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.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.