Rev­o­lu­tion Med­i­cines is adding As­traZeneca to its ros­ter of clin­i­cal col­lab­o­ra­tors, lend­ing its lead drug, RMC-4630, for a study pair­ing it with the phar­ma gi­ant’s KRAS G12C pro­gram.

As­traZeneca will spon­sor and con­duct the study once its now pre­clin­i­cal drug is ready for hu­man stud­ies, an arrange­ment sim­i­lar to the deal Rev­o­lu­tion has with Am­gen on so­tora­sib.

“Drug com­bi­na­tions are like­ly to be crit­i­cal for de­feat­ing in­her­ent drug re­sis­tance mech­a­nisms ex­ploit­ed by RAS-ad­dict­ed can­cers,” CEO Mark Gold­smith said in a state­ment.

An al­losteric SHP2 in­hibitor, RMC-4630 at­tract­ed Sanofi for a part­ner­ship that in­volved $50 mil­lion up­front, 80% of the R&D cost, and a swath of mile­stones adding up to $520 mil­lion. Rev­o­lu­tion is al­so work­ing on a pipeline — from its buy­out of Warp Dri­ve Bio — of drugs that di­rect­ly in­hib­it onco­genic RAS(ON) vari­ants, in­clud­ing KRASG12C(ON) and KRASG12D(ON). — Am­ber Tong

Val­lon Phar­ma­ceu­ti­cals files for $17 mil­lion IPO 

More than 70 biotechs have hit Wall Street so far this year, and Val­lon Phar­ma­ceu­ti­cals is look­ing to join them. The Philadel­phia-based com­pa­ny filed for a $17 mil­lion raise on Fri­day to de­vel­op its abuse-de­ter­rent pre­scrip­tion drugs for CNS dis­or­ders.

The com­pa­ny’s lead can­di­date, dubbed ADAIR (short for abuse-de­ter­rent am­phet­a­mine im­me­di­ate-re­lease),  is an oral for­mu­la­tion of im­me­di­ate-re­lease dex­troam­phet­a­mine for AD­HD and nar­colep­sy. Val­lon snagged the rights from Arc­turus in 2018, in re­turn for 33.7 mil­lion shares, ac­cord­ing to the S-1. It has com­plet­ed a Phase I piv­otal bioe­quiv­a­lence study and a Phase I food ef­fect study.

“We are al­so cur­rent­ly con­duct­ing a pre­clin­i­cal em­bry­ofe­tal study for which we an­tic­i­pate re­sults in the fourth quar­ter of 2020, and plan­ning to con­duct a 13-week pre­clin­i­cal tox­i­col­o­gy study on the fi­nal for­mu­la­tion of ADAIR and ad­di­tion­al pre­clin­i­cal stud­ies of un­in­tend­ed routes of ad­min­is­tra­tion such as IV and in­tranasal ad­min­is­tra­tion,” the S-1 states.

The com­pa­ny has not yet se­lect­ed a tick­er. — Nicole De­Feud­is 

Atea sets terms for pub­lic de­but, seeks to raise $253 mil­lion

Atea Phar­ma­ceu­ti­cals filed ear­li­er this month for a $100 mil­lion IPO. But ac­cord­ing to terms set Mon­day by the Boston-based biotech, it could stand to raise much more.

The com­pa­ny is look­ing to net $253 mil­lion by of­fer­ing 11 mil­lion shares at a range of $22 to $24. At the mid­point of the range, $23, Area would rake in $232.1 mil­lion, ac­cord­ing to the S-1/A.

The com­pa­ny is work­ing on an­tivi­ral ther­a­peu­tics to treat sin­gle-strand­ed ri­bonu­cle­ic acid (ss­R­NA) virus­es. Its lead can­di­date, AT-527, is cur­rent­ly in a Phase II tri­al to treat mod­er­ate Covid-19, with topline re­sults ex­pect­ed in the first half of next year.

This month, Roche agreed to pay $350 mil­lion for de­vel­op­ment and com­mer­cial­iza­tion rights to  AT-527 out­side of the US. — Nicole De­Feud­is 

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.