Lupin receives U.S. FDA approval for Tolvaptan tablets with 180-day exclusivity
Lupin Limited shares are in focus today following the announcement that the company has received U.S. FDA approval for its generic version of Tolvaptan Tablets, used for treating autosomal dominant polycystic kidney disease (ADPKD). This approval positions Lupin as the exclusive first-to-file generic manufacturer, granting the company 180 days of marketing exclusivity in the United States. Tolvaptan targets high-value U.S. nephrology market
Lupin's Tolvaptan Tablets – in strengths of 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg – are bioequivalent to Jynarque®, a brand marketed by Otsuka Pharmaceutical Company Ltd. The drug is indicated to slow kidney function decline in adults at risk of rapidly progressing ADPKD.
According to IQVIA data, Jynarque® generated estimated annual U.S. sales of $1.47 billion for the fiscal year ended December 2024, highlighting the significance of this launch for Lupin's U.S. business.
The drug will be manufactured at Lupin's Nagpur facility in India, and the company confirmed that a market launch is imminent. Strategic remarks from Lupin leadership
Vinita Gupta, CEO of Lupin, stated:
'We are very pleased to have obtained approval for generic Tolvaptan from the U.S. FDA. This marks a significant entry into the nephrology segment and demonstrates our commitment to addressing the unmet needs of patients globally.' Why this matters First-to-file status secures Lupin a 6-month window without generic competition in the U.S.
Entry into the nephrology segment marks a new therapy area for expansion.
Reinforces Lupin's U.S. presence, already a stronghold for the company's revenues. About Lupin
Lupin Limited, headquartered in Mumbai, is a global pharma leader with a footprint in over 100 markets. The company operates 15 manufacturing sites and 7 research centers worldwide. It has a strong presence in multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, and CNS segments. Its subsidiaries also cover diagnostics, digital health, and complex generics.
For more details, visit: www.lupin.com FAQs
What is Tolvaptan used for?
It is prescribed to slow kidney function decline in adults with ADPKD.
What is Lupin's advantage with this approval?
Lupin is the first generic filer, granting it 180-day market exclusivity in the U.S.
How big is the market opportunity?
The reference drug Jynarque® saw U.S. sales of approximately $1.47 billion in 2024.
When will Lupin launch the product?
Lupin has confirmed the launch is planned soon, with manufacturing handled at its Nagpur plant.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
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Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm. Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19. Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500mg/dl after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500mg/dl, after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®. HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤ Grade 2. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia. Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction. SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post-marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc. at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status, seizures, neurocognitive decline, or neuropathy, patients receiving CARVYKTI® are at risk for altered or decreased consciousness or coordination in the 8 weeks following CARVYKTI® infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery during this initial period, and in the event of new onset of any neurologic REACTIONS The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia. Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®. ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL) Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1 In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency's Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. ABOUT CARTITUDE-1 CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.2 ABOUT CARTITUDE-4 CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3 ABOUT LB1908 NCT05539430 is a Phase 1, open label, dose escalation, multicenter study to evaluate Claudin 18.2-targeting CAR-T cells (LB1908) in adult patients with unresectable, locally advanced or metastatic gastric, gastroesophageal junction, esophageal, or pancreatic adenocarcinoma.4 ABOUT LB2102 NCT05680922 is a Phase 1, first-in-human, open-label, multicenter, dose escalation and expansion study of DLL3-targeted chimeric antigen receptor T-cells (LB2102) in patients with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer.5 ABOUT MULTIPLE MYELOMA Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.6 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 ABOUT GASTRIC, ESOPHAGEAL AND PANCREATIC CANCERS Stomach, esophageal and pancreatic cancers affect the tissue or glands lining these organs. They are often diagnosed when the diseases have progressed to advanced stages. In the U.S., there are an estimated 123,920 people living with stomach cancer and 49,084 living with esophageal cancers.9,10 An estimated 89,248 people in the U.S. live with pancreatic cancer. While all three cancers are treatable, the five-year survival rate is just 32% for gastric cancer; 20% for esophageal cancer; and 11.5% for pancreatic cancer, with definitive treatment at all stages of progression.11,12,13 ABOUT SMALL CELL LUNG CANCER Lung cancer is a leading cause of cancer deaths, contributing to 25 percent of all cancer-related fatalities annually in the United States.14 Small cell lung cancer (SCLC) is the most aggressive, and accounts for roughly 10-15 percent of lung cancer cases in the United States.15,16 An estimated 30,000 to 35,000 people are newly diagnosed with the disease each year.16 This cancer becomes more difficult to treat once it has spread and becomes extensive stage SCLC. Approximately 60 to 70 percent of SCLC patients are diagnosed with metastatic SCLC.15,17 ABOUT LEGEND BIOTECH With over 2,600 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the US, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI's patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities. Learn more at and follow us on X (formerly Twitter) and LinkedIn. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute 'forward-looking statements' within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech's strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech's expectations for CARVYKTI® and its therapeutic potential; statements related to the potential results from ongoing studies in the CARTITUDE clinical development program; and the potential benefits of Legend Biotech's product candidates. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech's expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech's patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the 'Risk Factors' section of Legend Biotech's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. ‡ Sundar Jagannath, M.D., Network Director, Multiple Myeloma Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, has provided consulting, advisory, and speaking services to Legend Biotech; has not been paid for any media work. INVESTOR CONTACT: Jessie YeungTel: (732) 956-8271 PRESS CONTACT: MaryAnn OndishTel: (914) 552-4625media@ REFERENCES _____________________ 1 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.2 A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: Accessed October 2022.3 A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). Accessed March 2024.4 Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma. Available at: Accessed May 20255 DLL3-Directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage Small Cell Lung Cancer. Available at: Accessed May 20256 American Cancer Society. 'What is Multiple Myeloma?'. Available at: Accessed March 2024.7 American Cancer Society. 'Key Statistics About Multiple Myeloma.' Available at: Accessed March 20248 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: Accessed March 2023.9 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.10 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.11 American Cancer Society. Accessed May 2022.12 American Cancer Society. May 2022.13 Surveillance, Epidemiology, and End Results (SEER) Program. Accessed May 2022.14 American Cancer Society. 'Key Statistics for Lung Cancer.' Accessed November 2022.15 Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121(5):664-72.16 Rare Diseases. 'Rare Disease Database.' Accessed November 2022.17 Gong J, Salgia R. Managing patients with relapsed small-cell lung cancer. J Oncol Pract. 2018;14(6): in to access your portfolio
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Apple Intelligence gets even more powerful with new capabilities across Apple devices
Developers can now access the Apple Intelligence on-device foundation model to power private, intelligent experiences within their apps CUPERTINO, Calif., June 09, 2025--(BUSINESS WIRE)--Apple® today announced new Apple Intelligence™ features that elevate the user experience across iPhone®, iPad®, Mac®, Apple Watch®, and Apple Vision Pro™. Apple Intelligence unlocks new ways for users to communicate with features like Live Translation; do more with what's on their screen with updates to visual intelligence; and express themselves with enhancements to Image Playground™ and Genmoji™.1 Additionally, Shortcuts can now tap into Apple Intelligence directly, and developers will be able to access the on-device large language model at the core of Apple Intelligence, giving them direct access to intelligence that is powerful, fast, built with privacy, and available even when users are offline. These Apple Intelligence features are available for testing starting today, and will be available to users with supported devices set to a supported language this fall. "Last year, we took the first steps on a journey to bring users intelligence that's helpful, relevant, easy to use, and right where users need it, all while protecting their privacy. Now, the models that power Apple Intelligence are becoming more capable and efficient, and we're integrating features in even more places across each of our operating systems," said Craig Federighi, Apple's senior vice president of Software Engineering. "We're also taking the huge step of giving developers direct access to the on-device foundation model powering Apple Intelligence, allowing them to tap into intelligence that is powerful, fast, built with privacy, and available even when users are offline. We think this will ignite a whole new wave of intelligent experiences in the apps users rely on every day. We can't wait to see what developers create." Apple Intelligence features will be coming to eight more languages by the end of the year: Danish, Dutch, Norwegian, Portuguese (Portugal), Swedish, Turkish, Chinese (traditional), and Vietnamese. Live Translation Breaks Down Language Barriers For those moments when a language barrier gets in the way, Live Translation can help users communicate across languages when messaging or speaking. The experience is integrated into Messages, FaceTime®, and Phone, and enabled by Apple-built models that run entirely on device, so users' personal conversations stay personal. In Messages, Live Translation can automatically translate messages. If a user is making plans with new friends while traveling abroad, their message can be translated as they type, delivered in the recipient's preferred language, and when they get a response, each message can be instantly translated.2 On FaceTime calls, a user can follow along with translated live captions while still hearing the speaker's voice. And when on a phone call, the translation is spoken aloud throughout the conversation.3 New Ways to Explore Creativity with Updates to Genmoji and Image Playground Genmoji and Image Playground provide users with even more ways to express themselves. In addition to turning a text description into a