{"id":815393,"date":"2025-02-20T07:03:38","date_gmt":"2025-02-20T12:03:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/new-positive-donidalorsen-data-to-be-presented-at-aaaai-wao-joint-congress-highlight-sustained-hae-attack-rate-reduction-and-disease-control\/"},"modified":"2025-02-20T07:03:38","modified_gmt":"2025-02-20T12:03:38","slug":"new-positive-donidalorsen-data-to-be-presented-at-aaaai-wao-joint-congress-highlight-sustained-hae-attack-rate-reduction-and-disease-control","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/new-positive-donidalorsen-data-to-be-presented-at-aaaai-wao-joint-congress-highlight-sustained-hae-attack-rate-reduction-and-disease-control\/","title":{"rendered":"New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistcircle { list-style-type: circle }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control<\/b><\/p>\n<p class=\"bwalignc\"><b>\u2013 Data also show significant and clinically meaningful improvements in quality-of-life measures in new analyses from Phase 3 and Phase 2 clinical program \u2013<\/b><\/p>\n<p class=\"bwalignc\"><b>\u2013With a PDUFA date of August 21, 2025, donidalorsen positioned to be Ionis\u2019 second independent commercial launch \u2013<\/b><\/p>\n<p>CARLSBAD, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ionis.com%2F&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=Ionis+Pharmaceuticals%2C+Inc.&amp;index=1&amp;md5=5fbfedb7cb527dfb8a8197e51bbc68b2\">Ionis Pharmaceuticals, Inc.<\/a> (Nasdaq: IONS) today announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three year data from the Phase 2 open-label extension (OLE) study of donidalorsen, the company\u2019s investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE). Results will be presented at the 2025 American Academy of Allergy, Asthma &amp; Immunology (AAAAI) \/ World Allergy Organization (WAO) Joint Congress in San Diego, California.\n<\/p>\n<p>\nThe New Drug Application (NDA) for donidalorsen to prevent attacks of HAE in adult and pediatric patients 12 years of age and older is currently under review with the U.S. Food and Drug Administration (FDA), with a target action date of August 21, 2025.\n<\/p>\n<p>\n\u201cWhile there\u2019s been notable advancement in the HAE treatment landscape, there is still an urgent need for a medicine that effectively reduces attacks, is well tolerated and simple to administer. Across the breadth of presentations at the congress, we believe the totality of the clinical evidence underscores the potential of donidalorsen to be the prophylactic treatment of choice for people living with HAE,\u201d said Kenneth Newman, M.D., senior vice president, head of clinical development, Ionis. \u201cIn new analyses from our OASISplus prospective switch cohort, donidalorsen continued to demonstrate the ability to reduce the HAE attack rate burden and improve quality of life in patients previously on other prophylactic treatments, with the simplicity of monthly or every two-month self-administration via an autoinjector. As a first-in-class RNA-targeted medicine, we believe donidalorsen has the potential to advance the prophylactic treatment paradigm for HAE.\u201d\n<\/p>\n<p>\nIonis will have 11 presentations, as follows:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li><b>Efficacy and Safety of Donidalorsen In Adolescent Patients with Hereditary Angioedema: A Subanalysis of the Phase 3 OASIS-HAE Study<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nFeatured Poster Presentation: March 2, 3:30-5:00pm PT (Poster 890)\n<\/li>\n<li>\nPresenting Author: Joshua Jacobs\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Hereditary Angioedema Disease Control after Switching to Donidalorsen from Prior Long-Term Prophylaxis: Results from the OASISplus Open-Label Extension Study<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 601)\n<\/li>\n<li>\nPresenting Author: Marc Reidl\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Improvements in Quality-of-Life in Patients with HAE Receiving Donidalorsen: Post Hoc Analysis from the OASIS-HAE Study<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 648)\n<\/li>\n<li>\nPresenting Author: Danny Cohn\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Patient-Reported Injection-Site Pain and Treatment Satisfaction after Switching from Long-Term Prophylaxis to Donidalorsen for the Treatment of Hereditary Angioedema: Results from the OASISplus Study<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 599)\n<\/li>\n<li>\nPresenting Author: Marc Reidl\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Psychometric Validation of Angioedema Quality-of-Life Questionnaire in Hereditary Angioedema: Results from the OASIS-HAE Study<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: February 28, 2025, 2:45-3:45pm PT (Poster 216)\n<\/li>\n<li>\nPresenting Author: Aaron Yarlas\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Long-Term Analysis of the Phase 2 Open-Label Extension of Donidalorsen in Patients With Hereditary Angioedema<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 654)\n<\/li>\n<li>\nPresenting Author: Michael Manning\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Correlation between Subjective and Objective Disease Control in Hereditary Angioedema: Association between the Angioedema Control Test and Attack Rate<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 647)\n<\/li>\n<li>\nPresenting Author: Danny Cohn\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Long-Term Prophylaxis for Hereditary Angioedema: Real-World Experience in Selected US Allergy Clinics<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 739)\n<\/li>\n<li>\nPresenting Author: Huamin Henry Li\n<\/li>\n<\/ul>\n<\/li>\n<li><b>The Patient Experience of Hereditary Angioedema: Findings from a Racially Diverse Sample of Adult Patients<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: February 28, 2025, 2:45-3:45pm PT (Poster 215)\n<\/li>\n<li>\nPresenting Author: Aaron Yarlas\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Patient Preferences for Attributes of Prophylactic Treatment in Hereditary Angioedema: A Discrete-Choice Experiment<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 696)\n<\/li>\n<li>\nPresenting Author: Kathleen Villa\n<\/li>\n<\/ul>\n<\/li>\n<li><b>Participant Reported Ease-of-Use with a Prefilled, Single-dose, Disposable Autoinjector for the Treatment of Hereditary Angioedema<\/b>\n<ul class=\"bwlistcircle\">\n<li>\nPoster Presentation: March 2, 2025, 9:45-10:45am PT (Poster 699)\n<\/li>\n<li>\nPresenting Author: Hetal Khatri\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>\nIonis previously <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fir.ionis.com%2Fnews-releases%2Fnews-release-details%2Fionis-presents-positive-results-oasis-hae-and-oasisplus-studies&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=reported&amp;index=2&amp;md5=477e16743461d3ccf8dd1e0cb2bded13\">reported<\/a> positive results from the Phase 3 OASIS-HAE and OASISplus studies. Data from both studies were first presented at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Valencia, Spain, and results from OASIS-HAE were published in <i>The New England Journal of Medicine<\/i>.\n<\/p>\n<p><b>About Hereditary Angioedema (HAE)<\/b><\/p>\n<p>\nHAE is a rare and potentially life-threatening genetic condition that involves recurrent attacks of severe swelling (angioedema) in various parts of the body, including the hands, feet, genitals, stomach, face and\/or throat. HAE is estimated to affect more than 20,000 people in the U.S. and Europe. In the U.S., doctors frequently use prophylactic treatment approaches to prevent and reduce the severity of HAE attacks in patients.\n<\/p>\n<p><b>About Donidalorsen<\/b><\/p>\n<p>\nDonidalorsen is an investigational RNA-targeted medicine designed to target prekallikrein (PKK), which plays an important role in activating inflammatory mediators associated with acute attacks of hereditary angioedema (HAE). By reducing the production of PKK, donidalorsen could be an effective prophylactic approach to preventing HAE attacks, if approved.\n<\/p>\n<p>\nDonidalorsen is an investigational medicine that has not been approved for the treatment of any disease by regulatory authorities.\n<\/p>\n<p><b>About Ionis Pharmaceuticals, Inc.