The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder.
The main question it aims to answer is:
Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.

Start Date10 Oct 2025

Sponsor / Collaborator

Beni-Suef University

CTRI/2025/03/082315

/ Not yet recruitingPhase 2/3IIT

To comparative evaluation of the effect of local application of somatropin growth hormone on osseointegration and bone density around dental implant clinical and radiographic study - NIL

Start Date15 Mar 2025

Sponsor / Collaborator-

NCT05746650

/ RecruitingNot ApplicableIIT

Regulation of Protein Turnover in Connective Tissue From Muscle and Tendon Following Muscle Tissue Injury

The study is a 2-week human study where 40 patients who are scheduled to undergo reconstructive knee surgery are randomized to administration of GH or placebo following or without neuromuscular electrical stimulation of hamstring muscles.The overall aim is to determine, the role of muscle connective tissue protein synthesis in muscle injury and repair.

Start Date24 Feb 2023

Sponsor / Collaborator

Bispebjerg Hospital

100 Clinical Results associated with Somatropin (Merck Serono SA)

100 Translational Medicine associated with Somatropin (Merck Serono SA)

100 Patents (Medical) associated with Somatropin (Merck Serono SA)

166

Literatures (Medical) associated with Somatropin (Merck Serono SA)

01 Feb 2026·BMJ Open

Recombinant human growth hormone (rHGH) for muscle enhancement in knee osteoarthritis: protocol for a pilot, randomised placebo-controlled trial

Article

Author: Kiss, Alexander ; Shah, Ajay ; Burkhart, Timothy A ; Marks, Paul ; Whyne, Cari ; Tomescu, Sebastian ; Wasserstein, David N ; Ravi, Bheeshma ; Catapano, Michael

Introduction:

The management of active patients with symptomatic knee osteoarthritis (KnOA) who are too young for total knee arthroplasty poses a specific challenge to clinicians. Research studies show that improving quadriceps muscle strength improves pain and function; however, aspects of the disease render it difficult for patients to achieve and maintain improvements. Recombinant human growth hormone (rHGH) is shown to increase the magnitude and duration of muscle growth when combined with exercise treatment in adult populations. Hence, rHGH combined with physical therapy may provide meaningful benefits in the treatment of KnOA.

Methods and analysis:

This is a single-centre, double-blind, randomised trial to pilot a future Phase III trial from 2025 to 2028. Participants are aged 18–60 with clinical and radiographic evidence of isolated degenerative arthritis of the knee (patellofemoral or tibiofemoral). The investigational product is rHGH (Saizen (somatropin of rDNA origin, EMD Serono)) and a saline placebo. Participants will deliver the solution via subcutaneous injection area once per day at a dose of 0.5 mg HGH per body surface area (0.5 mg/m 2 ) for 6 weeks, alongside participation in a lower limb strengthening programme developed by rehabilitation specialists. 17 participants will be recruited into each study arm. The primary outcomes are feasibility (compliance with the study drug regimen for the 6-week administration period and enrolment rate) and safety (the proportion of minor and major adverse events between groups). The primary endpoint for these outcomes will be at 6 weeks. The secondary outcomes are knee extension strength, knee flexion strength, radiographic arthritis progression, thigh muscle circumference, MRI-measured quadriceps muscle volume and patient-reported outcome measures (Knee Osteoarthritis Outcome Score (KOOS), SF-20 and Tegner). The primary endpoint for these outcomes will be at 12 weeks, and the final endpoint will be 24 months, where final radiographic (X-ray) assessment will take place. The primary outcome of compliance will be a calculation of mean compliance between groups, which can be analysed as a t-test after the treatment period. A two-sample, two-sided t-test will compare the clinical (secondary) outcome of greatest interest: knee extension strength at baseline versus week 6 compared between treatment groups. Other secondary outcomes will be compared using a simple linear mixed-effects model. The χ 2 test will be used to determine whether the number of participants who made meaningful changes was different between groups. The null hypotheses are that the rHGH and placebo groups will have no difference in compliance rates, safety events, knee extension strength at 12 weeks and arthritis grade progression at 24 months.

Ethics and dissemination:

This study has been approved by the Sunnybrook Research Institute Research and Ethics Board (#6427) and received a no-objection letter from Health Canada Clinical Trials. The primary sponsor is the Sunnybrook Centre for Clinical Trial Studies (CCTS). The findings of this study will be published in a peer-reviewed journal and presented at orthopaedic conferences.

Trial registration number:

NCT07036003 .

01 Jan 2025·PLoS One

Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in Japan.

Article

Author: Benjumea, Darrin ; Wajnrajch, Michael P ; Jhingran, Priti ; Wogen, Jenifer ; Alvir, Jose ; Takasawa, Kei ; Chen, Yong ; Loftus, Jane

BACKGROUND:

Pediatric growth hormone deficiency (pGHD) is treated with daily somatropin (recombinant human growth hormone) injections. High rates of discontinuation and poor adherence to treatment, which are associated with worse growth outcomes, have been documented previously, for example in the US and Europe. Discontinuation of somatropin has not yet been evaluated using real-world data in Japan.

OBJECTIVES:

To describe discontinuation of, and persistence to, daily somatropin treatment among children with pGHD in Japan.

