Graziano Seghezzi Sofinno­va

Italy’s En­thera Phar­ma­ceu­ti­cals has grabbed a €28 mil­lion launch round to back its work on, lay­ing brag­ging rights to the largest A round ever for an Ital­ian biotech.

The com­pa­ny is us­ing “non­tra­di­tion­al” tech to tar­get au­toim­mune dis­eases, look­ing to re-es­tab­lish stem cell ca­pa­bil­i­ties in type 1 di­a­betes and in­flam­ma­to­ry bow­el dis­ease.

Graziano Seghezzi, man­ag­ing part­ner of Sofinno­va Part­ners, co-seed­ed the com­pa­ny, with Ab­b­Vie step­ping in to help out. This is Ab­b­Vie’s first in­vest­ment in the Ital­ian biotech scene.

CEO Gio­van­ni Am­a­bile said that “the funds raised will en­able us to ac­cel­er­ate our lead pro­gram Ent001 to clin­i­cal proof-of-con­cept. Through this and the de­vel­op­ment of our wider pipeline, we have the op­por­tu­ni­ty to bring re­al hope to pa­tients in need and to pro­vide ef­fec­tive and safe treat­ments.”

Bio­Th­eryX adds a $35M D round as biotech ven­ture pot swells

San Diego-based Bio­Th­eryX has gar­nered $35 mil­lion for its D round. And the CEO isn’t let­ting the oc­ca­sion go past with­out tout­ing the tech.

“We are pleased to have closed this fi­nanc­ing that will en­able us to ac­cel­er­ate ex­pan­sion of our on­go­ing clin­i­cal tri­al of BTX-A51, which I be­lieve may ul­ti­mate­ly be­come one of the most sig­nif­i­cant in­no­va­tions in the past 40 years for AML pa­tients and their fam­i­lies,” said CEO David Stir­ling.

The biotech’s mis­sion is “restor­ing pro­tein home­osta­sis, in­clud­ing pro­tein degra­da­tion and mod­u­la­tion, and mul­ti-ki­nase in­hi­bi­tion to de­vel­op treat­ments in­tend­ed to ex­tend and im­prove the qual­i­ty-of-life of pa­tients with life-threat­en­ing dis­eases.”

MSD Part­ners led the round and their part­ner Robert Platek is join­ing the board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.