What you need to know about this record-set­ting biotech IPO burst as 5 more crash the par­ty look­ing for $547M

This is what a blistering biotech IPO pace looks like.

A half-dozen companies raised $718 million last week; 4 are out to raise $520 million-plus this week and 5 filed on Friday for another $547-million plus. Total: $1.78 billion. In one narrow time slot. Not surprisingly, this comes after an explosion of venture investing that has added billions of dollars to biotechs in a matter of months.

If the industry was an anaconda, you’d be watching the baby pig as it travels down the coil.

Last week’s record-setting cloudburst of 5 biotech IPOs in one day — followed by the solo leap of Autolus on Friday — pushed the 6-month total of IPOs to date to 29 in all. And we have 4 more lining up to hit the scene in the last week of the first-half. That leaves the sector on track to beat the full run of 2017 IPOs, in half the time. And theoretically it could set us on a path to 2014 levels, when pent-up demand following a lengthy drought and eager acceptance unleashed a wild 66-IPO romp.

What follows is an in-depth overview of where we are, the detailed view of two top analysts on H2 ahead, the performance of the last 6 biotechs to go public and a breakdown of the 5 that filed on Friday — including some of the buzziest drug developers in the world.

For many analysts, this unprecedented stampede of new offerings was completely unexpected. And it raises some serious questions. Who are these companies and investors making overnight (paper) fortunes? How does this track record compare to your projections and what’s driving it? Can the market sustain something like 60-plus biotech IPOs this year? And what are the key trends involved?

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Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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#JPM23: Is 2023 go­ing to be a bet­ter year for biotech deal­mak­ing?

Last year offered a disappointing stretch for biotech, with fewer deals than expected and lots more headwinds. Endpoints News Editor-in-Chief John Carroll sat down with some of the industry’s top dealmakers to explore what happened, and what’s ahead in 2023. This transcript has been edited for brevity and clarity.

John Carroll:

I’d say this is one of the most important conversations that’s going on right now. Particularly, of course, at JP Morgan, because so many people have come here, specifically to get involved in a deal, to see what they can do about a deal, to see what the deal potential is, where things are headed, what the trends are. Everything that we’re going to be covering here in the next hour.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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