representing tens of millions of patients worldwide1. The global vitiligo drug market was estimated at approximately US$2.6 billion in 2025 and is projected to reach US$6.6 billion by 20302. Current approved treatments often prove intolerable for many patients, especially pediatric patients, and re-pigmentation can take a considerable amount of time, demonstrating a significant unmet need for new therapies that are effective, yet tolerable. Working with human skin will allow CDT to explore the potential of these combinations in the most physiologically relevant setting possible.

For further information or to discuss potential partnership opportunities, please contact the Company at info@cdtequity.com.

About QIMA Life Sciences

QIMA Life Sciences is a contract research organization specializing in cellular and molecular pharmacology. It partners with pharmaceutical and biotechnology companies to advance research and accelerate drug development through tailored, science-driven solutions spanning early discovery through clinical development. By combining preclinical and clinical research and testing solutions with advanced AI-driven image analysis and digital data platforms, QIMA Life Sciences enables companies to generate the robust scientific evidence needed to bring innovative drugs to patients with confidence. www.qima-lifesciences.com

About CDT Equity Inc.

CDT Equity Inc. (NASDAQ: CDT) is a data-driven biopharmaceutical development company focused on identifying, enhancing, and advancing high-potential therapeutic assets through scientific innovation and strategic partnerships. Originally established as Conduit Pharmaceuticals, the company has evolved into a broader, more agile platform that leverages artificial intelligence, solid-form chemistry, and efficient asset repositioning to accelerate the development of novel treatments. Looking ahead, CDT are committed to creating shareholder value through licensing, strategic M&A, and positioning the company as a platform for transformative innovation.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical facts contained in this press release, including statements regarding CDT’s future results of operations and financial position, CDT’s business strategy, prospective product candidates, product approvals, research and development cost timing and likelihood of success, plans and objectives of management for future operations, future results of current and anticipated studies and business endeavors with third parties, and future results of current and anticipated product candidates, are forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to; the effect that the reverse stock split may have on the price of the Company’s common stock; the ability or inability to maintain the listing of CDT’s securities on Nasdaq; the ability to recognize the anticipated benefits of the business combination completed in September 2023, which may be affected by, among other things, competition; the ability of the combined company to grow and manage growth economically and hire and retain key employees; the risks that CDT’s product candidates in development fail clinical trials or are not approved by the U.S. Food and Drug Administration or other applicable authorities on a timely basis or at all; changes in applicable laws or regulations; the possibility that CDT may be adversely affected by other economic, business, and/or competitive factors; and other risks and uncertainties identified in other filings made by CDT with the U.S. Securities and Exchange Commission. Moreover, CDT operates in a very competitive and rapidly changing environment. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond CDT’s control, you should not rely on these forward-looking statements as predictions of future events.

Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, CDT assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. CDT gives no assurance that it will achieve its expectations.

Investors
CDT Equity Inc.
Info@cdtequity.com

__________________________
1 https://onlinelibrary.wiley.com/doi/full/10.1002/ski2.317
2 https://www1.hkexnews.hk/app/sehk/2026/108643/documents/sehk26061501863.pdf

Renk Group AG: Release according to Article 40 (1) of the WpHG (the German Securities Trading Act) with the objective of Europe-wide distribution

18. Sep 2026 / 12:20 CET/CEST, transmitted by GlobeNewswire.

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


Notification of Major Holdings

1. Details of issuer

Name RENK Group AG
Street address Gögginger Straße 73
Postal code 86159
City Augsburg
LEI 894500H8CNSZ53EI6K63

2. Reason for notification

Acquisition/disposal of shares with voting rights

3. Details of person subject to the notification obligation

Legal entity

Name Location Country
UBS Group AG Zurich CH

4. Name(s) of shareholder(s) holding directly 3% or more voting rights, if different from details of person subject to the notification obligation

