Cyclosporine

- Crinetics adds potential best-in-class commercialized and Phase 3 endocrinology assets with ~$5 billion peak sales opportunity to Vertex’s portfolio - - PALSONIFY ® , Crinetics’ recently launched, first and only, once-daily oral therapy for adults with acromegaly has demonstrated strong and growing early uptake - - Atumelnant, a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist in Phase 3 development for congenital adrenal hyperplasia (CAH), has shown unique and transformative potential to both normalize androgen levels and enable management of patients with physiologic levels of glucocorticoids, the true goal of CAH management; atumelnant has also demonstrated therapeutic potential in patients with Cushing’s syndrome - - Acquisition adds to Vertex’s innovation pipeline, accelerates Vertex’s revenue growth and enhances long-term earnings pro - Vertex to host investor call today, July 6 at 4:30 p.m. ET - BOSTON & SAN DIEGO--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Crinetics for $85.00 per share in cash, for a total equity value of approximately $10.0 billion, or approximately $8.8 billion net of estimated cash acquired. The transaction was unanimously approved by both the Vertex and Crinetics Boards of Directors and is anticipated to close in the third quarter of 2026. Crinetics’ marketed medicine, PALSONIFY ® (paltusotine), received approval from the U.S. Food and Drug Administration (FDA) in September 2025. PALSONIFY was recently approved by the European Medicines Agency (EMA) and is under review by other global regulatory bodies. It is the first and only once-daily oral therapy for adults with acromegaly, a rare and debilitating condition caused by a pituitary tumor that secretes excess growth hormone, which affects an estimated 20,000 diagnosed people in the U.S. PALSONIFY leads to rapid disease control and normalization of key disease markers in both treatment-experienced and untreated populations. Since launch, PALSONIFY has demonstrated promising early commercial momentum, supported by strong demand across all patient segments, prescribing activity expansion, and growing reimbursement coverage, all of which reinforce its potential to redefine the treatment paradigm in acromegaly. Crinetics' most advanced pipeline candidate, atumelnant, is a once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist currently in Phase 3 development for congenital adrenal hyperplasia (CAH). Classic CAH, the most severe form of the disease, with 17,000 addressable patients in the U.S., is a rare, chronic genetic condition affecting the adrenal glands that has significant unmet medical need. Among other features, CAH is characterized by impaired cortisol synthesis and, in most cases, excess androgen production, both of which contribute to a range of serious health consequences. In Phase 2 studies, patients taking atumelnant were able to achieve near normalization of excess androgen levels on physiologic replacement doses of glucocorticoids. This unique therapeutic pro atumelnant to become the leading medical therapy for people struggling with CAH. Atumelnant was generally well tolerated with no treatment-related severe or serious adverse events to date. “Crinetics is an excellent strategic fit for Vertex, with its focus on serious diseases in specialty markets with significant unmet need, well-understood causal human biology, and potentially best-in-class medicines that could deliver transformative benefit to patients,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “We believe Vertex can build on the strong momentum of the PALSONIFY launch by applying our experience in commercializing medicines for rare genetic diseases. We are also excited by the significant potential of atumelnant to transform the treatment landscape for CAH, setting a new standard of care where patients do not have to choose between managing their excess adrenal androgens and enduring the side effects of high-dose steroids.” Dr. Kewalramani continued, “We look forward to working with the talented Crinetics team to rapidly advance their pipeline of medicines for patients living with serious, rare endocrine disorders. Together, these potential blockbuster assets build on our core CF business, ongoing launches and internal innovation portfolio, adding to our growth outlook and driving value for patients and shareholders.” “Nearly 18 years ago, we founded Crinetics with a clear goal of transforming the lives of patients living with endocrine-related diseases. Today marks a historic milestone as we embark on this next chapter with Vertex,” said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics Pharmaceuticals. “This partnership is anchored by a mutual commitment to science and a shared vision for delivering innovative treatments to patient communities that have long been underserved. Vertex’s global infrastructure and commercial footprint will serve to amplify the reach of our science and allow us to maximize the impact of PALSONIFY, atumelnant and our pipeline. I want to extend my deepest gratitude for the relentless dedication, brilliance and passion of our extraordinary employees, who