{"success":true,"data":{"pressRelease":{"id":"17645","rtpr_id":"nBw9j5Cv1a","ticker":"INCY","exchange":"NASDAQ","all_tickers":["INCY"],"title":"Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease","author":"Business Wire","published_at":"2026-05-01T21:28:00.102Z","article_body":"Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release\nTablets for the Treatment of Myelofibrosis, Polycythemia Vera and\nGraft-Versus-Host Disease\n\n\n * Jakafi XR is a once-daily, film-coated, extended-release formulation of\nJakafi(®) (ruxolitinib)\n\n * Once-daily Jakafi XR was shown to provide consistent, day-long exposure\ncomparable to twice-daily Jakafi\n\n * Jakafi XR will be available for pharmacy orders by May 8\n\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug\nAdministration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release\ntablets for the treatment of adults with intermediate- or high-risk\nmyelofibrosis (MF); adults with polycythemia vera (PV) who have had an\ninadequate response to or are intolerant of hydroxyurea; as well as adults and\nchildren aged 12 years and older with steroid-refractory acute\ngraft-versus-host disease (GVHD) or chronic GVHD after failure of one or two\nlines of systemic therapy.\n\nThis press release features multimedia. View the full release here:\nhttps://www.businesswire.com/news/home/20260501334677/en/\n(https://www.businesswire.com/news/home/20260501334677/en/)\n\n“The approval of Jakafi XR reinforces Incyte’s leadership in hematology\nand our focus on meeting the evolving needs of patients with\nmyeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief\nExecutive Officer, Incyte. “Jakafi XR offers appropriate patients and\nphysicians a once-daily option, expanding choice without changing the\nwell-established role of Jakafi in clinical practice.”\n\nFDA approval was based on a clinical study which demonstrated that a single 55\nmg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg\nJakafi tablet, the immediate-release (IR) dosage form, taken twice-daily\n(BID). This means that, based on key measures of steady-state drug exposure,\nit delivers the same active ingredient at comparable levels throughout the\nday, indicating the potential for similar clinical benefit.(1)\n\nThe safety of Jakafi XR has been established from adequate and well-controlled\nstudies of Jakafi in adult patients with myelofibrosis, polycythemia vera, and\nadult and pediatric patients with acute and chronic graft-versus-host-disease.\nThe most common adverse reactions associated with Jakafi in these studies\ninclude:\n\n\n * For certain patients with MF and PV: low platelet or red blood cell counts,\nbruising, dizziness, headache and diarrhea;\n\n * For patients with acute GVHD: low platelet counts, low red or white blood cell\ncounts, infections and swelling;\n\n * And for patients with chronic GVHD: low red blood cell or platelet counts and\ninfections, including viral infections.(2)\n\n“Patients living with chronic conditions like MPNs and GVHD often struggle\nwith managing complex treatment regimens or have multiple conditions,” said\nNaveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine at\nThe University of Texas MD Anderson Cancer Center. “Since its initial\napproval in 2011, ruxolitinib has helped transform the treatment landscape for\npatients with MPNs and GVHD. With the approval of Jakafi XR, appropriate\npatients now have the choice of a single daily tablet.” Researchers at UT MD\nAnderson have led several clinical trials in the development of ruxolitinib.\n\nIncyte is committed to supporting patients and removing barriers to access\nmedicines. Eligible patients in the U.S. who are prescribed Jakafi XR have\naccess to IncyteCARES (Connecting to Access, Reimbursement, Education and\nSupport), a comprehensive program offering personalized patient support,\nincluding financial assistance and ongoing education and additional resources.\nMore information about IncyteCARES is available by visiting\nwww.incytecares.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.incytecares.com&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=www.incytecares.com&index=1&md5=588effbc24fae4ea7734ce43ee724ae0)\nor calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.\n\nAbout Myelofibrosis\n\nMyelofibrosis (MF) is a part of a group of rare, chronic blood cancers called\nmyeloproliferative neoplasms, or MPNs. MF occurs when a bone marrow defect\nresults in an abnormal production of blood cells, causing scar tissue to form,\nwhich can lead to severe anemia, weakness, fatigue and an enlarged spleen and\nliver. MF can result from a progression of other bone marrow diseases,\nincluding polycythemia vera and essential thrombocythemia, or it can occur on\nits own.(3)\n\nAbout Polycythemia Vera\n\nPolycythemia Vera (PV) is a part of a group of rare, chronic blood cancers\ncalled myeloproliferative neoplasms, or MPNs.(3) PV occurs when bone marrow\nproduces too many red blood cells, white blood cells and often platelets.\nIncreased red blood cells and platelets can cause the blood to thicken,\nleading to an increased risk of blood clotting complications, including deep\nvein thrombosis, stroke or heart attack.(4)\n\nAbout Graft-Versus-Host Disease\n\nGraft-versus-host disease (GVHD) is a condition that can occur after an\nallogeneic stem cell transplant (the transfer of stem cells from a donor) in\nwhich the donated cells initiate an immune response and attack the transplant\nrecipient’s organs, leading to significant morbidity and mortality. There\nare two major forms of GVHD: acute, which generally occurs within 100 days of\ntransplant, and chronic, which generally occurs after 100 days of transplant.