Ar­ray shares surge as sec­ond chap­ter of its PhI­II can­cer com­bo sto­ry ends on an up­beat note

Ar­ray Bio­phar­ma stock got a bounce out of the up­beat as­sess­ment of the sec­ond part of its Phase III study of binime­tinib com­bined with en­co­rafenib, demon­strat­ing their abil­i­ty to sig­nif­i­cant­ly im­prove pro­gres­sion free sur­vival rates for pa­tients with BRAF-mu­tant ad­vanced melanoma. The top-line re­sults lay the foun­da­tion for an NDA, the com­pa­ny adds, which is ex­pect­ed to be de­liv­ered to the FDA this sum­mer.

Ar­ray CEO Ron Squar­er

Ar­ray’s shares $AR­RY surged 20% on Wednes­day as in­vestors and an­a­lysts got a chance to con­sid­er the da­ta on the MEK/BRAF in­hibitors. And while some of the an­a­lysts cov­er­ing the biotech felt that the Phase III news was a def­i­nite plus, there was a feel­ing that a sub­se­quent­ly an­nounced part­ner­ship with Mer­ck in­volv­ing Keytru­da — in which the phar­ma gi­ant will sim­ply con­tribute a quan­ti­ty of their check­point drug for a study — was a bit of a let­down af­ter spec­u­la­tion that a mon­ey deal was in the works.

In Phase III part 2, in­ves­ti­ga­tors looked at a com­bi­na­tion of 45 mg binime­tinib twice dai­ly plus 300 mg en­co­rafenib dai­ly against the con­trol arm of 300 mg en­co­rafenib alone. The com­bi­na­tion achieved a bet­ter me­di­an PFS — 12.9 months vs. 9.2 months; HR = 0.77.

The surge in the stock price helped re­pair some of the dam­age done a cou­ple of months ago when CEO Ron Squar­er had to walk back a promise that they had the da­ta need­ed for its first ap­proval of binime­tinib for NRAS-pos­i­tive melanoma.

Not­ed Leerink’s Michael Schmidt:

Giv­en the pos­i­tive out­come of COLUM­BUS tri­al Part 1 & 2, the like­li­hood of ap­proval of the binime­tinib/en­co­rafenib com­bi­na­tion in mid-2018 re­mains high which was ex­pect­ed by most in­vestors.

Part 1 was a 3-arm tri­al de­sign in 577 pa­tients with a 450 mg en­co­rafenib dose com­bined with binime­tinib com­pared to Zelb­o­raf. The me­di­an PFS rate for Ar­ray’s com­bo was 14.9 months vs. 7.3 months.

Schmidt was less im­pressed with Ar­ray’s deal with Mer­ck to com­bine binime­tinib with Keytru­da for col­orec­tal can­cer in an ear­ly study to test its po­ten­tial.

While this is in­cre­men­tal­ly pos­i­tive for AR­RY, we think a po­ten­tial deal (or even a buy-out of AR­RY) was wide­ly ex­pect­ed by in­vestors.

“The to­tal­i­ty of the COLUM­BUS re­sults, in­clud­ing es­ti­mat­ed pro­gres­sion free sur­vival, ob­jec­tive re­sponse rate, dose in­ten­si­ty and tol­er­a­bil­i­ty of the com­bi­na­tion, pro­vide a strong and con­sis­tent theme across mul­ti­ple end­points, un­der­scor­ing the promise of binime­tinib plus en­co­rafenib as an at­trac­tive treat­ment op­tion for pa­tients di­ag­nosed with BRAF-mu­tant melanoma,” said Kei­th T. Fla­her­ty, di­rec­tor of the Ter­meer Cen­ter for Tar­get­ed Ther­a­py, Mass­a­chu­setts Gen­er­al Hos­pi­tal.

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. 

Jason Kelly. Mike Blake/Reuters via Adobe

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.