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Milestone Monday: Signed, Sealed, Disappointed

Servier paid about 58% of the maximum price before the pivotal data arrived. This week’s deals show what upfront money secures and what it doesn’t.

Milestone Monday: Signed, Sealed, Disappointed
Keepy-uppies done to perfection. The minutes are another matter. Photo by Jhan Castillón / Unsplash

Every football fan knows the thrill of a big summer signing. He is unveiled in the club’s new shirt, scarf held aloft, keepy-uppies done to perfection, highlight reels doing the rounds on social media. What could possibly go wrong?

By November he is on the bench, and the fans are working out what the club actually paid.

Biopharma’s own transfer-to-bench saga played out last week. In June, Servier signed sevasemten from Edgewise Therapeutics in a deal worth up to $2.65bn. On Nov. 3, the drug failed its pivotal trial, and the bean-counting began.

Servier wasn’t the only club checking the scoreboard. Karyopharm, after two poor results, is heading into Chapter 11 and a merger. Abbott’s two new devices kept clean sheets at TCT while AbbVie snapped up a drug that Nxera had let go.

The Summer Signing Misses His Debut

Servier said its 18-month pivotal Phase II GRAND CANYON study of sevasemten in Becker muscular dystrophy (BMD) did not meet its primary endpoint. The drug showed no statistically significant benefit on the North Star Ambulatory Assessment (NSAA), a motor-function scale, and the secondary endpoints were also missed.

Servier hasn't released detailed data yet and said it is analyzing the full dataset and will present it later.

The form before the transfer move looked better. In the Phase II CANYON study, sevasemten met its primary endpoint, cutting creatine kinase (a marker of muscle damage) by an average 28% versus placebo in adults. Motor function on the NSAA, a secondary endpoint, remained stable.

Servier said the pivotal results don't match some of what was seen in CANYON. For now, sevasemten stays in the squad for Duchenne muscular dystrophy, with two Phase II trials, FOX and LYNX, still running.