Apitegromab - (SAPPHIRE)

July 19, 2026: Scholar Rock (NASDAQ: SRRK) said the EMA is reviewing the marketing authorisation application (MAA) for apitegromab for children and adults with spinal muscular atrophy (SMA), but the timing of a CHMP opinion depends on the FDA’s inspection classification for the Catalent Indiana LLC (part of Novo Nordisk) fill-finish site included in the MAA. The FDA conducted a general site inspection in April 2026, and the EMA is awaiting the FDA’s updated classification.

If the FDA reclassifies the Catalent Indiana facility, Scholar Rock expects a CHMP opinion later in 2026. If the site is not reclassified, the company plans to work with the EMA to advance the MAA by including a second fill-finish facility; this second facility is already included in the apitegromab BLA under FDA review in the U.S., which has a September 30, 2026 PDUFA action date.

Scholar Rock said it expects near-term clarity from the FDA and will provide an update on its Q2 earnings call on August 6, 2026.