\nBoth forms can affect multiple organ systems, including the skin,\ngastrointestinal (digestive) tract and liver.(5)\n\nAbout Jakafi XR™ (ruxolitinib) Extended-Release Tablets\n\nJakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD)\nformulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by\nthe U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis,\nincluding primary myelofibrosis, post-polycythemia vera myelofibrosis, and\npost-essential thrombocythemia myelofibrosis in adults; polycythemia vera in\nadults who have had an inadequate response to or are intolerant of\nhydroxyurea; steroid-refractory acute graft-versus-host disease in adult and\npediatric patients 12 years and older; and chronic graft-versus-host disease\nafter failure of one or two lines of systemic therapy in adult and pediatric\npatients 12 years and older.\n\nIt is not known if Jakafi XR is safe or effective in children for treatment of\nmyelofibrosis or polycythemia vera.\n\nJakafi XR and the Jakafi XR logo are trademarks of Incyte.\n\nAbout Jakafi(®) (ruxolitinib)\n\nJakafi(®) (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for\nthe treatment of polycythemia vera (PV) in adults who have had an inadequate\nresponse to or are intolerant of hydroxyurea; intermediate or high-risk\nmyelofibrosis (MF), including primary MF, post-polycythemia vera MF and\npost-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in\nadult and pediatric patients 12 years and older; and chronic GVHD after\nfailure of one or two lines of systemic therapy in adult and pediatric\npatients 12 years and older.\n\nIt is not known if Jakafi is safe or effective in children for treatment of\nmyelofibrosis or polycythemia vera.\n\nJakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi(®)\n(ruxolitinib) outside the U.S. Jakafi and the Jakafi logo are registered\ntrademarks of Incyte. Jakavi is a registered trademark of Novartis AG in\ncountries outside the United States.\n\nIMPORTANT SAFETY INFORMATION\n\nJAKAFI or JAKAFI XR can cause serious side effects, including:\n\nLow blood counts: JAKAFI or JAKAFI XR may cause low platelet, red blood cell,\nand white blood cell counts. If you develop bleeding, stop taking JAKAFI or\nJAKAFI XR and call your healthcare provider. Your healthcare provider will do\na blood test to check your blood counts before you start and regularly during\nyour treatment. Your healthcare provider may change your dose or stop your\ntreatment based on the results of your blood tests.\n\nTell your healthcare provider right away if you develop or have worsening\nsymptoms such as:\n\n\n * unusual bleeding\n\n * bruising\n\n * tiredness\n\n * shortness of breath\n\n * a fever\n\nInfection: You may be at risk for developing a serious infection during\ntreatment with JAKAFI or JAKAFI XR. Tell your healthcare provider if you\ndevelop any of the following symptoms of infection:\n\n\n * chills\n\n * nausea\n\n * vomiting\n\n * aches\n\n * weakness\n\n * fever\n\n * painful skin rash or blisters\n\nWorsening of symptoms after interrupting or stopping treatment. Signs and\nsymptoms of myelofibrosis may worsen after you stop treatment.\n\nDo not interrupt or stop treatment without talking to your healthcare\nprovider. Tell your healthcare provider right away if you have any of the\nfollowing after stopping treatment:\n\n\n * fever\n\n * trouble breathing\n\n * weakness\n\n * night sweats\n\n * feeling dizzy or lightheaded\n\n * pain in left upper stomach area or left shoulder\n\nCancer: Some people have had certain types of non-melanoma skin cancers during\ntreatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly\ncheck your skin during your treatment. Tell your healthcare provider if you\ndevelop any new or changing skin lesions during treatment.\n\nIncreases in cholesterol: You may have changes in your blood cholesterol\nlevels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider\nwill do blood tests to check your cholesterol levels about every 8 to 12 weeks\nafter you start taking JAKAFI or JAKAFI XR and as needed.\n\nIncreased risk of major cardiovascular events such as heart attack, stroke or\ndeath in people who have cardiovascular risk factors and who are current or\npast smokers while using another JAK inhibitor to treat rheumatoid arthritis:\n\nGet emergency help right away if you get any symptoms of a heart attack or\nstroke during treatment with JAKAFI or JAKAFI XR, including:\n\n\n * discomfort in the center of your chest that lasts for more than a few minutes\nor that goes away and comes back\n\n * severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or\njaw\n\n * pain or discomfort in your arms, back, neck, jaw, or stomach\n\n * shortness of breath with or without chest discomfort\n\n * breaking out in a cold sweat\n\n * nausea or vomiting\n\n * feeling lightheaded\n\n * weakness in one part or on one side of your body\n\n * slurred speech\n\nIncreased risk of blood clots: Blood clots in the veins of your legs (deep\nvein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in\npeople taking another JAK inhibitor for rheumatoid arthritis and may be\nlife-threatening.\n\nTell your healthcare provider right away if you have any signs and symptoms of\nblood clots during treatment with JAKAFI or JAKAFI XR, including:\n\n\n * swelling, pain, or tenderness in one or both legs\n\n * sudden, unexplained chest or upper back pain\n\n * shortness of breath or difficulty breathing\n\nPossible increased risk of new (secondary) cancers: People who take another\nJAK inhibitor for rheumatoid arthritis have an increased risk of new\n(secondary) cancers, including lymphoma and other cancers. People who smoke or\nwho smoked in the past have an added risk of new cancers.