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Giovanni Caforio, Bristol Myers Squibb CEO (Pablo Martinez Monsivais/AP Images)

The fi­nal hours and days are tick­ing away on a $6B bet as dead­line looms on a sus­pense­ful FDA de­ci­sion

The clock is ticking down to the year-end deadline for an FDA approval of liso-cel, and the suspense is killing investors.

You’ll recall that Bristol Myers CEO Giovanni Caforio insisted at the last minute of negotiations with Celgene execs that they had to replace cash on the table with a CVR $BMYRT tied to 3 key drug approvals by a certain deadline.

That’s all 3. Miss one, and anyone holding on to the $9 CVR would get nothing. For Bristol Myers, it’s a $6 billion play.

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Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

It's a big day for Mod­er­na — and the world — as the FDA stamps an EUA on their vac­cine. And there are some im­por­tant lessons to re­mem­ber

The FDA came through with an emergency authorization for Moderna’s mRNA vaccine for Covid-19 late Friday, in keeping with the fast delivery expected from regulators following a unanimous panel vote in its favor Thursday.

The approval has the greatest impact in the US, where Moderna is expected to rapidly start rolling out tens of millions of doses, even as a bitter wrangle develops over what is happening with Pfizer/BioNTech’s supply chain. In this case, unlike Pfizer, the biotech is marketing its very first product. Now, it has to literally deliver on schedule, while facing the same kind of skepticism that greeted the 10-year-old development revolutionary when they set out to build a pipeline.

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John Connolly speaks on an Endpoints News panel at the 2018 BIIS PharmCube/Endpoints conference in Shanghai (File photo)

John Con­nol­ly has a new mis­sion to tack on to his role at the Park­er In­sti­tute: in­ter­im chief of a buzzy biotech backed by a pair of bil­lion­aires

John Connolly, the new chief scientist at the Parker Institute for Cancer Immunotherapy, has a fresh mission on his plate.

Connolly’s been tapped to take the interim CEO spot at 3T Biosciences, a buzzy Bay Area startup that’s joined the whole cell therapy 2.0 movement with the help of 2 tech billionaires who have shown a big interest in cancer drug development: Peter Thiel and Sean Parker, who lent his name and direct involvement to his eponymous nonprofit.

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CRISPR up­start ticks off an­oth­er box on the IPO prep list as RA, SVB Leerink step in on a mega-raise

With 2020 set to bring the curtain down on a biotech IPO boom unlike anything we’ve seen before, you have to wonder which companies are setting the stage to try and follow up with their own S-1 in 2021. And Locanabio may be in the mix after today.

The San Diego-based biotech just brought in a mega-round, always helpful ahead of any IPO. In this case, that’s $100 million from a slate of investors that’s adding groups with a well-known taste for IPO strategies: Vida Ventures, RA Capital, Invus, Acuta Capital and an investment arm of market maker SVB Leerink. Rajul Jain, an MD who had been on the executive team at Kite before joining Vida with Arie Belldegrun, is moving to the Locanabio board.

Carl Hansen, AbCellera CEO (AbCellera)

Carl Hansen is just about ready to grab the key to the ex­clu­sive Cov­il­lion­aire club

It looks like AbCellera CEO Carl Hansen is set to join the Covillionaire club this week.

The antibody discovery outfit filed its updated S-1 on Monday, putting the range for the share price at $14 to $17. That pegs the market cap at the mid-range right around $5 billion, and Hansen has kept hold of what will be a 23% stake in the company, controlling 61,827,830 shares. And AbCellera is poised to haul in more than $400 million from the latest blockbuster IPO to hit Wall Street.

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Cap­ping Pas­cal So­ri­ot’s big turn­around, the an­a­lysts at Cowen say As­traZeneca is poised for a stel­lar year

Big Pharmas typically don’t get a lot of respect for R&D efforts. Their ROI is bad on a massive annual bill, there’s too much late-stage failure, analysts fret about the endurance of big franchises and the impact of generic competition.

Even as Pascal Soriot is staunching the bleeding around a badly handled Phase III readout for their Covid-19 vaccine, though, the AstraZeneca CEO is taking a bow today as Cowen lavishes praise on the pipeline and near-term prospects for the multinational — for the second year in a row.

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Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The FDA's in­sid­er re­view on ad­u­canum­ab was all about pol­i­tics, not sci­ence, and it threat­ens pa­tients and the bio­phar­ma in­dus­try alike

The FDA deserves kudos for drawing a line in the sand over their review of Covid-19 vaccines. They’ve made it clear — after deep skepticism began to appear following the debacle over convalescent plasma — just what they will need to see before handing out an EUA, thus saving the agency’s rep for enforcing standards essential to maintaining public trust in drugs.

That same integrity, though, has gone missing from the FDA’s stance on Biogen’s Alzheimer’s drug aducanumab. Despite a statistical analysis that highlights the conflicting nature of the Biogen $BIIB data, a post hoc dumpster dive operation to find supportive data and a move to shine up small cohort results as backup proof of efficacy, the FDA division responsible for Alzheimer’s chose to endorse adu for use among millions of patients.

Sean Bohen (file photo)

Sean Bo­hen just wrote the hand­book on how to make a quick for­tune in biotech

If you ask anyone in drug development about what motivates them — or even if you don’t — you’re going to get a regular double-barreled blast about patients and unmet medical needs if you’re covering this industry. Less discussed and just as important during a heady IPO boom is a shot at the overnight fortunes that are on offer in the middle of a pandemic.

Sean Bohen’s team at Olema just spelled it all out in an S-1 that can serve as a compactly written handbook on the subject — provided you know the background.

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