Life Molecular Imaging Secures Funding from the Alzheimer's Drug Discovery Foundation (ADDF) to Further Investigate [18F]F-DED PET in Alzheimer's Neuroinflammation
Joining forces to accelerate development and to create a potential new option for Neuroinflammation Imaging
BERLIN and BOSTON, May 20, 2025 /PRNewswire/ -- Life Molecular Imaging has received an investment from the Alzheimer's Drug Discovery Foundation (ADDF) to advance significant research in Alzheimer's disease (AD). The $2.16 million investment, spanning three years, will fuel the development of [18F]F‑DED, an investigational F18-labeled PET imaging agent designed to target monoamine oxidase B (MAO-B), a key enzyme linked to neuroinflammation.
This ambitious research initiative is a collaborative effort with two world-class institutions, including the University Hospital of Ludwig-Maximilian University (LMU; Munich, Germany) and the Barcelona Beta Brain Research Center (BBRC, Spain), with experts in neurology, nuclear medicine, psychiatry, and stroke and dementia research.
It is anticipated that using [18F]F-DED PET imaging during this project has the potential to provide critical insights into both sporadic and genetically predisposed AD patients, bridging the gap on the contribution of neuroinflammation between early and late stages of the disease.
Until now, PET imaging of neuroinflammation has faced challenges due to genetic polymorphisms affecting ligand binding, leading to inconsistent results.
'This new research, supported by the prestigious ADDF funding, provides a unique opportunity to investigate the spatial and temporal dynamics of neuroinflammation and its association with established biomarkers,' said Andrew Stephens, Chief Medical Officer at LMI.
'Neuroinflammation could be a potential key driver in the spread of tau pathology to the cortex in Alzheimer's disease. Leveraging PET imaging to explore its role presents a unique opportunity to deepen our understanding of disease progression,' added Matthias Brendel, Professor for Nuclear Medicine at LMU.
Gemma Salvadó Blasco, Group Leader of Neuroimaging Research BBRC, echoed this enthusiasm: 'By combining data from diverse Alzheimer's disease cohorts, we aim to unravel the complexities of disease progression. We're thrilled to embark on this exciting journey.'
'PET-Imaging tools provide important insights into understanding Alzheimer's disease and other neurodegenerative disorders and are integrated now into clinical care,' says Howard Fillit, MD, Co-Founder and Chief Science Officer of the ADDF. 'New imaging tools exploring neuroinflammation may offer a non-invasive approach to visualize astrocyte activity alongside established biomarkers to further examine the relationship between inflammation and Alzheimer's. If successful, this innovative approach will help deepen our understanding of the underlying disease.'
About
Neuroinflammation represents a key pathologic mechanism in many neurodegenerative diseases, including AD, movement disorders and multiple sclerosis. In the brain it can be mediated by reactive astrocytes (astrogliosis), which show increased activity of the enzyme monoamine oxidase B (MAO-B). The PET tracer [18F]F-DED is a deuterated deprenyl derivative that was designed to preferentially bind to areas with increased MAO-B activity (1,2).
About Life Molecular Imaging (LMI)
Life Molecular Imaging (LMI) is an international radiopharmaceutical company dedicated to developing and offering novel cutting-edge PET radiopharmaceuticals for imaging of neurodegenerative and cardiovascular diseases. The organization strives to be a leader in the molecular imaging field. Our mission is to pioneer innovative PET products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. By advancing novel PET radiopharmaceuticals for molecular imaging, LMI is focusing on a key field of modern medicine. LMI is an affiliate of Life Healthcare Group – an international people-centered, diversified healthcare organization with four decades of experience in the South African private healthcare sector. To learn more, please visit https://life-mi.com.
About Life Healthcare Group
Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 40 years' experience in the South African private healthcare sector, and currently operates 64 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, oncology, diagnostic and molecular imaging and health risk management services which include occupational health and wellness services. The Group also owns Life Molecular Imaging, a radiopharmaceutical business dedicated to developing and globally commercializing innovative molecular imaging agents for use in PET-CT diagnostics to detect specific diseases. Visit: https://www.lifehealthcare.co.za/.
