- earlier today, Sarepta Therapeutics Inc SRPT announced it would file for regulatory approval and seek accelerated FDA approval for SRP-9001 in Duchenne muscular dystrophy (DMD) this fall.
- Sarepta’s data disclosure earlier this month demonstrated statistically significant functional improvements across all of the company’s studies compared to an external matched control. Needham wrote.
- The analyst increased the Price target from $150 to $162reflecting an increase in expected EPS for 2025.
- Needham is optimistic based on emerging data from SRP-9001 studies that have shown clinical benefit, particularly when compared to a consistent natural history.
- Related: Sarepta reports one case of cardiac inflammation in a Duchenne gene therapy study.
- The analyst believes that SRP-9001 has the most manageable toxicity profile of any AAV-based gene therapy in DMD.
- Needham anticipates a high likelihood of an advisory committee prior to approval. It is likely that safety data from the ongoing EMBARK study will also be included in Adcomm materials.
- The analyst anticipates acceptance of the SRP-9001 risk mitigation application (approximately 2 months from submission), with accelerated approval and potential commercial launch in H2 2023.
- Price promotion: SRPT shares are up 8.16% to $92.95 during the market session last check Friday.
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