\n\nThe most common side effects of JAKAFI or JAKAFI XR include:\n\n\n * for certain types of polycythemia vera (PV) – low platelet or red blood cell\ncounts, bruising, dizziness, headache, and diarrhea\n\n * for certain types of myelofibrosis (MF) – low platelet or red blood cell\ncounts, bruising, dizziness, headache, and diarrhea\n\n * for acute GVHD – low platelet counts, low red or white blood cell counts,\ninfections, and swelling\n\n * for chronic GVHD – low red blood cell or platelet counts and infections,\nincluding viral infections\n\nThese are not all the possible side effects. Ask your pharmacist or healthcare\nprovider for more information. Call your doctor for medical advice about side\neffects.\n\nBefore taking JAKAFI or JAKAFI XR, tell your healthcare provider about:\n\n\n * all the medications, vitamins, and herbal supplements you are taking\n\n * your medical conditions, including if you\n\n\n* have or had low white or red blood cell counts\n\n * have an infection\n\n * have or had tuberculosis (TB) or have been in close contact with someone who\nhas TB\n\n * had shingles (herpes zoster)\n\n * have or had hepatitis B\n\n * have a high level of fat in your blood (high blood cholesterol or\ntriglycerides)\n\n * have or have had a blood clot, heart attack, other heart problems, or stroke\n\n * are a current or past smoker\n\n * had cancer\n\n * have or had liver or kidney problems or are on dialysis. If you are on\ndialysis, JAKAFI or JAKAFI XR should be taken after your dialysis\n\n * have any other medical condition\n\n\n\n\nWomen should not take JAKAFI or JAKAFI XR while pregnant or planning to become\npregnant. Do not breastfeed during treatment with JAKAFI or JAKAFI XR and for\n2 weeks after the final dose.\n\nHow should I take JAKAFI or JAKAFI XR?\n\n\n * Take exactly as your healthcare provider tells you.\n\n * Do not change your dose or stop taking JAKAFI or JAKAFI XR without first\ntalking to your healthcare provider. If you stop treatment, symptoms of your\ncondition may return.\n\n * If you miss a dose, take your next dose at your regular time. Do NOT take 2\ndoses at the same time.\n\n * You may have regular blood tests during your treatment. Based on the results,\nyour healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.\n\n\n * IF YOU ARE PRESCRIBED JAKAFI:\n\n\n* Take JAKAFI 2 times a day or exactly as your healthcare provider tells you,\nwith or without food.\n\n * JAKAFI may also be given through certain nasogastric tubes.\n\n * Tell your healthcare provider if you cannot take JAKAFI by mouth. Your\nhealthcare provider will decide if you can take JAKAFI through a nasogastric\ntube. Ask your healthcare provider to give you specific instructions on how to\nproperly take JAKAFI through a nasogastric tube.\n\n\n\n\n * IF YOU ARE PRESCRIBED JAKAFI XR:\n\n\n* Take JAKAFI XR 1 time a day with or without food.\n\n * Swallow JAKAFI XR whole. Do not split, crush, or chew.\n\n\n\n\nPlease see the Full Prescribing Information, including Patient Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.jakafi.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Full+Prescribing+Information%2C+including+Patient+Information&index=2&md5=e819018215b4708789745187f6e940a5)\n, which includes a more complete discussion of the risks associated with\nJAKAFI or JAKAFI XR at Jakafi.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.jakafi.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Jakafi.com&index=3&md5=a45495275f57cb22b946c2f80c67bd65)\n.\n\nYou are encouraged to report negative side effects of prescription drugs to\nthe FDA. Visit www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=4&md5=a7d7385482bec91d1b7bdf8d28f498f1)\n, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical\nInformation at 1-855-463-3463.\n\nAbout Incyte(®\n\n)Incyte is redefining what’s possible in biopharmaceutical innovation.\nThrough deep scientific expertise and a relentless focus on patients, we have\nbuilt an established portfolio of first-in-class medicines and an extensive\nportfolio of next-generation medicines across our key franchises: Hematology,\nOncology and Inflammation and Autoimmunity.\n\nTo learn more, visit Incyte.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fincyte.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Incyte.com&index=5&md5=65e8f63941520aa3045c24a8a9eaf8da)\nand Investor.Incyte.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestor.incyte.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Investor.Incyte.com&index=6&md5=6272fdd7a774d1270763df2b6f350eba)\n. Follow us on social media: LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fincyte%2Fposts%2F%3FfeedView%3Dall&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=LinkedIn&index=7&md5=90b5a6d4cb43b7cbea806a5bf9f07ff2)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2FIncyte&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=X&index=8&md5=b4d0bb8f0779a029e3ed2000feb386c1)\nand Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fincyte%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Instagram&index=9&md5=734b316419994949a2fd2cc0884c3bea)\n.\n\nIncyte is a registered trademark of Incyte.