Re­gen­eron $REGN is wast­ing no time in push­ing ahead with what it hopes is their first piv­otal study for the lat­est in what is be­com­ing a long line of PD-1 check­point drugs. In its earn­ings re­lease this morn­ing the big biotech says that it is re­cruit­ing pa­tients for a po­ten­tial reg­is­tra­tion Phase II study on ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma.

Mark Schoenebaum

ISI an­a­lyst Mark Schoenebaum added in a note this morn­ing that he’s keep­ing a close eye on their Phase II for non-small cell lung can­cer, which al­so launch­es this year.

Sanofi $SNY com­mit­ted back in 2015 to pay half of the $650 mil­lion de­vel­op­ment tab on REGN2810, part of a $1.8 bil­lion pack­age for a slate of im­muno-on­col­o­gy drugs — in­clud­ing mon­o­clon­al an­ti­bod­ies as well as bis­pecifics — that the two are now part­nered on. Sanofi’s own ef­forts in can­cer R&D stum­bled bad­ly, forc­ing a re­or­ga­ni­za­tion of its R&D ef­forts in one of many signs that the phar­ma gi­ant can’t seem to find its own path on drug de­vel­op­ment.

An­a­lysts see lit­tle to dis­tin­guish this PD-1 from the rest of the check­point field. But the next step in I/O in­volves a slew of com­bi­na­tion ther­a­pies that will look to change the land­scape on front­line ther­a­pies. Mer­ck and Bris­tol-My­ers Squibb got out in the mar­ket first, fol­lowed by Roche’s PD-L1 drug ate­zolizum­ab. Now As­traZeneca is fer­vent­ly pray­ing for a piv­otal suc­cess on dur­val­um­ab/treme­li­mum­ab — a cru­cial pro­gram for this phar­ma gi­ant — while Pfiz­er and Mer­ck KGaA close in on their own pro­gram.

Re­gen­eron scored a key court vic­to­ry yes­ter­day when the US Court of Ap­peals ruled in its fa­vor on Pralu­ent, stay­ing a de­ci­sion in Jan­u­ary that the PC­SK9 cho­les­terol drug should be jerked from the mar­ket due to the patent vi­o­la­tions seen with ri­val Repatha. Re­gen­eron and Sanofi al­so say that they’re ready to re­file sar­ilum­ab af­ter Sanofi’s Le Trait fa­cil­i­ty gets a clean bill of health. And they’re look­ing for a po­ten­tial megablock­buster ad­vance with a de­ci­sion look­ing on dupilum­ab. Oth­er late-stage mile­stones in­clude a Phase III for REGN2222 (an RSV-F An­ti­body) and a late-stage test for fas­inum­ab, an NGF an­ti­body for pain.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.