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Sarepta (SRPT) Seeks FDA Nod for DMD Gene Therapy Candidate
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Sarepta Therapeutics (SRPT - Free Report) submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its gene therapy candidate, SRP-9001, to treat ambulant patients with Duchenne muscular dystrophy (DMD). The therapy is being developed in partnership with Roche (RHHBY - Free Report) .
The BLA filing is supported by data from multiple studies from the clinical development program evaluating SRP-9001 in DMD. Earlier this June, Sarepta and Roche announced new functional data across these studies, demonstrating that treatment with SRP-9001 led to functional improvements in individuals suffering from DMD compared with a propensity-weighted external control group at multiple times. The time points vary from one-, two- and four years post-treatment.
Management also initiated a pivotal phase III study, EMBARK, last year. It will act as a confirmatory study seeking full approval for SRP-9001 in DMD.
Shares of Sarepta have risen 21.7% in the year-to-date period against the industry’s 25.2% decline.
Image Source: Zacks Investment Research
If approved by the FDA, SRP-9001 will be the first gene therapy available for DMD patients. The therapy is also expected to generate a billion dollars in revenue for Sarepta. The gene therapy has been granted Fast Track, Rare Pediatric Disease (RPD) and orphan drug designations by the FDA.
Sarepta and Roche entered into a licensing agreement in 2019 to develop SRP-9001 for DMD. Per the agreement, Roche has exclusive rights to launch and commercialize SRP-9001 in ex-U.S. markets.
Apart from SRP-9001, the company is also developing SRP-5051 (vesleteplirsen), its next-generation exon-skipping pipeline candidate for treating DMD patients with skipping exon 51.
Earlier this month, the FDA removed a clinical hold on clinical studies evaluating SRP-5051. As part of the condition for removing the clinical hold, Sarepta will modify the global protocols for clinical studies evaluating SRP-5051 to include expanded monitoring of urine biomarkers.
Sarepta’s commercial portfolio consists of three RNA-based PMO therapies, targeting DMD — Exondys 51, Vyondys 53 and Amondys 45. These drugs can potentially address nearly a third of all patients with DMD in the United States.
Sarepta currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the overall healthcare sector include Morphic (MORF - Free Report) and Sanofi (SNY - Free Report) . While Morphic sports a Zacks Rank #1 (Strong Buy) at present, Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 40.9% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.08 to $4.14. Earnings estimates for 2023 have increased from $4.25 to $4.29 during the same period. Shares of Sanofi have lost 24.2% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.
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Sarepta (SRPT) Seeks FDA Nod for DMD Gene Therapy Candidate
Sarepta Therapeutics (SRPT - Free Report) submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its gene therapy candidate, SRP-9001, to treat ambulant patients with Duchenne muscular dystrophy (DMD). The therapy is being developed in partnership with Roche (RHHBY - Free Report) .
The BLA filing is supported by data from multiple studies from the clinical development program evaluating SRP-9001 in DMD. Earlier this June, Sarepta and Roche announced new functional data across these studies, demonstrating that treatment with SRP-9001 led to functional improvements in individuals suffering from DMD compared with a propensity-weighted external control group at multiple times. The time points vary from one-, two- and four years post-treatment.
Management also initiated a pivotal phase III study, EMBARK, last year. It will act as a confirmatory study seeking full approval for SRP-9001 in DMD.
Shares of Sarepta have risen 21.7% in the year-to-date period against the industry’s 25.2% decline.
Image Source: Zacks Investment Research
If approved by the FDA, SRP-9001 will be the first gene therapy available for DMD patients. The therapy is also expected to generate a billion dollars in revenue for Sarepta. The gene therapy has been granted Fast Track, Rare Pediatric Disease (RPD) and orphan drug designations by the FDA.
Sarepta and Roche entered into a licensing agreement in 2019 to develop SRP-9001 for DMD. Per the agreement, Roche has exclusive rights to launch and commercialize SRP-9001 in ex-U.S. markets.
Apart from SRP-9001, the company is also developing SRP-5051 (vesleteplirsen), its next-generation exon-skipping pipeline candidate for treating DMD patients with skipping exon 51.
Earlier this month, the FDA removed a clinical hold on clinical studies evaluating SRP-5051. As part of the condition for removing the clinical hold, Sarepta will modify the global protocols for clinical studies evaluating SRP-5051 to include expanded monitoring of urine biomarkers.
Sarepta’s commercial portfolio consists of three RNA-based PMO therapies, targeting DMD — Exondys 51, Vyondys 53 and Amondys 45. These drugs can potentially address nearly a third of all patients with DMD in the United States.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Sarepta currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the overall healthcare sector include Morphic (MORF - Free Report) and Sanofi (SNY - Free Report) . While Morphic sports a Zacks Rank #1 (Strong Buy) at present, Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.38 to $1.80. Loss estimates for 2023 have narrowed from $3.91 to $3.62 during the same period. Shares of Morphic have lost 40.9% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.08 to $4.14. Earnings estimates for 2023 have increased from $4.25 to $4.29 during the same period. Shares of Sanofi have lost 24.2% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.