A clinical trial testing a migraine prevention therapy from Denmark-based Lundbeck has produced data that some on Wall Street see as mixed but still good enough to forge ahead with further development.
The therapy, called bocunebart, is designed to inhibit a nervous system protein known as PACAP. This protein regulates stress and, when triggered, causes pain-sensing nerves to fire and blood vessels in the head to drastically widen. Lundbeck’s study has been evaluating bocunebart — as a direct infusion to the veins or as an under-the-skin shot — in hundreds of patients who continued experiencing migraines even after trying up to four other treatments.
Lundbeck earlier this year said the second part of that mid-stage trial, which pitted the intravenous form of the drug against a placebo, had hit its main goal. The company provided more detailed results on Thursday. After 12 weeks, bocunebart-treated patients were on average reporting a decrease of 4.24 monthly migraine days, a significant difference from the 2.86-day reduction among participants given a placebo.
Lundbeck said the effects were more pronounced when looking at its entire Phase 2 program, which included another experiment titled “HOPE.” Across the program, average monthly migraine days fell by almost six in the bocunebart study arms compared to 3.6 in their placebo counterparts.
Patients also generally tolerated the drug well. The most commonly reported treatment-emergent adverse event was the common cold.
Based on the latest findings, Lundbeck plans to continue advancing the drug.
The results not only “strengthen our confidence in targeting the PACAP pathway,” but “mark an important milestone in our efforts to bring forward innovative treatments for people living with migraine, particularly those who continue to experience substantial disease burden despite currently available therapies,” said Johan Luthman, Lundbeck’s head of research and development.
Analysts at Jefferies acknowledged these latest data may be below what some investors had hoped to see, especially considering that, in the HOPE trial, there was a 2-day separation between the drug and placebo groups in the reduction of average monthly migraine days. Jefferies analysts themselves predicted this second, larger trial would show a 2.3- to 2.7-day difference.
In the two studies, roughly 50% to 70% of participants live with chronic migraines. The results, according to Shan Hama of Jefferies, indicate that Lundbeck’s drug has a stronger effect in this population, which “partially reconciles” it missing expectations in the broader population. “In totality, data show that the [chronic migraine] signal is likely the more relevant benchmark for [Phase 3 testing] and eventual positioning,” Hama wrote in a note to clients.
With bocunebart, Lundbeck holds a leading position among a cohort of companies trying to bring PACAP-targeting drugs to market. Though a new wave of migraine prevention treatments hit the market at the end of the last decade, many patients don't respond to these so-called anti-CGRP therapies.
Lundbeck knows this as well as any developer, as it sells Vyepti, one of a small handful of approved CGRP-blocking antibodies.
Sales figures for select antibody drugs for migraine prevention
| Product | Scientific name | Company | 2025 Sales |
|---|---|---|---|
| Emgality | galcanezumab | Eli Lilly | $748 million |
| Vyepti | eptinezumab | Lundbeck | $677 million |
| Ajovy | fremanezumab | Teva Pharmaceutical | $673 million |
SOURCE: Company disclosures. *Amgen, which shares rights to another drug in this class, Aimovig, doesn't break out sales of that product.
Lundbeck acquired Vypeti through the roughly $2 billion purchase of Alder BioPharmaceuticals, and now counts the drug as one of its key strategic brands and growth drivers. In 2025, Vyepti brought in almost 4.5 billion Danish kroner, or about $677 million, reflecting a 59% increase from the previous year. It also accounted for 18% of the company’s total revenue.
Lundbeck argues that bocunebart could be useful as a standalone product or in combination with Vyepti. At Jefferies, analysts forecast peak annual sales of the newer drug reaching $400 million.