The two best-sell­ing check­point in­hibitors — Mer­ck’s Keytru­da and Bris­tol My­ers Squibb’s Op­di­vo — are now ap­proach­ing their patent cliffs. And the bio­phar­ma in­dus­try is com­ing to terms with the fact that it may not be able to re­peat its suc­cess.

“My sense is that this search for a mag­ic bul­let has fad­ed. There's a much more cau­tious ap­proach now,” Evan Rach­lin, co-founder and man­ag­ing part­ner of the life sci­ences VC firm As­cen­ta Cap­i­tal, told End­points News.

In­stead, com­pa­nies are look­ing to bring the suc­cess­es of pre­ci­sion on­col­o­gy and tar­get­ed can­cer drugs to im­munother­a­py, match­ing spe­cif­ic pa­tient pop­u­la­tions with well-suit­ed drug reg­i­mens with­out the one-size-fits-all ap­proach of an­ti-PD-1 drugs.

“Check­point in­hibitors were this amaz­ing thing for 20-ish per­cent of pa­tients, and now you fo­cus on peo­ple who can't re­spond,” said Rach­lin, whose firm in­vest­ed in the re­cent­ly ac­quired Tubu­lis.

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 to­day'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.)

The biggest ques­tion Apogee Ther­a­peu­tics CEO Michael Hen­der­son gets from in­vestors?

"These are big mar­kets, this takes a lot of cap­i­tal — are you just go­ing to di­lute us every time you have da­ta?" Hen­der­son said in an in­ter­view with End­points News.

Hen­der­son now has an an­swer for Apogee's share­hold­ers: No. The au­toim­mune dis­ease drug de­vel­op­er on Wednes­day se­cured an up to $800 mil­lion roy­al­ty deal with Black­stone Life Sci­ences, a ma­jor pact that in­cludes the op­tion to get up to an ad­di­tion­al $500 mil­lion via debt from the biotech in­dus­try's largest pri­vate in­vest­ment fund.

Plus news about Kail­era, Al­fasig­ma, Jun­shi and Ku­ra.

⏰ FDA de­lays As­traZeneca’s camizes­trant PDU­FA date: The FDA has ex­tend­ed its PDU­FA date for As­traZeneca’s breast can­cer drug camizes­trant, a few days af­ter the drug won back­ing from EU reg­u­la­tors. The US agency has re&