Will the CHMP issue an opinion on apitegromab in spinal muscular atrophy before 30 June 2027?
deadline 2027-06-30
confidence high
tier 1 evidence
87%PolySignal estimate
Resolution criterion
Yes if the CHMP adopts an opinion, positive or negative, published in its meeting highlights, by 30 June 2027. A withdrawal of the application or the absence of an opinion count as no.
Verified starting state
The CHMP opinion is held up pending the FDA's classification of the Catalent Indiana fill-finish site, inspected in April 2026, or the addition of a second fill site to the MAA. Scholar Rock was targeting an opinion later in 2026. The blockage is industrial rather than scientific, on a timeline dependent on a third-party regulator. (20 July 2026)
What pushes it up
- The delay is explicitly identified as industrial/manufacturing rather than a scientific or clinical failure, which is generally easier to remediate [Starting State, Tier 1].
- Scholar Rock's internal target for an opinion was late 2026, suggesting they anticipated a resolution within months of the July 2026 update [Starting State, Tier 1].
- The deadline of June 30, 2027, provides a substantial nine-month buffer from the current date to resolve site classification or add a secondary fill-finish site [Starting State, Tier 1].
What pushes it down
- The September 2026 CHMP meeting highlights do not list apitegromab, indicating the 'later in 2026' target is under pressure [0, Tier 1].
- Industrial delays involving third-party regulators (FDA) and site inspections can be unpredictable and may extend beyond initial company estimates [Starting State, Tier 1].
What would move this number most
The timing of the FDA's re-classification of the Catalent Indiana site or the speed at which the EMA can validate an alternative manufacturing site.
How this number is built
| Deadline | 2027-06-30 |
| Base rate | 85% |
| Best evidence | tier 1 · 2 article(s) used |
| Independent runs | 85 · 88 (spread 3 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-09-20 09:02 |
| Model | gemini-3-flash-preview |
Sources consulted