METHODS:

This was a retrospective cohort study of children (≥3 and <16 years old) who were prescribed somatropin, using 2 Japan-based databases, Japan Medical Data Center (JMDC) and Medical Data Vision (MDV). Children were required to have ≥1 prescription for somatropin (first prescription = index date) within each study period (1 January 2002-30 September 2021 for JMDC and 1 January 2009-31 October 2021 for MDV) and ≥1 GHD diagnosis code without a somatropin prescription during the 6-months pre-index period. Children were required to be continuously enrolled in the database ≥6 months preceding and ≥3 months following index date. Children were followed for up to 48 months post-index. Early persistence was defined as the proportion of children with ≥1 refill of somatropin subsequent to the initial prescription. Discontinuation was defined as the first observation of a gap in therapy (using >60, > 90, and 120-day gap thresholds) between successive somatropin prescription fill dates. Persistence was defined as continuous refills of somatropin with no gaps in therapy. Time to discontinuation/non-persistence was evaluated using Kaplan-Meier methods, and Cox proportional hazards models identified predictors of time to discontinuation. This analysis utilized de-identified patient data from 2 large, Japanese-based retrospective databases; as such this study does not meet the requirements for institutional review board (IRB) review.

RESULTS:

Among the children included in this study (JMDC N = 452, MDV N = 573), most were male (JMDC 64.8%, MDV 60.0%). Mean age (standard deviation) was 8.8 (3.6) years in JMDC and 7.5 (3.6) years in MDV. Early persistence was high across both cohorts (JMDC 91.2%, MDV 83.4%). Using the 90-day gap definition for discontinuation, a sizable proportion of children discontinued over the follow-up period: JMDC 19% at 12 months, 35% at 48 months; and MDV 33% at 12 months, 54% at 48 months. Fewer discontinuations were observed with the 120-day gap definition (~16% at 48 months in JMDC, ~ 28% at 48 months in MDV) and more were observed with the 60-day gap definition (~67% at 48 months in JMDC, ~ 83% at 48 months in MDV). No meaningful predictors of discontinuation were identified.

CONCLUSIONS:

Despite high early persistence with somatropin, many children with pGHD in Japan were increasingly non-persistent over time: at 48 months post-index, at least 16% of children discontinued therapy, using the JDMC database and the most conservative measure of gap allowance. These results suggest a need for new strategies to support somatropin medication use over time among children with pGHD in Japan.

01 Jan 2025·HUMAN REPRODUCTION

Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial

Article

Author: Tadevosyan, Artak ; Phillips, Simon ; Mourad, Ali ; Jamal, Wael ; Hemmings, Robert ; Kadoch, Isaac-Jacques

Abstract:

STUDY QUESTION:

Does adjuvant growth hormone (GH) therapy in GnRH antagonist cycles improve reproductive outcomes in the general IVF population?

SUMMARY ANSWER:

Empiric adjuvant GH therapy in GnRH antagonist cycles does not improve IVF stimulation results or reproductive outcomes, including implantation, miscarriage, and clinical pregnancy rates.

WHAT IS KNOWN ALREADY:

Previous evidence regarding the benefits of GH therapy in IVF cycles has been inconclusive due to the lack of well-designed, large-scale randomized controlled trials (RCTs) in the general IVF population.

STUDY DESIGN, SIZE, DURATION:

This is a phase III open-label RCT involving 288 patients undergoing antagonist IVF cycles at the Ovo clinic in Montreal, Canada, between June 2014 and January 2020. Patients were randomly assigned at a 1:1 ratio to either the GH or control group. The intervention group received daily 2.5 mg subcutaneous injections of GH from Day 1 of ovarian stimulation until the day of oocyte retrieval, while the control group received standard ovarian stimulation without any adjuvant therapy.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Patients were expected normal responders. All embryo transfers, both fresh and frozen, resulting from the studied IVF cycle were included in an intention-to-treat and per-protocol analyses. The primary outcome was the clinical pregnancy rate, while secondary outcomes included the number of retrieved oocytes, good-quality embryos, maturation, fertilization, implantation, and miscarriage rates.

MAIN RESULTS AND THE ROLE OF CHANCE:

