Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seat­tle-based Presage Bio­sciences, which ap­proach­es drug de­vel­op­ment through its mi­cro­dos­ing plat­form, has some new part­ner­ships and cash to come with them.

Presage closed a $13 mil­lion fi­nanc­ing round Tues­day, aim­ing to ex­pand its net­work of clin­i­cal tri­al sites and ad­vance de­vel­op­ment of its mi­cro­dos­ing in­jec­tion de­vices. They al­so closed part­ner­ship deals with Mer­ck and Mav­er­ick Ther­a­peu­tics.

The fi­nanc­ing in­clud­ed $7 mil­lion from new in­vestors, in­clud­ing the Lab­Corp Ven­ture Fund, Bris­tol My­ers Squibb, and In­Harv Part­ners. An ad­di­tion­al $6 mil­lion con­vert­ible note from Take­da Ven­tures will con­vert to eq­ui­ty.

Presage’s big idea cen­ters around what they call Phase 0 test­ing, which us­es mi­cro­dos­es of mul­ti­ple drugs and com­bos on pa­tients to gauge their phar­ma­co­dy­nam­ic ef­fects. Their tech al­lows re­searchers to pep­per a tu­mor with mul­ti­ple ther­a­pies while in use by pa­tients, pro­vid­ing a bet­ter snap­shot of rel­a­tive ac­tiv­i­ty.

Tues­day’s new re­search col­lab­o­ra­tions with Mer­ck and Mav­er­ick will uti­lize Presage’s plat­form to eval­u­ate new on­col­o­gy pro­grams in these Phase 0 tri­als, bring­ing their to­tal num­ber of part­ners to five.

Kem­Pharm AD­HD drug wins ap­proval in chil­dren 6 and up

Kem­Pharm scored a new ap­proval on Wednes­day, and it’s send­ing their stock soar­ing.

The Cel­e­bra­tion, FL-based biotech notched the FDA OK for Azs­tarys, a once-dai­ly treat­ment for AD­HD in chil­dren aged six and old­er. Azs­tarys, for­mer­ly dubbed KP415, con­sists of serdexmethylphenidate, Kem­Pharm’s pro­drug of the drug Fo­calin, co-for­mu­lat­ed with an im­me­di­ate-re­lease ver­sion of the prod­uct.

Shares of Kem­Pharm $KMPH sky­rock­et­ed as much as 90% in ear­ly Wednes­day trad­ing, set­tling in at around a 70% in­crease lat­er in the morn­ing. Azs­tarys will be com­mer­cial­ly avail­able as soon as the sec­ond half of this year, and that process will be led by a sub­sidiary of Gur­net Point Cap­i­tal.

The ap­proval will al­so trig­ger a mile­stone pay­ment from Gur­net Point Cap­i­tal to Kem­Pharm, which may to­tal up to $468 mil­lion.

AD­HD has been a lu­cra­tive mar­ket for drug­mak­ers, ac­count­ing for near­ly $18 bil­lion of rev­enue in 2019, Kem­Pharm said.

The pe­di­atric field has proven tough for com­peti­tors, though, with the FDA spurn­ing Su­per­nus’ pitch last No­vem­ber. Reg­u­la­tors cit­ed con­cerns about an in-house lab used to an­a­lyze their ex­per­i­men­tal drug.

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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 the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Jim Green­wood opens new pol­i­cy shop, with an eye on drug price con­trols; Mod­er­na, CRISPR, Mus­tang re­ceive tax breaks in Mass­a­chu­setts

Capitol Hill heavyweight Jim Greenwood is taking his decades of experience in the intertwining worlds of biopharma and Congress to the law firm DLA Piper, where he’s opening up a new policy and regulatory practice alongside former Pfizer lawyer Geoffrey Levitt.

As Congress wrangles over how to bring down drug prices, the former BIO CEO told Endpoints News in an interview that his top three priorities will be, “Price controls, price controls and price controls.”

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.