Yahoo Finance Longboard (LBPH) Up 14% as Epilepsy Drug Gets Breakthrough Tag
Longboard Pharmaceuticals LBPH gained 14.4% on Jul 1 after it announced that the FDA has granted Breakthrough Therapy designation for its investigational drug, bexicaserin, to treat seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients aged two years or older.
Bexicaserin is LBPH’s potentially best-in-class and highly selective, oral and novel 5-HT2C receptor superagonist, which is being developed for DEEs.
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on an important clinical measure. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
The Breakthrough Therapy designation for the epilepsy candidate is a significant milestone for Longboard. It signifies the FDA's recognition of the company's innovative approach to potentially treating a wide range of DEE patients, addressing a significant unmet medical need.
Year to date, shares of LBPH have rallied 412.8% against the industry’s 6.32% decline.
The phase Ib/IIa PACIFIC study evaluated 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 for the DEE indications compared with placebo. All enrolled patients eventually received the highest tolerated dose of bexicaserin.
We remind the investors that earlier this year, Longboard announced that the PACIFIC study met its primary efficacy endpoint. 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.
Based on the success of the phase Ib/IIa PACIFIC study, LBPH is currently gearing up to initiate its global phase III program for bexicaserin to treat seizures associated with DEEs later in 2024.
Earlier in June 2024, the company also announced positive interim data from the ongoing 52-week open-label extension of the PACIFIC Study evaluating the candidate in DEE patients aged 12-65 years. Results demonstrated sustained and durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients.
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. Xenon is currently developing its lead candidate, azetukalner (XEN1101), in late-stage studies for treating focal onset seizures (FOS). Under XENE’s phase III epilepsy program, two identical phase III studies, X-TOLE2 and X-TOLE3, are currently evaluating azetukalner (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 late 2024 to early 2025. XENE plans to submit a regulatory application seeking approval of azetukalner for FOS, contingent upon the success of the X-TOLE2 study.
Xenon is also currently evaluating 25 mg azetukalner for an additional epilepsy indication, primary generalized tonic-clonic seizures (PGTCS). A phase III X-ACKT study of azetukalner in PGTCS is ongoing to support potential regulatory submissions in this additional epilepsy indication.
Longboard’s clinical-stage pipeline comprises another investigational candidate, LP659, which is currently in early-stage development as a potential treatment of rare neuroinflammatory conditions.
Zacks Rank and Stocks to Consider
Longboard currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industryworth mentioning are ALX Oncology Holdings ALXO and Compugen CGEN, 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 59.8%.
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 Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 11.6%.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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Longboard Pharmaceuticals, Inc. (LBPH) : Free Stock Analysis Report
