Sarepta Therapeutics

At the Morgan Stanley Healthcare Conference, Sarepta emphasized that marketed products generate cash flow while the siRNA pipeline supports long‑term growth. CEO Michael Severino noted early signs of stabilization after the safety‑related issues with ELEVIDYS, but expects meaningful commercial improvement only in 2027. Key near‑term catalysts are data from the multiple‑ascending‑dose studies of SRP‑1001 (FSHD) and SRP‑1003 (DM1) in the second half of 2026 and higher dose cohorts in early 2027; the PMO franchise remains robust with high treatment adherence. » Mere på de.investing.com

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. » Mere på 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. » Mere på de.investing.com