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Jazz Pharma's Xywav Succeeds in Idiopathic Hypersomnia Study
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Shares of Jazz Pharmaceuticals plc (JAZZ - Free Report) were up 8% on Thursday after the company announced positive top-line data from a phase III study, which is evaluating its newly-approved drug Xywav for a new indication. The placebo-controlled withdrawal study is evaluating Xywav oral solution for the treatment of adult patients with idiopathic hypersomnia, a chronic neurological disorder characterized by excessive daytime sleepiness. Currently, there are no approved treatments for the given indication.
In fact, so far this year, the stock has increased 3.7% against the industry’s decrease of 7.1%.
Data from the study showed that patients with idiopathic hypersomnia, treated with Xywav during the open-label titration period, achieved clinically meaningful improvements in the Epworth Sleepiness Scale (ESS), the primary endpoint of the above-mentioned study. Also, treatment with Xywav demonstrated a clinically meaningful maintenance of efficacy for ESS, Patient Global Impression of Change (PGIc) and Idiopathic Hypersomnia Severity Scale (IHSS). PGIc and IHSS were key secondary endpoints of the study.
Meanwhile, there were highly statistically significant deteriorations in patients who received placebo compared with Xywav for ESS.
Jazz plans to file a supplemental new drug application (sNDA) for Xywav to get the drug’s label updated for including the diopathic hypersomnia indication in the first quarter of 2021. The company will present the phase III study data at an upcoming medical conference.
Notably, Xywav (comprising calcium, magnesium, potassium and sodium oxybates) received a Fast Track designation from the FDA for the given indication in September 2020.
We note that Xywaz was approved by the FDA in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy, who are aged seven years and above. The company plans to launch the drug by this year-end.
Xywav is a low sodium formulation of Jazz’s key sleep disorder drug Xyrem. The low sodium content of the same boosts its potential as it can cater to a greater number of patients compared to Xyrem. A potential label expansion of Xywav will be a significant boost to the company in the future.
Onconova’s loss per share estimates have narrowed 7.7% for 2020 and 30.7% for 2021 over the past 60 days.
Ironwood earnings estimates have been revised 8% upward for 2020 and 50.8% for 2021 over the past 60 days.
Aclaris’ loss per share estimates have narrowed 5.3% for 2020 and 6.8% for 2021 over the past 60 days. The stock has surged 119.6% year to date.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.3% per year.
These 7 were selected because of their superior potential for immediate breakout.
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Jazz Pharma's Xywav Succeeds in Idiopathic Hypersomnia Study
Shares of Jazz Pharmaceuticals plc (JAZZ - Free Report) were up 8% on Thursday after the company announced positive top-line data from a phase III study, which is evaluating its newly-approved drug Xywav for a new indication. The placebo-controlled withdrawal study is evaluating Xywav oral solution for the treatment of adult patients with idiopathic hypersomnia, a chronic neurological disorder characterized by excessive daytime sleepiness. Currently, there are no approved treatments for the given indication.
In fact, so far this year, the stock has increased 3.7% against the industry’s decrease of 7.1%.
Data from the study showed that patients with idiopathic hypersomnia, treated with Xywav during the open-label titration period, achieved clinically meaningful improvements in the Epworth Sleepiness Scale (ESS), the primary endpoint of the above-mentioned study. Also, treatment with Xywav demonstrated a clinically meaningful maintenance of efficacy for ESS, Patient Global Impression of Change (PGIc) and Idiopathic Hypersomnia Severity Scale (IHSS). PGIc and IHSS were key secondary endpoints of the study.
Meanwhile, there were highly statistically significant deteriorations in patients who received placebo compared with Xywav for ESS.
Jazz plans to file a supplemental new drug application (sNDA) for Xywav to get the drug’s label updated for including the diopathic hypersomnia indication in the first quarter of 2021. The company will present the phase III study data at an upcoming medical conference.
Notably, Xywav (comprising calcium, magnesium, potassium and sodium oxybates) received a Fast Track designation from the FDA for the given indication in September 2020.
We note that Xywaz was approved by the FDA in July 2020 for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy, who are aged seven years and above. The company plans to launch the drug by this year-end.
Xywav is a low sodium formulation of Jazz’s key sleep disorder drug Xyrem. The low sodium content of the same boosts its potential as it can cater to a greater number of patients compared to Xyrem. A potential label expansion of Xywav will be a significant boost to the company in the future.
Zacks Rank & Other Stocks to Consider
Jazz currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the same sector include Onconova Therapeutics, Inc. , Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) and Aclaris Therapeutics, Inc. (ACRS - Free Report) , all carrying the same Zacks Rank as Jazz at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Onconova’s loss per share estimates have narrowed 7.7% for 2020 and 30.7% for 2021 over the past 60 days.
Ironwood earnings estimates have been revised 8% upward for 2020 and 50.8% for 2021 over the past 60 days.
Aclaris’ loss per share estimates have narrowed 5.3% for 2020 and 6.8% for 2021 over the past 60 days. The stock has surged 119.6% year to date.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.3% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>