A total of 288 patients were recruited and randomly assigned at a 1:1 ratio to either the GH or the control group. After excluding cycle cancellations and patients who did not undergo transfer, 105 patients remained in each group. The overall mean age was 38.0 years, the mean BMI was 25.11 kg/m2 and the mean anti-Müllerian hormone was 2.51 ng/ml. The cycle characteristics were similar between both groups. No differences were observed regarding the total dose of gonadotropins (4600 versus 4660 IU for the GH and control groups, respectively, P = 0.752), days of stimulation (11.4 versus 11.7 days, P = 0.118), and endometrial thickness (10.63 versus 10.94 mm, P = 0.372). Both the intention to treat (ITT) and per protocol analyses yielded similar results for stimulation outcomes. In the ITT analysis, no differences were found in the number of follicles ≥15 mm (7.8 versus 7.1, P = 0.212), retrieved oocytes (11.7 versus 11.2, P = 0.613), mature oocytes (8.5 versus 8.6, P = 0.851), maturation rate (73.8 versus 78.4%, P = 0.060), fertilization rate (64.3 versus 67.2%, P = 0.388), and good quality embryos (2.5 versus 2.6, P = 0.767). Reproductive outcomes in fresh embryo transfer showed no difference for implantation rate (38.2 versus 39.5%, P = 0.829), miscarriage rate (26.5 versus 31.1%, P = 0.653), clinical pregnancy rate (43.6 versus 50.0%, P = 0.406, rate difference, 95% CI: −0.06 [−0.22, 0.09]), and live birth rate (32.1 versus 33.3%, P = 0.860). The number of embryos needed to achieve a clinical pregnancy was 3.0 versus 2.5 in the GH and control groups, respectively. Similarly, reproductive outcomes in first frozen embryo transfer showed no difference for implantation rate (31.6 versus 45.3%, P = 0.178), miscarriage rate (28.6 versus 26.3%, P = 0.873), clinical pregnancy rate (35.1 versus 44.2%, P = 0.406, P = 0.356, rate difference, 95% CI: −0.09 [−0.28, 0.10]), and live birth rate (22.8 versus 32.6%, P = 0.277). The number of embryos needed to achieve a clinical pregnancy was 3.1 versus 2.4 in the GH and control groups, respectively.

LIMITATIONS, REASONS FOR CAUTION:

The study focused on expected normal responders, limiting its applicability to other patient populations such as poor responders.

WIDER IMPLICATIONS OF THE FINDINGS:

These findings suggest that adding GH therapy to ovarian stimulation in GnRH antagonist cycles may not benefit the general IVF population. Additional high-quality RCTs are warranted to identify subgroups of patients who might benefit from this treatment.

STUDY FUNDING/COMPETING INTEREST(S):

EMD Serono Inc., Mississauga, Canada, supplied Saizen® for the study, free of charge. In addition, they provided funding for the statistical analysis. I-J.K. declares grants or contracts from Ferring Pharmaceuticals, consulting fees from Ferring Pharmaceuticals, honoraria from Ferring Pharmaceuticals and EMD Serono, support for attending meetings or travel from Ferring Pharmaceuticals and EMD Serono, participation on a Data Safety Monitoring Board or Advisory Board for Ferring Pharmaceuticals, and stock or stock options from The Fertility Partners; W.J. declares support for attending meetings or travel from EMD Serono; and S.P. declares stock or stock options from The Fertility Partners. All other authors have no conflicts of interest to disclose.

TRIAL REGISTRATION NUMBER:

NCT01715324.

TRIAL REGISTRATION DATE:

25 October 2012.

DATE OF FIRST PATIENT’S ENROLMENT:

25 June 2014.

News (Medical) associated with Somatropin (Merck Serono SA)

17 Mar 2026

·www.biospace.com

New InsiGHTS Trial of TransCon® hGH (Lonapegsomatropin) in Turner Syndrome Demonstrated Comparable Efficacy and Safety to Daily Somatropin at Week 52

- Annualized height velocity of 9.05 cm/year (LS mean) for TransCon hGH-treated children was similar at Week 52 to daily somatropin-treated children - TransCon hGH showed a safety and tolerability pro to daily somatropin with no occurrences of slipped capital femoral epiphysis (SCFE) COPENHAGEN, Denmark, March 17, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced positive Week 52 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. investigating the safety, tolerability, and efficacy of once-weekly TransCon hGH (lonapegsomatropin; U.S. FDA-approved for pediatric and adult growth hormone deficiency (GHD) and approved in other territories for pediatric GHD) compared to daily somatropin in prepubertal children with Turner syndrome. New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old. They were treated with either TransCon hGH or daily somatropin. Doses were subsequently individualized based on IGF-1. At Week 52, children treated with TransCon hGH demonstrated improved annualized height velocity (AHV) similar to daily somatropin, independent of starting dose, with an LS mean AHV of 9.05 cm/year for all TransCon hGH-treated children, compared to 9.04 cm/year for those treated with daily somatropin. At Week 52, the mean dose for TransCon hGH was 0.22 mg/kg/week, while the mean dose for the daily somatropin cohort was 0.29 mg/kg/week. In the trial, TransCon hGH demonstrated a safety and tolerability pro to daily somatropin through follow-up of up to 143 weeks. Adverse events (AEs) were mild to moderate in severity, with no AEs leading to discontinuation of study drug. There were no occurrences of slipped capital femoral epiphysis (SCFE), consistent with the low rate of occurrence (<1%) in long-term safety data of daily somatropin use in Turner syndrome from published literature 1,2 . “These new results demonstrated safety and efficacy comparable to daily growth hormone with up to 143 weeks of follow-up, and support the potential of TransCon hGH as a differentiated therapy for short stature in the setting of growth hormone sufficiency and is being further studied in our recently initiated Phase 3 HighLiGHts basket trial to support label expansion,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. About Turner Syndrome Turner syndrome is the most common congenital sex chromosomal condition in females, with an estimated prevalence of 1 out of every 2,000 to 2,500 live female births. Short stature, associated with short stature homeobox-containing gene ( SHOX ) haploinsufficiency, is the most common clinical feature of Turner syndrome. Clinical manifestations of Turner syndrome affect multiple organ systems and are associated with significant and potentially life-threatening complications including cardiovascular disease, ovarian dysfunction, endocrine disease, renal malformation, liver disease, sensorineural hearing loss, and varied neuropsychological manifestations. About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management 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. Examples of such statements include, but are not limited to, statements relating to (i) the potential of TransCon hGH as a differentiated therapy for short stature in the setting of growth hormone sufficiency, (ii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients, and (iii) Ascendis’ ability to apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third‑party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on‑market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom‑to‑operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, and TransCon are trademarks owned by the Ascendis Pharma group. © March 2026 Ascendis Pharma A/S. Investor Contacts: Media Contact: Chad Fugere Melinda Baker Ascendis Pharma Ascendis Pharma ir@ascendispharma.com media@ascendispharma.com Patti Bank ICR Healthcare +1 (415) 513-1284 patti.bank@icrhealthcare.com 1 Darendeliler F, Karagiannis G, Wilton P. Horm Res. 2007;68 Suppl 5:41-47. doi:10.1159/000110474 2 Bell J, Parker KL, Swinford RD, et al. J Clin Endocrinol Metab 2010;95(1):167–177. doi:10.1210/jc.2009-0178.

