Ahead of second FDA chance, CorMedix winds down European business
The bear market struck again Thursday morning as a New Jersey-based antifungal biotech reported a significant shift in operations.
CorMedix will be shaking up much of its C-suite and halting operations in Europe, the company announced, as it looks to rebound from a March 2021 CRL. The company had re-filed its application about six weeks ago but the changes highlight the new direction as it prepares to meet the FDA once again.
The most prominent change comes at the top: Joe Todisco officially started his CEO tenure Tuesday, following the announcement of his appointment back in March. Tom Nusbickel, meanwhile, will step down from his role as chief commercial officer in a mutual parting of ways, CorMedix said.
Additionally, as CorMedix winds down its European business, it will also discontinue the distribution of Neutrolin, used to prevent catheter-related blood infections. Neutrolin is the company’s only approved product and is only approved in Europe.
The new focus, at least in the short term, will be securing approval of the device in the US, where it’s known as DefenCath. Other hires and promotions include a new executive VP of clinical operations, a senior VP and head of global quality and a VP of supply chain.
“I am excited to begin my tenure this week at CorMedix,” Todisco said in a statement. “The new hires we announced add significant expertise in quality, manufacturing and supply chain, and join a highly skilled team of professionals who I have had the privilege of getting to know over the past several weeks.”
Todisco’s new role comes after CorMedix’s former CEO, Khoso Baluch, retired last October after more than five years running the show. Baluch hung it up about a month after delays at a contract manufacturer led to the resubmission of DefenCath’s NDA.
CorMedix had previously said it has scheduled a new inspection and believes it will satisfy regulator concerns once they review the new pitch.
The biotech is far from the only company to change up its C-suite in recent months as the market downturn affects more and more companies. The XBI, the composite measurement of the biotech sector, was down another several percentage points Wednesday, but is up about 3% in Thursday’s early session.