Bioregnum channel feed

Clovis CEO Patrick Mahaffy (Getty)

Clo­vis On­col­o­gy her­alds a PARP vic­to­ry in front­line ovar­i­an can­cer — does any­one re­al­ly care much?

Early on Thursday, Clovis Oncology trumpeted positive Phase III data for their PARP player Rubraca in frontline maintenance care of ovarian cancer, outlining a much improved PFS rate compared to placebo.

The small-cap stock price $CLVS, which was eviscerated and relegated to Wall Street sideshow long ago, spiked 52%. That raised a cheer from the remaining faithful who have seen the stock tank 95% over the last 5 years, as Clovis has struggled to find its way as the third PARP playing against major league rivals at AstraZeneca — the dominant pioneer — and GSK, which saw their PARP acquisition as a key part of its new oncology strategy.

John Reed and Naimish Patel

Sanofi R&D team ac­cel­er­ates block­buster de­vel­op­ment ef­forts — while cast­ing doubt on a heavy­weight ri­val’s plans

When Paul Hudson took the CEO job at Sanofi, it was clear he had one hot hand to play with Dupixent and a legacy pipeline that was both distracted by incremental diabetes work and lacking much by way of exciting new drug programs with blockbuster potential.

Some, but not much.

So he did what any good CEO would do, jumping in after a fallow stretch: stripped out the unappealing and started hunting new deals, all while nurturing the cash cow by adding a slate of new development programs to build that pipeline-in-a-product all the Big Pharmas love.

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Daniel O'Day (Georgios Kefalas for AP)

As Gilead’s stock price gets blitzed af­ter a se­ries of prat­falls, why is Dan O’Day get­ting a small raise?

Over the past year, Gilead has been subjected to one nasty setback after the next. But it hasn’t even dented Daniel O’Day’s pay package.

True, his base pay is down a tad, from $1.7 to $1.65 million, according to the SEC filing. The non-equity incentive comp also dipped. But those stock awards and options jumped by more than $1.5 million in value, allowing the Roche vet to see his total compensation edge up from $19 million to $19.2 million, give or take a few bucks.

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Nick Leschly, 2seventy bio CEO (Jeff Rumans)

With its share price chewed to pieces, Nick Leschly's 2sev­en­ty scores $170M to help weath­er the storm

A little more than a week after bluebird’s CFO announced a quick exit as the company flagged an alarm about its ability to survive, the biotech’s longtime leader — Nick Leschly — is touting a $170 million deal designed to carry his spinout past the current carnage on Wall Street.

2seventy bio sold close to 14 million shares $TSVT to raise the cash, which the company is careful to point out will land on top of the $362 million stash the biotech ended the year with. Add in its Abecma revenue, where they’re partnered with Bristol Myers Squibb, and the crew is promising that they have the funds to weather the storm and get to 2025.

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Michel Vounatsos (Credit: World Economic Forum/Valeriano Di Domenico)

‘We would have no choice’: Bio­gen CEO Vounatsos isn’t about to let go of the bud­get axe — un­less they break that los­ing streak

Biogen CEO Michel Vounatsos is betting on success. But he’s keeping one hand firmly on the budget axe in case the cards stay cold. And he’s ready to chop as hard as necessary to keep the bottom line in shape.

In a fireside chat on Monday during the Cowen conference, Vounatsos repeatedly hit on the company’s campaign to overturn the punishing initial Medicare decision denying broad coverage of Aduhelm (aducanumab), insisting that Biogen can make a good case for access, promising both added clinical data as well as real world evidence. But unless things start to go its way — on Aduhelm and the upcoming lecanemab readout as well as the so-far commercially awkward zuranolone readout — the CEO stands ready to cut where he can’t add revenue.

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Werner Baumann, Bayer CEO (Malte Ossowski/SVEN SIMON/picture-alliance/dpa/AP Images)

Bay­er rush­es sup­port to Ukraine staff, help­ing with cash and hous­ing as Rus­sians at­tack ma­jor cities

Bayer execs covered all the major pocketbook issues you’d expect in its Q4 call with analysts today. But clearly the invasion of Ukraine — and the widening global crisis that has developed as bombs fall on a civilian population — has captured their attention. And it became a central focus in their presentation today.

“Before we go into the business performance,” Bayer CEO Werner Baumann said, “let me start with what is certainly top of mind for all of us. With the Russian invasion of Ukraine, the geopolitical order is shaken and we are deeply shocked and concerned with what is happening to the Ukrainian people. This war is no less than a threat to our freedom and democracy and we at Bayer condemn in the most vigorous way, this Russian attack.”

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Sen. Dick Durbin (D-IL) (J. Scott Applewhite, File/AP Images)

US sen­a­tor blasts J&J's Texas two-step bank­rupt­cy as the phar­ma gi­ant twists in the pub­lic spot­light

J&J has choreographed a legal dance that has taken the pharma giant straight into the waiting arms of a US senator. And the lawmaker has got some moves of his own.

Majority Whip Dick Durbin (D-IL) took to the Senate floor to excoriate J&J’s use of the Texas two-step move to escape a mountain of litigation surrounding claims that the pharma giant’s talc-based baby powder was laced with asbestos, triggering ovarian cancer or mesothelioma. It spun out those assets into a separate company last fall, then promptly filed for bankruptcy of the new company, looking to shield the giant corporation from a mob of angry litigants bristling with more than 38,000 lawsuits threatening billions in potential judgments.

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David Meek, Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Mi­rati gets a stan­dard re­view for its 'break­through' KRAS drug. And that is caus­ing some hand wring­ing

After the market close on Monday, Mirati issued a statement that the FDA had accepted its application for their KRAS drug adagrasib and is giving it a standard 10-month review, setting a PDUFA date way out toward the end of the year.

That’s not exactly what Mirati investors were looking for. Playing catch-up in lung cancer with Amgen — which got an accelerated approval for sotorasib (Lumakras) following a ferocious 3-year clinical campaign and is now pursuing a confirmatory study of the drug — Mirati was clearly hoping to get the short, snap review and look to get out in the market in the middle of the year. And a STAT piece initially indicated that the early Lumakras approval had triggered the lengthier review at Mirati — something that was then clarified with a remark that the company was not told why they got the standard look-see.

Stéphane Bancel (Photo by Steven Ferdman/Getty Images)

Mod­er­na’s once high-fly­ing stock buck­les un­der the weight of a biotech rout. Is it cheap yet?

Last fall, with the world grappling — not all that well — with a global pandemic, anything might have seemed possible for the newly minted billionaires running Moderna. Their stock was trading north of $450 a share and the company was flying high as its mRNA vaccine offered a radically new and disruptive tech for pandemics to come.

In the previous summer, Moderna had already leapfrogged the likes of GlaxoSmithKline in market cap — breaking the $100 billion mark — to enter the exclusive territory of Big Pharma players in the top 15. And some analysts were comparing it to Tesla, the electric automaker that seemed blissfully separated from financial reality.

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Stéphane Bancel speaking at Endpoints @ #JPM20 (Photo: Jeff Rumans for Endpoints News)

The FDA ap­proves Mod­er­na's rev­o­lu­tion­ary new Covid-19 vac­cine. What took so long?

Moderna just picked up its first-ever full BLA approval for its celebrated Covid-19 vaccine, and did it at what most everyone in the business would say was a blindingly fast 5 months from their application filing. But one of the big questions some people had after the news hit was why, after Pfizer and their partner BioNTech were able to move in a little more than half that time, did the FDA choose to wait here?

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