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JAZZ's Xywav sNDA for Hypersomnia Gets FDA Priority Review
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Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its new sleep drug, Xywav, in idiopathic hypersomnia. The FDA has also granted priority review to the sNDA, indicating speedy review. A decision on potential approval to Xywav’s label expansion in this indication from the FDA is expected by Aug 12, 2021.
Please note that Xywav 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 drug was launched in November.
The sNDA was filed based on data from a completed phase III study that evaluated Xywav oral solution in adult patients with idiopathic hypersomnia, a chronic neurological disorder characterized by excessive daytime sleepiness. Currently, there are no approved treatments for the given indication.
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.
Shares of Jazz have lost 1.7% so far this year compared with the industry’s decrease of 10.6%.
Please note that 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. At the end of 2020, Jazz had approximately 1,900 active Xywav cataplexy or narcolepsy patients. A potential approval for the label expansion of Xywav will be a significant boost to the company in the future. The company may launch the drug for the expanded patient population in the fourth quarter, if approved.
The company has a strong sleep disorder portfolio with Xyrem leading the path. Apart from Xyrem and Xywav, Sunosi is another drug in this portfolio. Meanwhile, the company also has a portfolio of several oncology drugs, which derives nearly one-third of product revenues.
We note that Jazz is in the process of diversifying its portfolio of drugs with the acquisition offer for British cannabinoid drug company, GW Pharmaceuticals . The acquisition will add GW Pharmaceuticals’ lead oral solution, Epidiolex, approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The acquisition will thus add a third high-growth commercial franchise to Jazz’s business.
The consensus estimate for Catalent’s 2021 earnings has improved from $2.75 per share to $2.83 over the past 60 days. The stock has risen 5.1% this year so far.
Avenue Therapeutics’ loss estimates have narrowed from 29 cents per share to 25 cents per share for 2021 over the past 60 days. The stock has rallied 19.5% this year so far.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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JAZZ's Xywav sNDA for Hypersomnia Gets FDA Priority Review
Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its new sleep drug, Xywav, in idiopathic hypersomnia. The FDA has also granted priority review to the sNDA, indicating speedy review. A decision on potential approval to Xywav’s label expansion in this indication from the FDA is expected by Aug 12, 2021.
Please note that Xywav 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 drug was launched in November.
The sNDA was filed based on data from a completed phase III study that evaluated Xywav oral solution in adult patients with idiopathic hypersomnia, a chronic neurological disorder characterized by excessive daytime sleepiness. Currently, there are no approved treatments for the given indication.
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.
Shares of Jazz have lost 1.7% so far this year compared with the industry’s decrease of 10.6%.
Please note that 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. At the end of 2020, Jazz had approximately 1,900 active Xywav cataplexy or narcolepsy patients. A potential approval for the label expansion of Xywav will be a significant boost to the company in the future. The company may launch the drug for the expanded patient population in the fourth quarter, if approved.
The company has a strong sleep disorder portfolio with Xyrem leading the path. Apart from Xyrem and Xywav, Sunosi is another drug in this portfolio. Meanwhile, the company also has a portfolio of several oncology drugs, which derives nearly one-third of product revenues.
We note that Jazz is in the process of diversifying its portfolio of drugs with the acquisition offer for British cannabinoid drug company, GW Pharmaceuticals . The acquisition will add GW Pharmaceuticals’ lead oral solution, Epidiolex, approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. The acquisition will thus add a third high-growth commercial franchise to Jazz’s business.
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked small drugmakers include Catalent, Inc. (CTLT - Free Report) and Avenue Therapeutics, Inc. (ATXI - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The consensus estimate for Catalent’s 2021 earnings has improved from $2.75 per share to $2.83 over the past 60 days. The stock has risen 5.1% this year so far.
Avenue Therapeutics’ loss estimates have narrowed from 29 cents per share to 25 cents per share for 2021 over the past 60 days. The stock has rallied 19.5% this year so far.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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