LA JOLLA, Calif. – Longboard Pharmaceuticals, Inc. (NASDAQ:LBPH) has launched a global Phase 3 clinical trial for its investigational drug, bexicaserin, aimed at treating seizures associated with Dravet syndrome in individuals aged two years and older. The trial, known as the DEEp SEA Study, has activated its first sites and plans to activate additional sites in the coming weeks.
The DEEp SEA Study is a double-blind, placebo-controlled trial designed to assess the efficacy of bexicaserin by monitoring countable motor seizures in approximately 160 participants ranging from two to 65 years old. The study will also evaluate the safety and tolerability of the drug. Participants will undergo a 5-week screening, followed by a 3-week dose titration period, and then a 12-week maintenance period on the highest tolerated dose. Following this phase, eligible participants may join a 52-week open-label extension study.
This Phase 3 study is part of Longboard’s broader DEEp Program, which aims to enroll around 480 participants across approximately 80 global sites, targeting a spectrum of Developmental and Epileptic Encephalopathies (DEEs).
Chad Orevillo, Longboard’s Executive Vice President and Head of Operations, expressed pride in the rapid progression from Phase 2 data to Phase 3 initiation, highlighting the company’s dedication to the DEEp Program’s execution and enrollment.
Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation, commended Longboard for its progress and efficient clinical development approach. She emphasized the significant unmet need in Dravet syndrome and other rare epileptic conditions.
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with DEEs in patients two years of age and older. Bexicaserin is a 5-HT2C receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes.
It is important to note that bexicaserin and LP659, another compound under development by Longboard, are not yet approved for marketing by the FDA or any other regulatory authority. The information presented here is based on a press release statement from Longboard Pharmaceuticals.
In other recent news, Longboard Pharmaceuticals has made significant strides in its drug development programs. The U.S. Food and Drug Administration (FDA) granted Orphan Drug and Rare Pediatric Disease designations to bexicaserin, Longboard’s drug candidate for Dravet syndrome treatment. This move could potentially expedite the drug’s development and review process. Longboard also plans to initiate its global Phase 3 DEEp program, starting with the DEEp SEA trial for Dravet syndrome, in the near future.
In the realm of analyst notes, H.C. Wainwright has increased its price target for Longboard to $80, maintaining a Buy rating. Baird, meanwhile, has maintained an Outperform rating with a steady price target of $60.00. Truist Securities initiated coverage on Longboard with a Buy rating and a price target of $60. These ratings indicate confidence in Longboard’s growth prospects.
In addition to bexicaserin, Longboard is also developing LP659, a candidate for neuroinflammatory conditions, which has completed a Phase 1 trial. These developments are part of Longboard’s recent efforts to address significant unmet needs in epilepsy treatment. However, it is important to note that both bexicaserin and LP659 are investigational compounds and have not yet been approved for marketing by the FDA or any other regulatory authority.
InvestingPro Insights
As Longboard Pharmaceuticals, Inc. (NASDAQ:LBPH) advances its clinical trials for bexicaserin, investors and industry observers are closely monitoring the company’s financial health and market performance. According to InvestingPro data, Longboard currently holds a market capitalization of approximately $1.2 billion. Despite the promise of its clinical programs, the company shows a negative P/E ratio of -14.6, suggesting that it is not currently profitable. This is further supported by an adjusted P/E ratio for the last twelve months as of Q2 2024, which stands at -18.78, reflecting ongoing financial challenges.
In terms of stock performance, Longboard has experienced a significant price uptick over the last six months, with a 55.45% return. This growth is part of a broader trend, as evidenced by a year-to-date price total return of 418.41% and a staggering one-year price total return of 458.21%. These figures indicate robust investor confidence over the past year, despite the company’s lack of profitability in the same period.
Two InvestingPro Tips that stand out for Longboard Pharmaceuticals are its strong cash position relative to debt and the concern that analysts have revised their earnings downwards for the upcoming period. Holding more cash than debt is a positive sign of financial stability, which may provide some cushion as the company invests heavily in its clinical trials. However, the downward earnings revisions by analysts could indicate potential headwinds or a conservative outlook on the company’s near-term revenue prospects.
For those interested in a deeper analysis, there are additional InvestingPro Tips available on InvestingPro’s platform, which can provide further insights into Longboard’s financial metrics and stock performance.
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