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The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S.BASEL, Switzerland and LONDON and NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms. VTAMA® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024. Plaque psoriasis and atopic dermatitis-commonly known as eczema-are common chronic inflammatory skin diseases affecting millions of people in the U.S. and around the globe.1,2 Psoriasis presents a significant impact to quality of life and atopic dermatitis is associated with a higher disease burden for women compared to men.3,4“The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to further expand our existing portfolio of established brands and biosimilar dermatology treatments,” said Kevin Ali, Chief Executive Officer of Organon. “Integrating the expertise of Dermavant into Organon’s U.S. organization marks the beginning of a new chapter in dermatology. We are excited to bring this nonbiologic non-steroidal topical option to the millions of patients suffering from a chronic skin condition like plaque psoriasis and, potentially in the future, atopic dermatitis.” “I would like to thank Kevin and the entire Organon team for their partnership in the acquisition of Dermavant,” said Mayukh Sukhatme, MD, President and Chief Investment Officer of Roivant. “This deal represents a true win-win outcome for Organon and Roivant in our mutual goal to address patient needs and is emblematic of Roivant’s ability to form non-traditional, value-enhancing collaborations on important medicines. We believe that Organon’s strong global commercial footprint will maximize the impact of VTAMA for patients globally, and we are excited to continue to share meaningfully in the success of VTAMA along the way.” About VTAMA® (tapinarof) cream, 1%VTAMA cream is a non-steroidal once-daily topical treatment. The safety and effectiveness of VTAMA cream was evaluated in randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for plaque psoriasis. The safety and efficacy of VTAMA for the treatment of atopic dermatitis was also evaluated in ADORING-1 and ADORING-2 Phase III clinical studies and is currently under review with the FDA. Important Safety Information Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. VTAMA cream is for use on the skin (topical) only. Do not use VTAMA cream in your eyes, mouth, or vagina. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s acquisition of Dermavant (including statements regarding the timing, benefits, and financial impact of such acquisition), potential regulatory approvals and other actions relating to VTAMA (including the expected timeframe thereof), and Organon’s expected financial results and condition. Forward-looking statements may be identified by words such as “pursuing,” “foresees,” “future,” “potential,” “potentially,” “expected,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward- looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our acquisition of Dermavant or any other planned acquisitions; weakening of economic conditions that could adversely affect the level of demand for Dermavant’s products; the risk that the business will not be integrated successfully; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the ability to retain key personnel; unknown liabilities; the risk of litigation and/or regulatory actions related to the completed acquisition; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect Organon’s cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon’s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites About Roivant Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; and mosliciguat, an inhaled soluble sGC activator in development for pulmonary hypertension associated with interstitial lung disease, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors, including (i) the possibility that the transaction may involve unexpected costs or liabilities, (ii) the risk that disruptions from the transaction will harm relationships with employees, customers and suppliers and other business partners or (iii) the risk that the achievement of the specified milestones or royalties described in the definitive agreement for the transaction may take longer to achieve than expected or may never be achieved and the resulting contingent milestone payments or royalties may never be realized. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekh keyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com 1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug; 157(8):1-7. doi:10.1001/jamadermatol.2021.2007 2 Eczema Prevalence. National Eczema Foundation. Eczema Prevalence, Quality of Life and Economic Impact.3 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L., Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be Aware of When Treating Women with Psoriasis. Int J Women’s Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/ 4 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P., Nedley, N., Delost, GR. The Global, Regional, and National Burden of Atopic Dermatitis in 195 Countries and Territories: An ecological study from the Global Burden of Disease Study 2017. 2021 Mar; 2: 12-18. JAAD International. doi: https://doi.org/10.1016%2Fj.jdin.2020.10.002. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/

- VTAMA® (tapinarof) cream, 1% demonstrated early, significant, and meaningful achievement of both no-to-minimal itch (mean weekly PP-NRS≤1) and sleep improvement in ADORING 1 and ADORING 2. - 31.4% and 33.0% of patients treated with VTAMA cream in ADORING 1 and ADORING 2, respectively achieved no-to-minimal itch at Week 8 (P=0.0072 and P=0.0003 versus vehicle). Results were statistically significant at Week 1, with continued improvement through Week 8. - Similarly, sleep improvements with VTAMA cream were statistically significant for patients ≥12 years old and <12 years old versus vehicle at Week 8 (both P<0.0001), with statistical significance achieved at Week 1, the earliest assessment. LONG BEACH, Calif., and BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data on the achievement of no-to-minimal itch (weekly mean Peak Pruritus Numerical Rating Scale (PP-NRS≤1); also referred to as an itch-free state) and sleep improvement in patients with atopic dermatitis as young as two years old at the American College of Allergy, Asthma and Immunology Annual Meeting, being held in Boston, MA, October 24-28, 2024. The data presented were generated from Dermavant’s Phase 3 ADORING 1 and ADORING 2 pivotal trials studying VTAMA cream, 1% in patients with moderate to severe atopic dermatitis as young as two years old. In the ADORING pivotal trials, adults and children (n=813) were randomized to VTAMA cream or vehicle once daily for eight weeks. In ADORING 1 and ADORING 2, vIGA-AD TM success, defined as vIGA-AD=0 or 1 and ≥2-grade improvement from baseline at Week 8, was achieved by 45% and 46% of patients on VTAMA cream vs 14% (P<0.0001) and 18% (P<0.0001) of patients on vehicle, respectively. The most common