- Earlier today, Sarepta Therapeutics Inc (NASDAQ: SRPT) announced that it would submit the marketing application and seek accelerated FDA approval for SRP-9001 in Duchenne Muscular Dystrophy (DMD) this fall.
- Sarepta’s data disclosures earlier this month showed statistically significant functional improvements across company studies compared to an external, matched control, Needham wrote.
- The analyst increased the price target from $150 to $162, reflecting an increase in expected EPS for 2025.
- Needham is bullish based on emerging data across SRP-9001 studies has shown clinical benefit, especially when considered against matched natural history.
- Related: Sarepta Reports One Heart Inflammation Case In Duchenne Gene Therapy Trial.
- The analyst believes SRP-9001 has the most manageable toxicity profile of all AAV-based gene therapies in DMD.
- Needham expects a high likelihood for an advisory committee ahead of approval. Likely, safety data from the ongoing EMBARK study will also be included in Adcomm materials.
- The analyst anticipates the application acceptance (~2 months post-filing) to de-risk SRP-9001, proceeding to an accelerated approval and potential launch in 2H of 2023.
- Price Action: SRPT shares are up 8.16% at $92.95 during the market session on the last check Friday.
| Mar 2022 | Morgan Stanley (NYSE:MS) | Maintains | Equal-Weight | |
| Mar 2022 | RBC Capital | Maintains | Outperform | |
| Feb 2022 | Morgan Stanley | Maintains | Equal-Weight |
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