LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of CorMedix Inc. (“CorMedix” or the “Company”) (NASDAQ: CRMD) investors concerning the Company’s possible violations of the federal securities laws.
If you suffered a loss on your CorMedix investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/cormedix-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at firstname.lastname@example.org to learn more about your rights.
In July 2020, CorMedix filed its New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for DefenCath, an antibacterial and antifungal solution, as a catheter lock solution with an initial indication for use of preventing certain catheter-related bloodstream infections.
On March 1, 2021, CorMedix announced the NDA would not be approved “in its present form” due to “concerns at the third-party manufacturing facility.” Moreover, the FDA “is requiring a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.”
On this news, CorMedix’s stock 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, CorMedix announced it would have to take additional steps to meet the FDA’s requirements for DefenCath’s manufacturing process, including “[a]ddressing FDA’s 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.”
On this news, CorMedix’s stock price fell $1.44 per share, or 15.37%, to close at $7.93 per share on April 14, 2021.
Then, on May 13, 2021, CorMedix announced that “[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.” Among other things, the Company was required “to generate sufficient data to demonstrate that [the filling] process is a controlled process and is consistent with the agency’s requirements for good manufacturing practice.”
On this news, CorMedix’s stock price fell $1.51 per share, or 19.97%, to close at $6.05 per share on May 14, 2021.
Whistleblower Notice: Persons with non-public information regarding CorMedix should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email email@example.com.
Glancy Prongay & Murray LLP is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. ISS Securities Class Action Services has consistently ranked GPM in its annual SCAS Top 50 Report. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM’s nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM’s lawyers have handled cases covering a wide spectrum of corporate misconduct including cases involving financial restatements, internal control weaknesses, earnings management, fraudulent earnings guidance and forward looking statements, auditor misconduct, insider trading, violations of FDA regulations, actions resulting in FDA and DOJ investigations, and many other forms of corporate misconduct. GPM’s attorneys have worked on securities cases relating to nearly all industries and sectors in the financial markets, including, energy, consumer discretionary, consumer staples, real estate and REITs, financial, insurance, information technology, health care, biotech, cryptocurrency, medical devices, and many more. GPM’s past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron’s, Investor’s Business Daily, Forbes, and Money.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.