Latest news with #Opzelura
Yahoo
4 days ago
- Business
- Yahoo
How Is Incyte's Stock Performance Compared to Other Biotech Stocks?
With a market cap of $13.3 billion, Incyte Corporation (INCY) is a global biopharmaceutical company focused on discovering, developing, and commercializing therapies in oncology, inflammation, and autoimmunity. The Wilmington, Delaware-based company has over 2,600 employees and a manufacturing and R&D footprint across North America, Europe, and Asia. Companies valued at $10 billion or more are generally labelled as 'large-cap' stocks, and Incyte fits this criterion perfectly. Its leadership stems from its strong portfolio of high-demand specialty drugs, notably Jakafi and Opzelura, which serve as key revenue drivers in the oncology and dermatology markets. Its robust research and development capabilities, with a diverse and advancing pipeline targeting cancer, inflammation, and autoimmune diseases, position it for long-term innovation. The Next Trillion-Dollar Boom? 3 Stocks to Buy with 300 Million Humanoid Robots on the Horizon. Warren Buffett's Berkshire Hathaway Now Pays 5% of All Corporate Income Taxes in America Meta's Mark Zuckerberg Says the Technology They're Developing Will 'See What You See and Hear What You Hear' Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. Despite that, INCY has fallen 19.9% from its 52-week high of $83.95, achieved on Nov. 8. Yet, shares of INCY have risen 8.6% over the past three months, compared to the SPDR S&P Biotech ETF's (XBI) 5.6% fall during the same time frame. INCY is down 2.6% on a YTD basis, lagging behind XBI's 8.7% gains. However, shares of Incyte have climbed 6.4% over the past 52 weeks, compared to XBI's 10.9% fall over the same time frame. INCY has been trading above its 200-day moving average since early June and has mostly stayed above its 50-day moving average since mid-May. On June 16, shares of Incyte rose more than 4% following the announcement of encouraging clinical trial results for its investigational therapy targeting a blood disorder. The company reported positive data from two separate studies, which demonstrated the treatment's potential effectiveness and safety in managing the condition, likely a form of myeloproliferative neoplasm or a related hematologic disease. The strong outcomes from these trials bolstered investor confidence in the strength of Incyte's R&D pipeline and its ability to diversify beyond its flagship drug, Jakafi. In comparison, rival Exelixis, Inc. (EXEL) outperformed INCY. Shares of Exelixis have gained 95.4% over the past 52 weeks and 30.2% on a YTD basis. Among the 25 analysts covering the stock, there is a consensus rating of 'Moderate Buy,' and its mean price target of $75.81 indicates an upswing potential of 12.7% from the prevailing price levels. On the date of publication, Kritika Sarmah did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on
Business Insider
21-06-2025
- Business
- Business Insider
Incyte announces FDA extends review period for Opzelura sNDA
The company states: 'Incyte (INCY) announced that the FDA has extended the review period for the supplemental New Drug Application, sNDA, for ruxolitinib cream, Opzelura, a topical Janus kinase inhibitor, for the treatment of children 2-11 years old with mild to moderate atopic dermatitis. The 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 data on the 0.75% strength submitted by Incyte in response to a recent FDA information request.' Steven Stein, M.D., Chief Medical Officer, Incyte stated: '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.' Confident Investing Starts Here:
Business Wire
20-06-2025
- Health
- 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.
Yahoo
13-05-2025
- Business
- Yahoo
INCY Q1 Earnings Call: New Product Launches and Pipeline Progress Drive Outperformance
Biopharmaceutical company Incyte Corporation (NASDAQ:INCY) reported Q1 CY2025 results exceeding the market's revenue expectations , with sales up 19.5% year on year to $1.05 billion. Its non-GAAP profit of $1.16 per share was 10.6% above analysts' consensus estimates. Is now the time to buy INCY? Find out in our full research report (it's free). Revenue: $1.05 billion vs analyst estimates of $989.2 million (19.5% year-on-year growth, 6.4% beat) Adjusted EPS: $1.16 vs analyst estimates of $1.05 (10.6% beat) Adjusted EBITDA: $227.5 million vs analyst estimates of $279.3 million (21.6% margin, 18.5% miss) Operating Margin: 19.5%, up from 10.4% in the same quarter last year Free Cash Flow Margin: 27.9%, up from 23.8% in the same quarter last year Market Capitalization: $11.78 billion Incyte's first quarter results reflected notable commercial momentum and pipeline advancement, with management attributing much of the company's performance to strong demand for Jakafi and the initial launch of Niktimvo. CEO Herve Hoppenot highlighted the successful rollout of Niktimvo in chronic graft-versus-host disease, as well as ongoing growth in Jakafi's polycythemia vera indication. Management also emphasized the positive impact of expanded formulary coverage for Opzelura, now preferred on two of the three largest pharmacy benefit manager formularies, resulting in broader patient access and higher net product revenue. Looking ahead, Incyte's leadership outlined several key revenue drivers. Hoppenot pointed to three additional planned product launches in 2025, continued progress in late-stage clinical studies, and several pivotal data readouts as critical to sustaining growth. CFO Christiana Stamoulis reaffirmed increased full-year guidance for Jakafi, citing favorable gross-to-net dynamics and persistent patient demand. Management also addressed tariff concerns, stating that dual US and European manufacturing provides flexibility, minimizing potential impacts from trade policy changes. Incyte's management detailed a quarter shaped by strong product demand, expanding market access, and pipeline milestones. Key topics included new product launches, growth in core