<\/b><\/p>\n<p>\nFor three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has six marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ionis.com%2F&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=Ionis.com&amp;index=3&amp;md5=0e9b73ddf60ae014a800d3a1837f1bc7\">Ionis.com<\/a> and follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fx.com%2Fionispharma&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=X+%28Twitter%29&amp;index=4&amp;md5=7da3fb5d061fc028f2613316cbb63d46\">X (Twitter)<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fionis-pharmaceuticals&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=5&amp;md5=96ad2d5b1a46f331778b235a734200cd\">LinkedIn<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Fionis_pharma%2F&amp;esheet=54210375&amp;newsitemid=20250219736352&amp;lan=en-US&amp;anchor=Instagram&amp;index=6&amp;md5=02aa47d38a4a197b674982fea01916ab\">Instagram<\/a>.\n<\/p>\n<p><b>Ionis Forward-looking Statements<\/b><\/p>\n<p>\nThis press release includes forward-looking statements regarding Ionis&#8217; business and the therapeutic and commercial potential of our commercial medicines, donidalorsen, additional medicines in development and technologies. Any statement describing Ionis&#8217; goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis&#8217; forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis&#8217; forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis&#8217; programs are described in additional detail in Ionis&#8217; annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.\n<\/p>\n<p>\nIn this press release, unless the context requires otherwise, &#8220;Ionis,&#8221; &#8220;Company,&#8221; &#8220;we,&#8221; &#8220;our&#8221; and &#8220;us&#8221; all refer to Ionis Pharmaceuticals and its subsidiaries.\n<\/p>\n<p>\nIonis Pharmaceuticals<sup>\u00ae<\/sup> is a registered trademark of Ionis Pharmaceuticals, Inc.\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250219736352r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250219736352\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250219736352\/en\/<\/a><\/span><\/p>\n<p><b>Ionis Investor Contact:<br \/>\n<\/b><br \/>D. Wade Walke, Ph.D.<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:IR@ionis.com\">IR@ionis.com<br \/>\n<\/a><br \/>760-603-2331\n<\/p>\n<p><b>Ionis Media Contact:<br \/>\n<\/b><br \/>Hayley Soffer<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:media@ionis.com\">media@ionis.com<br \/>\n<\/a><br \/>760-603-4679\n<\/p>\n<p><b>KEYWORDS:<\/b> United States North America California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Health FDA Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250219736352\/en\/2366088\/3\/Ionis_Logo_RGB.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control \u2013 Data also show significant and clinically meaningful improvements in quality-of-life measures in new analyses from Phase 3 and Phase 2 clinical program \u2013 \u2013With a PDUFA date of August 21, 2025, donidalorsen positioned to be Ionis\u2019 second independent commercial launch \u2013 CARLSBAD, Calif.&#8211;(BUSINESS WIRE)&#8211;Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three year data from the Phase 2 open-label extension (OLE) study of donidalorsen, the company\u2019s investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE). Results will be presented at the 2025 American &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/new-positive-donidalorsen-data-to-be-presented-at-aaaai-wao-joint-congress-highlight-sustained-hae-attack-rate-reduction-and-disease-control\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-815393","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/new-positive-donidalorsen-data-to-be-presented-at-aaaai-wao-joint-congress-highlight-sustained-hae-attack-rate-reduction-and-disease-control\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"New positive donidalorsen data to be presented at AAAAI\/WAO Joint Congress highlight sustained HAE attack rate reduction and disease control \u2013 Data also show significant and clinically meaningful improvements in quality-of-life measures in new analyses from Phase 3 and Phase 2 clinical program \u2013 \u2013With a PDUFA date of August 21, 2025, donidalorsen positioned to be Ionis\u2019 second independent commercial launch \u2013 CARLSBAD, Calif.&#8211;(BUSINESS WIRE)&#8211;Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it will present additional data from the pivotal Phase 3 OASIS and OASISplus studies, as well as three year data from the Phase 2 open-label extension (OLE) study of donidalorsen, the company\u2019s investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE). 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