have worked tirelessly to bring our scientific vision to life, as well as the clinical partners and patient communities who have championed our mission from the very beginning.” Financial Benefits The transaction is expected to contribute immediately to Vertex’s revenue growth via the ongoing launch of PALSONIFY, which has blockbuster potential in acromegaly. Longer term, atumelnant has the potential to be a multi-billion-dollar opportunity in CAH, with additional upside from its potential in Cushing’s syndrome. At peak, these assets have the potential to deliver more than $5 billion in combined annual revenue, which will further Vertex’s goal of delivering sustained double-digit revenue growth, in addition to industry leading operating margins. The transaction is expected to become accretive to non-GAAP operating income in 2029. Transaction Terms and Financing Under the terms of the merger agreement, Vertex will acquire all outstanding shares of Crinetics common stock for $85 per share in cash for a total equity value of approximately $10.0 billion or $8.8 billion net of estimated cash acquired. Vertex expects to finance the acquisition using a combination of cash on hand and debt, supported by $4.5 billion of fully committed bridge financing from Bank of America, N.A. and Morgan Stanley Senior Funding, Inc. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including receipt of regulatory approvals and approval by Crinetics shareholders. Advisors Morgan Stanley & Co. LLC and Lazard are acting as financial advisors to Vertex, and Kirkland & Ellis LLP is serving as legal counsel to Vertex. J.P. Morgan Securities LLC and Leerink Partners LLC are acting as financial advisors to Crinetics, and Paul, Weiss, Rifkind, Wharton & Garrison LLP and Morrison Foerster LLP are legal counsel to Crinetics. Vertex Conference Call and Webcast Vertex will host a conference call and webcast at 4:30 pm ET today, July 6, 2026. To access the call, please dial (833)-630-2124 (U.S.) or +1 (412)-317-0651 (International) and reference the “Vertex Pharmaceuticals Conference Call.” The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at in the “Investors” section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company's website in the “Investors” section. About Acromegaly Acromegaly is a rare, chronic hormonal disorder caused by the overproduction of growth hormone, most commonly due to a benign tumor of the pituitary gland. The disease is associated with significant morbidity, including cardiovascular complications, metabolic dysfunction and reduced quality of life. An estimated 20,000 diagnosed people are living with acromegaly in the United States alone. Prior to the approval of PALSONIFY, treatment options were largely limited to large-needle, intramuscular or deep subcutaneous injectable somatostatin analogues, which are not effective for all people, are often administered by a trained healthcare provider in a clinic or hospital setting and are associated with tolerability issues. About PALSONIFY (paltusotine) PALSONIFY (paltusotine) is the first once-daily oral somatostatin receptor ligand approved by the U.S. Food and Drug Administration for the treatment of adults with acromegaly. Approved in September 2025, PALSONIFY offers an effective once-daily oral alternative to injectable therapies. PALSONIFY selectively targets somatostatin receptors to reduce excess growth hormone and insulin-like growth factor-1 (IGF-1) levels. The therapy addresses a long-standing gap in acromegaly care, offering a differentiated option for people seeking effective disease control without the burden of injections. PALSONIFY was recently approved by the European Medicines Agency (EMA) and is under review by other global regulatory bodies. Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a group of inherited disorders of the adrenal gland characterized by, among other features, impaired cortisol synthesis and, in most cases, excess androgen production, leading to a range of serious health consequences. Classic CAH is the most severe form of the disease with 17,000 addressable patients in the U.S., all of whom require cortisol replacement. The goal of therapy in classic CAH is to replace cortisol to physiologic levels and to normalize excess adrenal androgens. In most patients, existing therapies allow for one or the other but not both, leaving patients exposed to the risks of cortisol or androgen excess. About Atumelnant Atumelnant is the first investigational once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R). By directly antagonizing the ACTH receptor in the adrenal cortex, atumelnant inhibits the downstream effects of excess ACTH irrespective of its origin, enabling sustained androgen control in classic CAH even as glucocorticoid doses are brought to physiologic levels. Data from a 12-week Phase 2 study demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH- related disease activity markers, including androstenedione and 17-hydroxyprogesterone, in a diverse population. Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome (ADCS), with the Phase 3 CALM-CAH trial and a Phase 1/2b trial in ADCS currently enrolling patients. PALSONIFY™ (paltusotine) INDICATION: PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS: Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue PALSONIFY if complications of cholelithiasis occur and treat appropriately. Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly. Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in PALSONIFY clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary. Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended. Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly. Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated. ADVERSE REACTIONS: Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis. DRUG INTERACTIONS: Strong or Moderate CYP3A4 Inducers: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Proton Pump Inhibitors: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg. Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment when used with PALSONIFY; follow therapeutic monitoring recommendations. Please see Full Prescribing Information including Patient Information . About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties. Crinetics’ first commercial product, PALSONIFY® (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2)-expressing neuroendocrine tumors and other SST2-expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit or follow us on LinkedIn , Facebook , Instagram , YouTube and X . Special Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 related to Crinetics, Vertex and the proposed acquisition of Crinetics by Vertex (the “ Transaction ”) that are subject to risks, uncertainties and other factors. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the beliefs of Crinetics and Vertex only as of the date of this press release, and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies’ and members of their senior management teams. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements include the statements made by Reshma Kewalramani, M.D. and Scott Struthers, Ph.D. in this press release, and statements that may relate to, but are not limited to: the benefits of the Transaction and associated integration plans; the expected timing of the completion of the Transaction and other transactions contemplated by the merger agreement (the “ Merger Agreement ”); the commercial potential of PALSONIFY and the anticipated potential of atumelnant and Crinetics’ other pipeline assets, including the potential for PALSONIFY to redefine the treatment paradigm in acromegaly and for atumelnant to become the leading therapy for people struggling with CAH; expectations that the Transaction will accelerate Vertex’s revenue growth and enhance Vertex’s long-term earnings profile, including the potential for more than $5 billion in annual revenue, and support Vertex’s goal of sustained double digit revenue growth; expectations that the Transaction will become accretive to non-GAAP operating income in 2029; expectations for Vertex’s financing of the Transaction, including support by the fully committed bridge financing; and any assumptions underlying any of the foregoing. Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements due to a number of risks and uncertainties. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: the occurrence of any event or circumstance that could give rise to the right of Crinetics or Vertex to terminate the Merger Agreement, including circumstances requiring payment of a termination fee pursuant to the Merger Agreement; failure to obtain applicable regulatory or Crinetics’ stockholder approval in a timely manner or otherwise; the risk that the Transaction may not close in the anticipated timeframe or at all due to one or more of the other closing conditions not being satisfied or waived; the possibility that competing offers will be made; the risk that there may be unexpected costs, charges or expenses resulting from the Transaction; risks related to the ability of Crinetics and Vertex to successfully integrate the businesses and the possibility that integration may be more difficult, time consuming or costly than expected; the risk that the Transaction disrupts Crinetics’ or Vertex’s current plans and operations; the risk that certain restrictions during the pendency of the proposed transaction may impact Crinetics’ ability to pursue certain business opportunities or strategic transactions; risks related to disruption of each company’s management’s time and attention from ongoing business operations due to the proposed transaction; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of Crinetics’ and/or Vertex’s common stock, credit ratings or operating results; the risk of litigation that could be instituted against the parties or their respective directors, managers or officers and/or regulatory actions related to the Transaction, including the effects of any outcomes related thereto; the effects of the Transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of regulatory approvals or actions, if any; the impact of competitive products and pricing; that Vertex may not realize the potential benefits of the Transaction; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; and