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Summit (SMMT): Rare Pediatric Disease Status for DMD Drug
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Summit Therapeutics plc (SMMT - Free Report) announced that it has received Rare Pediatric Disease designation from the FDA for one of its pipeline candidates, ezutromid (utrophin modulator), for the treatment of Duchenne muscular dystrophy (DMD).
A rare pediatric disease is one that affects less than 200,000 individuals in the U.S. from birth up to 18 years of age. We note that the FDA’s rare pediatric disease priority review voucher is received upon approval of a rare pediatric disease product and can be used to obtain priority review for a subsequent marketing application for a different product. Moreover, the voucher might be sold or transferred without limitation.
The rare pediatric priority review voucher program is set to expire on Oct 1, 2016, even though the U.S. Congress is currently considering legislation to extend the program. If the program is not renewed, the FDA will no longer award pediatric vouchers to otherwise eligible sponsors.
Early this week, Summit also announced that it has gained Fast Track designation from the FDA for ezutromid for the treatment of DMD.
We note that the FDA grants Fast Track status to facilitate the development and speed up the review process for candidates that are being developed for the treatment of serious conditions with an unmet medical need. Fast Track status will allow Summit to interact with the FDA more frequently throughout the development. The company can also make a rolling submission of its new drug application for the candidate, which will be considered for accelerated approval and priority review.
Ezutromid is currently being evaluated for the treatment of DMD in a phase II study – PhaseOut DMD – with 24-week biopsy data from initial group of patients anticipated in the second quarter/third quarter of fiscal 2017.
We note that the candidate also enjoys Orphan Drug status for DMD in both the U.S and the EU, which will make it eligible for additional regulatory support and market exclusivity upon approval.
We remind investors that last week Sarepta Therapeutics, Inc. (SRPT - Free Report) received accelerated approval for its DMD drug, Exondys 51, in the U.S. FDA approval makes Exondys 51 the first DMD treatment to gain approval in the U.S.
Apart from ezutromid, Summit also has ridinilazole in its pipeline. The candidate is in phase II development for the treatment of Clostridium difficile infection.
For 2016, Anika witnessed a 12.6% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped 22.1% year to date.
VIVUS has recorded an average positive surprise of 39.88% over the last four trailing quarters. Share price of the company has surged 12.1% year to date.
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Summit (SMMT): Rare Pediatric Disease Status for DMD Drug
Summit Therapeutics plc (SMMT - Free Report) announced that it has received Rare Pediatric Disease designation from the FDA for one of its pipeline candidates, ezutromid (utrophin modulator), for the treatment of Duchenne muscular dystrophy (DMD).
A rare pediatric disease is one that affects less than 200,000 individuals in the U.S. from birth up to 18 years of age. We note that the FDA’s rare pediatric disease priority review voucher is received upon approval of a rare pediatric disease product and can be used to obtain priority review for a subsequent marketing application for a different product. Moreover, the voucher might be sold or transferred without limitation.
The rare pediatric priority review voucher program is set to expire on Oct 1, 2016, even though the U.S. Congress is currently considering legislation to extend the program. If the program is not renewed, the FDA will no longer award pediatric vouchers to otherwise eligible sponsors.
SUMMIT THERAPTC Price
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Ezutromid Receives Fast Track Status in the U.S.
Early this week, Summit also announced that it has gained Fast Track designation from the FDA for ezutromid for the treatment of DMD.
We note that the FDA grants Fast Track status to facilitate the development and speed up the review process for candidates that are being developed for the treatment of serious conditions with an unmet medical need. Fast Track status will allow Summit to interact with the FDA more frequently throughout the development. The company can also make a rolling submission of its new drug application for the candidate, which will be considered for accelerated approval and priority review.
Ezutromid is currently being evaluated for the treatment of DMD in a phase II study – PhaseOut DMD – with 24-week biopsy data from initial group of patients anticipated in the second quarter/third quarter of fiscal 2017.
We note that the candidate also enjoys Orphan Drug status for DMD in both the U.S and the EU, which will make it eligible for additional regulatory support and market exclusivity upon approval.
We remind investors that last week Sarepta Therapeutics, Inc. (SRPT - Free Report) received accelerated approval for its DMD drug, Exondys 51, in the U.S. FDA approval makes Exondys 51 the first DMD treatment to gain approval in the U.S.
Apart from ezutromid, Summit also has ridinilazole in its pipeline. The candidate is in phase II development for the treatment of Clostridium difficile infection.
Summit currently carries a Zacks Rank #2 (Buy).
Stocks to Consider
A couple of favorably placed stocks in the health care sector are Anika Therapeutics Inc. (ANIK - Free Report) and VIVUS Inc. . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
For 2016, Anika witnessed a 12.6% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped 22.1% year to date.
VIVUS has recorded an average positive surprise of 39.88% over the last four trailing quarters. Share price of the company has surged 12.1% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>