{"id":3583,"date":"2012-10-16T20:22:53","date_gmt":"2012-10-17T00:22:53","guid":{"rendered":"https:\/\/cablemanpro.com\/wallstreetpr\/?p=3583"},"modified":"2012-10-16T21:23:40","modified_gmt":"2012-10-17T01:23:40","slug":"egyptians-revere-isis-investors-not-so-much-isis","status":"publish","type":"post","link":"https:\/\/cablemanpro.com\/wallstreetpr\/egyptians-revere-isis-investors-not-so-much-isis-3583","title":{"rendered":"Egyptians Revere Isis, Investors Not So Much (ISIS)"},"content":{"rendered":"<p>Shares of Isis Pharmaceuticals (NASDAQ: ISIS) fell off the proverbial cliff today as shares plummeted to $10.27, a loss of $2.88 per share or 21.9% percent.<\/p>\n<p>The reason for the loss was one-fold as the United States Food and Drug Administration expressed a <a href=\"http:\/\/finance.yahoo.com\/news\/isis-pharma-tumbles-kynamro-cancer-173425887.html\">number of concerns<\/a> regarding the company\u2019s key drug, Kynamro. The FDA expressed a number of serious cancer concerns for patients with homozygous familial hypercholesterolemia, a genetic disorder that causes patients to experience abnormally high levels of &#8220;bad&#8221; LDL cholesterol.<\/p>\n<p>The endocrinology drug committee of the FDA seems to have some real concerns for both Isis Pharmaceuticals and its partner in Kynamro, Genzyme. Genzyme is a division of French pharmaceutical company Sanofi (NYSE: SNY). The committee said that Kynamro was linked to both benign and cancerous tumors: 3.1% of patients, or 23 people treated with the drug, developed tumors in clinical trials compared to two patients treated with a placebo during those studies, or 0.9%.<\/p>\n<p>Fears of cancer from the use of Kynamro, or mipomersen, should not be viewed as entirely shocking to investors, employees of Isis Pharmaceuticals or the Food and Drug Administration. The panel\u2019s report also included documents that showed that cancers were seen in preclinical studies on mice, including liver cancers and hemangiosarcomas, or cancers of blood vessel cells.<\/p>\n<p>While perhaps not an \u201cout-of-the-blue\u201d surprise, today\u2019s announcement was enough to pound the stock over the course of today\u2019s trading.<\/p>\n<p>The Carlsbad, California-based company relies almost exclusively on development partnerships in Kynamro to enjoy a healthy revenue stream. Today\u2019s report suggests that this may turn out to no longer be a healthy revenue stream, but a carcinogenic one.<\/p>\n<p>Following the committee\u2019s announcement, Isis and Genzyme both posted their prepared questions for the FDA on the agency\u2019s website in a hope to avoid a scare, and also to prepare for Thursday\u2019s conversation with the FDA regarding the concerns it raised.<\/p>\n<p>The panel also pointed out that three people died during the clinical trials: Two died from heart attacks and the third from liver failure. While Isis will certainly point out that the patient who died of liver failure also had a number of other health concerns, the FDA parried this potential argument with &#8220;the potential for a contributing effect of mipomersen cannot be ruled out.&#8221;<\/p>\n<p>Jefferies &amp; Co. analyst <a href=\"http:\/\/finance.yahoo.com\/news\/isis-pharma-tumbles-kynamro-cancer-173425887.html\">Eun Yang<\/a> said the disclosure about tumors was &#8220;quite surprising.&#8221; Yang continued with the suggestion that, in all likelihood, the drug will not be approved in the United States. Even if Kynamro is approved, it will likely be heavily limited in its approved uses given the side effects and the large number of patients who dropped out of the clinical trials.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Shares of Isis Pharmaceuticals (NASDAQ: ISIS) fell off the proverbial cliff today as shares plummeted to $10.27, a loss of $2.88 per share or 21.9% [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3587,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"twitter_2902945987_2902945987":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[261,264,4],"tags":[462,138],"stock_ticker":[],"class_list":["post-3583","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-decliners","category-health","category-nasdaq-high-profiles","tag-isis","tag-sny","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - 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