Name
N/A

5. Date on which threshold was crossed or reached

16.09.2026

6. Total positions

% of voting rights attached to shares (total of details on total positions 7.a.) % of voting rights through instruments (total of details on total positions 7.b.1. + 7.b.2.) Total of both in % (details on total positions 7.a. + 7.b.) Total number of voting rights pursuant to Sec. 41 WpHG
New 1.1% 3.98% 5.08% 100,000,000
Previous notification n/a% n/a% n/a% –

7. Details on total positions

a. Voting rights attached to shares (Sec. 33, 34 WpHG)

ISIN Absolute In %
Direct (Sec. 33 WpHG) Indirect (Sec. 34 WpHG) Direct (Sec. 33 WpHG) Indirect (Sec. 34 WpHG)
DE000RENK730 0 1,096,315 0% 1.1%
Total 1,096,315 1.1%

b.1. Instruments according to Sec. 38 (1) no. 1 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Voting rights absolute Voting rights in %
Right to Recall of Lent Shares At any time 890,589 0.89%
Right of Use over Shares At any time 2,752,317 2.75%
Long Call Options 18/06/2027 60,000 0.06%
Voting rights absolute Voting rights in %
Total 3,702,906 3.7%

b.2. Instruments according to Sec. 38 (1) no. 2 WpHG

Type of instrument Expiration or maturity date Exercise or conversion period Cash or physical settlement Voting rights absolute Voting rights in %
Short Put Options 18/12/2026 – 15/12/2028 Physical 245,000 0.25%
Right of Use over Reverse Convertible At any time Cash 33,927 0.03%
Voting rights absolute Voting rights in %
Total 278,927 0.28%

8. Information in relation to the person subject to the notification obligation

Person subject to the notification obligation is not controlled nor does it control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer
X

Full chain of controlled undertakings starting with the ultimate controlling natural person or legal entity
Name % of voting rights (if at least 3% or more) % of voting rights through instruments (if at least 5% or more) Total of both (if at least 5% or more)
UBS Group AG
UBS AG
UBS Asset Management AG
UBS Asset Management (Europe) S.A.
–
UBS Group AG
UBS AG
UBS Asset Management AG
UBS Asset Management Holding (No. 2) Ltd
UBS Asset Management Holding Ltd
UBS Asset Management (UK) Ltd
–
UBS Group AG
UBS AG
UBS Asset Management AG
UBS Asset Management Holding (No. 2) Ltd
UBS Asset Management Holding Ltd
UBS Asset Management Life Ltd
–
UBS Group AG
UBS AG
UBS Asset Management AG
UBS Asset Management Switzerland AG
UBS Fund Management (Switzerland) AG
–
UBS Group AG
UBS AG
UBS Americas Holding LLC
UBS Americas Inc.
UBS Securities LLC
–
UBS Group AG
UBS AG
UBS Switzerland AG

9. In case of proxy voting according to Sec. 34 (3) WpHG

Date of general meeting

Total positions (6.) after general meeting:

% of voting rights attached to shares % of voting rights through instruments Total of both

10. Other useful information

Date

18.09.2026

End of message


GlobeNewsWire Distribution Services include regulatory announcements, financial/corporate news and press releases.

Archive at www.globenewswire.com


Language English
Company Renk Group AG
Gögginger Str. 73
86159 Augsburg
Germany
Internet https://www.renk.com/

HANGZHOU, China, Sept. 18, 2026 (GLOBE NEWSWIRE) — Since the beginning of September, CaoCao Inc. (2643.HK) has continued to expand its ecosystem of AI device partnerships. Following its launch on Doubao AI phones, CaoCao’s AI ride-hailing service officially integrated with HONOR YOYO on September 15 and received the “Innovative Partner” award at the 2026 HONOR Global Developer Conference. On September 17, CaoCao announced the integration of its AI ride-hailing service with OPPO Breeno Next.

Following the announcements, CaoCao’s shares extended their gains, rising more than 20% over two days.

