A mys­tery in­vestor is back­ing a new late-stage ef­fort to treat NASH, lead­ing an $80 mil­lion crossover round for Sagimet Bio­sciences.

The Se­ries F round was led by an “undis­closed pub­lic eq­ui­ty health­care in­vest­ment fund” and joined by Al­tium Cap­i­tal, HM Cap­i­tal, In­vus, and PFM Health Sci­ences, As­cle­tis, Klein­er Perkins, New En­ter­prise As­so­ci­ates, and Rock Springs Cap­i­tal. It comes on the heels of pos­i­tive mid-stage da­ta last June, when the com­pa­ny an­nounced a 61% re­sponse rate in 30 pa­tients and a me­di­an liv­er fat re­duc­tion of 28.2%.

A sec­ond undis­closed pub­lic health­care in­vest­ment fund al­so joined the round.

Sagimet, which was known as 3-V Bio­sciences un­til 2019, spe­cial­izes in FASN. The en­zyme is in­volved in lipid syn­the­sis; in­hibit­ing it, in the­o­ry, could re­duce fat pro­duc­tion and al­le­vi­ate dis­eases such as NASH and even can­cer. The com­pa­ny will use the cap­i­tal to help launch a Phase IIb tri­al.  — Ja­son Mast

Em­ploy­ees at GSK plant fear lay­offs af­ter No­var­tis sale

Glax­o­SmithK­line’s de­ci­sion to sell its gener­ics an­tibi­otics busi­ness to No­var­tis’s San­doz unit has brought fears of mass lay­offs to Ul­ver­ston, Eng­land, where the an­tibi­otics have been man­u­fac­tured.

Al­though GSK will con­tin­ue to sup­ply San­doz with the an­tibi­ot­ic, cephalosporin, for the next four years, the sale has put 130 jobs at “risk of re­dun­dan­cy,” The Mail re­port­ed.

This com­pa­ny has been a main­stay in the town, pro­vid­ing em­ploy­ment and re­sources,” town coun­cil­man David Web­ster told the British out­let. “It will be a great loss and a tremen­dous gap to fill in em­ploy­ment and co­op­er­a­tion.”

A GSK spokesper­son told The Mail that the sale was meant as part of a com­pa­ny-wide shift to fo­cus on R&D. The big phar­ma has pledged land to al­low Lake Bio­sciences, which man­u­fac­tures mon­o­clon­al an­ti­bod­ies, to build a £350 mil­lion fa­cil­i­ty there.  — Ja­son Mast

Seagen notch­es Tukysa OK in Eu­rope

Af­ter get­ting its Tukysa drug across the fin­ish line in the US last year, Seagen has done the same in Eu­rope.

The com­pa­ny an­nounced Fri­day morn­ing that the breast can­cer treat­ment had been giv­en the thumbs up by the Eu­ro­pean Com­mis­sion. Like in the US, it’s been ap­proved for the treat­ment of adults with HER2-pos­i­tive lo­cal­ly ad­vanced or metasta­t­ic breast can­cer, in com­bi­na­tion with Her­ceptin and capecitabine for those who have re­ceived at least two pri­or an­ti-HER2 treat­ments.

In Tukysa’s piv­otal tri­al in Eu­rope, the drug showed a 46% im­prove­ment for pro­gres­sion-free sur­vival com­pared to the con­trol arm of Her­ceptin and capecitabine, as well as im­prov­ing over­all sur­vival by 34%. Pa­tients were ran­dom­ized to the drug arm 2-to-1 in the dou­ble-blind­ed tri­al.

Tukysa is a ty­ro­sine ki­nase in­hibitor of the HER2 pro­tein and was orig­i­nal­ly de­vel­oped by Ar­ray Bio­Phar­ma, who li­censed it to Cas­ca­di­an Ther­a­peu­tics. Seat­tle Ge­net­ics bought Cas­ca­di­an for $614 mil­lion in 2018. — Max Gel­man

Once a promising $725 million play in immunology, Gilead’s big bet on filgotinib effectively disintegrated in December when the drugmaker reworked its partnership with Galapagos. Now, Galapagos is sporting safety data that will come as a relief — but will it make a difference on filgotinib’s chances in the US?

In a study designed to compare filgotinib’s effect on sperm count with placebo, Galapagos’ JAK inhibitor saw fewer patients post a 50% or more reduction in sperm concentration after 13 weeks of treatment, according to data from the MANTA and MANTA-RAy studies unveiled Thursday.

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.