Sarepta Therapeutics

Sarepta Therapeutics named Dr. Michael Severino as its new CEO effective July 28, 2026; Doug Ingram is stepping down and will remain in an advisory role through the end of 2026. The stock rose about 5.2% in premarket trading, driven by confidence in Severino’s experience at Tessera Therapeutics and AbbVie. Analysts warn of a challenging competitive landscape in Duchenne muscular dystrophy; attention also turns to the expected Q2 results on August 5. The share price was $16.49, well below the 52-week high of $25.32 but recovered from a low of $11.68. » Más en de.investing.com

The FDA has accepted the supplemental new drug applications (sNDAs) for AMONDYS 45 (Casimersen) and VYONDYS 53 (Golodirsen) for review and set a PDUFA date of February 28, 2027. The filings rely on the phase-3 ESSENCE study, which did not meet its primary endpoint but showed numerical trends and post‑hoc analyses favoring treatment. The news triggered a share gain of about 6.1% and was supported by Mizuho’s maintained 'Outperform' rating with a $31 price target and a favorable market backdrop. Full approval would remove substantial regulatory uncertainty for the PMO portfolio; the PMO franchise reported net product revenue of $228.6 million in Q1 2026. » Más en de.investing.com

Sarepta Therapeutics reported first-quarter Elevidys sales of $102 million versus $375 million in the year-ago quarter, driven by a restricted approval for ambulatory patients following FDA safety reviews. Total revenue was $730.8 million, down $14.1 million, partly offset by higher collaboration revenue. The stock fell about 10.3% in premarket trading to $122.96. » Más en de.investing.com