Arie Bellde­grun and David Chang score record IPO, now they plan to win the race to a his­toric FDA OK

Arie Bellde­grun and David Chang are once again in the race of a life­time — and they plan to stay in the lead to the first pi­o­neer­ing FDA OK in the field.

The two ex-Kite ex­ecs have pulled off the biggest biotech IPO of their gen­er­a­tion, up­siz­ing the of­fer­ing to 18 mil­lion shares and pric­ing at $18 a share — the top of the range.

Arie Bellde­grun

The Al­lo­gene of­fer­ing brought in $324 mil­lion, peg­ging the mar­ket val­ue of the com­pa­ny at $2.2 bil­lion, and un­der­writ­ers will soon have a chance to boost that some more. That sum edges out Ax­o­vant, which raised $315 mil­lion in 2015 to back an Alzheimer’s drug that turned out to be a com­plete bust.

“So far I have not seen a com­pa­ny that is all about al­lo­gene­ic,” Bellde­grun tells me in a phone in­ter­view, dis­cussing the off-the-shelf ap­proach to CAR-T they scooped up from Pfiz­er. “This is a huge op­por­tu­ni­ty.”

“We want to be in the lead,” he adds.

To do that, Al­lo­gene can now re­ly on a war chest filled with the bulk of the mon­ey raised in a mon­ster, $744 mil­lion fundrais­ing blitz through the year.

The next big tran­si­tion point comes in the first half next year, when they go in­to the clin­ic with their lead ther­a­py. If they stay on sched­ule — fol­low­ing an al­ways haz­ardous course of clin­i­cal de­vel­op­ment — Chang says they could grab piv­otal da­ta by the end of 2021. In the mean­time, they’ll al­so ush­er in an­oth­er clin­i­cal pro­gram in 2019, with an­oth­er ther­a­py that could pur­sue mul­ti­ple in­di­ca­tions in on­col­o­gy.

The pair have been there be­fore, rac­ing No­var­tis on per­son­al­ized CAR-T ther­a­pies. The phar­ma gi­ant just bare­ly edged them out. But that was a tech­nol­o­gy that was 15 years in the mak­ing, says Bellde­grun. Now they have a host of new tools, like gene edit­ing, at their dis­pos­al. And by carv­ing out a Pfiz­er group with 40 core staffers and a 4-year track record in pre­clin­i­cal work, they plan to make rel­a­tive­ly quick work of this new race.

We’ll see lat­er to­day how in­vestors like the lat­est biotech uni­corn to hit the Nas­daq, where Bellde­grun and Chang made their mark with Kite Phar­ma — which sold to Gilead for $12 bil­lion, mak­ing in­vestors a bit gid­dy.

David Chang

Over the last 6 months they’ve raised $744 mil­lion for the com­pa­ny in the wake of in-li­cens­ing Pfiz­er’s off-the-shelf CAR-T port­fo­lio, a fig­ure that would have been con­sid­ered some­thing of a pipe dream be­fore 2018 came around.

Now that the mon­ey blitz is done, open­ing up a 3-year run­way to an ap­point­ment with the FDA, the com­pa­ny will con­tin­ue a quest to de­vel­op the world’s first off-the-shelf CAR-T, a sci­en­tif­ic chal­lenge that could swipe aside the pi­o­neer­ing per­son­al­ized drugs that are now on the mar­ket at No­var­tis and Gilead.

They’ve al­ready dou­bled the size of the orig­i­nal team, and more hires are to come. Al­lo­gene al­so has some am­bi­tious plans to es­tab­lish a lead­ing man­u­fac­tur­ing ef­fort, which will be key to their ul­ti­mate suc­cess in the field.

Gold­man Sachs & Co, J.P. Mor­gan Se­cu­ri­ties, Cowen and Com­pa­ny, and Jef­feries are act­ing as the joint book-run­ning man­agers for the of­fer­ing. 

This year we’ve seen a rapid surge in new biotech IPOs, which was large­ly un­ex­pect­ed af­ter a cou­ple years of steady run­ning. And once again Bellde­grun and Chang have their tim­ing down per­fect­ly. In­evitably, a deal like this will raise ques­tions about just how hot things are on the Nas­daq right now, and whether we’re in a bub­ble.

But it’s not over yet.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.