Clinical ResultPhase 3Drug ApprovalPhase 2

05 Mar 2026

·www.emdgroup.com

Merck KGaA, Darmstadt, Germany: Guidance for 2025 Delivered, Growth Foundation in Place

Company delivered on financial guidance for 2025 Net sales around stable at € 21.1 billion; organic growth of +3.1%; foreign exchange effects of –3.7% EBITDA pre grew to € 6.1 billion; organic growth of +5.6%; foreign exchange effects of –5.0% Executive Board and Supervisory Board propose stable dividend of € 2.20 per share Outlook 2026: Net sales of € 20.0 – 21.1 billion and EBITDA pre of € 5.5 – 6.0 billion amid considerable foreign exchange headwinds Merck KGaA, Darmstadt, Germany, a leading science and technology company, delivered on its guidance for 2025 and achieved organic growth despite significant headwinds. Process Solutions in the Life Science business sector, the Cardiovascular, Metabolism & Endocrinology (CM&E) franchise within Healthcare and the Semiconductor Materials business within Electronics were the main contributors. “We once again demonstrated our resilience in 2025 in the face of significant geopolitical challenges and strong currency headwinds. Our consistent record of disciplined financial performance and sharp strategic focus over the last five years has paid off and made us larger, more profitable, more efficient, more flexible, and less leveraged. I’m very proud of where we stand today,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “As a diversified global business with a robust portfolio and core growth drivers in Process Solutions, Rare Diseases and Semiconductor Solutions, we are now well positioned for the decade ahead as our company’s next chapter begins.” Financial performance in 2025 In 2025, net sales of the Group grew organically by 3.1% compared with the previous year. Reported net sales declined by 0.3% to € 21.1 billion, mainly driven by a negative impact of –3.7% from foreign exchange effects concerning the U.S. dollar and various Asian currencies. Portfolio effects, especially the acquisition of SpringWorks and the divestment of the Surface Solutions business unit, made a net positive contribution of 0.4%. In the fourth quarter of 2025, net sales grew organically by 2.6%, while reported net sales declined by 3.1% compared with the year-earlier quarter. The company’s full-year EBITDA pre grew organically by 5.6% to € 6.1 billion. Foreign exchange had a negative effect of –5.0% while portfolio effects offset each other at 0.0%. The EBITDA pre margin improved by 0.2 percentage points to 28.9%. In the fourth quarter, reported EBITDA pre was down 3.2% while growing 3.1% organically. For the full year, earnings per share pre were € 8.34 (2024: € 8.63). The Executive Board and Supervisory Board will propose an unchanged dividend of € 2.20 per share to the Annual General Meeting on April 24, 2026. This would mark the fifteenth year in a row with an increasing or stable dividend. Merck KGaA, Darmstadt, Germany agreed with the U.S. administration to expand access to its portfolio of in vitro fertilization therapies in the United States. The company is also filing Pergoveris for expedited review under the U.S. Food and Drug Administration Commissioner’s National Priority Voucher program. Furthermore, the Group has reached an agreement with the U.S. Department of Commerce to be relieved from Section 232 pharmaceutical tariffs and has committed to further invest in the U.S. Outlook for 2026 For 2026, Merck KGaA, Darmstadt, Germany anticipates net sales between € 20.0 billion and € 21.1 billion and EBITDA pre between € 5.5 billion and € 6.0 billion. This corresponds to an organic net sales development of –1% to +2% and an organic EBITDA pre development of –4% to +1%. Foreign exchange effects are expected to have an influence of –4% to –2% on net sales and –7% to –3% on EBITDA pre. Overall, this translates to an expected EPS pre range of € 7.10 to € 8.00. This guidance assumes no U.S. sales of Mavenclad from March 2026 amid generic competition. It also excludes positive effects from a potential U.S. launch of Pergoveris. Life Science: Process Solutions drives return to growth The Process Solutions business unit powered growth in Life Science throughout the year, delivering four consecutive quarters of around 10% organic sales growth. Life Science net sales reached € 9.0 billion, with organic growth of 4.0% and portfolio effects of 0.1% dampened by foreign exchange effects of –3.4%. EBITDA pre remained around stable at € 2.6 billion. Organic growth of 3.9% was impacted by foreign exchange effects of –4.3%. Process Solutions, which markets solutions for the entire pharmaceutical production value chain, grew organically across its entire portfolio and in all regions. This growth was supported by demand for bioprocessing solutions and novel modalities such as antibody-drug conjugates. Driven primarily by higher demand from new customer projects and a normalizing market, net sales in Process Solutions grew organically by 10.7% year-on-year to € 3.8 billion. Order intake remains strong, with the book-to-bill ratio comfortably above 1. The business unit is strategically well positioned to capture market momentum and opportunities arising from the industry’s shift toward biologics. Science & Lab Solutions posted organic growth of 0.3% and positive portfolio effects of 0.2%. These were impacted by foreign exchange effects of –3.4%, resulting in net sales of € 4.5 billion. The business unit’s portfolio comprises products and services for pharmaceutical, biotechnology and academic research. Impacts during the year included the effects of U.S. policy changes and the extended government shutdown on spending by academic and government labs as