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Mallinckrodt DMD Drug Gets Fast Track Status in the U.S.
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Mallinckrodt Public Limited Company announced that it has received Fast Track designation in the U.S. for its Investigational New Drug (IND) application for Synacthen Depot for the treatment of patients with Duchenne muscular dystrophy (DMD).
We note that the FDA grants Fast Track status to facilitate the development and quicken the review process for the candidates that are being developed for the treatment of serious conditions that have an unmet medical need.
Synacthen Depot is currently approved and commercialized in ex-U.S. markets for certain autoimmune and inflammatory conditions.
Mallinckrodt revealed that it has initiated a phase I study on the product for the DMD indication.
DMD, a devastating and debilitating disease, represents a market where there is currently no approved drug, indicating significant unmet need for treatments.
We remind investors that Sarepta Therapeutics, Inc. (SRPT - Free Report) is looking for an approval of its DMD drug, eteplirsen. A New Drug Application (NDA) is currently under review in the U.S.
Moreover, Catabasis Pharmaceuticals, Inc. is developing its DMD candidate, edasalonexent (CAT-1004), in a phase II (MoveDMD) study. Results from the study are anticipated later this year. Edasalonexent enjoys Orphan drug, Fast Track and Rare Pediatric Disease designation in the U.S. for the treatment of DMD. The candidate also enjoys Orphan Medicinal Product designation for this indication in the EU.
Mallinckrodt currently carries a Zacks Rank #3 (Hold). ANI Pharmaceuticals, Inc. (ANIP - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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Mallinckrodt DMD Drug Gets Fast Track Status in the U.S.
Mallinckrodt Public Limited Company announced that it has received Fast Track designation in the U.S. for its Investigational New Drug (IND) application for Synacthen Depot for the treatment of patients with Duchenne muscular dystrophy (DMD).
We note that the FDA grants Fast Track status to facilitate the development and quicken the review process for the candidates that are being developed for the treatment of serious conditions that have an unmet medical need.
Synacthen Depot is currently approved and commercialized in ex-U.S. markets for certain autoimmune and inflammatory conditions.
Mallinckrodt revealed that it has initiated a phase I study on the product for the DMD indication.
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DMD, a devastating and debilitating disease, represents a market where there is currently no approved drug, indicating significant unmet need for treatments.
We remind investors that Sarepta Therapeutics, Inc. (SRPT - Free Report) is looking for an approval of its DMD drug, eteplirsen. A New Drug Application (NDA) is currently under review in the U.S.
Moreover, Catabasis Pharmaceuticals, Inc. is developing its DMD candidate, edasalonexent (CAT-1004), in a phase II (MoveDMD) study. Results from the study are anticipated later this year. Edasalonexent enjoys Orphan drug, Fast Track and Rare Pediatric Disease designation in the U.S. for the treatment of DMD. The candidate also enjoys Orphan Medicinal Product designation for this indication in the EU.
Mallinckrodt currently carries a Zacks Rank #3 (Hold). ANI Pharmaceuticals, Inc. (ANIP - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>