Ginkgo CEO Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: As Gink­go looks to clear its name, the feds have come sniff­ing around on the heels of short sell re­port

A month and a half af­ter a short sell at­tack near­ly brought Gink­go Bioworks’ new­ly pub­lic shares to its knees, the com­pa­ny on Mon­day took its largest step to date to­ward clear­ing its name. But it al­so re­vealed it’s cur­rent­ly the tar­get of a De­part­ment of Jus­tice probe.

Gink­go re­ceived an “in­for­mal in­quiry” from the DOJ con­nect­ed to the short sell re­port, re­leased last month by hedge fund Scor­pi­on Cap­i­tal, the com­pa­ny said dur­ing Mon­day’s third quar­ter earn­ings call. CEO Ja­son Kel­ly told an­a­lysts Gink­go is “co­op­er­at­ing” with reg­u­la­tors, sug­gest­ing the in­ves­ti­ga­tion re­mains on­go­ing.

“Short­ly af­ter the short sell­er re­port comes in, we re­ceived a pre­lim­i­nary in­quiry from the DOJ, in­for­mal,” Kel­ly said dur­ing the call, adding lat­er: “There’s not too much more I’d add at this point on it.”

The dis­clo­sure came in the same breath as Kel­ly say­ing its self-ap­point­ed in­de­pen­dent au­dit found all ac­cu­sa­tions of wrong­do­ing in the re­port to be “un­found­ed.” In a fol­low-up email ask­ing for com­ment, a Gingko spokesper­son re­ferred End­points News to Kel­ly’s re­marks and the earn­ings press re­lease.

Through spokesper­son Danielle Blevins, the De­part­ment of Jus­tice de­clined to com­ment.

“As a gen­er­al mat­ter, the De­part­ment does not con­firm, de­ny, or oth­er­wise com­ment on the ex­is­tence or non-ex­is­tence of in­ves­ti­ga­tions. We de­cline to com­ment fur­ther,” Blevins wrote to End­points in an email.

Though the probe is os­ten­si­bly con­nect­ed to the re­port, it’s not yet clear what in­for­ma­tion reg­u­la­tors sought from Gink­go or how broad the scope of the in­quiry is.

Back in Oc­to­ber, Scor­pi­on put out its re­port al­leg­ing Gingko was “a Franken­stein mash-up of the worst frauds of the last 20 years.” The hedge fund claimed there was a pat­tern of fraud at Gink­go, with the com­pa­ny fak­ing cus­tomer in­ter­est and over­hyp­ing a plat­form that’s seen a his­to­ry of fail­ure with­out any mean­ing­ful IP.

The re­port could not be con­firmed and short sell­ers — and the re­ports they put out — have a cer­tain rep­u­ta­tion about them. At the time, long­time stock com­men­ta­tor Cit­ron Re­search pushed back on the most se­ri­ous claims against Gink­go, say­ing the com­pa­ny us­es “roundtrip trans­ac­tions” to boost rev­enue re­ports but stopped short of call­ing it a “scam.”

But it’s sim­i­lar to what oc­curred af­ter Scor­pi­on re­leased a sep­a­rate re­port on Berke­ley Lights, send­ing that syn­bio play­er’s stock tank­ing as well. And Zymer­gen, the com­pa­ny Scor­pi­on re­ferred to as Gink­go’s “Siamese Twin,” blew up in spec­tac­u­lar fash­ion ear­li­er this year just months af­ter a mas­sive $500 mil­lion IPO.

Gink­go, too, is fac­ing the re­al­i­ties of be­ing a new­ly pub­lic com­pa­ny, hav­ing tak­en the SPAC route and re­verse merg­ing with Arie Bellde­grun’s blank-check com­pa­ny to raise a record $2.5 bil­lion. The deal set Gink­go’s mar­ket val­ue at $15 bil­lion, though the stock — trad­ing on Genen­tech’s old $DNA tick­er — hasn’t moved all that much since the merg­er closed in Sep­tem­ber.

Gink­go shares were down about 2.5% in ear­ly Mon­day trad­ing and are up about 27.5% since the SPAC process wrapped up.

This ar­ti­cle has been up­dat­ed to in­clude Gingko and the De­part­ment of Jus­tice’s re­spons­es to End­points’ re­quests for com­ment.

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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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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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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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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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.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.