About The Alzheimer's Drug Discovery Foundation (ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: http://www.alzdiscovery.org/.
References
1. Nag S, Fazio P, Lehmann L, et al. In Vivo and In Vitro Characterization of a Novel MAO-B Inhibitor Radioligand, 18F-Labeled Deuterated Fluorodeprenyl. J Nucl Med. 2016;57(2):315-320. doi:10.2967/jnumed.115.161083
2. Ballweg A, Klaus C, Vogler L, et al. [18F]F-DED PET imaging of reactive astrogliosis in neurodegenerative diseases: preclinical proof of concept and first-in-human data. J Neuroinflammation. 2023;20(1):68. Published 2023 Mar 11. doi:10.1186/s12974-023-02749-2
For media queries
Brittany Hahn | Marketing Communications Manager | Life Molecular Imaging
Tel: +1.484.735.2840 | [email protected]
For scientific information, please contact: Dr. Gérard N Bischof, PD | Scientific Project Manager | Life
Molecular Imaging| [email protected]
View original content to download multimedia: https://www.prnewswire.com/news-releases/life-molecular-imaging-secures-funding-from-the-alzheimers-drug-discovery-foundation-addf-to-further-investigate-18ff-ded-pet-in-alzheimers-neuroinflammation-302459645.html
SOURCE Life Molecular Imaging
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles

Business Insider
13 hours ago
- Business Insider
It's not just for gyms bros — scientists say a 50-cent muscle-building supplement slows aging and may counteract Alzheimer's
Creatine — long beloved by gym rats who mix it into protein shakes — is shaping up to be much more than a muscle building and fat loss supplement. Mounting research suggests it may also boost heart health, protect against Alzheimer's, improve mood, and strengthen your bones. While researchers typically have a healthy mistrust of supplements, creatine is the rare exception, recommended even among skeptical scientists and doctors: it's reliably safe, relatively inexpensive, and backed by extensive, high-quality studies. And it costs, on average, less than 50 cents per serving. "I don't know if there's anything on the planet that comes close to creatine from a multifactorial approach," Darren Candow, a top creatine researcher and professor of exercise physiology, nutrition and aging at Regina University in Canada, told Business Insider. Over the past decade, interest in creatine has skyrocketed, in tandem with research showing it can double up as a longevity supplement. As of May, the US creatine market is worth $456.6 million, up 36% from the prior year, according to data and analytics company Spins. "As much as we can define a longevity supplement at this point, creatine is probably one of the best in that category," Jordan Glen, supplement researcher and chief science officer for health startup SuppCo., an app that helps users find the right supplements for their goals, told Business Insider. Creatine drives your muscles to push harder without getting tired Creatine was first discovered in muscle tissue in 1832. Nearly a century later, scientists started to figure out how it's stored and used for energy in the human body. They experimented with extracting creatine from meat and later synthesizing it in a lab. But it wasn't until the Barcelona Olympic Games in 1992 that creatine went mainstream. The British gold-medal sprinters, sharing how they got in shape, gushed about the powerful effects of a little-known supplement: creatine. In 1993, the first commercial creatine hit store shelves, and sales boomed. Creatine is a raw material for producing ATP, a molecule that gives our cells energy. The majority of creatine is stored in the muscles, where it offers a ready fuel source for high-intensity effort. More creatine can improve strength and muscle gains by providing a bit more energy, helping you push a little bit harder and work out for longer before getting tired. Our bodies naturally produce creatine through a combination of amino acids. That's only a small amount, though. We can get more of it from some foods like red meat and fish — or, through supplements. In the past five years, demand for creatine as a fitness aid has spiked, with retail prices