In­vestors lost big as Alzheimer’s R&D went over the cliff in 2019. Will they ever come back?

Neu­rotrope this week joined the long line of bio­phar­ma com­pa­nies that have been mauled by clin­i­cal fail­ure for Alzheimer’s drugs. But their crushed shares ($NTRP down from more than $8 in June to pen­ny stock range to­day) rep­re­sent­ed just a tiny drop in the buck­et of red ink that has drained from play­ers which have pur­sued the great­est of all Holy Grails in drug R&D. Decades of de­feat, head­lined by the likes of solanezum­ab at Eli Lil­ly stretch­ing to the most re­cent sna­fu with Bio­gen’s ad­u­canum­ab, have forced a slew of play­ers to change course on their R&D strat­e­gy — or just leave it in lim­bo.

How bad is it?

Bio­gen’s shares tanked when ad­u­canum­ab bombed, forc­ing an ear­ly halt to the late-stage ef­fort. The mar­ket cap shriv­eled by bil­lions, and it’s still down about 29% from pre-cri­sis lev­els. That plunge came af­ter Roche’s crenezum­ab flopped, though Roche was much bet­ter po­si­tioned to han­dle the fail­ure. But its part­ner, AC Im­mune $ACIU saw its share price halved in the fall­out.

The field went over the cliff in 2019.

What makes this im­por­tant for the long run?

In­vestors and an­a­lysts don’t gen­er­al­ly care to en­ter a mine­field where the chance of be­ing blown sky-high has been run­ning 100% — a mes­sage that has been heard loud and clear in re­cent months. Bio­gen — still al­lied to Ei­sai — has es­sen­tial­ly been ad­vised to write off Alzheimer’s al­to­geth­er as a com­plete loss. The amy­loid hy­poth­e­sis lies in tat­ters, while a se­ries of BACE fail­ures al­so un­der­scored some trou­bling safe­ty is­sues that made it all the way in­to a se­ries of late-stage stud­ies.

No one here re­al­ly knows what they’re do­ing. And any new rounds of mid-stage da­ta claim­ing suc­cess against bio­mark­ers are wide­ly ig­nored. Be­cause the bio­mark­ers have nev­er been proven to be in­dica­tive of suc­cess.

And with­out in­vestor sup­port, you can for­get any ma­jor new for­ays in late-stage test­ing.

The fo­cus now has shift­ed to tau and com­bo ther­a­pies, as new com­pa­nies start to tout ques­tion­able ev­i­dence of “suc­cess” in or­der to try to lure in­vestors back. But af­ter you’ve been burned this many times, that ar­gu­ment will be hard to make.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.