Mod­er­na’s fi­nance chief said it's “too ear­ly to tell” whether the com­pa­ny’s goal of reach­ing break-even cash flow will be pushed back — once again — af­ter the FDA de­clined to re­view its flu shot for adults 50 and old­er.

The com­ments from Jamey Mock on Mod­er­na's earn­ings call Fri­day un­der­score the fi­nan­cial im­pli­ca­tions of the FDA’s re­fusal-to-file let­ter an­nounced ear­li­er this week. The agency ar­gued that Mod­er­na sped past rec­om­men­da­tions to use a high­er-dose flu shot as the com­para­tor prod­uct in its Phase 3 tri­al, though cor­re­spon­dence re­leased by the com­pa­ny that dates back more than a year and a half sug­gest­ed a re­view was nev­er in ques­tion.

Two years ago, CRISPR gene edit­ing pi­o­neer Feng Zhang and for­mer Il­lu­mi­na chief tech­nol­o­gy of­fi­cer Alex Ar­a­va­nis launched a start­up to de­vel­op med­i­cines that would change how genes are turned on and off with­out al­ter­ing DNA it­self.

That com­pa­ny, Moon­walk Bio­sciences, was ex­pect­ed to be­come a ma­jor con­tender in the grow­ing field of epi­ge­net­ic edit­ing. But now Moon­walk has dropped its orig­i­nal plans and piv­ot­ed to a more es­tab­lished class of ge­net­ic med­i­cines known as siR­NAs, End­points News has learned.

Epi­ge­net­ic edit­ing was sup­posed to be a safer, but still per­ma­nent al­ter­na­tive to tra­di­tion­al gene edit­ing. Moon­walk planned to use the tech­nol­o­gy to shut down dis­ease-caus­ing genes. But siR­NA drugs can do that too, and there’s far more in­fra­struc­ture and in­vest­ment cen­tered around these syn­thet­ic mol­e­cules.

Lund­beck said its next-gen­er­a­tion mi­graine pre­ven­tion drug cleared the bar in a Phase 2b study, set­ting the com­pa­ny up for late-stage tri­als that could start this year.

The Dan­ish drug­mak­er said the IV-de­liv­ered med­i­cine, bo­cunebart (Lu AG09222), was bet­ter than place­bo at re­duc­ing the num­ber of month­ly mi­graine days that pa­tients ex­pe­ri­enced dur­ing a 12-week re­view. The re­sults were sta­tis­ti­cal­ly sig­nif­i­cant.

To be in­clud­ed in the tri­al, dubbed PRO­CEED, pa­tients had to have failed one to four mi­graine pre­ven­tion drugs over the past 10 years.

The com­pa­ny did­n't share de­tails such as the scope of the mi­graine re­duc­tions or ex­act­ly how the drug and place­bo per­formed rel­a­tive to each oth­er. It said the drug was "gen­er­al­ly well-tol­er­at­ed" and plans to share more de­tails lat­er.

→ Paul Hud­son has tried to get the R&D en­gine hum­ming ever since he took over as CEO of Sanofi in Sep­tem­ber 2019. He even en­gi­neered a flur­ry of buy­outs in the past year, no­tably a $9.5 bil­lion pur­chase of Blue­print Med­i­cines. But he’s been dri­ving on bald tires for a while now, and Sanofi’s board de­cid­ed to pull him off the road.

Hud­son