{"id":298365,"date":"2026-02-19T02:01:13","date_gmt":"2026-02-19T02:01:13","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/298365\/"},"modified":"2026-02-19T02:01:13","modified_gmt":"2026-02-19T02:01:13","slug":"fda-accepts-bms-protein-degrader-for-review-disc-rare-disease-drug-rejected","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/298365\/","title":{"rendered":"FDA accepts BMS protein degrader for review; Disc rare disease drug rejected"},"content":{"rendered":"\n

This story was originally published on BioPharma Dive<\/a>. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter<\/a>. <\/p>\n

Today, a brief rundown of news from Bristol Myers Squibb and Cytokinetics as well as updates from Disc Medicine and Teva Pharmaceutical that you may have missed.<\/p>\n

The Food and Drug Administration has accepted Bristol Myers Squibb\u2019s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday<\/a>. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson\u2019s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment. In a Phase 3 trial, iberdomide plus Darzalex and dexamethasone helped significantly more people<\/a> with multiple myeloma become \u201cminimal residual disease negative\u201d compared to older combination treatment. Iberdomide\u2019s progress is one of the most important events in Bristol Myers\u2019 year as it tries to shake off a 2025 that included a round of cost cuts and clinical setbacks. \u2014 Jonathan Gardner<\/p>\n

Meanwhile, the FDA rejected Disc Medicine\u2019s application for accelerated approval of bitopertin,\u00a0the company said last Friday, though it indicated that it could evaluate data from a Phase 3 study<\/a> of the drug for the rare disease erythropoietic protoporphyria in a traditional setting. In a complete response letter<\/a>, the FDA wrote that two trials of bitopertin confirmed the drug\u2019s benefit in lowering levels of protoporphyrin IX, a substance that builds up in the red blood cells of people with EPP and causes extreme sensitivity to light. However, the agency wrote there are \u201cuncertainties\u201d regarding whether lower levels of protoporphyrin IX correlated to meeting sunlight exposure endpoints laid out in one of Disc\u2019s studies. The company received a \u201cnational priority\u201d voucher<\/a> last fall to speed up its review, though a report published by Stat News<\/a>\u00a0in the months following revealed skepticism over the drug\u2019s efficacy from Center for Biologics Evaluation and Research Director Vinay Prasad.\u00a0\u2014 Gwendolyn Wu<\/p>\n

The European Commission has approved Cytokinetics\u2019 pill Myqorzo to treat the heart condition obstructive hypertrophic cardiomyopathy, the company said Tuesday<\/a>. The approval for the 27 member countries of the European Union follows its U.S. OK by about two months. In the EU, Myqorzo could have some advantages over Bristol Myers\u2019\u00a0competing drug Camzyos, including more flexible dosing and no requirement for genotyping,\u00a0Stifel analyst James Condulis wrote in a note to clients. Camzyos, from the same class of drugs called cardiac myosin inhibitors, recorded sales of $1.1 billion in 2025, with its international sales growth outpacing that in the U.S.\u00a0\u2014 Jonathan Gardner<\/p>\n

Sanofi and Teva Pharmaceutical said their experimental antibody drug for ulcerative colitis and Crohn\u2019s disease, duvakitug, maintained its efficacy<\/a> over 44 weeks in the long-term extension stage of a Phase 2 trial. Remission and response rates for the high dose of 900 milligrams improved at the 44-week endpoint for both conditions compared with those seen at the main, 14-week endpoint, Jefferies analyst Dennis Ding wrote in a note to clients. That response rate compares favorably to competing drugs from the TL1A class being developed by Merck & Co. and Roche, Ding wrote. Merck and Roche have advanced their drugs into Phase 3 development.\u00a0\u2014 Jonathan Gardner<\/p>\n","protected":false},"excerpt":{"rendered":"This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free…\n","protected":false},"author":2,"featured_media":229778,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[25757,150880,11770,163,85,46,4272,150879,482,150881,69606,150882],"class_list":{"0":"post-298365","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-bristol-myers-squibb","9":"tag-combination-treatment","10":"tag-food-and-drug-administration","11":"tag-health","12":"tag-il","13":"tag-israel","14":"tag-johnson-johnson","15":"tag-jonathan-gardner","16":"tag-medication","17":"tag-minimal-residual-disease","18":"tag-multiple-myeloma","19":"tag-protoporphyrin-ix"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/298365","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=298365"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/298365\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/229778"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=298365"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=298365"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=298365"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}