Up­start Akero con­tin­ues its swoosh in­to NASH space with $70M wind­fall round

Akero Ther­a­peu­tics first swooshed on­to the NASH stage with a drug in-li­censed from Am­gen, re­cruit­ing Gilead’s An­drew Cheng as CEO sev­er­al months lat­er and mak­ing a cross-coun­try move to San Fran­cis­co. Now, it’s cap­ping an event­ful year with $70 mil­lion more to bankroll its Phase II work and scale the op­er­a­tions con­sid­er­ably.

An­drew Cheng

Led by Janus Hen­der­son In­vestors, the Se­ries B comes just six months af­ter Akero launched with $65 mil­lion in Se­ries A cash, sug­gest­ing that an IPO could be in sight.

The com­pa­ny is now on track to be­gin Phase II stud­ies of AKR-001 in mid-2019, with plans to build up com­mer­cial-scale man­u­fac­tur­ing and ex­pand its pipeline.

AKR-001 is a long-act­ing ana­log of FGF21, a meta­bol­ic hor­mone that CSO Tim Rolph has been work­ing with for the past 8 years, when he was still lead­ing re­search for Pfiz­er.

Tim Rolph

“It’s a mech­a­nism that us­es the whole body to get to a bet­ter place,” Rolph pre­vi­ous told End­points News. “It plays an es­sen­tial role restor­ing cells un­der stress — that’s what drove my in­ter­est.”

The com­pa­ny ex­plains the ex­pect­ed ef­fect this way:

With spe­cif­ic po­ten­cy at re­cep­tors FGFR1c, 2c and 3c but not FGFR4, AKR-001 is ex­pect­ed to re­duce liv­er fat, cel­lu­lar stress, in­flam­ma­tion and fi­bro­sis in pa­tients with NASH and to im­prove risk fac­tors of car­dio­vas­cu­lar dis­ease, re­duc­ing triglyc­erides and non-HDL cho­les­terol.

New in­vestors Red­mile Group, Box­er Cap­i­tal of Tavi­s­tock Group, Cor­morant As­set Man­age­ment, BVF Part­ners, Rock Springs Cap­i­tal and LifeSci Ven­ture Part­ners joined ex­ist­ing in­vestors for the round. They in­clude Ap­ple Tree Part­ners — which seed­ed the project and pro­vid­ed the ini­tial CEO, Jonathan Young — At­las Ven­ture, ven­Bio Part­ners and Ver­sant Ven­tures.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Eliot Charles, MiroBio executive chairman

Ox­ford spin­out nabs al­most $100M in new cash to test PD-1 in au­toim­mune dis­eases and hunt for a CEO

After about 15 years in an Oxford lab and three more years in the upstart world following a 2019 spinout, MiroBio is ready to enter UK clinical trials and, en route to the clinic, the biotech has picked up $97 million in Series B funds.

The £80 million financing round kicked off in earnest last September and includes a transatlantic consortium — led by Medicxi — ready to bankroll that first clinical trial, beginning “imminently,” as well as the debut study of a second program thereafter, executive chair Eliot Charles, an SR One venture partner, told Endpoints News.