Longboard Stock Soars on FDA Designations for Epilepsy Drug
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Shares of Longboard Pharmaceuticals LBPH gained 14% on Thursday after it announced that the FDA granted two designations — orphan drug and rare pediatric disease — to its lead pipeline drug bexicaserin for the treatment of Dravet syndrome (DS).
An orphan drug designation is granted by the FDA to the candidates developed to treat, diagnose or prevent a rare disease or condition. This designation makes the sponsor eligible to receive seven years of market exclusivity following a potential approval and tax credit for qualified clinical studies.
If the FDA grants a candidate rare pediatric disease designation, then upon potential approval of the drug, the sponsor is eligible to receive a priority review voucher (PRV). This PRV can either be used by the sponsor to obtain priority review for a different product or may even be sold by the sponsor to another to boost cash reserves.
The FDA designations come at a time when Longboard is planning to start a phase III study evaluating bexicaserin in DS patients in the coming weeks. The grant of these designations suggests that the agency recognizes the innovative approach of the LBPH drug for treating DS patients. The company’s stock price rose likely in response to this factor.
Year to date, shares of Longboard have skyrocketed 453.9% compared with the industry’s 1.3% growth.
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Recent Developments Responsible for the Surge in LBPH Stock
This surge in share price began at the onset of the year after management reported encouraging data from the phase Ib/IIa PACIFIC study, which evaluated bexicaserin for seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs). DS and Lennox-Gastaut Syndrome (LGS) are some of the many types of epilepsies that fall into the DEE group.
The PACIFIC study achieved its primary efficacy endpoint. Treatment with the drug achieved a median seizure reduction of 53.3% in the countable motor seizure frequency compared with 20.8% for those receiving placebo.
In June, management also reported positive interim data from an ongoing 52-week open-label extension of the PACIFIC Study evaluating bexicaserin in DEE patients. Results demonstrated sustained and durable response in seizure reduction and a favorable safety and tolerability profile across a broad range of DEE patients.
The FDA had previously granted breakthrough therapy designation (BTD) to bexicaserin in June for the treatment of seizures associated with DEEs. The grant of this designation makes Longboard the first company to receive it for this indication. Drugs that receive the BTD tag receive more intensive guidance and organizational support from the agency.