well as ongoing challenges in the market environment, especially in China. Additionally, early-stage biotech funding remained flat. This resulted in lower demand for laboratory products. Net sales in Life Science Services were impacted by non-repeating business from the previous year and came in at € 659 million in 2025. As of January 1, 2026, Life Science has transformed its business units to align its go-to-market approaches even more closely with specific customer experiences. Healthcare: Rare Diseases franchise underpins growth profile Healthcare had a solid year across franchises, with net sales in the business sector growing organically by 3.7% to € 8.6 billion in fiscal 2025. Portfolio effects from the acquisition of SpringWorks added growth of 2.2% while foreign exchange had an impact of –4.1%. EBITDA pre recorded an organic increase of 11.5%. Negative impacts resulted from foreign exchange effects of –8.5% and a minor portfolio effect of –0.1%. Overall, EBITDA pre increased to € 3.1 billion. The newly established Rare Diseases franchise contributed significantly to the results as of the third quarter of 2025, reflected as a portfolio effect. It includes sales from Ogsiveo, which treats progressing desmoid tumors, and Gomekli/Ezmekly, approved for plexiform neurofibromas associated with neurofibromatosis type 1. Merck KGaA, Darmstadt, Germany gained the worldwide rights for these products following the acquisition of SpringWorks. Together with pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor, the company’s Rare Diseases franchise is expected to contribute to organic growth throughout 2026. The Cardiovascular, Metabolism & Endocrinology (CM&E) franchise was the largest growth driver in Healthcare, posting organic year-on-year growth of 7.3% across all therapeutic areas. The franchise includes the diabetes medicine Glucophage, the beta-blocker Concor, the thyroid medicine Euthyrox, and Saizen, which is primarily used to treat growth hormone disorders. Net sales in the Neurology & Immunology (N&I) franchise increased by 1.9% organically compared with the previous year. Mavenclad, indicated for relapsing forms of multiple sclerosis, delivered organic growth of 16.6% and net sales of € 1.2 billion. This was driven primarily by increasing demand in North America and Europe. Rebif, also for relapsing forms of multiple sclerosis, saw net sales decline organically by 23.0% as expected. In the Oncology franchise, organic net sales growth was 0.3%. Erbitux, a treatment for metastatic colorectal cancer and for cancer of the head and neck, grew organically by 6.6% amid a challenging competitive environment in China. Due to strong competition, net sales for Bavencio, which is used to treat locally advanced or metastatic urothelial carcinoma, declined organically by 13.8%. Net sales of the Fertility franchise remained around stable, with organic growth of 0.4% in 2025. Gonal-f, a follicle-stimulating hormone treatment for infertility, declined organically by 6.7%. Pergoveris, indicated for the stimulation of follicular development in women, grew organically by 22.6% across all regions. Electronics: Semiconductor Materials delivers sustained growth momentum The artificial intelligence (AI) boom sustained strong demand in Electronics. The Semiconductor Materials business was the business sector’s main growth engine, delivering high single-digit organic growth for the year and the eighth consecutive quarter of strong year-on-year growth. Delivery Systems & Services (DS&S) recorded an organic decline in net sales caused by prolonged delays to large customer projects. This was the main driver behind the 0.6% organic decline in net sales of Electronics in 2025. The divestment of Surface Solutions led to a portfolio effect of –3.2% despite a positive contribution from the acquisition of Unity-SC. Foreign exchange effects were –3.3%. Overall, net sales declined to € 3.5 billion. EBITDA pre decreased 14.1% year-on-year to € 833 million. One-time effects in the second quarter of 2025 and lower sales in DS&S more than offset the growth of Semiconductor Materials. Organic performance decreased by 9.0%. Foreign exchange and portfolio effects had a negative impact of –4.4% and –0.7% respectively. Net sales of Semiconductor Solutions declined organically by 1.4% to € 2.5 billion. Semiconductor Materials achieved strong organic sales growth driven by the demand for high-value materials that enable AI chip systems and advanced nodes. Advanced nodes are the latest semiconductor manufacturing processes that enable smaller feature sizes and the most powerful chips. DS&S recorded a sales decline in the double-digit percentage range. The company expects the business to stabilize in 2026 and to return to growth in the medium term. Optronics delivered net sales of € 772 million. The business unit comprises the businesses with liquid crystals, photoresists for display applications, OLED materials, and metrology and inspection equipment for semiconductor and optoelectronic manufacturing. The overall increase of 3.2% came on the back of organic growth of 0.6% and portfolio effects of 5.8% from the acquisition of Unity-SC. With the divestment of Surface Solutions, which closed at the end of July 2025, Electronics has transformed into a pure-play business with a primary focus on the semiconductor market. Company drives forward science and technology Merck KGaA, Darmstadt, Germany made significant strides in science and technology. In Life Science, the acquisition of HUB Organoids further strengthens its position in next-generation biology. Organoids are a key resource for researchers, leveraging 3D cell cultures to generate earlier, more predictive