Retiring CorMedix CEO Khoso Baluch

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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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