actual or contingent liabilities related to the Transaction. In addition, the product candidates being developed by Crinetics are subject to all the risks inherent in the drug development process, and there can be no assurance that the development of these product candidates will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Vertex’s and Crinetics’ businesses, particularly those risks listed under the heading “Risk Factors” and the other cautionary factors discussed in the parties’ periodic reports filed with the Securities and Exchange Commission (the “ SEC ”), including Vertex’s and Crinetics’ annual reports on Form 10-K for the year ended December 31, 2025, and quarterly reports on Form 10-Q and current reports on Form 8-K, all of which are available on the SEC’s website at . You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to Vertex and Crinetics, and Vertex and Crinetics disclaim any obligation to update the information contained in this press release as new information becomes available, except as required by law. Additional Information and Where to Find It This press release is being made in respect of the proposed transaction between Crinetics and Vertex. Contacts Vertex Investors: InvestorInfo@vrtx.com | +1 617–341–6108 Media: mediainfo@vrtx.com | U.S.: +1 617–341–6992 Crinetics Pharmaceuticals, Inc. Investors: Gayathri Diwakar Head of Investor Relations gdiwakar@crinetics.com (858) 345-6340 Media: Natalie Badillo Head of Corporate Communications nbadillo@crinetics.com (858) 345-6075 Read full story here

If approved, Opzelura ® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failed AD, the most common type of eczema which affects 230 million people globally, 1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life 2 Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated 3,4,5 MORGES, Switzerland--(BUSINESS WIRE)-- $INCY --Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura ® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP opinion is based on results from the pivotal Phase 3 TRuE-AD4 study ( NCT06238817 ), supported by the Phase 3 TRuE-AD1 ( NCT03745638 ) and TRuE-AD2 ( NCT03745651 ) studies, evaluating the safety and efficacy of ruxolitinib cream in adults with AD. 4,6,7 In TRuE-AD4 , ruxolitinib cream significantly improved the clinical signs and symptoms of moderate AD, including itch, as early as Day 2 and was well tolerated in adults who had an inadequate response, intolerance or contraindication to both TCSs and TCIs. 3 The TRuE‑AD4 study met its co‑primary endpoints at Week 8, with a statistically significantly higher proportion of patients on ruxolitinib cream versus vehicle cream achieving a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI75), and, separately, Investigator’s Global Assessment Treatment Success (IGA‑TS, defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a two-point improvement from baseline). 3 Efficacy was maintained following the initial treatment period with 84.3% of patients achieving EASI75 and 70.6% achieving IGA-TS with as needed therapy at Week 24. 5 Mean affected body surface area (BSA) decreased markedly from 15.1% at baseline to 2.5% at Week 8 and remained low at Week 24 (2.5%), while itch relief (NRS4; ≥4-point improvement in Itch Numeric Rating Scale) remained high (74.3% at Week 8 and 64.7% at Week 24) with ruxolitinib cream treatment. 3,5 Additionally, patients treated with ruxolitinib cream also showed improvements in quality of life, with mean Dermatology Life Quality Index (DLQI) scores improving from 19.3 at baseline to 4.3 at Week 8, compared with 19.1 to 10.7 with vehicle cream (control). 3 Ruxolitinib cream was well tolerated, with no serious infections, major adverse cardiovascular events, malignancies or thromboses reported during the 24-week treatment period. 4 The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%). 3 “In clinical practice, many adults with moderate AD do not achieve the level of disease control they need, despite available topical therapies, and the impact on quality of life can be considerable,” said Dr. Andreas Wollenberg, Professor of Dermatology and Allergy, University Hospital Augsburg, Germany. “The data supporting this positive CHMP opinion suggest that ruxolitinib cream may offer an effective new topical treatment option for appropriate adult patients in Europe and may help delay or prevent progression to systemic therapy, potentially helping to address an important gap for those who have struggled to achieve lasting relief.” AD, the most common type of eczema, is a chronic, recurring, inflammatory and highly pruritic skin condition that affects up to 4% of adults worldwide, with an estimated prevalence of 4.4-7.1% of adults in Europe.2, 8 , 9 , 10 Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. 