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Jazz (JAZZ) Enrols First Patient in Essential Tremor Study
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Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the first patient in a phase IIb study has been enrolled to evaluate its investigational drug suvecaltamide (JZP385) for the treatment of essential tremors (ET), a common movement disorder.
The phase IIb study will enrol 400 adults across the United States and Europe to evaluate the safety and efficacy of JZP385 as a once-daily oral capsule in adults with moderate to severe ET. The primary efficacy endpoint of the study is the change from baseline to Week 12 on the Tremor Research Group Essential Tremor Rating Assessment Scale composite outcome score, a scale that measures the functional impact due to the tremors.
Jazz expects to provide top-line data from this phase IIb study in first-half 2024.
Shares of Jazz have declined 26.3% so far this year compared with the industry’s 20.8% fall.
Image Source: Zacks Investment Research
ET is marked by oscillations of at least one body part on account of involuntary rhythmic muscle movements that can occur 4-12 times per second. Per management, ET is estimated to occur in 11 million people across the United States, United Kingdom and key countries in the European Union.
Currently, there is no cure for ET. In fact, no new drug has been approved for ET in more than 50 years. Although therapies like beta blockers, anticonvulsant medicines, and neurosurgical procedures are used to control its symptoms, they are not well tolerated and are unable to fully control the tremors.
Suvecaltamide was added to Jazz’s portfolio with the 2019 acquisition of Cavion. Prior to the acquisition, Cavion conducted a phase II study in 2017, which evaluated suvecaltamide as a twice-daily formulation in adults with ET. The study demonstrated proof-of-concept while supporting the drug’s continued development.
A successful development of suvecaltamide will help cater to the unmet need of this patient population and provide an impetus to Jazz’s expanding neuroscience franchise.
Jazz’s neuroscience franchise — which consists of three sleep disorder drugs (Xyrem, Sunosi, and Xywav) and one seizure drug (Epidiolex) — is a key revenue generator for the company. The marketed neuroscience drugs generated more than 75% of product revenues amounting to $646.1 million for third-quarter 2021. Meanwhile, Jazz continues to boost this franchise through acquisitions or partnerships. In May 2021, Jazz acquired a British cannabinoid drug company, GW Pharmaceuticals. The acquisition added Epidiolex — approved for the treatment of seizures associated with two rare and severe forms of epilepsy, namely Lennox-Gastaut syndrome and Dravet syndrome — to its portfolio
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Endo International , GlaxoSmithKline (GSK - Free Report) and IVERIC bio . While Endo International sports a Zacks Rank #1 (Strong Buy), both GlaxoSmithKline and IVERIC bio carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.84 in the past 60 days. The same for 2022 has increased from $2.25 to $2.47 in the past 60 days.
Earnings of Endo International beat estimates in all the last four quarters, delivering a surprise of 57.7%, on average.
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $2.82 to $3.05 in the past 60 days. The same for 2022 has increased from $3.08 to $3.25 in the past 60 days. Shares of Glaxo have risen 18.6% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 122.4% in the year so far.
IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.
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Jazz (JAZZ) Enrols First Patient in Essential Tremor Study
Jazz Pharmaceuticals plc (JAZZ - Free Report) announced that the first patient in a phase IIb study has been enrolled to evaluate its investigational drug suvecaltamide (JZP385) for the treatment of essential tremors (ET), a common movement disorder.
The phase IIb study will enrol 400 adults across the United States and Europe to evaluate the safety and efficacy of JZP385 as a once-daily oral capsule in adults with moderate to severe ET. The primary efficacy endpoint of the study is the change from baseline to Week 12 on the Tremor Research Group Essential Tremor Rating Assessment Scale composite outcome score, a scale that measures the functional impact due to the tremors.
Jazz expects to provide top-line data from this phase IIb study in first-half 2024.
Shares of Jazz have declined 26.3% so far this year compared with the industry’s 20.8% fall.
ET is marked by oscillations of at least one body part on account of involuntary rhythmic muscle movements that can occur 4-12 times per second. Per management, ET is estimated to occur in 11 million people across the United States, United Kingdom and key countries in the European Union.
Currently, there is no cure for ET. In fact, no new drug has been approved for ET in more than 50 years. Although therapies like beta blockers, anticonvulsant medicines, and neurosurgical procedures are used to control its symptoms, they are not well tolerated and are unable to fully control the tremors.
Suvecaltamide was added to Jazz’s portfolio with the 2019 acquisition of Cavion. Prior to the acquisition, Cavion conducted a phase II study in 2017, which evaluated suvecaltamide as a twice-daily formulation in adults with ET. The study demonstrated proof-of-concept while supporting the drug’s continued development.
A successful development of suvecaltamide will help cater to the unmet need of this patient population and provide an impetus to Jazz’s expanding neuroscience franchise.
Jazz’s neuroscience franchise — which consists of three sleep disorder drugs (Xyrem, Sunosi, and Xywav) and one seizure drug (Epidiolex) — is a key revenue generator for the company. The marketed neuroscience drugs generated more than 75% of product revenues amounting to $646.1 million for third-quarter 2021. Meanwhile, Jazz continues to boost this franchise through acquisitions or partnerships. In May 2021, Jazz acquired a British cannabinoid drug company, GW Pharmaceuticals. The acquisition added Epidiolex — approved for the treatment of seizures associated with two rare and severe forms of epilepsy, namely Lennox-Gastaut syndrome and Dravet syndrome — to its portfolio
Jazz Pharmaceuticals PLC Price
Jazz Pharmaceuticals PLC price | Jazz Pharmaceuticals PLC Quote
Zacks Rank & Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Endo International , GlaxoSmithKline (GSK - Free Report) and IVERIC bio . While Endo International sports a Zacks Rank #1 (Strong Buy), both GlaxoSmithKline and IVERIC bio carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.84 in the past 60 days. The same for 2022 has increased from $2.25 to $2.47 in the past 60 days.
Earnings of Endo International beat estimates in all the last four quarters, delivering a surprise of 57.7%, on average.
GlaxoSmithKline’s earnings per share estimates for 2021 have increased from $2.82 to $3.05 in the past 60 days. The same for 2022 has increased from $3.08 to $3.25 in the past 60 days. Shares of Glaxo have risen 18.6% in the year so far.
Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed once, with the average surprise being 15.3%.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 122.4% in the year so far.
IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.