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Praxis Stock Up as Epilepsy Candidate Shows Reduction in Seizures
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Shares of Praxis Precision Medicines (PRAX - Free Report) gained 4.2% on Sept. 4 after the company announced positive top-line data from its mid-stage EMBOLD proof of concept study evaluating relutrigine (PRAX-562) to treat SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients.
Praxis’ EMBOLD Study Reduces Seizures in Epilepsy Patients
Data from the phase II EMBOLD study of relutrigine showed that patients treated with relutrigine experienced a placebo-adjusted reduction of 46% in countable monthly motor seizures. Five patients achieved a 28-day seizure free status, which translates to more than 30% of the evaluable patients, while receiving relutrigine compared with none on placebo.
Patients receiving the candidate also observed a clinically meaningful improvement in disruptive behavior, communication, seizure severity and intensity and alertness after 16 weeks of treatment. Additionally, eight patients in the long-term extension period of the study experienced a median reduction in motor seizures of 75%.
Year to date, shares of Praxis have skyrocketed 148.6% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Praxis also reported that relutrigine was “generally safe and well tolerated” by patients during the EMBOLD study. In fact, seven patientsincreased the daily dose to the maximum-allowed dose of the candidate during the study period, and no patient required dose reduction. Adverse events related to treatment were mostly mild to moderate in severity and did not result in any discontinuations.
Based on the encouraging outcomes, Praxis has already initiated the registrational phase of the EMBOLD study, evaluating relutrigine for SCN2A and SCN8A DEE. There are currently no approved treatments for these indications.
Praxis’ Relutrigine is an investigational, first-in-class and small molecule, which is being developed as a preferential inhibitor of persistent sodium current for the epilepsy indication. Persistent sodium current is a key driver of seizure symptoms in SCN2A-DEE and SCN8A-DEE. The candidate enjoys the Orphan Drug designation and Rare Pediatric Designation in the United States for the above indications. In the EU, relutrigine enjoys the Orphan Drug designation for the same indications.
Other Candidates in Praxis’ Clinical-Stage Pipeline
Praxis’ lead candidate, ulixacaltamide, is currently being evaluated in two separate studies under the company’s phase III Essential3 program for the treatment of essential tremor. Top-line results from both studies are anticipated in the second half of 2024. Subject to positive data readouts, these studies will form the basis for a planned new drug application submission, seeking approval for ulixacaltamide to treat essential tremor in 2025.
Praxis is also currently evaluating another candidate, PRAX-628, for the treatment of focal onset seizures (FOS). In the second-quarter earnings release, the company stated that it plans to initiate four studies as part of the PRAX-628 ENERGY program to generate efficacy, safety and pharmacokinetics data, which are expected to support regulatory registrations globally.
Praxis Precision Medicines, Inc. Price and Consensus
Although there are no approved drugs for treating DEE indications, another company, Xenon Pharmaceuticals (XENE - Free Report) , is currently developing novel therapies for several epilepsy indications. In December 2019, Xenon entered into a collaboration agreement with Neurocrine Biosciences (NBIX - Free Report) granting the latter an exclusive license to XEN901, now known as NBI-921352, which is a selective Nav1.6 sodium channel inhibitor. Neurocrine is currently evaluating NBI-921352 in a phase II study to treat pediatric patients with SCN8A DEE. Per the terms of the agreement with Neurocrine, XENE is eligible to receive certain clinical, regulatory and commercial milestone-based payments, as well as royalties on future sales.
Xenon is developing its lead candidate, azetukalner, a differentiated Kv7 potassium channel,for treating epilepsy and other neurological disorders. Two identical phase III studies, under the company’s late-stage epilepsy program, are currently evaluating azetukalner to treat FOS patients.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
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Praxis Stock Up as Epilepsy Candidate Shows Reduction in Seizures
Shares of Praxis Precision Medicines (PRAX - Free Report) gained 4.2% on Sept. 4 after the company announced positive top-line data from its mid-stage EMBOLD proof of concept study evaluating relutrigine (PRAX-562) to treat SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients.
Praxis’ EMBOLD Study Reduces Seizures in Epilepsy Patients
Data from the phase II EMBOLD study of relutrigine showed that patients treated with relutrigine experienced a placebo-adjusted reduction of 46% in countable monthly motor seizures. Five patients achieved a 28-day seizure free status, which translates to more than 30% of the evaluable patients, while receiving relutrigine compared with none on placebo.
Patients receiving the candidate also observed a clinically meaningful improvement in disruptive behavior, communication, seizure severity and intensity and alertness after 16 weeks of treatment. Additionally, eight patients in the long-term extension period of the study experienced a median reduction in motor seizures of 75%.
Year to date, shares of Praxis have skyrocketed 148.6% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Praxis also reported that relutrigine was “generally safe and well tolerated” by patients during the EMBOLD study. In fact, seven patientsincreased the daily dose to the maximum-allowed dose of the candidate during the study period, and no patient required dose reduction. Adverse events related to treatment were mostly mild to moderate in severity and did not result in any discontinuations.
Based on the encouraging outcomes, Praxis has already initiated the registrational phase of the EMBOLD study, evaluating relutrigine for SCN2A and SCN8A DEE. There are currently no approved treatments for these indications.
Praxis’ Relutrigine is an investigational, first-in-class and small molecule, which is being developed as a preferential inhibitor of persistent sodium current for the epilepsy indication. Persistent sodium current is a key driver of seizure symptoms in SCN2A-DEE and SCN8A-DEE. The candidate enjoys the Orphan Drug designation and Rare Pediatric Designation in the United States for the above indications. In the EU, relutrigine enjoys the Orphan Drug designation for the same indications.
Other Candidates in Praxis’ Clinical-Stage Pipeline
Praxis’ lead candidate, ulixacaltamide, is currently being evaluated in two separate studies under the company’s phase III Essential3 program for the treatment of essential tremor. Top-line results from both studies are anticipated in the second half of 2024. Subject to positive data readouts, these studies will form the basis for a planned new drug application submission, seeking approval for ulixacaltamide to treat essential tremor in 2025.
Praxis is also currently evaluating another candidate, PRAX-628, for the treatment of focal onset seizures (FOS). In the second-quarter earnings release, the company stated that it plans to initiate four studies as part of the PRAX-628 ENERGY program to generate efficacy, safety and pharmacokinetics data, which are expected to support regulatory registrations globally.
Praxis Precision Medicines, Inc. Price and Consensus
Praxis Precision Medicines, Inc. price-consensus-chart | Praxis Precision Medicines, Inc. Quote
Other Players in the Epilepsy Market
Although there are no approved drugs for treating DEE indications, another company, Xenon Pharmaceuticals (XENE - Free Report) , is currently developing novel therapies for several epilepsy indications. In December 2019, Xenon entered into a collaboration agreement with Neurocrine Biosciences (NBIX - Free Report) granting the latter an exclusive license to XEN901, now known as NBI-921352, which is a selective Nav1.6 sodium channel inhibitor. Neurocrine is currently evaluating NBI-921352 in a phase II study to treat pediatric patients with SCN8A DEE. Per the terms of the agreement with Neurocrine, XENE is eligible to receive certain clinical, regulatory and commercial milestone-based payments, as well as royalties on future sales.
Xenon is developing its lead candidate, azetukalner, a differentiated Kv7 potassium channel,for treating epilepsy and other neurological disorders. Two identical phase III studies, under the company’s late-stage epilepsy program, are currently evaluating azetukalner to treat FOS patients.
Zacks Rank & Stock to Consider
Praxis currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Illumina, Inc. (ILMN - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 6.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.