2020’s NDA list is packed with com­mer­cial firsts — from his­toric to hap­haz­ard. Have we reached a tip­ping point?

In drug R&D, a suc­cess­ful late-stage de­vel­op­ment pro­gram is like a wide­ly shared celebri­ty love af­fair. An­a­lysts will swoon over peak sales pro­jec­tions. De­vel­op­ers can hug them­selves for a job well done. Even reg­u­la­tors get in on the act, bull­ish at of­fi­ci­at­ing over a high­er stan­dard of pro­duc­tiv­i­ty, with a nod to break­throughs and new first-in-class drugs to con­tem­plate.

This is the time for rose-tint­ed glass­es.

Then if and when the ap­provals come through, the love af­fair gets to look a lot more like a mar­riage.

Now you ac­tu­al­ly have to sell the drug af­ter years of pro­mot­ing its fu­ture. If a com­mer­cial hard­ship de­vel­ops, you get to put your head down and work things out, one way or an­oth­er. And for an un­for­giv­ing Street, there are no ex­cus­es for any laps­es on the num­bers.

You go from mak­ing promis­es, to keep­ing them. Or the board will find some­one who can.

This is the new re­al­i­ty for 24 biotechs that boast­ed of a first drug ap­proval in 2020 — close to half of the 55 com­pa­nies that claimed all or part of one or more new drug ap­provals last year.

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