{"id":517182,"date":"2021-07-23T16:30:20","date_gmt":"2021-07-23T20:30:20","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gainey-mckenna-egleston-announces-a-class-action-lawsuit-has-been-filed-against-cormedix-inc-crmd\/"},"modified":"2021-07-23T16:30:20","modified_gmt":"2021-07-23T20:30:20","slug":"gainey-mckenna-egleston-announces-a-class-action-lawsuit-has-been-filed-against-cormedix-inc-crmd","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gainey-mckenna-egleston-announces-a-class-action-lawsuit-has-been-filed-against-cormedix-inc-crmd\/","title":{"rendered":"Gainey McKenna &amp; Egleston Announces a Class\u00a0Action Lawsuit Has Been Filed Against CorMedix Inc. (CRMD)"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">NEW YORK, July  23, 2021  (GLOBE NEWSWIRE) &#8212; Gainey McKenna &amp; Egleston announces that a class action lawsuit has been filed against CorMedix Inc. (\u201cCorMedix\u201d or the \u201cCompany\u201d) (NASDAQ: CRMD) in the United States District Court for the District of New Jersey on behalf of those who purchased or otherwise acquired CorMedix publicly traded securities between July 8, 2020 and May 13, 2021, inclusive (the \u201cClass Period\u201d).<\/p>\n<p align=\"justify\">The Complaint alleges that Defendants made material misrepresentations concerning the following: (1) deficiencies existed with respect to DefenCath\u2019s manufacturing process and\/or at the facility responsible for manufacturing DefenCath; (2) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form; (3) Defendants had downplayed the true scope of the deficiencies with DefenCath\u2019s manufacturing process and\/or at the facility responsible for manufacturing DefenCath; and (4) as a result, the Company\u2019s public statements were materially false and misleading at all relevant times.<\/p>\n<p align=\"justify\">On March 1, 2021, CorMedix issued a press release \u201cannounc[ing] that the [FDA] cannot approve the [NDA] for DefenCath . . . in its present form.\u201d CorMedix informed investors that the \u201cFDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility\u201d; that the \u201cFDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns\u201d; that, \u201c[w]hen we are informed of the issues, we will schedule an investor conference call to provide an update on our expected timeline for resolution\u201d; and that, \u201c[a]dditionally, FDA is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.\u201d On this news, CorMedix\u2019s stock price fell $5.98 per share, or 39.87%, to close at $9.02 per share on March 1, 2021.<\/p>\n<p align=\"justify\">Then, on April 14, 2021, Defendants announced that CorMedix would have to take additional steps to meet the FDA\u2019s requirements for DefenCath\u2019s manufacturing process, including \u201c[a]ddressing FDA\u2019s concerns regarding the qualification of the filling operation [that] may necessitate adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath.\u201d On this news, CorMedix\u2019s stock price fell $1.44 per share, or 15.37%, to close at $7.93 per share on April 14, 2021.<\/p>\n<p align=\"justify\">Finally, on May 13, 2021, CorMedix announced that \u201c[b]ased on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.\u201d After an analyst pressed for clearer information on DefenCath\u2019s manufacturing deficiencies on a conference call held that same day, Phoebe Mounts, CorMedix\u2019s Executive Vice President and General Counsel, finally disclosed, inter alia, that \u201cthere are times when there may be unexpected results obtained\u201d; that the FDA \u201cexpect[s] us to generate sufficient data to demonstrate that [the filling] process is a controlled process and is consistent with the agency\u2019s requirements for good manufacturing practice\u201d; that \u201csterility is a very important part of that process,\u201d as well as \u201cthe accuracy in making sure the right volume of DEFENCATH is loaded into the vials\u201d; that \u201cwe are talking about thousands of vials during the manufacturing run\u201d; that Defendant must \u201cgenerat[e] of a lot of data to make sure that . . . all the equipment has been qualified for the intended use and every step in the manufacturing process has been qualified\u201d; that \u201cth[e] process needs to be very robust, [and] needs to be reproducible\u201d; and that \u201cthe burden is on the manufacturer to demonstrate that the facility can do that process reducibly and generate the required product for commercial distribution.