insights and in turn supporting more informed decisions throughout drug development. Additionally, the partnership with imec is aimed at developing microfluidic devices that simulate the functions of human organs using living cells. This collaboration combines the expertise of Merck KGaA, Darmstadt, Germany in cells and organs with imec’s advanced sensor technology, providing scientists with critical insights into cellular responses to medications. The company also invested € 500 million in its Semiconductor Solutions mega-site in Kaohsiung, Taiwan. This site focuses on semiconductor materials, especially thin films – a technology that allows materials to be deposited and removed on an atomic level, enabling more layers, higher complexity and new chip architectures essential for advanced semiconductors. Regarding its sustainability ambition, Merck KGaA, Darmstadt, Germany exceeded its climate target to halve absolute Scope 1 (direct) and Scope 2 (indirect) greenhouse gas emissions by 2030. The company achieved a 60% reduction compared with the 2020 baseline at the end of 2025 – five years ahead of schedule. This is a major milestone toward the company’s goal of achieving climate neutrality by 2040. Overview of the key figures Group Key figures Change € million 2025 2024 € million % Net sales 21,102 21,156 -54 -0.3% Operating result (EBIT)1 3,601 3,645 -44 -1.2% Margin (% of net sales)1 17.1% 17.2% EBITDA2 5,899 5,779 120 2.1% Margin (% of net sales)1 28.0% 27.3% EBITDA pre1 6,109 6,072 37 0.6% Margin (% of net sales)1 28.9% 28.7% Profit after tax 2,615 2,786 -171 -6.1% Earnings per share (€) 6.00 6.39 -0.39 -6.1% Earnings per share pre (€)1 8.34 8.63 -0.29 -3.4% Operating cash flow 3,932 4,586 -654 -14.3% 1 Not defined by IFRS Accounting Standards. 2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Group Net sales by business sector € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change 2024 Share Life Science 8,980 42% 4.0% -3.4% 0.1% 0.7% 8,916 42% Healthcare 8,607 41% 3.7% -4.1% 2.2% 1.8% 8,455 40% Electronics 3,515 17% -0.6% -3.3% -3.2% -7.1% 3,785 18% Group 21,102 100% 3.1% -3.7% 0.4% -0.3% 21,156 100% 1 Not defined by IFRS Accounting Standards. Life Science Net sales by business unit € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change 20242 Share Science & Lab Solutions 4,536 51% 0.3% -3.4% 0.2% -2.9% 4,672 52% Process Solutions 3,785 42% 10.7% -3.5% 0.3% 7.5% 3,522 40% Life Science Services 659 7% -4.5% -3.4% -0.9% -8.7% 722 8% Life Science 8,980 100% 4.0% -3.4% 0.1% 0.7% 8,916 100% 1 Not defined by IFRS Accounting Standards. 2 Previous-year figures have been adjusted owing to an internal realignment. Healthcare Net sales by major product lines/products € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change1 2024 Share Oncology 1,926 22% 0.3% -4.5% – -4.2% 2,009 24% thereof: Erbitux® 1,176 14% 6.6% -5.5% – 1.2% 1,162 14% thereof: Bavencio® 612 7% -13.8% -2.9% – -16.7% 735 9% Rare Diseases 188 3% thereof: Ogsiveo® 134 2% thereof: Gomekli® 55 1% Neurology & Immunology 1,659 19% 1.9% -3.6% – -1.7% 1,688 20% thereof: Mavenclad® 1,194 14% 16.6% -4.1% – 12.4% 1,062 13% thereof: Rebif® 465 5% -23.0% -2.8% – -25.8% 626 7% Fertility 1,457 17% 0.4% -5.1% – -4.6% 1,528 18% thereof: Gonal-f® 735 9% -6.7% -5.0% – -11.7% 833 10% thereof: Pergoveris® 329 4% 22.6% -5.2% – 17.4% 280 3% Cardiovascular, Metabolism & Endocrinology 3,050 35% 7.3% -3.8% – 3.4% 2,949 35% thereof: Glucophage® 975 11% 5.9% -3.7% – 2.3% 954 11% thereof: Concor® 625 7% 4.7% -2.3% – 2.4% 611 7% thereof: Euthyrox® 653 8% 9.4% -3.9% – 5.4% 619 7% thereof: Saizen® 388 5% 13.0% -6.8% – 6.2% 366 4% Other 328 4% 280 3% Healthcare 8,607 100% 3.7% -4.1% 2.2% 1.8% 8,455 100% 1 Not defined by IFRS Accounting Standards. Electronics Net sales by business unit € million 2025 Share Organic growth¹ Exchange rate effects1 Acquisitions/ divestments1 Total change 2024 Share Semiconductor Solutions 2,494 71% -1.4% -3.7% -0.1% -5.2% 2,631 69% Optronics 772 22% 0.6% -3.2% 5.8% 3.2% 748 20% Surface Solutions 249 7% 1.9% -1.3% -39.5% -38.8% 406 11% Electronics 3,515 100% -0.6% -3.3% -3.2% -7.1% 3,785 100% 1 Not defined by IFRS Accounting Standards. Report on expected developments € million Net sales EBITDA pre1 Free cash flow Group • ~20,000 to 21,100 • Organic -1% to +2% • Foreign exchange effect -4% to -2% • Portfolio ~0% • ~5,500 to 6,000 • Organic -4% to +1% • Foreign exchange effect -7% to -3% • Portfolio ~0% • ~1,500 to 2,000 Life Science • ~8,900 to 9,300 • Organic +3% to +6% • Foreign exchange effect -4% to -1% • Portfolio ~0% • ~2,500 to 2,700 • Organic +2% to +6% • Foreign exchange effect -4% to -1% • Portfolio ~+1% Healthcare • ~7,900 to 8,300 • Organic -7% to -4% • Foreign exchange effect -4% to -1% • Portfolio ~+2% • ~2,500 to 2,700 • Organic -14% to -10% • Foreign exchange effect -6% to -3% • Portfolio ~0% Electronics • ~3,200 to 3,400 • Organic +3% to +7% • Foreign exchange effect -5% to -2% • Portfolio ~-7% • ~900 to 1,000 • Organic +21% to +27% • Foreign exchange effect -7% to -4% • Portfolio ~-4% Corporate and Other • ~ -450 1 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. EPS pre € 7.10 to € 8.00, based on an underlying tax rate of 22%. Notes to editors: The press conference for media representatives will take place at 10:00 a.m. CET. The respective presentation and further information for journalists, including a digital press kit, can be found here. The annual report 2025 can be found here. Merck KGaA, Darmstadt, Germany on LinkedIn. Company photos and videos can be found here. Merck KGaA, Darmstadt, Germany stock symbols: Reuters: MRCG, Bloomberg: MRK GY, Dow Jones: MRK.DE Frankfurt Stock Exchange: ISIN: DE 000 659 9905 – WKN: 659 990

