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.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.