Jeremy Bender, Day One Biopharmaceuticals CEO

Two days af­ter show­ing strong pe­di­atric can­cer da­ta, Day One taps $150M in pub­lic cap­i­tal

Pub­lic biotechs can still raise mon­ey, but it comes with a big caveat: The clin­i­cal da­ta must im­press.

It ap­pears the mar­ket re­act­ed so with Day One Bio­phar­ma­ceu­ti­cals, as the biotech plans to se­cure $150 mil­lion this week in a pub­lic of­fer­ing. The four-year-old com­pa­ny is fol­low­ing a trend of biotechs go­ing straight to the mar­ket hours or days af­ter re­leas­ing re­sults that out­per­form ex­pec­ta­tions and pad the case for a drug’s po­ten­tial reg­u­la­to­ry path.

The fig­ure was orig­i­nal­ly $125 mil­lion, but the biotech seems to have gar­nered enough in­ter­est from in­vestors over the course of Tues­day on the back of a Sun­day night re­lease of clin­i­cal da­ta show­ing a for­mer Take­da drug worked well in treat­ing kids with a cer­tain form of brain can­cer.

The South San Fran­cis­co biotech had al­ready seen its shares $DAWN more than dou­ble since Fri­day’s clos­ing price, go­ing from $6.62 be­fore the week­end to $16 apiece be­fore Wednes­day’s open­ing bell. The com­pa­ny went pub­lic 54 weeks ago at an ini­tial price of $16, though that fig­ure surged on day one.

Day One’s drug, known as tovo­rafenib and in-li­censed from Take­da, had an ef­fect on many pa­tients in a mid-stage study, the biotech said Sun­day. An over­all re­sponse rate of 64% was record­ed among the first 22 evalu­able pa­tients who have a brain tu­mor known as re­cur­rent or pro­gres­sive low-grade glioma (pLGG).

The re­sults come from FIRE­FLY-1, which in­cludes a reg­is­tra­tion co­hort among three arms. That co­hort has en­rolled all pa­tients and will read out in 2023. A fil­ing is ex­pect­ed in the first half of next year, Cowen an­a­lysts not­ed. The an­a­lysts pre­dict­ed $675 mil­lion in peak sales in the R/R set­ting.

A Phase III study will be­gin in front­line pLGG, Day One de­cid­ed based on the new da­ta.

Oth­er biotechs have gone down this path in re­cent months. De­spite mas­sive head­winds and a shut­tered en­try on­to Wall Street for near­ly every am­bi­tious biotech, some list­ed com­pa­nies have been able to pull in new funds af­ter re­leas­ing da­ta that ex­cite in­vestors and throw some weight be­hind their the­ses.

Three com­pa­nies got the ball rolling in late March, over the span of 24 hours. As­cendis Phar­ma, ar­genx and Apel­lis Phar­ma­ceu­ti­cals reeled in a to­tal of $1.5 bil­lion in new monies af­ter late-stage and long-term da­ta on var­i­ous drugs.

More biotechs have fol­lowed suit since April show­ers be­gan. An­oth­er drug out of Take­da spurned a sim­i­lar fol­low-on of­fer­ing for Phath­om Phar­ma­ceu­ti­cals, which looked to the mar­ket for an­oth­er $260 mil­lion af­ter se­cur­ing FDA ap­proval to treat adults in­fect­ed by H. py­lori bac­te­ria. Re­zo­lute nabbed $130 mil­lion af­ter a Phase II da­ta drop in May, and Tar­sus sought about $75 mil­lion the same week af­ter a Phase III win for an eye drop.

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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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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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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