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Longboard Pharma (LBPH) Up on Upbeat Data From Epilepsy Study
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Longboard Pharmaceuticals, Inc. (LBPH - Free Report) announced positive top-line results from the early to mid-stage PACIFIC study evaluating its lead investigational candidate, bexicaserin (LP352), for the treatment of seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).
Bexicaserin is Longboard Pharma’s potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist, which is being developed for DEEs. Participant DEE diagnoses included DS, LGS and other qualifying DEEs (DEE Other).
Per the data readout from the study, evaluable patients treated with bexicaserin experienced a median reduction of 53.3% in the countable motor seizure frequency from baseline compared with a 20.8% decrease for those receiving placebo. This comprised the primary efficacy endpoint of the PACIFIC study.
The company also reported the achievement of a median seizure reduction of 72.1%, 48.1% and 61.2% in DS, LGS and DEE Other cohorts, respectively.
Longboard Pharma’s stock skyrocketed 316.3% in the last trading session as the investors cheered the encouraging top-line results from the PACIFIC study of bexicaserin for the treatment of seizures associated with DEEs. Over the past year, shares of LBPH have rallied 395.1% against the industry’s 11.9% fall.
Image Source: Zacks Investment Research
The phase Ib/IIa PACIFIC study is evaluating the safety, tolerability, efficacy and pharmacokinetics of thrice-daily, three doses of bexicaserin (6 mg, 9 mg and 12 mg) in 52 patients aged between 12 and 65 years compared with placebo. All enrolled patients eventually received the highest tolerated dose of bexicaserin.
In the study, bexicaserin demonstrated a favorable safety and tolerability profile. Although there were a few discontinuations in the bexicaserin group due to an adverse event, most participants completed the PACIFIC study. Per Longboard Pharma, all patients who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.
The company plans to share additional data from the study at an upcoming medical conference. LBPH plans to advance bexicaserin into global phase III development.
However, it is important to note that there are other players in the market developing novel therapies for various epilepsy indications, an example being Xenon Pharmaceuticals (XENE - Free Report) . Xenon is currently developing its lead candidate, XEN1101, in late-stage development for treating focal onset seizures (FOS). Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are currently evaluating XEN1101 (15 mg or 25 mg) as an adjunctive treatment in patients with FOS.
Xenon expects to complete patient enrollment in the X-TOLE2 study in the second half of 2024. The company is also currently evaluating 25 mg XEN1101 for an additional epilepsy indication, primary generalized tonic-clonic seizures (PGTCS). A phase III X-ACKT study of XEN1101 in PGTCS is ongoing to support potential regulatory submissions in epilepsy indications.
Longboard Pharmaceuticals, Inc. Price and Consensus
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 69 cents. Over the past year, shares of PBYI have gained 7.7%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 24.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
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Longboard Pharma (LBPH) Up on Upbeat Data From Epilepsy Study
Longboard Pharmaceuticals, Inc. (LBPH - Free Report) announced positive top-line results from the early to mid-stage PACIFIC study evaluating its lead investigational candidate, bexicaserin (LP352), for the treatment of seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).
Bexicaserin is Longboard Pharma’s potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist, which is being developed for DEEs. Participant DEE diagnoses included DS, LGS and other qualifying DEEs (DEE Other).
Per the data readout from the study, evaluable patients treated with bexicaserin experienced a median reduction of 53.3% in the countable motor seizure frequency from baseline compared with a 20.8% decrease for those receiving placebo. This comprised the primary efficacy endpoint of the PACIFIC study.
The company also reported the achievement of a median seizure reduction of 72.1%, 48.1% and 61.2% in DS, LGS and DEE Other cohorts, respectively.
Longboard Pharma’s stock skyrocketed 316.3% in the last trading session as the investors cheered the encouraging top-line results from the PACIFIC study of bexicaserin for the treatment of seizures associated with DEEs. Over the past year, shares of LBPH have rallied 395.1% against the industry’s 11.9% fall.
Image Source: Zacks Investment Research
The phase Ib/IIa PACIFIC study is evaluating the safety, tolerability, efficacy and pharmacokinetics of thrice-daily, three doses of bexicaserin (6 mg, 9 mg and 12 mg) in 52 patients aged between 12 and 65 years compared with placebo. All enrolled patients eventually received the highest tolerated dose of bexicaserin.
In the study, bexicaserin demonstrated a favorable safety and tolerability profile. Although there were a few discontinuations in the bexicaserin group due to an adverse event, most participants completed the PACIFIC study. Per Longboard Pharma, all patients who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.
The company plans to share additional data from the study at an upcoming medical conference. LBPH plans to advance bexicaserin into global phase III development.
However, it is important to note that there are other players in the market developing novel therapies for various epilepsy indications, an example being Xenon Pharmaceuticals (XENE - Free Report) . Xenon is currently developing its lead candidate, XEN1101, in late-stage development for treating focal onset seizures (FOS). Under the phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are currently evaluating XEN1101 (15 mg or 25 mg) as an adjunctive treatment in patients with FOS.
Xenon expects to complete patient enrollment in the X-TOLE2 study in the second half of 2024. The company is also currently evaluating 25 mg XEN1101 for an additional epilepsy indication, primary generalized tonic-clonic seizures (PGTCS). A phase III X-ACKT study of XEN1101 in PGTCS is ongoing to support potential regulatory submissions in epilepsy indications.
Longboard Pharmaceuticals, Inc. Price and Consensus
Longboard Pharmaceuticals, Inc. price-consensus-chart | Longboard Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Longboard Pharma currently carries a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 69 cents. Over the past year, shares of PBYI have gained 7.7%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have gained 24.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.