up 150% and sales increased by 90% year over year, despite steadily rising costs. And it's not just for muscle-hungry gym bros. While men continue to make up the majority of creatine users, about 21% of the creatine buyers are women, according to data from nationwide supplement retailers The Vitamin Shoppe. At SuppCo, both Glen, the CSO, and Steve Martocci, the CEO, said their wives have recently started taking creatine — reflecting a broader trend of women as a growing consumer base. What changed? Martocci pointed to more evidence dispelling the myth that creatine is just for muscle men to bulk up. Plus, early research suggests creatine can support hormonal health for women, helping to counteract shifts that can occur during the menstrual cycle by helping to maintain levels of glycogen in the muscle for better energy and performance. Creatine slows aging and boosts brain health, per new research In June, a small study found that patients with Alzheimer's disease saw a boost to their cognitive function after supplementing creatine. "We think that just providing more energy to the brain could be useful," Scott Forbes, a sports science researcher and professor at Brandon University who was not involved in the study, told Business Insider. "The brain actually uses about 20% of your total energy expenditure, even though it only weighs about 2% of your body weight. So for a tissue, it's very energetically demanding," Forbes said. Creatine also seems to have an anti-inflammatory effect, making the brain more resilient against stresses that would wear down its ability to perform. "We know that too much inflammation or too much oxidative stress can also lead to poor cognition or poor brain functions," Forbes said. Other recent studies have found that supplementing creatine could also help to mitigate the effects of aging or a concussion. "The theory is that the brain can remodel itself or at least maintain its function during times of stress," Candow, the aging researcher at Regina University, told Business Insider. "I don't know anybody in the world that's not stressed." The new research is expanding creatine's reach to consumers beyond the gym, according to Muriel Gonzalez, president of nationwide supplement retailer The Vitamin Shoppe. "Creatine is undergoing a major transformation — from a niche sports nutrition supplement to a versatile tool for daily health and longevity," Gonzalez told Business Insider over email. Total creatine sales have spiked by 300% from 2019 to 2024 at The Vitamin Shoppe, and are continuing to grow at a double-digit pace, according to company data. Should you be taking creatine? You'll be disappointed if you expect to transform your life, and health, with a few doses of creatine. A supplement can provide a boost but ultimately makes a relatively small difference. Your overall diet, exercise, and lifestyle are far more important. Still, the bottom line is that more and more research supports taking creatine for a huge range of benefits, with very little downside. "I think almost everybody should consider taking creatine," Forbes, the science researcher at Brandon University, said. Even in high doses over a long time period, side effects are mild, such as gastrointestinal upset and a slight increase in water retention, since creatine pulls water into the muscles. "Overall it's one of the safest supplements out there," Eric Gonzalez, a neuroscience professor at Texas Christian University who has studied creatine, told Business Insider. "If anyone wants to go on a supplement, creatine won't hurt you, there's only going to be an upside." If you're losing weight — including those on a GLP-1 drug that triggers weight loss — creatine can help you retain muscle mass, promoting a higher ratio of muscle to body fat. For those looking to boost brain health or mood, early studies suggest that 10-30 grams a day may be beneficial. Glen previously conducted research on senior Olympians who took creatine and found it helped them get stronger and faster while avoiding age-related decline. "We're never too old to take creatine," he said.

