Scholar Rock (SRRK) could face some friction during the early commercialization of Isembyld after the drugmaker clarified that the US Food and Drug Administration has required a post-marketing pregnancy safety study and requested 15-day reports for serious and non-serious fracture cases, Truist Securities said in a note Tuesday.

The FDA recently approved Isembyld to treat spinal muscular atrophy in adults and children two years of age and older.

The fracture rate observed in the Isembyld trial appears consistent with historical rates in patients with spinal muscular atrophy, while management reported no change in bone mineral density in the Phase 2 EMBRACE study, Truist said.

The brokerage expects fracture reports to be reflected in periodic FDA Adverse Event Reporting System updates, as Scholar Rock does not expect to announce individual new fracture cases.

Truist continues to see potential for Isembyld to reach peak sales of $2.3 billion.

Truist maintained a buy rating with $76 price target.

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