\u201d On this news, CorMedix\u2019s stock price fell $1.51 per share, or 19.97%, to close at $6.05 per share on May 14, 2021.<\/p>\n<p align=\"justify\">Investors who purchased or otherwise acquired shares of CorMedix during the Class Period should contact the Firm<strong><em> prior to the September 20, 2021 <\/em><\/strong>lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.\u00a0 If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna &amp; Egleston at (212) 983-1300, or via e-mail at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ffRyRGKRUF2fP1Jf08plYEZ3Du5WLbbRYFLl3ixbAGL-FZ64Y4G-wM-FOxMlhzvOtZirOieqWo0ijHKU-ZQZQUC8oRl-y0fK2T6lqc8HH8I=\" rel=\"nofollow noopener\" target=\"_blank\"><u>tjmckenna@gme-law.com<\/u><\/a> or <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=bwgshZZujsHxYC5gtmnj10E5VBTq7EQpQRZ3I69xbYSRvtj7CAk408ces58PWJGxBIMyAZmINPoYUfbBYdMg0QsasswnvVdvS8pqwJ6Fjys=\" rel=\"nofollow noopener\" target=\"_blank\"><u>gegleston@gme-law.com<\/u><\/a>.<\/p>\n<p align=\"justify\">Please visit our website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=h9qjMPRmAkZwYVd645KGPKB852XlqYMULUHnEXk3HvnMfsNIuk6K_8xSdY9f4QQMzlbKjFvD2LJV9kyqp_cydSqKcRFJ_IJh2-xhv7j5kaw=\" rel=\"nofollow noopener\" target=\"_blank\"><u>http:\/\/www.gme-law.com<\/u><\/a> for more information about the firm.\u00a0<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODI4NTk2OSM0MzEyNjM4IzIwMTc3MDQ=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/4624c85b-f2aa-4ae2-b197-c3b2c730b6eb\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) &#8212; Gainey McKenna &amp; Egleston announces that a class action lawsuit has been filed against CorMedix Inc. (\u201cCorMedix\u201d or the \u201cCompany\u201d) (NASDAQ: CRMD) in the United States District Court for the District of New Jersey on behalf of those who purchased or otherwise acquired CorMedix publicly traded securities between July 8, 2020 and May 13, 2021, inclusive (the \u201cClass Period\u201d). The Complaint alleges that Defendants made material misrepresentations concerning the following: (1) deficiencies existed with respect to DefenCath\u2019s manufacturing process and\/or at the facility responsible for manufacturing DefenCath; (2) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form; (3) Defendants had &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/gainey-mckenna-egleston-announces-a-class-action-lawsuit-has-been-filed-against-cormedix-inc-crmd\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Gainey McKenna &amp; Egleston Announces a Class\u00a0Action Lawsuit Has Been Filed Against CorMedix Inc. (CRMD)&#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-517182","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Gainey McKenna &amp; Egleston Announces a Class\u00a0Action Lawsuit Has Been Filed Against CorMedix Inc. (CRMD) - 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\/gainey-mckenna-egleston-announces-a-class-action-lawsuit-has-been-filed-against-cormedix-inc-crmd\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gainey McKenna &amp; Egleston Announces a Class\u00a0Action Lawsuit Has Been Filed Against CorMedix Inc. (CRMD) - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"NEW YORK, July 23, 2021 (GLOBE NEWSWIRE) &#8212; Gainey McKenna &amp; Egleston announces that a class action lawsuit has been filed against CorMedix Inc. (\u201cCorMedix\u201d or the \u201cCompany\u201d) (NASDAQ: CRMD) in the United States District Court for the District of New Jersey on behalf of those who purchased or otherwise acquired CorMedix publicly traded securities between July 8, 2020 and May 13, 2021, inclusive (the \u201cClass Period\u201d). The Complaint alleges that Defendants made material misrepresentations concerning the following: (1) deficiencies existed with respect to DefenCath\u2019s manufacturing process and\/or at the facility responsible for manufacturing DefenCath; (2) in light of the foregoing deficiencies, the FDA was unlikely to approve the DefenCath NDA for CRBSIs in its present form; (3) Defendants had &hellip; Continue reading &quot;Gainey McKenna &amp; Egleston Announces a Class\u00a0Action Lawsuit Has Been Filed Against CorMedix Inc. 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