Brind.

The EMA issued a negative opinion on July 25, 2025, recommending the rejection of Sarepta's Elevidys application for European clearance.

2 reports, 2 independent Updated Jul 25

Gone quiet Reached 2 outlets in its first 24 hours

Reports: 2
Developments: 1
Repetition: 50%

New informationRepeats or wire copies

AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Some supportReported by 2 outlets

The EMA issued a negative opinion on July 25, 2025, recommending the rejection of Sarepta's Elevidys application for European clearance.

Who's involved

What this event is mainly about

EMA Sarepta Hoffmann-La Roche Europe

Keep exploring

The entities involved

EMA
Japanese vocalist of the group DUSTCELL

Nothing else this week.
Sarepta
Nothing else this week.
Hoffmann-La Roche
Swiss healthcare company
- Natera's Signatera test is undergoing a Phase III trial across US sites, sponsored by NRG Oncology, while facing patent litigation.Sun 02:44
- Hoffmann-La Roche opened a new R&D center in Boston.Sat 11:08
Europe
terrestrial continent located in north-western Eurasia
- The European Commission aims to strengthen homegrown AI capabilities while global advanced models face usage restrictions.Mon 17:49
- The European Central Bank is forced to raise interest rates due to energy price shocks from the Iran war and an influx of Chinese exports.Mon 17:49

Coverage

Newest first; wire copies grouped

Jul 25BioPharma DiveSarepta woes mount as Duchenne gene therapy knocked back in Europe This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Div
Jul 25Pharmaceutical TechnologyCHMP rejects Elevidys in latest setback for Sarepta Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP)