Shire plc announced that the FDA has granted Breakthrough Therapy Designation to two candidates in its rare diseases pipeline – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).
The FDA generally grants Breakthrough Therapy Designation to a candidate that is intended to treat a serious or life-threatening disease or condition with preliminary clinical evidence indicating that the drug could demonstrate substantial improvement on one or more clinically significant endpoints over the current standard of care. This designation will enable the company to obtain intensive guidance from the FDA and be eligible for a rolling and priority review for the drug application.
Shire acquired global rights to SHP625 through its 2014 buyout of Lumena while the Meritage Pharma acquisition provided it with worldwide rights to SHP621.
We remind investors that the company suffered a setback when preliminary results of a phase II study, CAMEO, on SHP625 for cholestatic liver disease showed no significant reduction from baseline in serum alkaline phosphatase or other liver parameters.
Currently, SHP621 is in phase III development for EoE, while SHP625 is in phase II trials for PFIC. Successful development and commercialization of these candidates will strengthen Shire’s gastrointestinal (GI) franchise significantly. The Feb 2015 takeover of NPS Pharma acquisition also boosted Shire’s GI portfolio by adding Gattex (short bowel syndrome) and Natpara (hypoparathyroidism) to its portfolio.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Abbott Laboratories (ABT - Free Report) . While the first Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Abbott Labs is a Zacks Rank #2 (Buy) stock.
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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
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Shire plc announced that the FDA has granted Breakthrough Therapy Designation to two candidates in its rare diseases pipeline – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).
The FDA generally grants Breakthrough Therapy Designation to a candidate that is intended to treat a serious or life-threatening disease or condition with preliminary clinical evidence indicating that the drug could demonstrate substantial improvement on one or more clinically significant endpoints over the current standard of care. This designation will enable the company to obtain intensive guidance from the FDA and be eligible for a rolling and priority review for the drug application.
Shire acquired global rights to SHP625 through its 2014 buyout of Lumena while the Meritage Pharma acquisition provided it with worldwide rights to SHP621.
We remind investors that the company suffered a setback when preliminary results of a phase II study, CAMEO, on SHP625 for cholestatic liver disease showed no significant reduction from baseline in serum alkaline phosphatase or other liver parameters.
Currently, SHP621 is in phase III development for EoE, while SHP625 is in phase II trials for PFIC. Successful development and commercialization of these candidates will strengthen Shire’s gastrointestinal (GI) franchise significantly. The Feb 2015 takeover of NPS Pharma acquisition also boosted Shire’s GI portfolio by adding Gattex (short bowel syndrome) and Natpara (hypoparathyroidism) to its portfolio.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Abbott Laboratories (ABT - Free Report) . While the first Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Abbott Labs is a Zacks Rank #2 (Buy) stock.
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 >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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