\n\nForward-Looking Statements\n\nExcept for the historical information set forth herein, the matters set forth\nin this release, including statements regarding when Jakafi XR will be\navailable in pharmacies; Incyte’s leadership in hematology and its\ncommitment to supporting the MPN and GVHD communities, Incyte’s focus on\nadvancing innovative treatments that help address the needs of patients, the\npotential for Jakafi XR to provide a successful treatment option for patients\nand offer patients and their providers choice and flexibility and Incyte’s\nintent to work closely with payers and providers to help ensure access to\nJakafi XR, contain predictions, estimates, and other forward-looking\nstatements.\n\nThese forward-looking statements are based on Incyte’s current expectations\nand are subject to risks and uncertainties that may cause actual results to\ndiffer materially, including risks and uncertainties regarding research and\ndevelopment of products and product candidates, determinations made by the\nFDA, EMA and other regulatory agencies, Incyte’s dependence on its\nrelationships with and changes in the plans of its collaboration partners; the\nefficacy or safety of Incyte’s products, the acceptance of Incyte’s\nproducts in the marketplace; market competition, unexpected variations in the\ndemand for Incyte’s products; the effects of announced or unexpected price\nregulation or limitations on reimbursement or coverage for Incyte’s\nproducts, sales, marketing, manufacturing and distribution requirements,\nincluding Incyte’s ability to successfully commercialize and build\ncommercial infrastructure for newly approved products and any additional\nproducts that become approved; greater than expected expenses, including\nexpenses relating to litigation or strategic activities, variations in foreign\ncurrency exchange rates; and other risks detailed in Incyte’s reports filed\nwith the Securities and Exchange Commission, including its annual report on\nForm 10-K and its quarterly report on Form 10-Q for the quarter ended March\n31, 2026. Incyte disclaims any intent or obligation to update these\nforward-looking statements\n _________________________ \n (1 )Gong X, et al. ASH 2025. Poster 5045. \n (2) Data on File. Incyte Corporation. \n (3 )Blood Cancer United. Myelofibrosis (MF). \n https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/myelofibrosis-mf \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fmyelofibrosis-mf&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fmyelofibrosis-mf&index=10&md5=baca4d0a00f4153010103674b6e70e76) \n . Accessed May 2026. \n (4 )Blood Cancer United. Polycythemia vera (PV) \n https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/polycythemia-vera-pv \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fpolycythemia-vera-pv&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fpolycythemia-vera-pv&index=11&md5=b51057952a32216b8fa4a271f86828dd) \n . Accessed May 2026. \n (5 )National Library of Medicine. The European Blood and Marrow \n Transplantation Textbook for Nurses: Under the Auspices of EBMT. \n https://www.ncbi.nlm.nih.gov/books/NBK543657/ \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK543657%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK543657%2F&index=12&md5=ed4742e0d8f680b848388e81dc0c4f77) \n . Accessed May 2026. \n\n\n \n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260501334677/en/\n(https://www.businesswire.com/news/home/20260501334677/en/)\n\nMedia \n\nmedia@incyte.com (mailto:media@incyte.com)\n\nInvestors \n\nir@incyte.com (mailto:ir@incyte.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw9j5Cv1a","title":"Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease","author":"Business Wire","ticker":"INCY","created":"2026-05-01T21:28:00.102Z","tickers":["INCY"],"exchange":"NASDAQ","article_body":"Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release\nTablets for the Treatment of Myelofibrosis, Polycythemia Vera and\nGraft-Versus-Host Disease\n\n\n * Jakafi XR is a once-daily, film-coated, extended-release formulation of\nJakafi(®) (ruxolitinib)\n\n * Once-daily Jakafi XR was shown to provide consistent, day-long exposure\ncomparable to twice-daily Jakafi\n\n * Jakafi XR will be available for pharmacy orders by May 8\n\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug\nAdministration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release\ntablets for the treatment of adults with intermediate- or high-risk\nmyelofibrosis (MF); adults with polycythemia vera (PV) who have had an\ninadequate response to or are intolerant of hydroxyurea; as well as adults and\nchildren aged 12 years and older with steroid-refractory acute\ngraft-versus-host disease (GVHD) or chronic GVHD after failure of one or two\nlines of systemic therapy.\n\nThis press release features multimedia. View the full release here:\nhttps://www.businesswire.com/news/home/20260501334677/en/\n(https://www.businesswire.com/news/home/20260501334677/en/)\n\n“The approval of Jakafi XR reinforces Incyte’s leadership in hematology\nand our focus on meeting the evolving needs of patients with\nmyeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief\nExecutive Officer, Incyte. “Jakafi XR offers appropriate patients and\nphysicians a once-daily option, expanding choice without changing the\nwell-established role of Jakafi in clinical practice.”\n\nFDA approval was based on a clinical study which demonstrated that a single 55\nmg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg\nJakafi tablet, the immediate-release (IR) dosage form, taken twice-daily\n(BID). This means that, based on key measures of steady-state drug exposure,\nit delivers the same active ingredient at comparable levels throughout the\nday, indicating the potential for similar clinical benefit.