2 The CHMP opinion is now being reviewed by the European Commission (EC), which has the authority to grant approval for all centrally authorized products in the European Union (EU). If approved, this would be the second indication for Opzelura in the EU, which was previously approved by the EC for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. About TRuE-AD4 TRuE-AD4 (NCT06238817) is a randomized, double-blind, vehicle-controlled Phase 3b study designed to evaluate the efficacy and safety of Opzelura ® (ruxolitinib) cream in adults with moderate atopic dermatitis (AD). The study enrolled 241 patients (≥18 years old) who met the specific inclusion criteria, including an IGA (Investigator's Global Assessment) score of 3 and an EASI (Eczema Area and Severity Index) score greater than 7 at both screening and Day 1, and who have AD on 10% to 20% of their Body Surface Area (BSA; excluding scalp). Patients also had to have a documented history of inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) within the 12 months prior to the screening visit. Patients were randomized 2:1 to receive Opzelura applied twice daily (BID) or vehicle (non-medicated cream) BID. At Week 8, patients who achieved EASI50 continued double-blind, BID treatment, applied as needed for an additional 16 weeks. Patients for whom EASI50 was not achieved at two consecutive visits ≥1 week apart were eligible to enter the escape arm at Week 8 or later, in which open-label Opzelura cream was applied as needed. The co-primary endpoints of TRuE-AD4 were the proportion of patients achieving IGA Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline, and EASI75, defined as ≥75% improvement in EASI score, at Week 8. Secondary endpoints included the proportion of patients with a ≥4-point improvement in NRS4 (≥4-point improvement in Itch Numeric Rating Scale) score at various time points. Other efficacy measures included the proportion of patients who achieved IGA-TS, NRS4, EASI75, a reduction from baseline in the affected body surface area (%BSA), change from baseline in the skin pain NRS score, EASI50 and more, measured at various time points. The study also tracked the frequency, duration and severity of adverse events associated with the use of Opzelura. For more information on the study, visit . About Opzelura ® (ruxolitinib) cream Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is 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 2 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 Opzelura. Opzelura is a registered trademark of Incyte . For more information, see the Opzelura SmPC . About Incyte ® Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology, and Inflammation & Autoimmunity. To learn more, visit Incyte.com and Investor.Incyte.com . Follow us on social media: LinkedIn , X and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding whether and when ruxolitinib cream might become a new treatment option for patients in the EU with moderate AD; ruxolitinib cream’s potential to delay or prevent progression to systemic therapy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data 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; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s products; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements. _____________________________ 1 Tiang J, Zhang, D Yang, Y, et al. Global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. Br J Dermatol. 2023 Dec 20;190(1):55-61. doi: 10.1093/bjd/ljad339 2 Global Atopic Dermatitis Atlas. Global report on atopic dermatitis 2022. Available at: . Accessed June 2026 3 Carrascosa JM, Prajapati VH, and Hong HC, et al. Efficacy and safety of ruxolitinib cream in adults with moderate atopic dermatitis: results from TRuE-AD4, a phase 3b, randomized, double-blind, vehicle-controlled study. Results presented at the International Symposium on Atopic Dermatitis (ISAD), Melbourne, Australia, 2025. Available at: . Accessed June 2026 4 ClinicalTrials.Gov. A study to evaluate the efficacy, and safety study of ruxolitinib cream in adults with moderate atopic dermatitis (TRuE-AD4). Available at: . Accessed June 2026 5 Wollenberg A, Hong HC, Agius E, et al. Long-term disease control and safety with ruxolitinib cream in adults with moderate atopic dermatitis following failure of prior topical therapies: results from the TRuE-AD4 phase 3b study. Results presented at the European Academy of Dermatology and Venereology (EADV) Symposium, Athens, Greece, 2026. Accessed May 2026. Available at: . Accessed June 2026 6 ClinicalTrials.Gov. Topical ruxolitinib evaluation in atopic dermatitis study 1 (TRuE AD1) - an efficacy and safety study of ruxolitinib cream in adolescents and adults with atopic dermatitis. Available at: . Accessed June 2026 7 ClinicalTrials.Gov. TRuE AD2 - an efficacy and safety study of ruxolitinib cream in adolescents and adults with atopic dermatitis. Available at: . Accessed June 2026 8 Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy . 2018;73(6):1284-1293. Link to source ( ) 9 Silverberg JI, Barbarot S, Gadkari A, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol . 2021;126(4):417-428.e2. Link to source ( ) 10 Eckert L, Gupta S, Gadkari A, et al. Burden of illness in adults with atopic dermatitis: Analysis of national health and wellness survey data from France, Germany, Italy, Spain, and the United Kingdom. J Am Acad Dermatol. 2019;81(1):187-195. Link to source ( ) Contacts Incyte Contacts: Media media@incyte.com Investors ir@incyte.com