Arc­turus takes an­oth­er le­gal stab at for­mer CEO as pub­lic bat­tle turns se­ri­ous for the com­pa­ny

The bit­ter and pub­lic feud be­tween small RNA med­i­cines com­pa­ny Arc­turus Ther­a­peu­tics $ARCT and its for­mer CEO Joe Payne is rag­ing on Fri­day, with a brand new law­suit (yes, an­oth­er one) launched against Payne and a few of his as­so­ciates.

Joseph Payne

In the law­suit, Arc­turus al­leges that Payne and his as­so­ciates Bradley Soren­son, Pe­ter Far­rell, and An­drew Sas­sine (col­lec­tive­ly re­ferred to as “the Payne group”) have failed to file cer­tain pa­per­work with the SEC. Specif­i­cal­ly, the law­suit ac­cus­es the group for mul­ti­ple vi­o­la­tions of fed­er­al dis­clo­sure and re­port­ing rules un­der Sec­tion 13(d) of the Ex­change Act and Reg­u­la­tion 13D.

Arc­turus says it’s seek­ing in­junc­tive re­lief to com­pel the Payne group to com­ply with these reg­u­la­tions, but per­haps more im­por­tant­ly, the law­suit al­so seeks to pre­vent Payne and his as­so­ciates from “con­tin­u­ing to mis­lead the vot­ing share­hold­ers of Arc­turus lead­ing up to the next ex­tra­or­di­nary gen­er­al meet­ing of share­hold­ers.”

In oth­er words, Arc­turus is hop­ing if it airs Payne’s dirty laun­dry, then share­hold­ers won’t side with Payne’s pro­pos­al to re­place the whole Arc­turus board with his own ap­point­ments.

Payne, the for­mer chief ex­ec­u­tive who was fired from Arc­turus for al­leged­ly putting his own self-in­ter­ests be­fore the com­pa­ny’s, has been a bit of a thorn in the com­pa­ny’s side over the past cou­ple of months. Payne took the first pub­lic swing in the bat­tle roy­al, claim­ing that four board mem­bers con­spired on his ouster. But then Arc­turus hit back with its own state­ment, even as it com­plied with Payne’s re­quest to vote on new board mem­bers.

Then late last month, the drawn out fight took a nasty turn when Arc­turus launch­es its first law­suit against Payne, seek­ing dam­ages and in­junc­tive re­lieve and de­tail­ing Payne’s mul­ti­ple al­leged mis­con­ducts. Those in­clud­ed op­er­at­ing a “lu­cra­tive side busi­ness dur­ing busi­ness hours” and at­tempt­ing to trans­fer Arc­turus’ IP for no ap­par­ent rea­son dur­ing his tenure, in ad­di­tion to or­ches­trat­ing a move to block Arc­turus’ rou­tine au­dit­ing ac­tiv­i­ty.

But things are start­ing to get re­al for Arc­turus, it says, as Payne’s ac­tions could have se­ri­ous con­se­quences for the com­pa­ny. That move with the au­di­tors, for ex­am­ple, could po­ten­tial­ly re­sult in Arc­turus get­ting boot­ed from the Nas­daq. In a state­ment, Arc­turus had this to say:

“The Payne Group’s ac­tions are cal­cu­lat­ed non-dis­clo­sures that promise to keep Arc­turus share­hold­ers in the dark at this crit­i­cal time in the Com­pa­ny’s his­to­ry, caus­ing di­rect and on­go­ing harm to the Com­pa­ny and its share­hold­ers as the EGM ap­proach­es. We be­lieve that if Payne and his as­so­ciates are al­lowed to con­tin­ue to evade dis­clo­sure re­quire­ments and op­er­ate in vi­o­la­tion of Reg­u­la­tion 13D, Arc­turus will not be able to have a free and fair di­rec­tor elec­tion.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

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Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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