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Stéphane Bancel (AP Images)

mGx M&A? Mod­er­na ex­ecs are lever­ag­ing their Covid cash on gene edit­ing, gene ther­a­py deals

Moderna’s little business deal with Autolus earlier this week looks like a predinner snack ahead of the main course to come.

During his Q2 call with analysts on Thursday, Moderna CEO Stéphane Bancel got more than a few eyebrows to raise with his comments on BD plans. Now that the company’s market cap has hit an Everest-high cruising altitude above $165 billion — levitating up 78% in the past month — with a megablockbuster ginning money on hand, Bancel is prepared to put that cash and kind to use. And he made it clear that gene editing/gene therapies are right at the heart of this new move.

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Tillman Gerngross (Adagio)

A glob­al pan­dem­ic fi­as­co sets the stage for Till­man Gern­gross to in­tro­duce his biotech uni­corn to Wall Street

This morning we got a better look at the numbers Tillman Gerngross has in mind for his pandemic play at Adagio Therapeutics. And not surprisingly, they are big.

Gerngross has had plenty of experience judging value in biotech. And at a time the top mRNA players at Moderna and BioNTech/Pfizer are reaping some vast gains from their truly revolutionary new vaccines for Covid-19, it’s clear that the Dartmouth professor has been building a unicorn of his own.

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Biogen's ad on NYT Magazine directing readers to a 'symptoms quiz' (Zachary Brennan for Endpoints News)

Bio­gen wast­ed no time in rolling out a ‘dis­ease aware­ness’ cam­paign for Alzheimer's as an R&D marathon turns in­to a sprint. A top an­a­lyst awards gold, sil­ver and bronze

Biogen and the FDA found a way to stir a tempest of controversy and dismay over the accelerated approval of an unproven Alzheimer’s drug. But the big biotech is plowing straight ahead into the maelstrom with a well-prepared kickoff of an advertising campaign aimed at sparking patient interest in a drug that a growing lineup of healthcare institutions are refusing to administer.

Biogen and Eisai have started running a slick campaign to focus attention on mild cognitive impairment, featuring an elderly couple — Jim and Jane — now confronting the disease. That comes with a handy “symptoms quiz” on forgetfulness — how often do you forget stuff? — and a stat that 1 in 12 Americans over 50 suffer from MCI. You can also find a specialist for Alzheimer’s, if you feel the need.

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Till­man Gern­gross is bet­ting well over $500M that the pan­dem­ic will nev­er re­al­ly end. Here’s the IPO pitch

Tillman Gerngross doesn’t waffle.

The longtime Dartmouth professor and Adimab founder tends to pick a course and drive straight for the goal. If he sees a big, ugly nail, he’ll start to design a hammer for it. And jumping straight into the global pandemic, he quickly decided that he had the best shot at producing a powerful antibody that could protect billions of people from the worst public health crisis in a century.

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Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

With Mod­er­na shares fly­ing at a pan­dem­ic high, the mar­ket cap has now pierced the $100B mark, leapfrog­ging Glax­o­SmithK­line

Back just before the pandemic hit the world in early 2020, Moderna’s shares were trading right around $20 a share. Today, it’s above $250 a share — up 3% this morning — and the market cap has pierced the $100 billion mark.

Working solo, the biotech high flyer has changed the world and saved lives with its highly effective and apparently safe vaccine for Covid-19, developed in record time. And that’s been worth a valuation that’s close to twice that of the other big mRNA success story: BioNTech, which is partnered with an unabashedly triumphant Pfizer. The Big Pharma partner has shared the profits and the glory with BioNTech, which has seen its own share price soar from around $30 to $217.

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IPOs and ven­ture in­vest­ing rock on in Q2 as SPAC at­tack takes a break. But what hap­pened to the deals and M&A?

Right now, investments in biotech are continuing to flow at record levels, with IPOs booming and VCs continuing to invest from a fat round of new funds. But they’re definitely stealing all the thunder from an anemic set of deals and a quiet M&A scene where most big players have been sitting it out.

Chris Dokomajilar, the numbers maestro at DealForma, broke down the most recent set of numbers for us. You can see what the trends are in the charts below. Here’s his take on the key points:

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Is 9 years too long to run a con­fir­ma­to­ry study for a drug like ad­u­canum­ab? In Sarep­ta’s case, it isn’t enough time

The storm of controversy that broke over the FDA’s decision to provide an accelerated approval for aducanumab proved contentious on several levels. And near the top of the list was the FDA’s liberal allowance of a 9-year timeline for Biogen to complete a confirmatory study of the suspect therapy that flat failed one of its Phase IIIs.

One of the favorite stats execs in the industry like to cite is an average of 10 years and a billion dollars to develop a drug — early start to FDA OK finish — though that number is typically wildly variable from program to program. But not even the most generous timelines would include 9 years for a confirmatory study.

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FDA interim commissioner Janet Woodcock (AP Images)

The FDA has now poked a hor­net's nest of con­tro­ver­sy in the House. And that could sting Bio­gen's mega block­buster quest in Alzheimer's

Biogen has earned two powerful critics in the House of Representatives as the storm of controversy that surrounds their experimental Alzheimer’s drug aducanumab now moves to Congress.

Rep. Frank Pallone, Jr., chairman of the Committee on Energy and Commerce, and Rep. Carolyn Maloney, chairwoman of the Committee on Oversight and Reform, announced late Friday that their committees would put a spotlight on the FDA’s decision to hand Biogen a megablockbuster accelerated approval based on a selection of data from conflicting clinical studies.

The language in their statement makes it crystal clear that they have some pointed questions for the regulators — led by FDA interim chief Janet Woodcock — about the broad-label OK that puts the drug in front of millions of desperate Alzheimer’s patients for $56,000, a price which will be amplified by related procedures to monitor patients:

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Just how sad­ly mis­guid­ed is the FDA on ad­u­canum­ab?

I doubt very much that Biogen paid anyone at the FDA to get an approval on aducanumab with this generous (?) label. But if they had, I doubt that even the execs at Biogen would have asked for this much.

Cheating requires some caution, if you expect to get away with it. And this one goes way past a cautious manipulation of regulatory powers in accomplishing a megablockbuster company goal worth potentially tens of billions of dollars.

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Ex­clu­sive: Helsinn chief Ric­car­do Braglia spells out a block­buster plan to take the fam­i­ly phar­ma pub­lic — with an eye on new can­cer drug deals, spin­out

Late on Friday, as the biopharma industry in the US was making a rush to the exits for a 3-day weekend, BridgeBio put out word that the FDA had come through on a critical first OK for QED, one of their many subs pushing a drug through clinical development. The agency offered an accelerated approval for Truseltiq (infigratinib), a new therapy for cases of cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

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