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Jazz Initiates Phase III Study for Narcolepsy Candidate
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Jazz Pharmaceuticals plc (JAZZ - Free Report) recently announced the initiation of patient enrollment in a phase III study evaluating the efficacy and safety of its pipeline candidate, JZP-258, for the potential treatment of adult narcolepsy patients with cataplexy and excessive daytime sleepiness (EDS).
JZP-258 is an oxybate product candidate with 90% less sodium content than its marketed product Xyrem (sodium oxybate). Xyrem is currently approved for narcolepsy with cataplexy and EDS and, at the highest approved dose of 9 grams per night, contains 1,640 mg of sodium.
Jazz’s shares have traded above the Zacks classified Medical-Drugs industry so far this year. Specifically the company’s shares gained 27.3% while the industry registered an increase of 3.9%.
The phase III study is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study. It is mainly initiated to reduce sodium intake in narcolepsy patients. The study is expected to achieve clinically meaningful goals as patients with narcolepsy are at risk for high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The study is expected to enroll approximately 185 patients in order to randomize around 130 patients.
The study will be conducted across approximately 60 centers in the EU and the U.S.
We note that JZP-258 was earlier evaluated in a phase I study in 60 healthy adults, which demonstrated a safety profile similar to Xyrem. However, the company expects JZP-258 to offer more meaningful clinical benefit to patients than Xyrem.
Per the company’s press release one in 2,000 people in the U.S. is affected by narcolepsy, with symptoms typically appearing in early adulthood. Estimates show that 50% or more narcolepsy patients remain undiagnosed for as long as 10 years. Hence, timely approval of the drug will provide the company to reach out to a huge number of patients affected with the disease.
Addus HomeCare’s earnings estimates increased from $1.38 to $1.41 for 2017 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 10.14%.
The Advisory Board’s earnings per share estimates increased from $1.41 to $1.48 for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 33.41%.
BioCryst Pharma’s loss per share estimates narrowed from 88 cents to 66 cents for 2017 and from a loss of 93 cents to 70 cents over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 20%.
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Jazz Initiates Phase III Study for Narcolepsy Candidate
Jazz Pharmaceuticals plc (JAZZ - Free Report) recently announced the initiation of patient enrollment in a phase III study evaluating the efficacy and safety of its pipeline candidate, JZP-258, for the potential treatment of adult narcolepsy patients with cataplexy and excessive daytime sleepiness (EDS).
JZP-258 is an oxybate product candidate with 90% less sodium content than its marketed product Xyrem (sodium oxybate). Xyrem is currently approved for narcolepsy with cataplexy and EDS and, at the highest approved dose of 9 grams per night, contains 1,640 mg of sodium.
Jazz’s shares have traded above the Zacks classified Medical-Drugs industry so far this year. Specifically the company’s shares gained 27.3% while the industry registered an increase of 3.9%.
The phase III study is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study. It is mainly initiated to reduce sodium intake in narcolepsy patients. The study is expected to achieve clinically meaningful goals as patients with narcolepsy are at risk for high sodium intake-related consequences, including hypertension and other cardiovascular diseases. The study is expected to enroll approximately 185 patients in order to randomize around 130 patients.
The study will be conducted across approximately 60 centers in the EU and the U.S.
We note that JZP-258 was earlier evaluated in a phase I study in 60 healthy adults, which demonstrated a safety profile similar to Xyrem. However, the company expects JZP-258 to offer more meaningful clinical benefit to patients than Xyrem.
Per the company’s press release one in 2,000 people in the U.S. is affected by narcolepsy, with symptoms typically appearing in early adulthood. Estimates show that 50% or more narcolepsy patients remain undiagnosed for as long as 10 years. Hence, timely approval of the drug will provide the company to reach out to a huge number of patients affected with the disease.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Key Picks
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Addus HomeCare Corporation (ADUS - Free Report) , The Advisory Board Company and BioCryst Pharmaceuticals, Inc. (BCRX - Free Report) . Each of these stocks carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Addus HomeCare’s earnings estimates increased from $1.38 to $1.41 for 2017 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 10.14%.
The Advisory Board’s earnings per share estimates increased from $1.41 to $1.48 for 2017 over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 33.41%.
BioCryst Pharma’s loss per share estimates narrowed from 88 cents to 66 cents for 2017 and from a loss of 93 cents to 70 cents over the last 30 days. The company posted positive earnings surprises in three of the four trailing quarters, with an average beat of 20%.
More Stock News: 8 Companies Verge on Apple-Like Run
Did you miss Apple's 9X stock explosion after they launched their iPhone in 2007? Now 2017 looks to be a pivotal year to get in on another emerging technology expected to rock the market. Demand could soar from almost nothing to $42 billion by 2025. Reports suggest it could save 10 million lives per decade which could in turn save $200 billion in U.S. healthcare costs.
A bonus Zacks Special Report names this breakthrough and the 8 best stocks to exploit it. Like Apple in 2007, these companies are already strong and coiling for potential mega-gains. Click to see them right now >>