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.

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

A pivot into neoantigen immunotherapies was not enough to save Genocea Biosciences after all.

The 16-year-old biotech said it would be closing down and laying off all remaining employees “except those deemed necessary to complete an orderly wind down” of operations. It has also delivered a formal notice to Nasdaq, notifying the stock exchange of its intent to delist voluntarily.

The move comes a month after Genocea laid off 75% of its workforce and revealed it’s looking for strategic alternatives, such as a sale, merger or reverse merger. At the end of 2021, it had 74 employees.