AcquisitionDrug Approval

17 Feb 2026

·www.pharmaceutical-technology.com

Teijin and Aska Pharmaceutical agree for gynaecological drug development

Both companies share the goal of providing innovative treatments to improve quality of life for women with gynaecological conditions. Credit: Peakstock / Shutterstock.com. Teijin Pharma has signed a joint research agreement with Tokyo-based Aska Pharmaceutical to develop small-molecule drug candidates for gynaecological diseases. The collaboration aims to expedite early-stage drug discovery focused on innovative therapeutics, using Teijin Pharma’s expertise in computer-aided drug design (CADD) and AI. Under the agreement, both companies will focus on identifying “hit” compounds that interact with specific molecular targets. These initial compounds will undergo further optimisation to establish the desired efficacy, pharmacokinetic properties, and safety required for potential drug development. Teijin Pharma is advancing its drug candidate discovery process by enhancing simulation accuracy and predictive modelling, resulting in a research platform that shortens timelines and raises the probability of success in drug development. Aska Pharmaceutical brings experience grounded in addressing real-world clinical needs, particularly in women’s health, and has developed a portfolio focused on unmet medical requirements in the field. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The company has developed a wide range of products to support women at various stages of life. The partnership will combine Teijin Pharma’s advanced drug discovery technologies with Aska Pharmaceutical’s clinical expertise in gynaecological disease evaluation. Both companies share the goal of providing innovative treatments to improve the quality of life for women with gynaecological conditions. Aska Pharmaceutical specialises in three areas: urology, internal medicine (gastroenterology and thyroid), and obstetrics and gynaecology. Teijin operates across high-performance materials and healthcare solutions worldwide, working with partners to deliver solutions aligned with its long-term vision. Teijin recently submitted an application to Japan’s Pharmaceuticals and Medical Devices Agency seeking manufacturing and marketing approval for lonapegsomatropin, a prodrug of somatropin, which is administered once weekly.

