The cen­ter­piece of Sanofi’s im­munol­o­gy ef­forts suc­ceed­ed in two more Phase 3 eczema stud­ies in the US, the com­pa­ny an­nounced Fri­day, set­ting up a pos­si­ble FDA sub­mis­sion be­fore the end of the year.

But the pro­gram, known as am­lite­limab, once again ap­peared to un­der­per­form mar­ket leader Dupix­ent on a mea­sure­ment of skin clear­ance, po­ten­tial­ly mud­dy­ing the out­look. And in one of the tri­als, am­lite­limab did not reach sta­tis­ti­cal sig­nif­i­cance on the EU-spe­cif­ic pri­ma­ry end­points.

The mixed re­sults for a drug that's been hyped as a po­ten­tial block­buster had lim­it­ed im­pact on Sanofi's stock price SNY, in stark con­trast to Sep­tem­ber's 9% plunge af­ter a dis­ap­point­ing pre­vi­ous am­lite­limab read­out.

F2G plans to re­sub­mit its an­ti­fun­gal to the FDA af­ter col­lect­ing Phase 3 da­ta this com­ing June, CEO Francesco Maria Lavi­no told End­points News.

The biotech's oral can­di­date, called olo­rofim, was spurned by the FDA in 2023 for use in in­va­sive fun­gal in­fec­tions. At the time of a $100 mil­lion Se­ries H in Sep­tem­ber 2024, Lavi­no said the biotech aimed to re­sub­mit af­ter col­lect­ing more Phase 2b da­ta on the drug.

Now, F2G will wait about six to eight months longer than ini­tial­ly planned to re­sub­mit for ap­proval, so it can in­clude the Phase 3 da­ta, the ex­ec­u­tive said.

"The FDA en­cour­aged us to look for a bet­ter his­tor­i­cal con­trol," Lavi­no told End­points on Fri­day. "We tried, but the re­al­i­ty is that in the mean­time, the Phase 3 start­ed en­rolling well, so we de­cid­ed to re­al­ly fo­cus on a Phase 3 ap­proach, es­pe­cial­ly be­cause this is far more de-risked and be­cause of the 12 years of reg­u­la­to­ry ex­clu­siv­i­ty."

→ Eli Lil­ly is one of many large phar­mas that have hired dis­placed or dis­grun­tled FDA of­fi­cials in the past year, and Karin Bok is its lat­est pick­up. Bok re­signed in No­vem­ber as deputy di­rec­tor for the FDA’s Of­fice of Vac­cines Re­search and Re­view, and now her LinkedIn page in­di­cates that she’s cur­rent­ly the CSO for in­fec­tious dis­eases at Lil­ly. Ex-CBER chief Pe­ter Marks re­cent­ly joined Lil­ly as head of in­fec­tious dis­eases, and Rachael Ana­tol is in charge of glob­al reg­u­la­to­ry pol­i­cy and strat­e­gy for the In­di­anapo­lis phar­ma’s ge­net­ic med­i­cine unit af­ter she was oust­ed as deputy su­per of­fice di­rec­tor at the Of­fice of Ther­a­peu­tic Prod­ucts. Lil­ly told End­points News that it had no fur­ther com­ment on Bok's ap­point­ment.