NEW YORK, September 14, 2021 / PRNewswire / – Pomerantz LLP announces that a class action lawsuit has been filed against CorMedix, Inc. (“CorMedix” or the “Company”) (NASDAQ: CRMD) and certain of its officers. The class action, filed in United States District Court of the District of New Jersey, and listed under 21-cv-16855, is in the name of an extended class composed of all persons and entities other than the Defendants who have purchased or otherwise acquired securities of CorMedix between October 16, 2019 and May 13, 2021, both dates inclusive (the “Extended Recourse Period”), seeking to recover damages caused by Defendants in violation of federal securities laws and to exercise remedies under §§ 10 (b) and 20 (a ) of the Securities Exchange Act of 1934 (the “Exchange Act”) and rule 10b-5 promulgated by virtue of it, against the Company and certain of its senior executives.
If you are a shareholder who purchased securities of CorMedix during the Extended Class Period, you have up to September 20, 2021 ask the court to appoint you as the principal plaintiff for the class. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
CorMedix is a biopharmaceutical company focused on the development and commercialization of therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States and globally. The Company is focused on the development of its flagship product candidate, DefenCath, a purported new antibacterial and antifungal solution designed to prevent costly and dangerous catheter-related bloodstream infections (“CRBSI”). DefenCath is available in Europe and the Middle East under the Neutrolin brand since 2013.
In the United States, CorMedix completed phase 3 of the clinical development of DefenCath in July 2019 and ultimately appeared ready to submit a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) for approval, including its manufacturing information, the October 16, 2019. On that day, the first day of the Class Period, the Company announced that “[t]a FDA has supported the manufacturing program offered by Neutrolin, including active pharmaceutical ingredients (APIs), container closure and testing, and has indicated that it will conduct a thorough review of all CMCs [“Chemistry, Manufacturing, and Control”] information as well as to assess the commercial readiness of the various manufacturing facilities at the time of filing the NDA “and that”[n]o other CMC meetings with the FDA [we]is planned before the submission of the NDA. “
In February 2020, CorMedix has begun its continued submission of its NDA for DefenCath as a catheter locking solution with an initial indication for the use of prevention of CRBSI in patients with end stage renal disease who receive hemodialysis through a venous catheter central. The submission of the NDA was completed in july 2020.
The complaint alleges that, throughout the Extended Class Action Period, the Defendants made materially false and / or misleading statements, and failed to disclose material adverse facts regarding the business, operations and prospects of the Company. . Specifically, the Defendants failed to disclose to investors: (i) deficiencies existed with respect to the manufacturing process of DefenCath and / or the facility responsible for manufacturing DefenCath; (ii) in light of the above shortcomings, it was unlikely that the FDA would approve the DefenCath NDA for CRBSIs in its current form; (iii) the defendants had downplayed the actual extent of the deficiencies in the manufacturing process of DefenCath and / or the facility responsible for the manufacture of DefenCath; and (iv) accordingly, the Company’s public statements were materially false and misleading at all material times.
At March 1, 2021, CorMedix issued a press release “announced[ing] that the [FDA] cannot approve the [NDA] for DefenCath. . . in its current form. CorMedix informed investors that “FDA noted concerns with third party manufacturing facility after review of records requested by FDA and provided by manufacturing facility”; that the “FDA has not specified the issues and CorMedix intends to work with the manufacturing facility to develop a resolution plan when the FDA notifies the facility of specific issues; than, “[w]When we are made aware of the issues, we will set up a conference call with investors to take stock of our planned resolution schedule ”; and, “[a]In addition, the FDA requires a manual extraction study to demonstrate that the labeled volume can be routinely withdrawn from the vials despite an existing ongoing check to demonstrate the fill volume within specifications.
On this news, the CorMedix share price fell $ 5.98 per share, or 39.87%, to close at $ 9.02 per share on March 1, 2021.
Then on April 14, 2021, the defendants announced that CorMedix should take additional steps to meet FDA requirements for the manufacturing process of DefenCath, including “[a]address FDA concerns regarding the qualification of the filling operation [that] may require adjustments in the process and the generation of additional data on operating parameters for the manufacture of DefenCath. “
On this news, the CorMedix share price fell $ 1.44 per share, or 15.37%, to close at $ 7.93 per share on April 14, 2021.
Finally, on May 13, 2021, CorMedix announced that “[b]Based on our analyzes, we concluded that further process qualification will be required with subsequent validation to address the deficiencies identified by the FDA. Phoebe’s mounts, Executive Vice President and General Counsel of CorMedix, finally revealed, among others, that “there are times when unexpected results can be achieved”; that the FDA “expects[s] generate enough data to demonstrate that[ the filling] process is a controlled process and complies with the agency’s requirements for good manufacturing practice ”; that “sterility is a very important part of this process”, as well as “the precision to ensure that the right volume of DEFENCATH is loaded into the vials”; that “we are talking about thousands of vials during the manufacturing cycle” ; that the defendant must “generate[e] a lot of data to make sure that. . . all equipment has been qualified for the intended use and every step of the manufacturing process has been qualified “; that” e[e] the process must be very robust, [and] must be reproducible ”; and that “the onus is on the manufacturer to demonstrate that the facility can perform this process reducibly and generate the product required for commercial distribution.”
On this news, the CorMedix share price fell $ 1.51 per share, or 19.97%, to close at $ 6.05 per share on May 14, 2021.
The Pomerantz firm, with offices in new York, Chicago, Los Angeles, and Paris is recognized as one of the leading firms in the areas of corporate law, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz was a pioneer in the field of class actions in securities. Today, more than 80 years later, Pomerantz continues the tradition it established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous multi-million dollar damages on behalf of the members of the group. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext 7980
View original content to download multimedia:https://www.prnewswire.com/news-releases/pomerantz-law-firm-announces-the-filing-of-a-class-action-against-cormedix-inc-and-certain-officers–crmd-301376837 .html
SOURCE Pomerantz LLP