LA JOLLA, Calif. - Longboard Pharmaceuticals, Inc. (NASDAQ:LBPH) has announced interim results from its ongoing open-label extension (OLE) study of bexicaserin, which is being evaluated for treating Developmental and Epileptic Encephalopathies (DEEs). The study indicated a median reduction of 56.1% in countable motor seizures over approximately six months.
Participants from the placebo group in the prior PACIFIC study who transitioned to bexicaserin in the OLE also showed a 57.3% median reduction in seizure frequency. These findings suggest a sustained response to the drug and support its potential as a treatment option for DEEs.
The PACIFIC OLE study is a 52-week, Phase 2 trial designed to assess the long-term safety and efficacy of multiple doses of bexicaserin in patients with a variety of DEEs, including Dravet syndrome and Lennox-Gastaut syndrome. All participants who completed the PACIFIC study chose to enroll in the OLE, with 95.1% remaining in the ongoing study.
Safety and tolerability results were favorable, with the most common treatment-emergent adverse events being upper respiratory infections, COVID-19, pneumonia, sinusitis, seizures, and decreased appetite. One participant discontinued due to lethargy, and another withdrew consent.
Longboard Pharmaceuticals focuses on developing medicines for neurological diseases, with a portfolio targeting specific G protein-coupled receptors (GPCRs). Bexicaserin, also known as LP352, is a central nervous system agent that selectively activates the 5-HT2C receptor without affecting 5-HT2B and 5-HT2A receptor subtypes.
The company has scheduled an End of Phase 2 meeting for this summer and plans to initiate a global Phase 3 program for bexicaserin later in the year. Longboard is also conducting a Phase 1 clinical trial for another product candidate, LP659, which is anticipated to report top-line data in the second quarter of 2024.
The information reported is based on a press release statement from Longboard Pharmaceuticals, Inc.
In other recent news, Longboard Pharmaceuticals has been making significant strides in the biopharmaceutical industry with its novel therapeutic candidate, bexicaserin, which targets neurological disorders, particularly epilepsy. The drug has shown promising results in the Phase 1b/2a PACIFIC trial, with a significant reduction in seizure frequency. The safety profile of bexicaserin has also been favorable, setting the stage for an end-of-Phase-2 meeting with the FDA to discuss the design of the Phase 3 program.
Baird has initiated coverage of Longboard with an Outperform rating and a price target of $36.00, while H.C. Wainwright & Co and Cantor Fitzgerald maintain a "Buy" and "Overweight" rating respectively, both with a $60 price target. These ratings reflect confidence in Longboard's clinical pipeline and strategic direction, especially with the company's focus on DEEs, a subset of epilepsy with significant unmet needs.
These are recent developments and investors are eyeing several key milestones for Longboard, including anticipated OLE data for bexicaserin in the latter half of 2024 and a critical end-of-Phase-2 meeting with the FDA. The company's clear roadmap for advancing its lead candidate into Phase 3 trials and the potential to address a significant unmet need in the epilepsy market have reinforced analyst confidence.
InvestingPro Insights
As Longboard Pharmaceuticals, Inc. (NASDAQ:LBPH) continues to make strides with its drug bexicaserin, investors and industry watchers are keeping a close eye on the company's financial health and market performance.
According to InvestingPro data, Longboard holds a market capitalization of $682.34 million, signaling a considerable size within the biopharmaceutical sector. Despite the challenges in profitability, with a reported operating income of -$62.91 million for the last twelve months as of Q1 2024, the company has demonstrated significant market momentum with a 6-month price total return of 286.56%.
InvestingPro Tips highlight that Longboard has more cash than debt on its balance sheet, which is a positive indicator of the company's financial stability. Moreover, two analysts have revised their earnings upwards for the upcoming period, reflecting a potentially optimistic outlook on the company's future performance.
Still, it is worth noting that analysts do not expect the company to be profitable this year, and it suffers from weak gross profit margins. For investors seeking a deeper understanding of Longboard's financials and future prospects, there are 9 additional InvestingPro Tips available, which can be accessed by visiting InvestingPro. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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