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Sarepta (SRPT) Sells Priority Review Voucher for $102M
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Sarepta (SRPT - Free Report) announced the completion of the sale of its Rare Pediatric Disease Priority Review Voucher (“PRV”) for $102 million.
The monetization of the PRV will enable management to develop more transformative therapies as it plans to invest the proceeds into the company’s research and development (“R&D”) efforts.
Year to date, Sarepta’s shares have lost 13.7% compared with the industry’s 10.2% decline.
Image Source: Zacks Investment Research
The PRV was awarded to the company last month after the FDA granted accelerated approval to its adeno-associated virus-based gene therapy Elevidys to treat ambulatory pediatric patients aged between four and five years with Duchenne muscular dystrophy (“DMD”).
Following this approval, Elevidys is the first one-shot gene therapy approved for treating DMD.A progressive and degenerative disorder, DMD leads to weakness and wasting away of the body’s muscles.
The FDA approval comes after several delays and questions over the effectiveness of Elevidys. In May, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (“CTGTAC”) voted 8:6, narrowly recommending approval for Elevidys. This was likely due to the FDA’s concerns on Elevidys. Per the CTGTAC, the clinical studies conducted to date do not provide unambiguous evidence that the gene therapy will benefit DMD patients.
Based on the above factors, the FDA — in consultation with the company — decided to currently restrict the use of Elevidys in DMD patients aged between four and five years. The agency stated that it will grant a non-age restricted expansion to Elevidysprovided the phase III EMBARK study achieves its objectives. The EMBARK study is the proposed confirmatory study that will seek full approval for Elevidys in DMD indication. Top-line results from the EMBARK study are expected in fourth-quarter 2023.
Elevidyshas been developed by Sarepta in collaboration with Roche (RHHBY - Free Report) . Sarepta and Roche entered into a licensing agreement in 2019 to jointly develop and commercialize Elevidys. Per the agreement, Roche has exclusive rights to launch and commercialize the gene therapy in ex-U.S. markets.
Apart from Elevidys, Sarepta’s commercial portfolio consists of three RNA-based PMO therapies targeting DMD — Exondys 51, Vyondys 53 and Amondys 45. These three drugs can potentially address nearly a third of all patients with DMD in the United States.
Sarepta develops SRP-5051 (vesleteplirsen), its next-generation exon-skipping pipeline candidate to treat DMD patients with skipping exon 51. This February, management also started an early-stage study (VOYAGENE) evaluating its other gene therapy candidate, SRP-9003, in patients with Limb-girdle muscular dystrophy (LGMD) type 2E/R4.
In the past 60 days, the estimate for AbbVie’s 2023 and 2024 EPS have increased from $10.96 to $10.99 and $11.03 to $11.04, respectively. Shares of AbbVie are down 14.8% in the year-to-date period.
Earnings of AbbVie beat estimates in each of the last four quarters, witnessing an average earnings surprise of 1.78%.
In the past 60 days, the estimate for Vertex’s 2023 and 2024 EPS have increased from $14.45 to $14.48 and $15.52 to $15.69, respectively. Shares of Vertex are up 20.6% in the year-to-date period.
Earnings of Vertex beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.51%.
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Sarepta (SRPT) Sells Priority Review Voucher for $102M
Sarepta (SRPT - Free Report) announced the completion of the sale of its Rare Pediatric Disease Priority Review Voucher (“PRV”) for $102 million.
The monetization of the PRV will enable management to develop more transformative therapies as it plans to invest the proceeds into the company’s research and development (“R&D”) efforts.
Year to date, Sarepta’s shares have lost 13.7% compared with the industry’s 10.2% decline.
Image Source: Zacks Investment Research
The PRV was awarded to the company last month after the FDA granted accelerated approval to its adeno-associated virus-based gene therapy Elevidys to treat ambulatory pediatric patients aged between four and five years with Duchenne muscular dystrophy (“DMD”).
Following this approval, Elevidys is the first one-shot gene therapy approved for treating DMD.A progressive and degenerative disorder, DMD leads to weakness and wasting away of the body’s muscles.
The FDA approval comes after several delays and questions over the effectiveness of Elevidys. In May, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (“CTGTAC”) voted 8:6, narrowly recommending approval for Elevidys. This was likely due to the FDA’s concerns on Elevidys. Per the CTGTAC, the clinical studies conducted to date do not provide unambiguous evidence that the gene therapy will benefit DMD patients.
Based on the above factors, the FDA — in consultation with the company — decided to currently restrict the use of Elevidys in DMD patients aged between four and five years. The agency stated that it will grant a non-age restricted expansion to Elevidysprovided the phase III EMBARK study achieves its objectives. The EMBARK study is the proposed confirmatory study that will seek full approval for Elevidys in DMD indication. Top-line results from the EMBARK study are expected in fourth-quarter 2023.
Elevidyshas been developed by Sarepta in collaboration with Roche (RHHBY - Free Report) . Sarepta and Roche entered into a licensing agreement in 2019 to jointly develop and commercialize Elevidys. Per the agreement, Roche has exclusive rights to launch and commercialize the gene therapy in ex-U.S. markets.
Apart from Elevidys, Sarepta’s commercial portfolio consists of three RNA-based PMO therapies targeting DMD — Exondys 51, Vyondys 53 and Amondys 45. These three drugs can potentially address nearly a third of all patients with DMD in the United States.
Sarepta develops SRP-5051 (vesleteplirsen), its next-generation exon-skipping pipeline candidate to treat DMD patients with skipping exon 51. This February, management also started an early-stage study (VOYAGENE) evaluating its other gene therapy candidate, SRP-9003, in patients with Limb-girdle muscular dystrophy (LGMD) type 2E/R4.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Sarepta currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include AbbVie (ABBV - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the estimate for AbbVie’s 2023 and 2024 EPS have increased from $10.96 to $10.99 and $11.03 to $11.04, respectively. Shares of AbbVie are down 14.8% in the year-to-date period.
Earnings of AbbVie beat estimates in each of the last four quarters, witnessing an average earnings surprise of 1.78%.
In the past 60 days, the estimate for Vertex’s 2023 and 2024 EPS have increased from $14.45 to $14.48 and $15.52 to $15.69, respectively. Shares of Vertex are up 20.6% in the year-to-date period.
Earnings of Vertex beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.51%.