A month after a manufacturing hiccup led to a CRL, CorMedix CEO will retire
After more than 5 years at the helm of New Jersey-based biopharma CorMedix, Khoso Baluch is retiring, and the move has triggered a ripple of change within its executive leadership team, leading CFO Matt David to take over as interim CEO, while maintaining his current role.
The departure comes about a month after delays at a contract manufacturer led to the resubmission of a new drug application for DefenCath, an antibacterial and antifungal treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis. The drug was granted fast-track designation by the FDA, but delays at the CMO’s site led to a complete response letter.
Stocks plummeted 24% after news of the delays broke. Before the opening bell Tuesday, CorMedix’s stock was valued at $4.82. The FDA has apparently told the company that the delays were unrelated to the manufacturing of DefenCath.
David joined CorMedix in May 2020 as the CFO and EVP, coming over from Ovid Therapeutics, where he spent about two years as the head of strategy. The majority of his career has been in healthcare banking, and he received his MD from New York University School of Medicine in 2003.
As the company’s board of directors — which Baluch also retired from — moves to replace the former CEO, Baluch will serve as an advisor to ensure a smooth transition.
“I am honored to take on the role of interim CEO during this important time for the Company,” David said in the press release. “With a strong executive team spanning regulatory, medical affairs, clinical operations and commercial, and a highly supportive board which includes proven healthcare industry leaders, I believe we are well positioned to continue our efforts to bring DefenCath to the hemodialysis patient community.”
John Armstrong, the EVP for technical operations, also retired Monday. Phoebe Mounts, EVP and head of regulatory compliance and legal, will have direct authority over the company’s technical operations group, including a group of consultants that are working on addressing the situation with the CMO.
Myron Kaplan, the chairman of the board, said in a statement:
On behalf of the entire Board, I thank Khoso and Jack for their dedicated service and contributions to CorMedix. Khoso has been instrumental in refocusing the Company and guiding it strategically while building a highly experienced executive team. Matt’s energy and leadership, with the support of CorMedix’s Board of Directors and experienced management team, enable him to continue the important work underway to progress DefenCath, while the CEO search is ongoing.