Genmoji, users can now mix together emoji and combine them with descriptions to create something new. When users make images inspired by family and friends using Genmoji and Image Playground, they have the ability to change expressions or adjust personal attributes, like hairstyle, to match their friend's latest look. In Image Playground, users can tap into brand-new styles with ChatGPT, like an oil painting style or vector art. For moments when users have a specific idea in mind, they can tap Any Style and describe what they want. Image Playground sends a user's description or photo to ChatGPT and creates a unique image. Users are always in control, and nothing is shared with ChatGPT without their permission. Visual Intelligence Helps Users Search and Take Action Building on Apple Intelligence, visual intelligence extends to a user's iPhone screen so they can search and take action on anything they're viewing across their apps. Visual intelligence already helps users learn about objects and places around them using their iPhone camera, and it now enables users to do more, faster, with the content on their iPhone screen. Users can ask ChatGPT questions about what they're looking at on their screen to learn more, as well as search Google, Etsy, or other supported apps to find similar images and products. If there's an object a user is especially interested in, like a lamp, they can highlight it to search for that specific item or similar objects online. Visual intelligence also recognizes when a user is looking at an event and suggests adding it to their calendar.4 Apple Intelligence then extracts the date, time, and location to prepopulate these key details into an event. Users can access visual intelligence for what's on their screen by simply pressing the same buttons used to take a screenshot. Users will have the choice to save or share their screenshot, or explore more with visual intelligence. Apple Intelligence Expands to Fitness on Apple Watch Workout Buddy is a first-of-its-kind workout experience on Apple Watch with Apple Intelligence that incorporates a user's workout data and fitness history to generate personalized, motivational insights during their session.5 To offer meaningful inspiration in real time, Workout Buddy analyzes data from a user's current workout along with their fitness history, based on data like heart rate, pace, distance, Activity rings, personal fitness milestones, and more. A new text-to-speech model then translates insights into a dynamic generative voice built using voice data from Fitness+ trainers, so it has the right energy, style, and tone for a workout. Workout Buddy processes this data privately and securely with Apple Intelligence. Workout Buddy will be available on Apple Watch with Bluetooth headphones, and requires an Apple Intelligence-supported iPhone nearby. It will be available starting in English, across some of the most popular workout types: Outdoor and Indoor Run, Outdoor and Indoor Walk, Outdoor Cycle, HIIT, and Functional and Traditional Strength Training. Apple Intelligence On-Device Model Now Available to Developers Apple is opening up access for any app to tap directly into the on-device foundation model at the core of Apple Intelligence. With the Foundation Models framework, app developers will be able to build on Apple Intelligence to bring users new experiences that are intelligent, available when they're offline, and that protect their privacy, using AI inference that is free of cost. For example, an education app can use the on-device model to generate a personalized quiz from a user's notes, without any cloud API costs, or an outdoors app can add natural language search capabilities that work even when the user is offline. The framework has native support for Swift®, so app developers can easily access the Apple Intelligence model with as few as three lines of code. Guided generation, tool calling, and more are all built into the framework, making it easier than ever to implement generative capabilities right into a developer's existing app. Shortcuts Get More Intelligent Shortcuts are now more powerful and intelligent than ever. Users can tap into intelligent actions, a whole new set of shortcuts enabled by Apple Intelligence. Users will see dedicated actions for features like summarizing text with Writing Tools or creating images with Image Playground. Now users will be able to tap directly into Apple Intelligence models, either on-device or with Private Cloud Compute, to generate responses that feed into the rest of their shortcut, maintaining the privacy of information used in the shortcut. For example, a student can build a shortcut that uses the Apple Intelligence model to compare an audio transcription of a class lecture to the notes they took, and add any key points they may have missed. Users can also choose to tap into ChatGPT to provide responses that feed into their shortcut. Additional New Features Apple Intelligence is even more deeply integrated into the apps and experiences that users rely on every day: The most relevant actions in an email, website, note, or other content can now be identified and automatically categorized in Reminders. Apple Wallet® can now identify and summarize order tracking details from emails sent from merchants or delivery carriers. This works across all of a user's orders, giving them the ability to see their full order details, progress notifications, and more, all in one place. Users can create a poll for anything in Messages, and with Apple Intelligence, Messages can detect when a poll might come in handy and suggest one. In addition, Backgrounds in the Messages app lets a user personalize their chats with stunning designs, and they can create unique backgrounds that fit their conversation with Image Playground. These features build on a wide range of Apple Intelligence capabilities that are already available to users: Writing Tools can help users rewrite, proofread, and summarize the text they have written. And with Describe Your Change, users can describe