(1)\n\nThe safety of Jakafi XR has been established from adequate and well-controlled\nstudies of Jakafi in adult patients with myelofibrosis, polycythemia vera, and\nadult and pediatric patients with acute and chronic graft-versus-host-disease.\nThe most common adverse reactions associated with Jakafi in these studies\ninclude:\n\n\n * For certain patients with MF and PV: low platelet or red blood cell counts,\nbruising, dizziness, headache and diarrhea;\n\n * For patients with acute GVHD: low platelet counts, low red or white blood cell\ncounts, infections and swelling;\n\n * And for patients with chronic GVHD: low red blood cell or platelet counts and\ninfections, including viral infections.(2)\n\n“Patients living with chronic conditions like MPNs and GVHD often struggle\nwith managing complex treatment regimens or have multiple conditions,” said\nNaveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine at\nThe University of Texas MD Anderson Cancer Center. “Since its initial\napproval in 2011, ruxolitinib has helped transform the treatment landscape for\npatients with MPNs and GVHD. With the approval of Jakafi XR, appropriate\npatients now have the choice of a single daily tablet.” Researchers at UT MD\nAnderson have led several clinical trials in the development of ruxolitinib.\n\nIncyte is committed to supporting patients and removing barriers to access\nmedicines. Eligible patients in the U.S. who are prescribed Jakafi XR have\naccess to IncyteCARES (Connecting to Access, Reimbursement, Education and\nSupport), a comprehensive program offering personalized patient support,\nincluding financial assistance and ongoing education and additional resources.\nMore information about IncyteCARES is available by visiting\nwww.incytecares.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.incytecares.com&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=www.incytecares.com&index=1&md5=588effbc24fae4ea7734ce43ee724ae0)\nor calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.\n\nAbout Myelofibrosis\n\nMyelofibrosis (MF) is a part of a group of rare, chronic blood cancers called\nmyeloproliferative neoplasms, or MPNs. MF occurs when a bone marrow defect\nresults in an abnormal production of blood cells, causing scar tissue to form,\nwhich can lead to severe anemia, weakness, fatigue and an enlarged spleen and\nliver. MF can result from a progression of other bone marrow diseases,\nincluding polycythemia vera and essential thrombocythemia, or it can occur on\nits own.(3)\n\nAbout Polycythemia Vera\n\nPolycythemia Vera (PV) is a part of a group of rare, chronic blood cancers\ncalled myeloproliferative neoplasms, or MPNs.(3) PV occurs when bone marrow\nproduces too many red blood cells, white blood cells and often platelets.\nIncreased red blood cells and platelets can cause the blood to thicken,\nleading to an increased risk of blood clotting complications, including deep\nvein thrombosis, stroke or heart attack.(4)\n\nAbout Graft-Versus-Host Disease\n\nGraft-versus-host disease (GVHD) is a condition that can occur after an\nallogeneic stem cell transplant (the transfer of stem cells from a donor) in\nwhich the donated cells initiate an immune response and attack the transplant\nrecipient’s organs, leading to significant morbidity and mortality. There\nare two major forms of GVHD: acute, which generally occurs within 100 days of\ntransplant, and chronic, which generally occurs after 100 days of transplant.\nBoth forms can affect multiple organ systems, including the skin,\ngastrointestinal (digestive) tract and liver.(5)\n\nAbout Jakafi XR™ (ruxolitinib) Extended-Release Tablets\n\nJakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD)\nformulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by\nthe U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis,\nincluding primary myelofibrosis, post-polycythemia vera myelofibrosis, and\npost-essential thrombocythemia myelofibrosis in adults; polycythemia vera in\nadults who have had an inadequate response to or are intolerant of\nhydroxyurea; steroid-refractory acute graft-versus-host disease in adult and\npediatric patients 12 years and older; and chronic graft-versus-host disease\nafter failure of one or two lines of systemic therapy in adult and pediatric\npatients 12 years and older.\n\nIt is not known if Jakafi XR is safe or effective in children for treatment of\nmyelofibrosis or polycythemia vera.\n\nJakafi XR and the Jakafi XR logo are trademarks of Incyte.\n\nAbout Jakafi(®) (ruxolitinib)\n\nJakafi(®) (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for\nthe treatment of polycythemia vera (PV) in adults who have had an inadequate\nresponse to or are intolerant of hydroxyurea; intermediate or high-risk\nmyelofibrosis (MF), including primary MF, post-polycythemia vera MF and\npost-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in\nadult and pediatric patients 12 years and older; and chronic GVHD after\nfailure of one or two lines of systemic therapy in adult and pediatric\npatients 12 years and older.\n\nIt is not known if Jakafi is safe or effective in children for treatment of\nmyelofibrosis or polycythemia vera.\n\nJakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi(®)\n(ruxolitinib) outside the U.S. Jakafi and the Jakafi logo are registered\ntrademarks of Incyte. Jakavi is a registered trademark of Novartis AG in\ncountries outside the United States.