20 hours ago
Diabetes drug may cut migraine days in half with little weight loss: Study
Drugs in the same family as Ozempic and Wegovy are known for treating diabetes and helping with weight loss, but a small, early-stage study suggested they might also ease migraines -- even when there's no weight loss. The benefit appears to come from lowering pressure in the brain, Dr. Simone Braca, a neurologist at the University of Naples Federico II and lead author of the study, explained to ABC News. 'This study is very interesting in that the GLP 1s are hypothesized to lower brain pressure, which can then lower your chance of getting a headache or a migraine,' Braca said. The small, 12-week study tracked 26 adults with obesity who had chronic or frequent migraines. Published in Headache -- the official journal of the American Headache Society -- and presented at this week's European Academy of Neurology meeting in Finland, it tested liraglutide, a type of GLP-1 drug commonly used for diabetes and weight loss. After taking a daily 1.8 mg dose of liraglutide for three months -- the amount typically used to treat diabetes -- their average number of headache days per month dropped from 20 to about nine. Participants also reported less disability from migraines, with scores on a standard headache impact scale cut by more than half. Although some participants lost a small amount of weight, Braca said the few lost pounds were not meaningful enough to explain the improvement in migraines. Instead, Braca pointed to pressure from cerebrospinal fluid -- the liquid that surrounds and cushions the brain and spine. He said he believes that even slight buildups of this fluid can press on nearby veins and nerves in the brain, potentially triggering migraines. 'An increased pressure of the spinal fluid in the brain may be one of the mechanisms underlying migraine,' Braca said. 'And if we target this mechanism, this preliminary evidence suggests that it may be helpful for migraine.' Nearly half of patients reported at least a 50% reduction in headache days, according to the Headache paper. About 40% experienced mild side effects like nausea or constipation. None stopped taking the medication. With such promising results, Braca and his research team, led by Dr. Roberto De Simone, are already planning larger trials. Future studies will measure brain pressure more directly and explore whether other GLP 1 drugs might also offer the same relief but with fewer side effects. 'There are still a substantial portion of migraine patients that face an unmet need and that live with its burden,' he said. 'New drugs that could target other pathways, I think that could be reassuring to those patients and give them hope.' The study adds to growing evidence that GLP-1 drugs may have benefits beyond diabetes and weight loss. Researchers are already studying these medications for a range of other conditions, including reducing the risk of heart disease and stroke, easing symptoms of addiction and treating Alzheimer's disease.


Business Wire
a day ago
- Business Wire
Update on FDA Review of Ruxolitinib Cream (Opzelura ®) for Children Ages 2-11 with Atopic Dermatitis
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura ®), a topical Janus kinase (JAK) inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 19, 2025. The FDA extended the PDUFA action date to allow time to review additional chemistry, manufacturing and controls (CMC) data on the 0.75% strength submitted by Incyte in response to a recent FDA information request. 'Atopic dermatitis (AD) is a chronic immune-mediated skin condition that can be difficult to manage, particularly for the millions of children in the U.S. affected by AD,' said Steven Stein, M.D., Chief Medical Officer, Incyte. 'We are confident in the potential of ruxolitinib cream to become an important non-steroidal, topical treatment option for pediatric patients with atopic dermatitis and we will continue to work closely with the FDA to ensure the Agency has all of the information needed to complete its review.' The sNDA submission for ruxolitinib cream in pediatric AD was based on data from the Phase 3 TRuE-AD3 study, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with AD. The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator's Global Assessment-treatment success (IGA-TS), a measure of treatment efficacy, than patients treated with vehicle control (non-medicated cream). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 was also achieved. The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, and no new safety signals were observed. No serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses were reported during the 8-week vehicle-controlled period. The most common treatment-related adverse event among patients treated with Opzelura was application site pain (2.7% vs 0% in vehicle arm). These events were mild and did not lead to treatment interruption. About Opzelura ® (ruxolitinib) Cream Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In Europe, Opzelura ® (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura and the Opzelura logo are registered trademarks of Incyte. IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back have diabetes, chronic lung disease, HIV, or a weak immune system have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have or have had hepatitis B or C live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired have ever had any type of cancer, or are a current or past smoker have had a heart attack, other heart problems, or a stroke have had blood clots in the veins of your legs or lungs in the past have high cholesterol or triglycerides have or have had low white or red blood cell counts are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose. After starting OPZELURA: Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have. Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing. Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. About Incyte Dermatology Incyte's science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen sclerosus, and prurigo nodularis. To learn more, visit the Dermatology section of About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for ruxolitinib cream to provide a successful treatment option for pediatric patients with AD; Incyte's plans to work with FDA; and Incyte's expectations with regard to the PDUFA date for its sNDA and regulatory approval, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and other regulatory agencies; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended March 31, 2025. We disclaim any intent or obligation to update these forward-looking statements.