Af­ter three FDA re­jec­tions dat­ing back to 2023, Out­look Ther­a­peu­tics said the agency has re­versed course re­gard­ing its re­for­mu­lat­ed ver­sion of Avastin for the eye con­di­tion known as wet AMD.

"The FDA con­clud­ed that sub­stan­tial ev­i­dence of ef­fec­tive­ness has been es­tab­lished" for the oph­thalmic re­for­mu­la­tion — to be known as Lyte­na­va — if ap­proved in the US, the com­pa­ny said in a state­ment Tues­day. Out­look held meet­ings with the agency in March and April, and said the FDA grant­ed the ap­peal as part of a for­mal dis­pute-res­o­lu­tion process through its Of­fice of New Drugs.

Out­look's stock OTLK rose more than 50% Tues­day morn­ing as the com­pa­ny said it plans to for­mal­ly re­sub­mit its ap­pli­ca­tion for Lyte­na­va next month. The FDA did­n't im­me­di­ate­ly re­spond to ques­tions on Out­look's com­ments.

We’ve spent the past year on Post-Hoc Live talk­ing about ex­is­ten­tial mo­ments for US biotech — the down­turn, the re­cov­ery, Chi­na, MFN and more. On Wednes­day's show, we’re joined by one of the lead­ing in­dus­try vet­er­ans sound­ing the alarm.

Je­re­my Levin has seen bio­phar­ma from prac­ti­cal­ly every van­tage point — he’s led deal­mak­ing in big phar­ma, found­ed biotechs and tak­en the big-pic­ture per­spec­tive as chair­man of BIO. Like many ex­pe­ri­enced bio­phar­ma lead­ers, he’s wor­ried about US pol­i­cy and he’s wor­ried about Chi­na.

At 11:30 am ET, I’ll talk with Dr. Levin about what the biggest prob­lems have been, and what so­lu­tions US pol­i­cy­mak­ers should put in place. (He al­so has a new book out where he talks about many of these is­sues.)

Health­care mar­ket­ing and adtech com­pa­ny Swoop just bought a phar­ma­cy start­up.

Nim­bleRx is one of a hand­ful of dis­rup­tive phar­ma­cy star­tups that bet big on mak­ing the phar­ma­cy ex­pe­ri­ence more con­ve­nient, in par­tic­u­lar by help­ing in­de­pen­dent phar­ma­cies with con­sumer-fac­ing ser­vices like pre­scrip­tion de­liv­ery and mes­sag­ing via soft­ware it pro­vides. The plan for the ac­qui­si­tion is to lever­age that re­la­tion­ship with phar­ma­cies to help New York-based Swoop get clos­er to pa­tients.

“This is a point where a pa­tient is ready to make a de­ci­sion," Swoop pres­i­dent Scott Rines told End­points News.

Swoop can then reach a pa­tient low­er in the mar­ket­ing fun­nel rather than at a high­er lev­el, where Swoop has his­tor­i­cal­ly op­er­at­ed by build­ing aware­ness with pa­tients and providers about cer­tain con­di­tions and treat­ments. "So it's a re­al­ly nat­ur­al pro­gres­sion when you think about the mar­ket­ing fun­nel,” he said.

RIO DE JANEIRO — Re­searchers at Lila Sci­ences were left scratch­ing their heads over the lab re­sults.

They had built AI mod­els to se­lect mR­NA mol­e­cules that ex­press high lev­els of a de­sired pro­tein. Af­ter test­ing near­ly one mil­lion se­quences in the lab, the mod­els were get­ting quite good at that goal.

But the AI al­so picked mol­e­cules that were ex­cep­tion­al­ly sta­ble, re­fus­ing to dis­in­te­grate like typ­i­cal mR­NA. Even af­ter a cou­ple weeks, Lila's mol­e­cules were ex­press­ing pro­teins at the same lev­el as com­pa­ra­ble mR­NA does af­ter a cou­ple of days.

The sur­prise was that Lila's sci­en­tists didn’t ask for su­per-durable mol­e­cules. It just hap­pened, said Ben Kom­pa, Lila co-founder and head of AI lab in­no­va­tion, de­scrib­ing it as an “emer­gent ca­pa­bil­i­ty” of AI. He be­lieves these new re­sults are “a glimpse of RNA su­per­in­tel­li­gence” and sug­gest the start­up is on the right path to cre­at­ing AI that per­forms every step of the sci­en­tif­ic method bet­ter than hu­mans.

Astel­las Phar­ma is aim­ing to dou­ble sales for its five key med­i­cines, in­clud­ing Pfiz­er-part­nered blad­der can­cer drug Pad­cev, through fis­cal year 2030 un­der a new five-year strat­e­gy it pub­lished Tues­day.

The Japan­ese drug­mak­er said it ex­pects to achieve twice as much in fis­cal year 2030 sales ver­sus last year's for the five prod­ucts that in­clude Pad­cev, stom­ach can­cer treat­ment Vy­loy and va­so­mo­tor symp­toms med­i­cine Veozah. Those drugs, along with Iz­er­vay and Xospa­ta, made a com­bined 480.3 bil­lion yen ($3.02 bil­lion) last fis­cal year. Dou­bling that fig­ure should help Astel­las work to­ward reach­ing a pos­si­ble record high of 1 tril­lion yen ($6 bil­lion) in rev­enues by the mid-2030s.

The com­pa­ny’s strat­e­gy in­volves launch­ing the five prod­ucts in new mar­kets and se­cur­ing key la­bel ex­pan­sions for Pad­cev and Vy­loy. These two med­i­cines reached 221.2 bil­lion yen ($1.39 bil­lion) and 63.1 bil­lion yen ($396 mil­lion) in 2025 sales, re­spec­tive­ly.