\n\nIMPORTANT SAFETY INFORMATION\n\nJAKAFI or JAKAFI XR can cause serious side effects, including:\n\nLow blood counts: JAKAFI or JAKAFI XR may cause low platelet, red blood cell,\nand white blood cell counts. If you develop bleeding, stop taking JAKAFI or\nJAKAFI XR and call your healthcare provider. Your healthcare provider will do\na blood test to check your blood counts before you start and regularly during\nyour treatment. Your healthcare provider may change your dose or stop your\ntreatment based on the results of your blood tests.\n\nTell your healthcare provider right away if you develop or have worsening\nsymptoms such as:\n\n\n * unusual bleeding\n\n * bruising\n\n * tiredness\n\n * shortness of breath\n\n * a fever\n\nInfection: You may be at risk for developing a serious infection during\ntreatment with JAKAFI or JAKAFI XR. Tell your healthcare provider if you\ndevelop any of the following symptoms of infection:\n\n\n * chills\n\n * nausea\n\n * vomiting\n\n * aches\n\n * weakness\n\n * fever\n\n * painful skin rash or blisters\n\nWorsening of symptoms after interrupting or stopping treatment. Signs and\nsymptoms of myelofibrosis may worsen after you stop treatment.\n\nDo not interrupt or stop treatment without talking to your healthcare\nprovider. Tell your healthcare provider right away if you have any of the\nfollowing after stopping treatment:\n\n\n * fever\n\n * trouble breathing\n\n * weakness\n\n * night sweats\n\n * feeling dizzy or lightheaded\n\n * pain in left upper stomach area or left shoulder\n\nCancer: Some people have had certain types of non-melanoma skin cancers during\ntreatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly\ncheck your skin during your treatment. Tell your healthcare provider if you\ndevelop any new or changing skin lesions during treatment.\n\nIncreases in cholesterol: You may have changes in your blood cholesterol\nlevels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider\nwill do blood tests to check your cholesterol levels about every 8 to 12 weeks\nafter you start taking JAKAFI or JAKAFI XR and as needed.\n\nIncreased risk of major cardiovascular events such as heart attack, stroke or\ndeath in people who have cardiovascular risk factors and who are current or\npast smokers while using another JAK inhibitor to treat rheumatoid arthritis:\n\nGet emergency help right away if you get any symptoms of a heart attack or\nstroke during treatment with JAKAFI or JAKAFI XR, including:\n\n\n * discomfort in the center of your chest that lasts for more than a few minutes\nor that goes away and comes back\n\n * severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or\njaw\n\n * pain or discomfort in your arms, back, neck, jaw, or stomach\n\n * shortness of breath with or without chest discomfort\n\n * breaking out in a cold sweat\n\n * nausea or vomiting\n\n * feeling lightheaded\n\n * weakness in one part or on one side of your body\n\n * slurred speech\n\nIncreased risk of blood clots: Blood clots in the veins of your legs (deep\nvein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in\npeople taking another JAK inhibitor for rheumatoid arthritis and may be\nlife-threatening.\n\nTell your healthcare provider right away if you have any signs and symptoms of\nblood clots during treatment with JAKAFI or JAKAFI XR, including:\n\n\n * swelling, pain, or tenderness in one or both legs\n\n * sudden, unexplained chest or upper back pain\n\n * shortness of breath or difficulty breathing\n\nPossible increased risk of new (secondary) cancers: People who take another\nJAK inhibitor for rheumatoid arthritis have an increased risk of new\n(secondary) cancers, including lymphoma and other cancers. People who smoke or\nwho smoked in the past have an added risk of new cancers.\n\nThe most common side effects of JAKAFI or JAKAFI XR include:\n\n\n * for certain types of polycythemia vera (PV) – low platelet or red blood cell\ncounts, bruising, dizziness, headache, and diarrhea\n\n * for certain types of myelofibrosis (MF) – low platelet or red blood cell\ncounts, bruising, dizziness, headache, and diarrhea\n\n * for acute GVHD – low platelet counts, low red or white blood cell counts,\ninfections, and swelling\n\n * for chronic GVHD – low red blood cell or platelet counts and infections,\nincluding viral infections\n\nThese are not all the possible side effects. Ask your pharmacist or healthcare\nprovider for more information. Call your doctor for medical advice about side\neffects.\n\nBefore taking JAKAFI or JAKAFI XR, tell your healthcare provider about:\n\n\n * all the medications, vitamins, and herbal supplements you are taking\n\n * your medical conditions, including if you\n\n\n* have or had low white or red blood cell counts\n\n * have an infection\n\n * have or had tuberculosis (TB) or have been in close contact with someone who\nhas TB\n\n * had shingles (herpes zoster)\n\n * have or had hepatitis B\n\n * have a high level of fat in your blood (high blood cholesterol or\ntriglycerides)\n\n * have or have had a blood clot, heart attack, other heart problems, or stroke\n\n * are a current or past smoker\n\n * had cancer\n\n * have or had liver or kidney problems or are on dialysis. If you are on\ndialysis, JAKAFI or JAKAFI XR should be taken after your dialysis\n\n * have any other medical condition\n\n\n\n\nWomen should not take JAKAFI or JAKAFI XR while pregnant or planning to become\npregnant. Do not breastfeed during treatment with JAKAFI or JAKAFI XR and for\n2 weeks after the final dose.\n\nHow should I take JAKAFI or JAKAFI XR?\n\n\n * Take exactly as your healthcare provider tells you.