With HONOR YOYO, users can simply state their ride needs. YOYO can automatically identify pickup and drop-off points, match users with CaoCao’s mobility resources, select an appropriate vehicle type and route, and complete the booking. In this collaboration, CaoCao opened up caocao-cli for the first time, a standard interface that enables AI agents to invoke CaoCao services, making CaoCao the first platform in the AI mobility sector to use CLI-based integration with on-device agents. The interface introduces a unique idempotency key, an explicit confirmation flag and a unified Trace ID, ensuring that network retries do not result in duplicate bookings, critical actions require user confirmation, and the entire service chain is traceable and auditable.

With OPPO Breeno Next, users can search for CaoCao’s AI agent, “Xiao Cao,” and state their ride needs in natural language. They can then compare fares across vehicle types, book a ride with one tap and track their trip directly within the interface. In this collaboration, CaoCao upgraded caocao-mcp, its unified standard protocol that enables AI agents to invoke CaoCao services, making CaoCao’s AI ride-hailing service the first AI mobility service in Breeno Next to support UI interaction. Depending on agent capabilities, caocao-mcp also supports multiple interaction formats, including text, web pages and interactive cards.

From Doubao AI phones to HONOR YOYO and OPPO Breeno Next, CaoCao’s AI ride-hailing service is becoming available across a growing range of endpoints. Building on its scalable, systematic capabilities in fleet dispatching, asset management, user services and compliance operations, CaoCao has enabled efficient connections between AI agents and mobility resources on its platform.

Contact:
Jing Liu   
Jing.Liu3@caocaoglobal.com

Press release – No. 16 / 2026

Zealand Pharma receives positive CHMP opinion for Zeydovio™ (glepaglutide) for the treatment of short bowel syndrome

  • The CHMP of the European Medicines Agency has recommended the approval of Zeydovio™ (glepaglutide) for the treatment of short bowel syndrome
  • The positive CHMP opinion marks the first major advancement in short bowel syndrome treatment in Europe in more than a decade
  • Zeydovio’s™ evidenced efficacy combined with its simple delivery, positions it as a transformative therapy for people living with short bowel syndrome
  • Two thirds of patients treated with glepaglutide achieved a clinical response of at least a 20% reduction in weekly parenteral support volume, and one in seven weaned off parenteral support entirely, after 24 weeks of treatment
  • Zealand Pharma continues to advance glepaglutide toward patients globally with active enrolment into the Phase 3 EASE-5 trial to support a U.S. NDA


Copenhagen, Denmark, September 18, 2026
– Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for Zeydovio™ (glepaglutide), a long-acting, next-generation GLP-2 analog, for the treatment of adults with short bowel syndrome (SBS).

“The positive opinion for Zeydovio™ is the first major advancement in short bowel syndrome treatment in Europe in more than a decade. Those living with short bowel syndrome face significant daily burdens and are susceptible to significant health risks from parenteral support, and every day free from it can be life changing. In the Phase 3 trials, Zeydovio™ significantly reduced parenteral support volume, reducing the number of days required for many patients and eliminating the need for it entirely in others,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “Offering simple dosing twice weekly via a ready-to-use autoinjector, Zeydovio™ holds potential as a transformative therapy for SBS that could meaningfully ease the burden of disease management for thousands of patients.”

The positive opinion is based on data from the pivotal Phase 3 EASE-1 trial, in which twice-weekly glepaglutide demonstrated statistically significant and superior reductions in parenteral support requirements in SBS patients with intestinal failure (IF) compared to placebo. These data were supported by interim results from the EASE-2 and EASE-3 trials, the long-term extension trials of up to two years, and results from a mechanistic trial (EASE-4) providing evidence of glepaglutide’s pharmacodynamic effects in improving intestinal absorption. In the clinical trials to date, glepaglutide treatment appeared safe and well tolerated. Results from the EASE-2 and EASE-3 trials, which confirmed the long-term efficacy and safety of glepagutide, are expected to be presented at scientific meetings in 2027.