a specific change they want to apply to their text, like making a dinner party invite read like a poem. Clean Up in Photos allows users to remove distracting elements while staying true to the moment as they intended to capture it. Visual intelligence builds on Apple Intelligence and helps users learn about objects and places around them instantly. Genmoji allow users to create their own emoji by typing a description. And just like emoji, they can be added inline to messages, or shared as a sticker or reaction in a Tapback. Image Playground gives users a way to create playful images in moments, with concepts like themes, costumes, accessories, and places. And they can add their own text descriptions, and create images in the likeness of a family member or friend using photos from their photo library. Image Wand can transform a rough sketch into a polished image that complements a user's notes. Mail summaries give users a way to view key details for an email or long thread by simply tapping or clicking Summarize. Smart Reply provides users with suggestions for a quick response in Mail and Messages. Siri® is more natural and helpful, with the option to type to Siri and tap into its product knowledge about the features and settings on Apple products; Siri can also follow along if a user stumbles over their words, and maintain context from one request to the next. Access to ChatGPT is integrated in Writing Tools and Siri, giving users the option to tap into ChatGPT's image- and document-understanding capabilities without needing to jump between tools. Natural language search in Photos makes it easier for users to find a photo or video by simply describing it. Users can create a memory movie in Photos by typing a description. Summaries of audio transcriptions in Notes are automatically generated to surface important information at a glance. Users can generate summaries of call transcriptions to highlight important details. Priority Messages, a section at the top of the inbox in Mail, shows the most urgent emails, like a same-day invitation to lunch or a boarding pass. Priority Notifications appear at the top of a user's notifications, highlighting important notifications that may require immediate attention. Notification summaries give users a way to scan long or stacked notifications and provide key details right on the Lock Screen. Previews in Mail and Messages show users a brief summary of key information without needing to open a message. The Reduce Interruptions Focus surfaces only the notifications that might need immediate attention. A Breakthrough for Privacy in AI Designed to protect users' privacy at every step, Apple Intelligence uses on-device processing, meaning that many of the models that power it run entirely on device. For requests that require access to larger models, Private Cloud Compute extends the privacy and security of iPhone into the cloud to unlock even more intelligence so a user's data is never stored or shared with Apple; it is used only to fulfill their request. Independent experts can inspect the code that runs on Apple silicon servers to continuously verify this privacy promise, and are already doing so. This is an extraordinary step forward for privacy in AI. Availability All of these new features are available for testing starting today through the Apple Developer Program at and a public beta will be available through the Apple Beta Software Program next month at Users who enable Apple Intelligence on supported devices set to a supported language will have access this fall, including all iPhone 16 models, iPhone 15 Pro, iPhone 15 Pro Max, iPad mini (A17 Pro), and iPad and Mac models with M1 and later, with Siri and device language set to the same supported language: English, French, German, Italian, Portuguese (Brazil), Spanish, Japanese, Korean, or Chinese (simplified). More languages will be coming by the end of this year: Danish, Dutch, Norwegian, Portuguese (Portugal), Swedish, Turkish, Chinese (traditional), and Vietnamese. Some features may not be available in all languages or regions, and availability may vary due to local laws and regulations. For more details, visit Apple revolutionized personal technology with the introduction of the Macintosh in 1984. Today, Apple leads the world in innovation with iPhone, iPad, Mac, AirPods, Apple Watch, and Apple Vision Pro. Apple's six software platforms — iOS, iPadOS, macOS, watchOS, visionOS, and tvOS — provide seamless experiences across all Apple devices and empower people with breakthrough services including the App Store, Apple Music, Apple Pay, iCloud, and Apple TV+. Apple's more than 150,000 employees are dedicated to making the best products on earth and to leaving the world better than we found it. 1 Genmoji and Image Playground are available in English, French, German, Italian, Portuguese (Brazil), Spanish, and Japanese.2 Live Translation in Messages supports English (U.S., UK), French (France), German, Italian, Japanese, Korean, Portuguese (Brazil), Spanish (Spain), and Chinese (simplified).3 Live Translation in Phone and FaceTime is available for one-on-one calls in English (U.S., UK), French (France), German, Portuguese (Brazil), and Spanish (Spain).4 The ability to add an event to Calendar with visual intelligence is available in English on all iPhone 16 models, iPhone 15 Pro, and iPhone 15 Pro Max.5 Workout Buddy will be available on Apple Watch Series 6 or later, Apple Watch SE (2nd generation), and Apple Watch Ultra and Ultra 2 with an Apple Intelligence-supported iPhone starting in English. NOTE TO EDITORS: For additional information visit Apple Newsroom ( or email Apple's Media Helpline at © 2025 Apple Inc. All rights reserved. Apple, the Apple logo, Apple Intelligence, iPhone, iPad, Mac, Apple Watch, Apple Vision Pro, Image Playground, Genmoji, FaceTime, Swift, Apple Wallet and Siri are trademarks of Apple. Other company and product names may be trademarks of their respective owners. View source version on Contacts Nadine HaijaApplenhaija@ Anna TabetAppleatabet@
