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Why Sarepta's (SRPT) Stock Price Moved Up 17% on Tuesday
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Shares of Sarepta (SRPT - Free Report) rose 16.7% on Jan 9, after the company’s CEO Douglas Ingram made positive remarks on the company’s regulatory filing seeking label expansion for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. The comments were made during a discussion at the J.P. Morgan Healthcare Conference.
During the discussion, Ingram remained ‘hopeful’ that Elevidys will be able to secure the label expansion for Elevidys to treat all DMD patients, irrespective of age and ambulation status. The therapy was initially approved by the FDA last June under the accelerated pathway to treat ambulatory pediatric patients aged between four and five years with DMD. Following the accelerated nod, it became the first approved gene therapy for DMD.
Assuming a priority review on the filing, the CEO expects to secure the label expansion approval for Elevidys in August.
The positive remarks from the CEO come just a day after Sarepta reported encouraging preliminary/unaudited results for the fourth quarter and full year 2023. Per the company, Elevidys sales are expected to be around $131.3 million for the fourth quarter, bringing the total sales figure to around $200.4 million for the full year. This is an encouraging figure for a treatment that was commercially launched in third-quarter 2023.
In the past year, Sarepta’s shares have inched up 0.5% against the industry’s 11.1% fall.
Image Source: Zacks Investment Research
Sarepta’s label expansion 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. In a recent interview with STAT news, a top agency official seemed inclined to grant full approval to Elevidys, subject to the ongoing review of data.
Sarepta 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. As part of the agreement, Sarepta will also record collaboration revenues on the ex-U.S. sales made by Roche.
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.
Another company that is developing its own DMD gene therapy is Solid Biosciences (SLDB - Free Report) . The FDA recently cleared Solid Biosciences’ investigational new drug (IND) to start a phase I/II study on SGT-003 in pediatric patients with DMD. This study is expected to begin shortly. Last month, the agency also granted fast-track designation to Solid Biosciences’ gene therapy in DMD indication.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have swung from a loss of 10 cents per share to earnings of 2 cents. During the same period, estimates for 2024 have narrowed from a loss of 22 cents to a loss of 6 cents. Shares of CytomX have lost 42.8% in the past year.
CytomX Therapeutics’ 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 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
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Why Sarepta's (SRPT) Stock Price Moved Up 17% on Tuesday
Shares of Sarepta (SRPT - Free Report) rose 16.7% on Jan 9, after the company’s CEO Douglas Ingram made positive remarks on the company’s regulatory filing seeking label expansion for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. The comments were made during a discussion at the J.P. Morgan Healthcare Conference.
During the discussion, Ingram remained ‘hopeful’ that Elevidys will be able to secure the label expansion for Elevidys to treat all DMD patients, irrespective of age and ambulation status. The therapy was initially approved by the FDA last June under the accelerated pathway to treat ambulatory pediatric patients aged between four and five years with DMD. Following the accelerated nod, it became the first approved gene therapy for DMD.
Assuming a priority review on the filing, the CEO expects to secure the label expansion approval for Elevidys in August.
The positive remarks from the CEO come just a day after Sarepta reported encouraging preliminary/unaudited results for the fourth quarter and full year 2023. Per the company, Elevidys sales are expected to be around $131.3 million for the fourth quarter, bringing the total sales figure to around $200.4 million for the full year. This is an encouraging figure for a treatment that was commercially launched in third-quarter 2023.
In the past year, Sarepta’s shares have inched up 0.5% against the industry’s 11.1% fall.
Image Source: Zacks Investment Research
Sarepta’s label expansion 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. In a recent interview with STAT news, a top agency official seemed inclined to grant full approval to Elevidys, subject to the ongoing review of data.
Sarepta 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. As part of the agreement, Sarepta will also record collaboration revenues on the ex-U.S. sales made by Roche.
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.
Another company that is developing its own DMD gene therapy is Solid Biosciences (SLDB - Free Report) . The FDA recently cleared Solid Biosciences’ investigational new drug (IND) to start a phase I/II study on SGT-003 in pediatric patients with DMD. This study is expected to begin shortly. Last month, the agency also granted fast-track designation to Solid Biosciences’ gene therapy in DMD indication.
Sarepta Therapeutics, Inc. Price
Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote
Zacks Rank & A Key Pick
Sarepta sports a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the overall healthcare sector includes CytomX Therapeutics (CTMX - Free Report) , which flaunts a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have swung from a loss of 10 cents per share to earnings of 2 cents. During the same period, estimates for 2024 have narrowed from a loss of 22 cents to a loss of 6 cents. Shares of CytomX have lost 42.8% in the past year.
CytomX Therapeutics’ 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 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.