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JAZZ Falls as Suvecaltamide Tremor Study Fails to Meet Goals
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Jazz Pharmaceuticals (JAZZ - Free Report) announced that a mid-stage study evaluating the efficacy and safety of its investigational candidate, suvecaltamide (JZP385), in adult patients with essential tremor (ET) did not meet its primary endpoint.
Suvecaltamide is a highly selective and state-dependent modulator of T-type calcium channels, which play a role in the brain's control of muscle movement.
Per the data readout from the phase IIb study (NCT05122650), treatment with suvecaltamide 30mg failed to achieve statistical significance on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score compared with placebo.
TETRAS is a validated clinical scale designed specifically for the assessment of ET severity.
The study also failed to achieve statistical significance on the key secondary endpoint of the Clinical Global Impression-Severity scale, which is a measure of the severity of illness compared with placebo at week 12.
However, treatment with suvecaltamide 30mg demonstrated numeric improvements on the primary endpoint and key secondary endpoint of the ET study compared with placebo. The numeric improvements were not statistically significant.
The company stated that the reason behind the ET study's failure was the better-than-expected performance of the placebo group from baseline to week 12. Per the company, the improvement upon treatment with placebo was higher than what was observed in the prior T-CALM study of suvecaltamide.
Jazz’s shares lost 4.7% during trading hours on Jun 20, after the company announced the news. Year to date, shares of JAZZ have plunged 12.7% compared with the industry’s 9.6% decline.
Image Source: Zacks Investment Research
Moreover, the investigational candidate was overall well-tolerated in the mid-stage study with a safety profile consistent with previous studies. No new safety signals were identified upon treatment with suvecaltamide. Adverse events related to treatment with the candidate were mostly mild to moderate in severity. Only one patient in the phase IIb study experienced a serious adverse event considered treatment related by the investigator.
JAZZ is also conducting a phase II study of suvecaltamide for Parkinson's disease tremor. The results are anticipated in the first quarter of 2025. The findings from this study will be crucial in determining the future direction of their research and development program for suvecaltamide.
Interestingly, the failure of Jazz’s ET study resulted in a stock price gain of 6.4% for competitor firm Praxis Precision Medicines (PRAX - Free Report) , which is also developing a candidate for ET. PRAX’s most advanced product candidate, ulixacaltamide (formerly known as PRAX-944), is currently being evaluated in a late-stage study for the ET indication. Top-line data from the phase III study is expected in the second half of 2024.
Praxis Precision’s ulixacaltamide has the same mechanism of action as Jazz’s suvecaltamide, both targeting the T-type calcium channels. A positive data readout from the late-stage study will provide PRAX with a significant edge over its competitor, while likely boosting the stock price.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 53.8%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 67.8%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
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JAZZ Falls as Suvecaltamide Tremor Study Fails to Meet Goals
Jazz Pharmaceuticals (JAZZ - Free Report) announced that a mid-stage study evaluating the efficacy and safety of its investigational candidate, suvecaltamide (JZP385), in adult patients with essential tremor (ET) did not meet its primary endpoint.
Suvecaltamide is a highly selective and state-dependent modulator of T-type calcium channels, which play a role in the brain's control of muscle movement.
Per the data readout from the phase IIb study (NCT05122650), treatment with suvecaltamide 30mg failed to achieve statistical significance on the primary endpoint of change from baseline to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite outcome score compared with placebo.
TETRAS is a validated clinical scale designed specifically for the assessment of ET severity.
The study also failed to achieve statistical significance on the key secondary endpoint of the Clinical Global Impression-Severity scale, which is a measure of the severity of illness compared with placebo at week 12.
However, treatment with suvecaltamide 30mg demonstrated numeric improvements on the primary endpoint and key secondary endpoint of the ET study compared with placebo. The numeric improvements were not statistically significant.
The company stated that the reason behind the ET study's failure was the better-than-expected performance of the placebo group from baseline to week 12. Per the company, the improvement upon treatment with placebo was higher than what was observed in the prior T-CALM study of suvecaltamide.
Jazz’s shares lost 4.7% during trading hours on Jun 20, after the company announced the news. Year to date, shares of JAZZ have plunged 12.7% compared with the industry’s 9.6% decline.
Image Source: Zacks Investment Research
Moreover, the investigational candidate was overall well-tolerated in the mid-stage study with a safety profile consistent with previous studies. No new safety signals were identified upon treatment with suvecaltamide. Adverse events related to treatment with the candidate were mostly mild to moderate in severity. Only one patient in the phase IIb study experienced a serious adverse event considered treatment related by the investigator.
JAZZ is also conducting a phase II study of suvecaltamide for Parkinson's disease tremor. The results are anticipated in the first quarter of 2025. The findings from this study will be crucial in determining the future direction of their research and development program for suvecaltamide.
Interestingly, the failure of Jazz’s ET study resulted in a stock price gain of 6.4% for competitor firm Praxis Precision Medicines (PRAX - Free Report) , which is also developing a candidate for ET. PRAX’s most advanced product candidate, ulixacaltamide (formerly known as PRAX-944), is currently being evaluated in a late-stage study for the ET indication. Top-line data from the phase III study is expected in the second half of 2024.
Praxis Precision’s ulixacaltamide has the same mechanism of action as Jazz’s suvecaltamide, both targeting the T-type calcium channels. A positive data readout from the late-stage study will provide PRAX with a significant edge over its competitor, while likely boosting the stock price.
Jazz Pharmaceuticals PLC Price and Consensus
Jazz Pharmaceuticals PLC price-consensus-chart | Jazz Pharmaceuticals PLC Quote
Zacks Rank and Stocks to Consider
Jazz currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings (ALXO - Free Report) and Annovis Bio (ANVS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 53.8%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 67.8%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.