Joe Todisco, new CorMedix CEO

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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Carolyn Bertozzi, predicted by some to become a Nobel laureate, clinched one of the world’s top awards in the wee hours of Wednesday, winning the Nobel Prize in Chemistry alongside a repeat winner and a Copenhagen researcher.

The Stanford professor, Morten Meldal of University of Copenhagen and 2001-awardee K. Barry Sharpless of Scripps shared the prize equally. The Nobel is sometimes split in quarters and/or halves.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Robert Arch, OncoSec Medical CEO

Pen­ny stock, Mer­ck part­ner lays off 45% of staff to reach PhII read­out by ear­ly 2023

Another biotech is feeling the chill of the bear market, laying off staff in an effort to preserve cash.

Cancer immunotherapy startup OncoSec Medical announced Tuesday evening it would lay off about 45% of its workforce, or 18 employees, it estimated in an SEC filing. OncoSec made the move to better position the company to complete a Phase II trial for its sole program in melanoma, CEO Robert Arch said in a statement.

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New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

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