\n\n * Do not change your dose or stop taking JAKAFI or JAKAFI XR without first\ntalking to your healthcare provider. If you stop treatment, symptoms of your\ncondition may return.\n\n * If you miss a dose, take your next dose at your regular time. Do NOT take 2\ndoses at the same time.\n\n * You may have regular blood tests during your treatment. Based on the results,\nyour healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.\n\n\n * IF YOU ARE PRESCRIBED JAKAFI:\n\n\n* Take JAKAFI 2 times a day or exactly as your healthcare provider tells you,\nwith or without food.\n\n * JAKAFI may also be given through certain nasogastric tubes.\n\n * Tell your healthcare provider if you cannot take JAKAFI by mouth. Your\nhealthcare provider will decide if you can take JAKAFI through a nasogastric\ntube. Ask your healthcare provider to give you specific instructions on how to\nproperly take JAKAFI through a nasogastric tube.\n\n\n\n\n * IF YOU ARE PRESCRIBED JAKAFI XR:\n\n\n* Take JAKAFI XR 1 time a day with or without food.\n\n * Swallow JAKAFI XR whole. Do not split, crush, or chew.\n\n\n\n\nPlease see the Full Prescribing Information, including Patient Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.jakafi.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Full+Prescribing+Information%2C+including+Patient+Information&index=2&md5=e819018215b4708789745187f6e940a5)\n, which includes a more complete discussion of the risks associated with\nJAKAFI or JAKAFI XR at Jakafi.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.jakafi.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Jakafi.com&index=3&md5=a45495275f57cb22b946c2f80c67bd65)\n.\n\nYou are encouraged to report negative side effects of prescription drugs to\nthe FDA. Visit www.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=4&md5=a7d7385482bec91d1b7bdf8d28f498f1)\n, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical\nInformation at 1-855-463-3463.\n\nAbout Incyte(®\n\n)Incyte is redefining what’s possible in biopharmaceutical innovation.\nThrough deep scientific expertise and a relentless focus on patients, we have\nbuilt an established portfolio of first-in-class medicines and an extensive\nportfolio of next-generation medicines across our key franchises: Hematology,\nOncology and Inflammation and Autoimmunity.\n\nTo learn more, visit Incyte.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fincyte.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Incyte.com&index=5&md5=65e8f63941520aa3045c24a8a9eaf8da)\nand Investor.Incyte.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestor.incyte.com%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Investor.Incyte.com&index=6&md5=6272fdd7a774d1270763df2b6f350eba)\n. Follow us on social media: LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fincyte%2Fposts%2F%3FfeedView%3Dall&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=LinkedIn&index=7&md5=90b5a6d4cb43b7cbea806a5bf9f07ff2)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2FIncyte&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=X&index=8&md5=b4d0bb8f0779a029e3ed2000feb386c1)\nand Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fincyte%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=Instagram&index=9&md5=734b316419994949a2fd2cc0884c3bea)\n.\n\nIncyte is a registered trademark of Incyte.\n\nForward-Looking Statements\n\nExcept for the historical information set forth herein, the matters set forth\nin this release, including statements regarding when Jakafi XR will be\navailable in pharmacies; Incyte’s leadership in hematology and its\ncommitment to supporting the MPN and GVHD communities, Incyte’s focus on\nadvancing innovative treatments that help address the needs of patients, the\npotential for Jakafi XR to provide a successful treatment option for patients\nand offer patients and their providers choice and flexibility and Incyte’s\nintent to work closely with payers and providers to help ensure access to\nJakafi XR, contain predictions, estimates, and other forward-looking\nstatements.\n\nThese forward-looking statements are based on Incyte’s current expectations\nand are subject to risks and uncertainties that may cause actual results to\ndiffer materially, including risks and uncertainties regarding research and\ndevelopment of products and product candidates, determinations made by the\nFDA, EMA and other regulatory agencies, Incyte’s dependence on its\nrelationships with and changes in the plans of its collaboration partners; the\nefficacy or safety of Incyte’s products, the acceptance of Incyte’s\nproducts in the marketplace; market competition, unexpected variations in the\ndemand for Incyte’s products; the effects of announced or unexpected price\nregulation or limitations on reimbursement or coverage for Incyte’s\nproducts, sales, marketing, manufacturing and distribution requirements,\nincluding Incyte’s ability to successfully commercialize and build\ncommercial infrastructure for newly approved products and any additional\nproducts that become approved; greater than expected expenses, including\nexpenses relating to litigation or strategic activities, variations in foreign\ncurrency exchange rates; and other risks detailed in Incyte’s reports filed\nwith the Securities and Exchange Commission, including its annual report on\nForm 10-K and its quarterly report on Form 10-Q for the quarter ended March\n31, 2026. Incyte disclaims any intent or obligation to update these\nforward-looking statements\n _________________________ \n (1 )Gong X, et al. ASH 2025. Poster 5045. \n (2) Data on File. Incyte Corporation. \n (3 )Blood Cancer United. Myelofibrosis (MF). \n https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/myelofibrosis-mf \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fmyelofibrosis-mf&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fmyelofibrosis-mf&index=10&md5=baca4d0a00f4153010103674b6e70e76) \n . Accessed May 2026. \n (4 )Blood Cancer United. Polycythemia vera (PV) \n https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/polycythemia-vera-pv \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fpolycythemia-vera-pv&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fbloodcancerunited.org%2Fblood-cancer%2Fmyeloproliferative-neoplasms-mpns%2Fpolycythemia-vera-pv&index=11&md5=b51057952a32216b8fa4a271f86828dd) \n . Accessed May 2026. \n (5 )National Library of Medicine. The European Blood and Marrow \n Transplantation Textbook for Nurses: Under the Auspices of EBMT. \n https://www.ncbi.nlm.nih.gov/books/NBK543657/ \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK543657%2F&esheet=54527308&newsitemid=20260501334677&lan=en-US&anchor=https%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fbooks%2FNBK543657%2F&index=12&md5=ed4742e0d8f680b848388e81dc0c4f77) \n . Accessed May 2026. \n\n\n \n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260501334677/en/\n(https://www.businesswire.com/news/home/20260501334677/en/)\n\nMedia \n\nmedia@incyte.com (mailto:media@incyte.com)\n\nInvestors \n\nir@incyte.com (mailto:ir@incyte.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-05-01T21:28:00.159096042Z","server_sent_at_ms":1777670880159},"received_at":"2026-05-01T21:28:00.314Z","source_url":"https://www.businesswire.com/news/home/20260501334677/en/"},"analysis":{"id":"12919","press_release_id":"17645","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"Incyte announced FDA approval of Jakafi XR, a once-daily extended-release formulation of ruxolitinib, for myelofibrosis, polycythemia vera, and graft-versus-host disease.\n\nThe approval is supported by clinical data showing that a single 55 mg Jakafi XR tablet taken once daily is bioequivalent to the standard 25 mg twice-daily dosage.\n\nJakafi XR will be available for pharmacy orders by May 8, providing patients with a more convenient dosing option while maintaining the established efficacy of the original formulation.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Incyte secures FDA approval for once-daily Jakafi XR, extending the lifecycle of its flagship hematology franchise."},"keyFigures":{"drugName":"Jakafi XR (ruxolitinib)","customDimensions":{"bioequivalence":"55 mg Jakafi XR QD bioequivalent to 25 mg Jakafi BID","availabilityDate":"May 8"}},"quotedText":"The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD","namedEntities":{"people":[{"name":"Bill Meury","role":"Chief Executive Officer"},{"name":"Naveen Pemmaraju","role":"Professor of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center"}],"products":["Jakafi XR","Jakafi","ruxolitinib","Jakavi","IncyteCARES"],"companies":[{"name":"Incyte","ticker":"INCY"},{"name":"Novartis AG","relationship":"partner"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"The University of Texas MD Anderson Cancer Center","relationship":"research institution"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"FDA approval of a new extended-release formulation (Jakafi XR) for Incyte's flagship drug Jakafi. While a significant lifecycle management event that expands patient choice and convenience, it is an incremental improvement to an existing product rather than a first-in-class binary event."},"tickerRelevance":{"others":[],"primary":"INCY"},"globalImportance":45,"audienceRelevance":55,"eventTypeSecondary":["product_launch"],"importanceComponents":{"tickerTier":"mid-to-large cap biopharma","eventGravity":"established drug line extension","franchiseValue":"high (Jakafi is key revenue driver)"}},"event_type":"fda_approval","event_type_secondary":["product_launch"],"sentiment":"bullish","material_impact_score":4,"narrative":"Incyte announced FDA approval of Jakafi XR, a once-daily extended-release formulation of ruxolitinib, for myelofibrosis, polycythemia vera, and graft-versus-host disease.\n\nThe approval is supported by clinical data showing that a single 55 mg Jakafi XR tablet taken once daily is bioequivalent to the standard 25 mg twice-daily dosage.\n\nJakafi XR will be available for pharmacy orders by May 8, providing patients with a more convenient dosing option while maintaining the established efficacy of the original formulation.","key_figures":{"drugName":"Jakafi XR (ruxolitinib)","customDimensions":{"bioequivalence":"55 mg Jakafi XR QD bioequivalent to 25 mg Jakafi BID","availabilityDate":"May 8"}},"named_entities":{"people":[{"name":"Bill Meury","role":"Chief Executive Officer"},{"name":"Naveen Pemmaraju","role":"Professor of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center"}],"products":["Jakafi XR","Jakafi","ruxolitinib","Jakavi","IncyteCARES"],"companies":[{"name":"Incyte","ticker":"INCY"},{"name":"Novartis AG","relationship":"partner"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"The University of Texas MD Anderson Cancer Center","relationship":"research institution"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:a2703c5a1b5285fe","schema_hash":"sha256:1f8af1196c7db48c","created_at":"2026-05-01T21:29:53.727Z","global_importance":45,"audience_relevance":55,"importance_components":{"tickerTier":"mid-to-large cap biopharma","eventGravity":"established drug line extension","franchiseValue":"high (Jakafi is key revenue driver)"}},"durationMs":113034,"modelName":"glm-4.7"}}