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.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.