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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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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

The $70B ques­tion: What’s Pfiz­er go­ing to do with all that Covid vac­cine cash?

Pfizer’s latest deal a few days ago to sell Europe 1.8 billion doses of BioNTech’s mRNA vaccine — 900 million guaranteed and 900 million optioned — has added a new layer of financial frosting on a large cake it’s been baking.

Ronny Gal at Bernstein sat down to do some back-of-the-envelope figuring on the deal, factoring in their earlier price point of 15.5 euros per dose, and calculated that the pharma giant has locked in a windfall of $20 billion in free cash flow for itself through next year — based on expected sales of $70 billion.

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Rob Davis (Merck)

There’s a new team oc­cu­py­ing the ex­ec­u­tive suite at Mer­ck. And they’ve got a new game plan

Now that Rob Davis and his newly recruited crew of C-suite execs are about to take full control of Merck, it’s time to update the strategy manual and fire up some enthusiasm for the pharma giant with a refreshed game plan.

And who better to get that message across than sell-side analysts on Wall Street?

Davis — who technically has to wait until July 1 to assume the title — and new CFO Caroline Litchfield had a virtual sit-down with a group of analysts this week to make sure they knew that they were raring to do things…somewhat differently. And that includes using a financial windfall and streamlining drive to allow the BD side to up their game gambling while demonstrating a willingness to tear down the digital curtain thrown around Phase I and spotlight early-stage research.

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Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, via Getty Images)

FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

As a matter of official policy, the FDA doesn’t comment about unapproved drugs and the data gathered to back them.

As an unofficial policy, though, the agency can still be provoked by a seemingly unending stream of promotional releases to call a company out for a complete and utter failure.

So it was today with CytoDyn, a biotech company that has a habit of blasting statements out about their drug leronlimab, which has been touted as a potential treatment for Covid-19.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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