adverse reactions (incidence ≥1%) in patients treated with VTAMA cream were folliculitis, nasopharyngitis, headache, asthma, and influenza. Peak Pruritus Numerical Rating Scale (PP-NRS) data, a patient reported outcome, were used to assess pruritus (itch) relief. Sleep improvement was assessed using question two, (Over the last week, on how many nights has your/your child’s sleep been disturbed because of eczema?) on the Patient Oriented Eczema Measure (POEM), using a 5-point scale. Results: A statistically significant improvement in sleep, achievement of no-to-minimal itch (PP-NRS≤1), and mean weekly PP-NRS<2 targets were observed as early as Week 1 (first assessment) with continued improvement observed through Week 8 in patients with atopic dermatitis treated with VTAMA cream versus vehicle. The proportion of patients with atopic dermatitis achieving no-to-minimal itch was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 31.4% vs 17.4% (P=0.0072) and 33.0% vs 14.0% (P=0.0003). The proportion of patients with atopic dermatitis achieving PP-NRS<2 was statistically significantly higher in VTAMA cream groups compared with vehicle as early as Week 1 (the first assessment) and continued through Week 8 in both ADORING 1 and ADORING 2: 48.1% vs 28.4% (P=0.0006) and 46.8% vs 19.6% (P<0.0001). Sleep improvement reached statistical significance with VTAMA cream versus vehicle at Week 1, the earliest assessment, and continued through Week 8 in a pooled analyses for ADORING 1 and ADORING 2 in both patients with atopic dermatitis aged 2-11 years and ≥12 years: -1.7 vs -1.0 (P<0.0001) and -1.4 vs -0.8 (P<0.0001). “In the ADORING 1 and ADORING 2 trials, VTAMA cream demonstrated an early, significant, and meaningful achievement of no-to-minimal itch and improvement in sleep, for patients with atopic dermatitis” said Eric Simpson, MD, MCR, the Frances J. Storrs Medical Dermatology Professor and Director of the CLEAR Eczema Center, at the Oregon Health & Science University. “Itch frequently causes sleep disturbance in patients with atopic dermatitis, which can be especially burdensome for young patients and their families. In the ADORING pivotal trials, VTAMA cream demonstrated significant itch reduction and sleep improvement, in patients with atopic dermatitis, versus vehicle and was well-tolerated in both adults and children down to two years of age. Subject to FDA approval, VTAMA cream could become a compelling new treatment option for atopic dermatitis patients, most of whom regard itch as one of the most bothersome symptoms of their disease.” About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study. About Atopic Dermatitis Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck. Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease. About Dermavant Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized, product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023. Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration. IMPORTANT SAFETY INFORMATION Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. See full Prescribing Information and Patient Information. For more information, please visit and follow us on Twitter ( @dermavant ) and LinkedIn ( Dermavant Sciences ). © 2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co. Contacts dna Communications: Jillian Parker Account Director, Media Relations, Healthcare jparker@dna-comms.com 732-501-2624

Board-certified dermatologist, Dr. Sandra Lee , widely known as Dr. Pimple Popper , among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream 1.5% WILMINGTON, Del. --(BUSINESS WIRE)--Oct. 10, 2024-- Incyte (Nasdaq:INCY) announced today the expansion of its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD) and their paths to finding relief. Building on last year’s program launch in partnership with Mandy Moore , the Moments of Clarity program will now feature several additional real-life patient perspectives, including that of Dr. Sandra Lee and Emily, a mom of three, who share their emotional experiences and the impact AD has had on their lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241009443934/en/ In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream 1.5%. Opzelura is a nonsteroidal, twice-daily cream that is indicated for the short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended. Use of Opzelura in combination with biologics, other JAK inhibitors or potent immunosuppressants is not recommended. “While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee . “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication. I partnered with Incyte on their Moments of Clarity program to share my story and to empower others to seek out a treatment that is right for them.” AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the U.S. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. “We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta , Executive Vice President, General Manager, U.S. Dermatology, Incyte . “We are proud to elevate the patient voice and share the real, lived experience with Opzelura as part of our commitment to patients and to providing a treatment that can help address some of the most burdensome symptoms of AD. Our hope is that the Moments of Clarity program helps those living with eczema connect with others and inspires them to have conversations with their doctor.” OPZELURA is not for everyone. See below for IMPORTANT SAFETY INFORMATION including boxed Warning for Serious Infections, Increased Risk of Death, Lymphoma and other Cancers, Major Cardiovascular Events and Blood Clots. To hear more visit MyMomentsofClarity.com. All individuals were compensated for their participation. 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. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022 , Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan . Opzelura is a registered trademark 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: After starting OPZELURA: 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. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: 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. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. 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 to help restore normal immune function and bring the body closer to homeostasis. 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 planus, lichen sclerosus and prurigo nodularis To learn more, visit the Dermatology section of Incyte.com. 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 Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and 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; determinations made by the FDA and other regulatory authorities outside of the United States ; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission , including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2024 . Incyte disclaims any intent or obligation to update these forward-looking statements. 1 National Eczema Association . What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte