As­traZeneca shares have been surg­ing in the wake of the Brex­it breakup vote, and some boost­ers of the UK phar­ma gi­ant are in­ter­pret­ing the ral­ly as a sign of re­newed hope in its pipeline rather than just a bit of spec­u­la­tion on some thin ru­mors about a po­ten­tial takeover bid by No­var­tis.

As­traZeneca in­vestor Daniel Ma­ho­ny, a fund man­ag­er at Po­lar Cap­i­tal LLP, had this to tell Bloomberg:

As­tra is show­ing a bit of leg this year be­cause of pipeline mis­steps by oth­ers. It wouldn’t sur­prise me if the shares move up more from here. The pipeline is com­ing in­to view.’

That par­tic­u­lar mis­step he’s re­fer­ring to is Bris­tol-My­ers’ epic fail on its Phase III lung can­cer study for Op­di­vo, which im­me­di­ate­ly ben­e­fit­ed ri­val Mer­ck and its check­point in­hibitor Keytru­da.

As­traZeneca has a late-stage study of its own check­point in lung can­cer, called MYS­TIC, and a read­out for dur­val­um­ab in ear­ly 2017 could set the stage for a first-line move. Ac­cord­ing to clin­i­cal­tri­als.gov, the study com­pares dur­val­um­ab with or with­out the CT­LA-4-tar­get­ing treme­li­mum­ab against the stan­dard of care in a first-line set­ting, and it’s due to de­liv­er da­ta in Jan­u­ary.

As­traZeneca, though, has been a late-com­er to the whole check­point in­hi­bi­tion mar­ket. Some months ago it warned that it would take a me­thod­i­cal ap­proach to study­ing dur­val­um­ab, which is in a long line­up of tri­als. Roche has al­ready fol­lowed up with a check­point ap­proval, and an al­liance of Pfiz­er and Mer­ck KGaA may make it to the fourth spot ahead of As­traZeneca.

In ad­di­tion, As­traZeneca had to ac­knowl­edge an­oth­er set­back for its can­cer pipeline – Pas­cal So­ri­ot’s prime hope for de­liv­er­ing big gains in rev­enue – this week with the sec­ond Phase III fail­ure for one-time block­buster hope­ful selume­tinib. And treme­li­mum­ab failed as a so­lo drug against mesothe­lioma at the end of Feb­ru­ary.

While a prospec­tive fifth-place mar­ket fin­ish may sound un­en­vi­able to the av­er­age bio­phar­ma ob­serv­er, As­traZeneca’s core in­vestors say there’s lots to be bull­ish about. And Mys­tic may make all the dif­fer­ence.

“There’s a huge amount of po­ten­tial pipeline val­ue rid­ing on the out­come of that clin­i­cal tri­al,” Dani Saurym­per, man­ag­er of the AXA Fram­ling­ton Health Funds in Lon­don, tells the busi­ness news ser­vice. “No­var­tis would be tak­ing on sig­nif­i­cant risk if they were to pur­sue an ac­qui­si­tion of As­traZeneca pri­or to the an­nounce­ment of those clin­i­cal tri­al re­sults.”

If No­var­tis is ac­tu­al­ly think­ing about it at all.

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.