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Sarepta's (SRPT) Application for DMD Drug Accepted in the EU
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Sarepta Therapeutics, Inc. SRPT announced that the European Medicines Agency (EMA) has validated its Marketing Authorization application (MAA) for Exondys 51 (eteplirsen).
Sarepta’s year-to-date share price performance has been much better than that of the Zacks classified Medical Biomed/Genetics industry. Though the stock’s price declined 22.3% during this period, it compared favorably to the industry’s 25.2% decline.
Note that in Sep 2016, the FDA had granted accelerated approval to the drug for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. The FDA approval significantly boosted Sarepta’s growth prospects given that Exondys 51 is now the first DMD treatment in the U.S.
Meanwhile, the company continues to evaluate the drug in several clinical trials under the name eteplirsen.
Sarepta was looking for a conditional approval of Exondys 51 in the EU through the centralized procedure. The validation confirms that the submission is complete. Consequently, the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP) will start. The standard review period is 210 days (plus additional time for applicant to respond to questions from the agency).
We note that Sarepta is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. DMD is one of the most fatal genetic disorders, which affects approximately one in every 3,500–5,000 males worldwide.
A tentative approval in the EU will boost the drug’s growth prospects significantly.
Sarepta currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Heska Corp. , Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 92.2% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 87.9% year to date.
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Sarepta's (SRPT) Application for DMD Drug Accepted in the EU
Sarepta Therapeutics, Inc. SRPT announced that the European Medicines Agency (EMA) has validated its Marketing Authorization application (MAA) for Exondys 51 (eteplirsen).
Sarepta’s year-to-date share price performance has been much better than that of the Zacks classified Medical Biomed/Genetics industry. Though the stock’s price declined 22.3% during this period, it compared favorably to the industry’s 25.2% decline.
Note that in Sep 2016, the FDA had granted accelerated approval to the drug for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. The FDA approval significantly boosted Sarepta’s growth prospects given that Exondys 51 is now the first DMD treatment in the U.S.
Meanwhile, the company continues to evaluate the drug in several clinical trials under the name eteplirsen.
Sarepta was looking for a conditional approval of Exondys 51 in the EU through the centralized procedure. The validation confirms that the submission is complete. Consequently, the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP) will start. The standard review period is 210 days (plus additional time for applicant to respond to questions from the agency).
We note that Sarepta is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. DMD is one of the most fatal genetic disorders, which affects approximately one in every 3,500–5,000 males worldwide.
A tentative approval in the EU will boost the drug’s growth prospects significantly.
Sarepta currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Heska Corp. , Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 92.2% year to date.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 87.9% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>