Mi­to­chon­dria biotech re­ceives Morn­ing­side buy­out of­fer af­ter PhII fail; On­col­o­gy mi­cro­cap with­draws IPO plans

Not even two months af­ter re­port­ing a Phase II fail for its lead drug can­di­date, Stealth Bio­Ther­a­peu­tics is now be­ing eyed for a po­ten­tial ac­qui­si­tion, with one firm want­i­ng to take it pri­vate.

Stealth re­port­ed Mon­day that Morn­ing­side Ven­ture In­vest­ments sent Stealth’s board of di­rec­tors a non-bind­ing pre­lim­i­nary pro­pos­al to ac­quire all out­stand­ing shares not yet owned by Morn­ing­side for 2.6 cents per share and 31.3 cents per ADS.

Ac­cord­ing to a state­ment that Stealth put out, the board had pre­vi­ous­ly formed a com­mit­tee of three in­de­pen­dent di­rec­tors (Kevin McLaugh­lin, Fran­cis Chen, and Lou Lange) to “eval­u­ate all strate­gic al­ter­na­tives avail­able to the Com­pa­ny.” That com­mit­tee, Stealth said, ex­pects to re­tain a fi­nan­cial ad­vi­sor to as­sist with its eval­u­a­tion of that of­fer or any oth­er al­ter­na­tive trans­ac­tions open to pur­suit.

Stealth’s share price $MI­TO cur­rent­ly hov­ers around 28 cents a share.

The board and the com­mit­tee said that no de­ci­sions have been made yet and that “The Com­pa­ny does not un­der­take any oblig­a­tion to pro­vide any up­dates with re­spect to any trans­ac­tion, ex­cept as re­quired un­der ap­plic­a­ble law.”

Stealth’s elamipre­tide failed on pri­ma­ry goals in low lu­mi­nance vi­su­al acu­ity and ge­o­graph­ic at­ro­phy pro­gres­sion in pa­tients with GA sec­ondary to dry age-re­lat­ed mac­u­lar de­gen­er­a­tion. It’s the com­pa­ny’s most re­cent fail af­ter the FDA re­fused the drug for ge­net­ic con­di­tion Barth syn­drome last fall.

Phase I neoanti­gen biotech pulls back $9 mil­lion IPO plans

New Jer­sey biotech Ad­vax­is has de­cid­ed to pull back its plans for an IPO.

The can­cer-fo­cused biotech had orig­i­nal­ly filed for an IPO last month, ini­tial­ly aim­ing to raise $9 mil­lion shares for ap­prox­i­mate­ly $3.70 a share. As of right now, the com­pa­ny is ex­am­in­ing drug can­di­date ADXS-504 in a Phase I clin­i­cal tri­al an­nounced last Ju­ly in pa­tients with “bio­chem­i­cal­ly re­cur­rent prostate can­cer.”

The biotech, found­ed more than three decades ago in 1987, planned to list on Nas­daq un­der the tick­er ADXS. It did not list why it was with­draw­ing its IPO plans, but ac­cord­ing to an amend­ed S-1 filed on May 24, the pro­ceeds were go­ing to be used “for work­ing cap­i­tal and oth­er gen­er­al cor­po­rate pur­pos­es.”

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

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

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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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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No­vo Nordisk touts an­oth­er once-week­ly in­sulin win; Mere­o's board bat­tle heats up again

Novo Nordisk has completed the posting of topline results across its six Phase IIIa clinical trials in the ONWARDS program, rounding out a full-fledged effort to bring another diabetes treatment to market.

In ONWARDS 5, once-weekly insulin icodec was found to be non-inferior to once-daily basal insulin in reducing HbA1c, the Danish Big Pharma reported Monday. With that, the 52-week open-label trial met its primary endpoint at the end of the study.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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