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Sarepta (SRPT) Seeks Label Expansion for DMD Gene Therapy
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Sarepta (SRPT - Free Report) announced that it has submitted an efficacy supplement to the biologics license application (BLA) with the FDA seeking to expand the treatment label for Elevidys, the first approved gene therapy for Duchenne muscular dystrophy (DMD).
The BLA supplement seeks full approval for Elevidys to treat all DMD patients, irrespective of age and ambulation status. It also requests the FDA to grant priority review to the submission.
The FDA had initially granted accelerated approval to Elevidys in June to treat ambulatory pediatric patients aged between four and five years with DMD.
Year to date, Sarepta’s shares have lost 13.7% compared with the industry’s 10.2% decline.
Image Source: Zacks Investment Research
The BLA supplement is mainly supported by data from the phase III EMBARK study, announced in October 2023, which also serves as the confirmatory study for Elevidys’ full approval in DMD indication. Though the study failed to achieve its primary endpoint, it achieved statistical significance on all pre-specified key secondary endpoints, indicating that treatment with Elevidys modifies the course of DMD indication.
Management claims to have discussed the above results with the FDA, who had previously indicated that they are open to reviewing the data for label expansion based on the totality of evidence from the EMBARK study.
Sarepta has developed Elevidys in collaboration with Roche (RHHBY - Free Report) . Sarepta and Roche entered into a licensing agreement in 2019 to develop and commercialize Elevidys jointly. Per the agreement, Roche has exclusive rights to launch and commercialize the gene therapy in ex-U.S. markets.
To satisfy regulatory requirements for Elevidys’ approval outside the United States, Sarepta is also evaluating the safety and efficacy of Elevidys in the ongoing phase III ENVISION study in non-ambulatory and ambulatory DMD patients.
Sarepta currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) and Novo Nordisk (NVO - Free Report) . While Galapagos sports a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk 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, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 10.1% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.99 to $3.14. Shares of NVO have surged 51.8% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
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Sarepta (SRPT) Seeks Label Expansion for DMD Gene Therapy
Sarepta (SRPT - Free Report) announced that it has submitted an efficacy supplement to the biologics license application (BLA) with the FDA seeking to expand the treatment label for Elevidys, the first approved gene therapy for Duchenne muscular dystrophy (DMD).
The BLA supplement seeks full approval for Elevidys to treat all DMD patients, irrespective of age and ambulation status. It also requests the FDA to grant priority review to the submission.
The FDA had initially granted accelerated approval to Elevidys in June to treat ambulatory pediatric patients aged between four and five years with DMD.
Year to date, Sarepta’s shares have lost 13.7% compared with the industry’s 10.2% decline.
Image Source: Zacks Investment Research
The BLA supplement is mainly supported by data from the phase III EMBARK study, announced in October 2023, which also serves as the confirmatory study for Elevidys’ full approval in DMD indication. Though the study failed to achieve its primary endpoint, it achieved statistical significance on all pre-specified key secondary endpoints, indicating that treatment with Elevidys modifies the course of DMD indication.
Management claims to have discussed the above results with the FDA, who had previously indicated that they are open to reviewing the data for label expansion based on the totality of evidence from the EMBARK study.
Sarepta has developed Elevidys in collaboration with Roche (RHHBY - Free Report) . Sarepta and Roche entered into a licensing agreement in 2019 to develop and commercialize Elevidys jointly. Per the agreement, Roche has exclusive rights to launch and commercialize the gene therapy in ex-U.S. markets.
To satisfy regulatory requirements for Elevidys’ approval outside the United States, Sarepta is also evaluating the safety and efficacy of Elevidys in the ongoing phase III ENVISION study in non-ambulatory and ambulatory DMD patients.
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 Galapagos (GLPG - Free Report) and Novo Nordisk (NVO - Free Report) . While Galapagos sports a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk 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, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 10.1% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.99 to $3.14. Shares of NVO have surged 51.8% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.