In HKEX's first test in 2019, CStone seeks up to $304M in IPO for­tune

As the Nas­daq ush­ered in its first biotech uni­corns of 2019 with the list­ings of Alec­tor and Gos­samer, CStone is kick­ing things off at the Hong Kong Stock Ex­change with a po­ten­tial $304 mil­lion (HK$2.39 bil­lion) price tag on its IPO.

At the top of the range, each of the 186 mil­lion CStone shares would sell at $1.63 (HK$12.8). That’s down 23% from its orig­i­nal tar­get of $400 mil­lion ($HK$3.1 bil­lion), Caix­in re­port­ed. While the val­u­a­tion is un­clear, the com­pa­ny dis­closed in its prospec­tus that it was val­ued at $1.05 bil­lion in its most re­cent ven­ture round.

Backed by some of the flashiest names in biotech in­clud­ing ARCH, WuXi and Sin­ga­pore’s GIC, and helmed by Sanofi vet Frank Jiang, CStone had boast­ed of pock­et­ing the largest Se­ries B round — $260 mil­lion — in the his­to­ry of Chi­nese bio­phar­ma. And it’s put the mon­ey to work, hav­ing burned through $148 mil­lion by last Sep­tem­ber, do­ing some heavy R&D lift­ing for its I/O pipeline, li­cens­ing com­mer­cial rights to Agios’ AML drug and poach­ing a Gold­man Sachs banker to be its CFO.

GIC has agreed to be a cor­ner­stone in­vestor along­side Boyu Cap­i­tal, In­dus Funds and Is­hana Cap­i­tal, pledg­ing a to­tal of $95 mil­lion, which would trans­late to 30%-plus of the to­tal of­fer­ing and a com­bined 6% stake in CStone.

Frank Jiang

It’s now late-stage crunch time, with the spot­light on its PD-L1 in­hibitor CS1001. Catch­ing up with the first wave of home­grown check­points to hit the Chi­nese mar­ket — fol­low­ing ap­provals for In­novent and Jun­shi, which both went pub­lic on the HKEX re­cent­ly — CStone is start­ing out with small­er in­di­ca­tions like clas­si­cal Hodgkin’s lym­phoma and nat­ur­al killer T cell lym­phoma, with plans to sub­mit NDAs in H2 2019 and H1 2020, re­spec­tive­ly.

Phase III tri­als in non-small cell lung can­cer, gas­tric can­cer and he­pa­to­cel­lu­lar car­ci­no­ma will com­mence some time be­fore those sub­mis­sions, the com­pa­ny writes in its fil­ing.

CStone’s de­but on Feb­ru­ary 26 (one week af­ter it prices) will be close­ly watched as in­vestors find out whether its stock will take a quick plunge like As­cle­tis’ and BeiGene’s — both have yet to re­cov­er — or en­joy the kind of cheer­ful ral­ly Jun­shi and In­novent saw late last year.

Al­most a year af­ter the HKEX opened up to pre-rev­enue biotechs, the ju­ry is still out.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.

An­oth­er hic­cup for GW Phar­ma's seizure drug ri­val, as Zo­genix dis­clos­es FDA re­view de­lay

Zogenix has had a troubling 2020 so far. Earlier this month, its experimental seizure drug met the main goal in a pivotal study in patients with Lennox-Gastaut Syndrome, but the company saw its shares plummet after the magnitude of the therapy’s effect fell short of Wall Street expectations. On Thursday, the drug developer said that the FDA had extended the review of the drug in patients with Dravet syndrome by three months.