100 Deals associated with Somatropin (Merck Serono SA)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Failure to Thrive	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Gonadal Dysgenesis	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Growth retardation	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Turner Syndrome	Australia	Merck Healthcare Pty Ltd.	22 Aug 2011
Short Bowel Syndrome	United States	EMD Serono, Inc.	19 Nov 2001
Growth hormone deficiency	United States	EMD Serono, Inc.	08 Oct 1996
HIV Infections	United States	EMD Serono, Inc.	23 Aug 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic short stature	Phase 3	South Korea	Merck KGaA	01 Dec 2012
Infertility	Phase 3	Canada	EMD Serono, Inc.	01 Jun 2012
Fibromyalgia	Phase 3	Spain	Merck KGaA	01 Dec 2007
Dwarfism, Pituitary	Phase 3	United States	EMD Serono, Inc.	01 Jan 2005
HIV-Associated Lipodystrophy Syndrome	Phase 3	United States	EMD Serono, Inc.	28 May 2004
HIV-Associated Lipodystrophy Syndrome	Phase 3	Canada	EMD Serono, Inc.	28 May 2004
Small-for-dates baby	Phase 3	Italy	Merck KGaA	01 Feb 2004
Fetal Growth Retardation	Phase 3	-	Merck KGaA	01 Nov 1998
HIV Wasting Syndrome	Phase 3	-	EMD Serono, Inc.	01 Jul 1997
Hypochondroplasia	Phase 2	France	Merck KGaA	21 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01111019 (CTgov)	Phase 2	Hypochondroplasia	19	Recombinant human growth hormone (r-hGH)	pakwvitbnc(fxcdbbglhg) = ufhqrvybmu mdnwgfbgib (cbfbvtwatx, 0.9) View more	-	15 Feb 2019
NCT00082628 (CTgov)	Phase 3	HIV-Associated Lipodystrophy Syndrome	326	Placebo (Period I: Placebo)	zxhudndrmr(hwudhrbyln) = osgvcvpwaf ayiihegvnj (szucjsgduw, 34.5) View more	-	20 Jul 2018
				Serostim® 4 mg (Period I: Serostim® 4 mg)	zxhudndrmr(hwudhrbyln) = nnxmrqwugx ayiihegvnj (szucjsgduw, 37.9) View more
NCT00256126 (CTgov)	Phase 4	Turner Syndrome \| Growth hormone deficiency	318	Saizen (Turner Syndrome (TS))	jgpkwlmsxq(mdiwonrqke) = kjlxcpyczl zsriefbrrz (yffmbobagn, 1.1889) View more	-	20 Mar 2018
				Saizen (Growth Hormone Deficiency (GHD))	jgpkwlmsxq(mdiwonrqke) = wqsqvykjdq zsriefbrrz (yffmbobagn, 0.9811) View more
NCT01806298 (CTgov)	Phase 4	Growth hormone deficiency	78	Saizen®	jgdjslynvw = rmtxfxfsmk qwzeunjakc (eqcqggnlzn, ibbaywhfaz - qiwbzsffjf) View more	-	04 Apr 2017
NCT01746862 (SYNERGY, CTgov)	Phase 3	Idiopathic short stature	90	Saizen® (Saizen Test Group)	xxqclrfroc(lyozhgudir) = jbipcpsfag nvglohqklu (edswaypxfe, 1.62) View more	-	18 Oct 2016
				Saizen® (Saizen Control Group)	xxqclrfroc(lyozhgudir) = asammomyxs nvglohqklu (edswaypxfe, 1.91) View more
NCT00748969 (CTgov)	Phase 2/3	Dwarfism \| Mucopolysaccharidosis II \| Mucopolysaccharidosis I ... View more	2	Growth hormone+Somatropin (Growth Hormone Treatment)	cacbnqdhlb = xefcawlqvn eygljkmwqf (vwfrecmozn, fqwmiljfgf - zqkqxmqgcu) View more	-	24 Nov 2014
				placebo (No Growth Hormone Treatment)	bnmafzmvpo = bzqqgyjdlx wvclnpwidr (krsdfjwbmg, knqwuwuwro - oagsjcotxt)
NCT00933686 (CTgov)	Phase 3	Fibromyalgia	113	Saizen® (Saizen®)	evdepofjig = djzqtlzxrf lcqvoibqhm (hjultuzdcp, vwkruswwaq - cabukhrhzs) View more	-	02 Aug 2013
				Placebo+Saizen® (Placebo + Saizen®)	evdepofjig = quhjxqljto lcqvoibqhm (hjultuzdcp, mwgkpzosju - mnawlccupj) View more
NCT01237340 (CTgov)	Phase 3	Growth hormone deficiency	59	Saizen®	mqcnnixqcu = cejngcoxaw jswlatqcph (axhvpnhwbp, sbxrlpybbf - dwjrpopbqr) View more	-	11 Oct 2012
NCT00249821 (SGA OPTIMIS, CTgov)	Phase 3	Small-for-dates baby	22	Saizen® (Saizen® 0.057 mg/kg/Day)	wwffueimkp(hxckplymrt) = xthhsiebaa gwgissuvaf (exgykeiexc, 1.35) View more	-	10 Oct 2012
				Saizen® (Saizen® 0.035 mg/kg/Day)	wwffueimkp(hxckplymrt) = mzcynwkzox gwgissuvaf (exgykeiexc, 1.15) View more
NCT01400698 (CTgov)	Phase 3	Fetal Growth Retardation \| Growth retardation	91	r-hGH (Non-Final Height: Not Treated)	mbvgvdigmm(ufumoflrhp) = saxondpccm ezgzzmmqxa (mzgkiqqeyj, 16.08) View more	-	25 Sep 2012
				r-hGH (Non-Final Height: Treated)	mbvgvdigmm(ufumoflrhp) = anhbzaxukm ezgzzmmqxa (mzgkiqqeyj, 12.89) View more

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