As­traZeneca push­es back OS read­out on MYS­TIC to H2; An­thera shares oblit­er­at­ed in re­peat PhI­II flop

→ The much-an­tic­i­pat­ed over­all sur­vival da­ta of As­traZeneca’s $AZN piv­otal lung can­cer tri­al will be de­liv­ered lat­er than ex­pect­ed, the UK drug­mak­er an­nounced this morn­ing. In­vestors will now have to wait un­til the sec­ond half of 2018 for the fi­nal analy­sis of Imfinzi’s im­pact on OS, in­stead of the first half. The re­sults from the MYS­TIC tri­al re­mains a ma­jor cat­a­lyst af­ter the check­point in­hibitor failed to meet the pri­ma­ry end­point of pro­gres­sion-free sur­vival (PFS), send­ing a shock wave to As­traZeneca’s stock prices last Ju­ly. The tri­al tests Imfinzi both as a monother­a­py and in com­bi­na­tion with treme­li­mum­ab against chemother­a­py in first-line non-small cell lung can­cer, an all-im­por­tant are­na in the bat­tle for check­point drug dom­i­nance.

If at first you don’t suc­ceed in biotech, maybe you should just cut your loss­es and move on. That les­son may be top of mind to­day for An­thera $ANTH af­ter re­searchers re­port­ed that its lead drug Sollpu­ra failed a re­peat Phase III study for cas­es of ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy caused by cys­tic fi­bro­sis. The biotech had al­ready felt the sting of in­vestor dis­sat­is­fac­tion when an ear­li­er Phase III al­so failed. This time sci­en­tists had hoped that more agres­sive dos­ing would fix the prob­lem. It didn’t. An­thera’s shares were evis­cer­at­ed, drop­ping 82% and leav­ing the stock deep in pen­ny stock ter­ri­to­ry.

Malvern, PA-based Realm Ther­a­peu­tics says that their Phase II study of a new ther­a­py for al­ler­gic con­junc­tivi­tis failed, forc­ing the biotech to dump the drug. PR013 was a top­i­cal oph­thalmic so­lu­tion. Realm’s shares (AIM: $RLM) took a dive on the news.

→  Ox­ford Uni­ver­si­ty spin­out OxSy­Bio stepped out to­day with a £10 mil­lion ($13.9 mil­lion) Se­ries A round, join­ing the in­creas­ing­ly crowd­ed space of “tis­sue bio­print­ing” star­tups. This one is de­vel­op­ing a 3D print­er tech­nol­o­gy that can print bi­o­log­i­cal ma­te­ri­als, with the ul­ti­mate goal of mak­ing ther­a­peu­tic tis­sues for pa­tients. This is not un­like the goals of San Diego’s more ma­ture Organo­vo, or the rel­a­tive new­com­er Ste­moniX. OxSy­Bio was found­ed back in 2014 on re­search con­duct­ed in the lab of Pro­fes­sor Ha­gan Bay­ley, the found­ing aca­d­e­m­ic be­hind Ox­ford Nanopore Tech­nolo­gies. The new fi­nanc­ing round was led by Wood­ford In­vest­ment Man­age­ment along­side new and ex­ist­ing back­ers, ac­cord­ing to a com­pa­ny state­ment.


With ad­di­tion­al re­port­ing by Brit­tany Meil­ing and Am­ber Tong.

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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[via AP Images]

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.