Au­toim­mune biotech Kiniksa prices up­sized $152M IPO as Schol­ar Rock bags $75M for pre­clin­i­cal SMA drug

Two biotechs that have been on par­al­lel IPO tracks are blast­ing off with siz­able sup­port for their Nas­daq de­buts.

Kiniksa got the bulki­er raise among the two, reap­ing $152 mil­lion at $18 a share — up from the $126 mil­lion it was look­ing for — by of­fer­ing 8.44 mil­lion shares, or 21% more than orig­i­nal­ly planned. Schol­ar Rock, mean­while, got what it asked for, pric­ing its $75 mil­lion IPO at the mid­point of $14.

Both biotechs are head­quar­tered in the Boston/Cam­bridge hub, with Kiniksa fur­ther along in the clin­ic.

Sanj Pa­tel, Kiniksa

Lex­ing­ton, MA-based Kiniksa ap­pealed to in­vestors with a pipeline of drugs for au­toin­flam­ma­to­ry and au­toim­mune con­di­tions, in­clud­ing three clin­i­cal-stage prod­uct can­di­dates that the pub­lic of­fer­ing is meant to fund. Its most ad­vanced as­set is an ap­proved in­ter­leukin-1 drug li­censed from Re­gen­eron named Ar­c­a­lyst (rilona­cept). The drug is cur­rent­ly mar­ket­ed for cry­opy­rin-as­so­ci­at­ed pe­ri­od­ic syn­dromes, but CEO Sanj Pa­tel and his team think it might be able to treat the in­flam­ma­to­ry car­dio­vas­cu­lar dis­ease peri­cardi­tis.

The biotech, which will list as $KN­SA, is con­duct­ing an open-la­bel Phase II study for rilona­cept, with plans to en­ter Phase III this year. Gold­man Sachs and JP Mor­gan act­ed as lead man­agers on the deal.

Nagesh Ma­han­thap­pa, Schol­ar Rock

Run by Nagesh Ma­han­thap­pa, Schol­ar Rock is for now ded­i­cat­ed to bring­ing its spinal mus­cu­lar at­ro­phy ther­a­py SRK-015 in­to the clin­ic, with hopes to dis­cov­er ad­di­tion­al in­di­ca­tions by the sec­ond half of next year. Un­like ri­vals from No­var­tis and Roche/Bio­gen, Schol­ar Rock’s drug in­hibits la­tent, not ac­tive, myo­statin. In do­ing so, the treat­ment aims to boost mus­cle mass and strength in SMA pa­tients.

The mon­ey will al­so boost oth­er pre­clin­i­cal R&D ac­tiv­i­ties based on Schol­ar Rock’s plat­form tech­nol­o­gy — which tar­gets growth fac­tors by har­ness­ing supra­cel­lu­lar ac­ti­va­tion — in ar­eas rang­ing from fi­bro­sis and im­muno-on­col­o­gy to ane­mias as­so­ci­at­ed with iron re­stric­tion.

With Jef­feries, Cowen & Com­pa­ny and BMO Cap­i­tal Mar­kets act­ing as lead man­agers, Schol­ar Rock can be spot­ted on Nas­daq un­der the sym­bol $SRRK.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.