franchises, and the impact of healthcare policy changes. Jakafi growth in polycythemia vera: Management cited robust volume increases for Jakafi, especially in the polycythemia vera indication, supported by early intervention data and effective physician education campaigns. They expect polycythemia vera to become the largest driver for Jakafi over time. Opzelura's expanded access: The addition of Opzelura to Optum Premium's preferred formulary improved its commercial coverage to 94%, enhancing growth prospects for both atopic dermatitis and vitiligo indications. Niktimvo launch momentum: The launch of Niktimvo for chronic graft-versus-host disease exceeded initial expectations, with rapid uptake across leading bone marrow transplant centers. Management noted that 95% of top centers have used the product. Pipeline data readouts: Positive phase 2 and phase 3 clinical data for pipeline assets such as povorcitinib in hidradenitis suppurativa and chronic spontaneous urticaria were highlighted, with management aiming for three additional product launches in 2025. Tariff risk mitigation: Management explained that dual sourcing and geographically diversified manufacturing reduce the impact of potential pharmaceutical tariffs, while inventory levels for at-risk inputs remain sufficient to support near-term supply needs. Management's outlook for the next several quarters focuses on continued product launches, new clinical data, and operational efficiency as the main themes underpinning future performance. Multiple product launches ahead: The company expects three more launches in 2025, which management believes will materially expand the commercial portfolio and near-term revenue base. Advancing pipeline milestones: Several late-stage and pivotal clinical trials are on track for readouts this year, including phase 3 studies in dermatology and oncology, which could broaden Incyte's approved indications and market reach. Operational flexibility and risk management: Diversified manufacturing and inventory strategies are expected to safeguard supply continuity, while management cited ongoing investments in R&D and commercial infrastructure as essential for long-term growth. Michael Schmidt (Guggenheim): Asked how much Jakafi's polycythemia vera growth is driven by new patient starts versus ongoing therapy; management noted both contribute, with new patient education and persistence supporting future expansion. David Lebowitz (Citi): Inquired about povorcitinib's positioning in chronic spontaneous urticaria relative to biologics; management responded it could serve both pre- and post-biologic patient populations, with some preferring an oral option first. Salveen Richter (Goldman Sachs): Sought details on Opzelura's growth by indication and steps to improve access for atopic dermatitis; management described stable growth across both indications and ongoing efforts to expand formulary coverage and patient support services. Jessica Fye (JPMorgan): Asked about capital allocation and the potential for further share repurchases; management emphasized prioritizing pipeline investment, with business development focused on early-stage partnerships. Madeline (William Blair): Queried whether positive phase 2 data in chronic spontaneous urticaria alters Incyte's plans for other related programs; management noted satisfaction with current pipeline progress, with no plans to restart previously discontinued programs. In the coming quarters, the StockStory team will be monitoring (1) the pace and breadth of new product launches and their initial market adoption, (2) the timing and outcome of late-stage clinical data readouts, particularly in dermatology and oncology, and (3) the continued expansion of commercial coverage for Opzelura and other key products. Execution on these initiatives, along with effective supply chain management amid evolving tariff risks, will be critical for tracking Incyte's strategic progress. Incyte currently trades at a forward P/E ratio of 10.3×. Should you load up, cash out, or stay put? The answer lies in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-small-cap company Comfort Systems (+782% five-year return). Find your next big winner with StockStory today. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
29-04-2025
- Business
- Reuters
Incyte raises 2025 sales forecast for blood cancer drug after solid quarter
April 29 (Reuters) - Incyte Corp (INCY.O), opens new tab raised its annual sales forecast for its blood cancer treatment Jakafi on Tuesday, after robust sales of the drug helped it beat Wall Street estimates for quarterly results. Apart from higher demand, Incyte attributed the first-quarter sales to policy benefits from the Inflation Reduction Act and less destocking by retailers and distributors. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Sales from Jakafi rose 24% from a year ago to $709 million for the quarter, compared with analysts' estimate of $638.4 million. Jakafi, a treatment for myelofibrosis and polycythemia vera cancers, is also approved for a condition called acute graft-versus-host disease, a condition where the donor's bone marrow or stem cells attack the recipient's body. Incyte now expects annual sales of Jakafi between $2.95 billion and $3 billion, up from prior range of $2.93 billion to$2.98 billion. Analysts expected annual sales of $2.96 billion for the drug, according to data compiled by LSEG. The drugmaker is also banking on its skin disorder drug Opzelura, a treatment for vitiligo and mild-to-moderate atopic dermatitis in patients 12 years and older, to drive growth as it braces for Jakafi to lose key patents in 2028. Although sales from Opzelura rose 38% from a year ago to $119 million for the quarter, they fell short of analysts' estimate of $131.6 million. On an adjusted basis, Incyte earned $1.16 per share in the quarter ended March 31, outperforming analysts' estimate of $1.02 per share. Total revenue for the quarter was $1.05 billion, beating an estimate of $993.1 million.
