So you just got a BTD for your top drug? Don't be sur­prised to see the en­thu­si­asm fiz­zle fast among in­vestors

We’ve al­ready seen stud­ies spot­light­ing how the FDA’s break­through ther­a­py des­ig­na­tion can lead doc­tors and pa­tients to get un­rea­son­ably pumped about a drug — even though that was nev­er the idea. But it seems that in­vestors have be­come large­ly im­mune to the buzz, at best los­ing in­ter­est quick­ly.

How do we know?

A group of re­searchers took a list of 218 BTDs, sliced away the ex-US and pri­vate com­pa­nies, and then tracked the stock re­ac­tion to the an­nounce­ment. Di­vid­ing the list in­to com­mer­cial and pre-com­mer­cial out­fits, they found that the more ma­ture com­pa­nies es­sen­tial­ly saw no re­sponse in the tick­er price. The less ma­ture pre-com­mer­cial biotechs got a clear pop on their stock price, but that just last­ed a few days and then quick­ly fiz­zled.

They re­port­ed their find­ings in Na­ture Re­views.

Cred­it: Na­ture Re­views

Click on the im­age to see the full-sized ver­sion

In the Pipeline blog­ger Derek Lowe took a look and of­fered his as­tute opin­ion that if you went back to the ear­ly days of the BTD pro­gram, you would prob­a­bly have seen more op­ti­mism on Wall Street. Clear­ly, though, that ex­cite­ment over a BTD an­nounce­ment fad­ed long ago. You get 218 press re­leas­es on the same thing, peo­ple stop jump­ing so fast.

For Big Phar­ma, it’s un­like­ly that the agency’s 6th or 7th BTD for an es­tab­lished prod­uct — say Keytru­da — would change any­one’s fi­nan­cial fore­cast. And even where it may have made a dif­fer­ence for a po­ten­tial block­buster — let’s call out J&J’s es­ke­t­a­mine, which was clear­ly helped out by the agency’s en­dorse­ment in its cam­paign to over­come more neg­a­tive than pos­i­tive piv­otal da­ta — it’s hard to in­flu­ence a mam­moth val­u­a­tion with a sin­gle BTD on a sin­gle pro­gram.

Of course, the FDA wasn’t try­ing to game the stock mar­ket with their BTD pro­gram. The FDA has re­peat­ed­ly held up BTDs, along with fast track des­ig­na­tions, etc, as their com­mit­ment to speed­ing up the process to reach a de­ci­sion — and few peo­ple in the in­dus­try would doubt their sin­cer­i­ty on that score. Over the last year we’ve al­so seen FDA com­mis­sion­er Scott Got­tlieb of­fer var­i­ous sug­ges­tions for fur­ther ac­cel­er­at­ing the process at a time over­all new drug ap­provals are rid­ing an all-time high.

All that does add val­ue in the in­dus­try — but it’s a long way from the kind of cat­a­lyst in­vestors look for.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

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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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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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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