Elizabeth Holmes leaves federal court after the verdict in San Jose, CA, Jan. 3, 2022 (Nic Coury/AP Images)

Ther­a­nos founder Eliz­a­beth Holmes found guilty on four counts of de­fraud­ing in­vestors

The Ther­a­nos saga has cap­ti­vat­ed the phar­ma world over the last two decades, from its found­ing to its sharp rise and even sharp­er de­cline. And late Mon­day, its founder and for­mer CEO Eliz­a­beth Holmes was found guilty on sev­er­al counts re­lat­ed to mis­lead­ing in­vestors, with each car­ry­ing a max­i­mum of up to 20 years in prison.

Ju­rors re­turned the ver­dict Mon­day evening, find­ing Holmes guilty on one count of con­spir­a­cy to com­mit wire fraud and three counts of wire fraud against spe­cif­ic in­vestors, with sev­er­al news out­lets re­port­ing on the re­sult. Holmes was found not guilty on four counts re­lat­ed to de­fraud­ing pa­tients and ju­rors dead­locked on three counts of mis­lead­ing in­di­vid­ual in­vestors.

A mis­tri­al was sub­se­quent­ly de­clared for the lat­ter three charges, CN­BC re­port­ed. Holmes is like­ly to ap­peal the guilty ver­dicts.

Found­ed in 2003 when Holmes was a stu­dent at Stan­ford, Ther­a­nos gained promi­nence by promis­ing to of­fer quick and easy screen­ing tests us­ing just a few drops of a pa­tient’s blood pricked from their fin­gers. Holmes made waves her­self as a rare woman CEO in Sil­i­con Val­ley’s man-dom­i­nat­ed cul­ture, rais­ing more than $900 mil­lion from big-name in­vestors and earn­ing Ther­a­nos a val­u­a­tion as high as $9 bil­lion.

But things be­gan un­rav­el­ing quick­ly af­ter a Wall Street Jour­nal in­ves­ti­ga­tion in 2015 paint­ed the pic­ture of a com­pa­ny strug­gling to hold things to­geth­er, us­ing third-par­ty tech­nol­o­gy to run most of its tests. The re­port cit­ed un­named em­ploy­ees who said they were side­lined af­ter rais­ing con­cerns over the tests’ re­li­a­bil­i­ty.

Ther­a­nos even­tu­al­ly shut­tered in 2018, mark­ing an end to the busi­ness but not the com­pa­ny’s le­gal trou­bles. In ad­di­tion to Holmes, pros­e­cu­tors charged her for­mer boyfriend and deputy Ramesh “Sun­ny” Bal­wani with sim­i­lar counts, with Bal­wani ex­pect­ed to stand tri­al next month. Bal­wani has de­nied the al­le­ga­tions.

The Holmes and Ther­a­nos sagas have cap­ti­vat­ed ob­servers, of­fer­ing a rare look in­side the nor­mal­ly se­cre­tive Sil­i­con Val­ley and spawn­ing doc­u­men­taries try­ing to record the his­to­ry. Few Val­ley ex­ecs have been charged for white col­lar crimes, as the tri­al os­ten­si­bly pre­sent­ed a warn­ing to oth­er star­tups who might think of stretch­ing the truth to in­vestors.

As Holmes files an ap­peal mov­ing for­ward, a hear­ing for the hung charges is ex­pect­ed to be held next week, at which point Holmes is like­ly to face her sen­tenc­ing. The four sen­tences will prob­a­bly be served con­cur­rent­ly and it’s un­like­ly Holmes faces the max­i­mum of 20 years, giv­en she has no pri­or con­vic­tions.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.