The CHMP’s opinion will now be reviewed by the European Commission, with a final decision on the Marketing Authorization Application (MAA) expected within approximately 67 days. Subject to European Commission approval, the marketing authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

Zealand Pharma is actively engaging in partnership discussions for the future global commercialization of glepaglutide for SBS.

The Phase 3 EASE-5 trial, designed to provide further confirmatory evidence to support a regulatory submission in the U.S., is ongoing, with patient recruitment progressing well.

About short bowel syndrome
Short bowel syndrome (SBS) is a rare, chronic and severe disease associated with reduced or complete loss of intestinal function, leaving many patients chronically dependent on complex parenteral support (PS). While life-sustaining, parenteral support poses significant restrictions on patients’ ability to engage in daily activities. In addition, they are at risk of experiencing a number of serious and life-threatening complications such as sepsis, blood clots, liver damage and renal impairment.

About glepaglutide
Glepaglutide is a long-acting GLP-2 analog in development for the treatment of short bowel syndrome, aiming to reduce or eliminate the need for parenteral support by improving intestinal function. With its long half-life and high stability in aqueous solution, glepaglutide is developed for twice-weekly, subcutaneous administration via a ready-to-use, single-dose autoinjector. The U.S. FDA has granted orphan drug designation for glepaglutide for the treatment of SBS.

About the EASE Clinical Trial Program
The Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for PS in SBS patients with intestinal failure.

EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial in 106 SBS patients with intestinal failure who were dependent on PS for at least three days per week. Patients were evenly randomized to receive glepaglutide 10 mg once or twice weekly, or placebo. The primary endpoint was the absolute change in weekly PS volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week compared to 2.85 liters/week in the placebo group (p=0.0039). Clinical efficacy was observed in patients with and without colon-in-continuity. Among patients receiving glepaglutide twice weekly, 65.7% achieved a clinical response, defined as at least 20% reduction in weekly PS volume at 24 weeks (versus 38.9% in the placebo group), and 51.4% of patients achieved a reduction in PS days of at least 1 day/week (versus 19.4% in the placebo group). Nine patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients achieved enteral autonomy. For patients treated twice weekly, 14% (n=5) achieved enteral autonomy. Glepaglutide treatment appeared safe and well tolerated.

In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the two-year long-term safety and efficacy extension trial, EASE-2.

EASE-2 (NCT03905707) was a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to glepaglutide 10 mg once- or twice-weekly. In addition, a smaller group of patients not previously treated with glepaglutide were directly randomized to receive glepaglutide 10 mg once- or twice weekly. In an interim analysis after at least six months of treatment, clinical response across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS.

Patients who completed EASE-2 were eligible for EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. The EASE-2 and EASE-3 trials were completed in 2026, and the remaining patients have rolled over to a new extension trial, EASE-6 (NCT07228403). Results from the EASE-2 and EASE-3 trials are expected to be presented at scientific meetings in 2027.

EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide once weekly on intestinal fluid and energy uptake, providing evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. The primary endpoint was absolute change in intestinal wet weight absorption. Secondary endpoints assessed changes in energy, electrolyte, and macronutrient absorption after 24 weeks of treatment. Additional endpoints included changes in PS use, body composition and safety after 52 weeks of treatment. At week 24, mean numerical increase in intestinal wet weight absorption was 398 g/day (p=0.0585) and mean energy absorption 1038 kJ/day (p=0.0215). Improvements occurred in electrolyte and macronutrient absorption. At week 52, mean PS volume was reduced by 800 mL/day (p=0.0106) with a reduction in mean PS energy content of 866 kJ/day (p=0.0103).

