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.

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Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year, according to Forbes.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.