🔴 Scholar Rock is trading 10% down today after FDA requires pregnancy-safety study

Scholar Rock is trading 10% down at $46.64 after clarifying that FDA approval of ISEMBYLD includes post-marketing safety commitments.

• Management had incorrectly stated during the September 14 investor call that no bone or reproductive-safety requirements applied.
• The FDA requires a pregnancy-safety study and 15-day fracture alert reports, intensifying concerns about regulatory and commercial execution risk.
• Barclays downgraded the stock to Equal Weight; the decline follows Scholar Rock’s 6.42% September 14 drop and a 2.11% biotech-sector decline amid active intraday trading.