EASE-5 (NCT07197944) is a randomized, double-blind, placebo-controlled Phase 3 trial, designed to confirm the efficacy and safety of glepaglutide twice weekly, followed by a long-term, open-label safety evaluation in SBS patients with intestinal failure.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.

To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.

Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

Forward looking statements 
This press release contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Zealand Pharma® is a registered trademark of Zealand Pharma A/S.

Contacts
Eric Rojas (Investors)
Vice President, Head of Investor Relations
erojas@zealandpharma.com

Neshat Anis Ahmadi (Investors)
Investor Relations Manager
neahmadi@zealandpharma.com

Rachel James-Owens (Media)
Vice President, Corporate Communications and Media Relations
RJamesOwens@zealandpharma.com

Andreas Hylleberg (Media)
Director, External Communications
Zealand Pharma
Email: AHylleberg@zealandpharma.com

Amber Fennell, Jessica Hodgson, and Sean Leous (Media)
ICR Healthcare
ZealandPharma@icrhealthcare.com
+44 (0) 7739 658 783

Transaction in Own Shares

September 17, 2026

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Shell plc (the ‘Company’) announces that on 17 September 2026 it purchased the following number of Shares for cancellation.

Aggregated information on Shares purchased according to trading venue:

Date of Purchase Number of Shares purchased Highest price paid Lowest price paid Volume weighted average price paid per share Venue Currency
17/09/2026 1,175,000 £ 35.9250 £ 35.4750 £ 35.6929 LSE GBP
17/09/2026 – – – – Chi-X (CXE) GBP
17/09/2026 – – – – BATS (BXE) GBP
17/09/2026 600,000 € 42.0450 € 41.3850 € 41.6270 XAMS EUR
17/09/2026 – – – – CBOE DXE EUR
17/09/2026 – – – – TQEX EUR

These share purchases form part of the on- and off-market limbs of the Company’s existing share buy-back programme previously announced on 30 July 2026. 

In respect of this programme, Goldman Sachs International will make trading decisions in relation to the securities independently of the Company for a period from 30 July 2026 up to and including 23 October 2026.

The on-market limb will be effected within certain pre-set parameters and in accordance with the Company’s general authority to repurchase shares on-market. The off-market limb will be effected in accordance with the Company’s general authority to repurchase shares off-market pursuant to the off-market buyback contract approved by its shareholders and the pre-set parameters set out therein. The programme will be conducted in accordance with Chapter 9 of the UK Listing Rules and Article 5 of the Market Abuse Regulation 596/2014/EU dealing with buy-back programmes (“EU MAR”) and EU MAR as “onshored” into UK law from the end of the Brexit transition period (at 11:00 pm on 31 December 2020)  through the European Union (Withdrawal) Act 2018 (as amended by the European Union (Withdrawal Agreement) Act 2020), and as amended, supplemented, restated, novated, substituted or replaced by the Financial Services Act, 2021 and relevant statutory instruments (including, The Market Abuse (Amendment) (EU Exit) Regulations (SI 2019/310)), from time to time (“UK MAR”) and the Commission Delegated Regulation (EU) 2016/1052 (the “EU MAR Delegated Regulation”) and the EU MAR Delegated Regulation as “onshored” into UK law from the end of the Brexit transition period (at 11:00 pm on 31 December 2020) through the European Union (Withdrawal) Act 2018 (as amended by the European Union (Withdrawal Agreement) Act 2020), and as amended, supplemented, restated, novated, substituted or replaced by the Financial Services Act, 2021 and relevant statutory instruments (including, The Market Abuse (Amendment) (EU Exit) Regulations (SI 2019/310)), from time to time.

In accordance with EU MAR and UK MAR, a breakdown of the individual trades made by Goldman Sachs International on behalf of the Company as a part of the buy-back programme is detailed below.

Enquiries:

Media International: +44 (0) 207 934 5550; U.S. and Canada: https://www.shell.us/about-us/news-and-insights/media/submit-an-inquiry.html

 

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