A Fore­site-in­cu­bat­ed biotech that de­buted just eight months ago closed a new mega fi­nanc­ing round on Thurs­day, and with it comes a com­pa­ny re­brand­ing.

Es­ker Ther­a­peu­tics will now call it­self Alu­mis fol­low­ing the com­ple­tion of a $200 mil­lion Se­ries B, the biotech an­nounced Thurs­day. The funds are ex­pect­ed to go to­ward Alu­mis’ pipeline, in­clud­ing its lead pro­gram ESK-001, a TYK2 in­hibitor tar­get­ing the pan-JAK path­way that the com­pa­ny has tout­ed as po­ten­tial­ly safer than cur­rent JAK in­hibitors.

“The fund­ing re­al­ly serves for us to ad­vance the pro­gram in­to the clin­ic, and then we have al­so a pipeline build­ing be­hind it,” CEO Mar­tin Babler told End­points News in an in­ter­view. “And we want to al­so make sure that we can take full ad­van­tage of our da­ta an­a­lyt­ics plat­form to re­al­ly ex­plore ad­di­tion­al tar­gets and ad­di­tion­al in­di­ca­tions.”

The lead com­pound is be­ing eval­u­at­ed in pso­ri­a­sis, and a Phase I safe­ty and tol­er­a­bil­i­ty study was ex­pect­ed to read out by the end of 2021. Though the com­pa­ny hasn’t put out a press re­lease with the da­ta yet, Babler said Alu­mis is “ex­treme­ly pleased” with the mol­e­cule.

“The fea­tures that we see is re­al­ly that we have a great PK pro­file, and that we have good se­lec­tiv­i­ty,” he said. “We’re on track to re­al­ly un­der­stand how this mol­e­cule stacks up against oth­ers in the field.”

For­mer CEO and founder June Lee had pre­vi­ous­ly said she ex­pect­ed the pro­gram to serve as a proof-of-con­cept for the rest of Alu­mis’ plat­form. By aim­ing to iden­ti­fy cer­tain ge­net­ic tar­gets, Lee not­ed she want­ed to serve pa­tients she felt had been in the “come-one-come-all” im­munol­o­gy mar­ket.

ESK-001 will have plen­ty of com­pe­ti­tion as the JAK field has seen much crowd­ing in re­cent years. Though Lee said Alu­mis’ mol­e­cule sprout­ed from the same class as Bris­tol My­ers Squibb’s deu­cravac­i­tinib, that drug beat out Am­gen’s Ote­zla in a piv­otal head-to-head pso­ri­a­sis tri­al last year, and the FDA has set a PDU­FA date for Sep­tem­ber.

“Fun­da­men­tal­ly, TYK2 is a mem­ber of the class of the JAK in­hibitors, but it has re­al­ly a dif­fer­en­ti­at­ed pro­file,” Babler said. “And one of the things about this mol­e­cule, it’s one of sev­er­al al­losteric TYK2 in­hibitors that are in de­vel­op­ment. And those in­hibitors re­al­ly don’t have a lot of JAK phar­ma­col­o­gy. And so we don’t re­al­ly see at least so far from from the lead­ing mol­e­cule in this class, which is the BMS mol­e­cule, and our own and oth­ers, the same phar­ma­col­o­gy that you see with JAK in­hibitors.”

Out­side this mol­e­cule, the com­pa­ny is aim­ing to de­vel­op oth­er can­di­dates in the im­munol­o­gy space, with Babler say­ing in a re­lease Thurs­day the com­pa­ny may look to ac­quire oth­er as­sets in ad­di­tion to build­ing out its pipeline.

The JAK space has been shak­en in re­cent months by re­peat­ed safe­ty is­sues, fol­low­ing a post-mar­ket­ing study for Pfiz­er’s Xel­janz that el­e­vat­ed the con­cerns in ear­ly 2021. De­spite the re­newed scruti­ny, the FDA has waved through new JAK in­hibitors re­cent­ly, ap­prov­ing Xel­janz and Ab­b­Vie’s Rin­voq for new in­di­ca­tions last month.

But the drugs came with ex­pand­ed warn­ings and a key la­bel change, say­ing they can on­ly be tak­en af­ter a pa­tient has failed on one or more TNF block­ers such as Hu­mi­ra. The shift came af­ter reg­u­la­tors flagged the risk of car­dio­vas­cu­lar events in pa­tients old­er than 50 with boxed warn­ings on Xel­janz, Rin­voq and Eli Lil­ly’s Olu­mi­ant.

“While we have a lead as­set, this is al­so about build­ing an en­tire pipeline be­hind it,” Babler said. “And so we are ac­tive­ly work­ing on sev­er­al oth­er pro­grams that we will dis­close at the ap­pro­pri­ate time.”

Four months after the FDA put two clinical trials from Curis on clinical hold, the FDA is now apparently content with how the biotech will change up managing one of the studies.

The Massachusetts oncology biotech put out word early Thursday that the federal regulator lifted a partial clinical hold of the company’s Phase I/II study of emavusertib in lymphoma, following a new data package that the biotech recently submitted to the agency. Shares of the biotech $CRIS, hovering just above penny stock territory, shot up more than 55% in early trading before settling at close to a 30% share price boost.

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.