The U.S. Food and Drug Administration (FDA) has approved Impel NeuroPharma Inc.’s (IMPL) nasal spray, Trudhesa (dihydroergotamine mesylate), for the treatment of migraine with or without aura in adults. The company plans to launch the nasal spray in early October.
Washington-based Impel is a late-stage pharmaceutical company that develops transformative therapies to treat patients suffering from diseases with high unmet medical needs. The company’s shares closed 19.3% lower at $18.65 on Monday.
Trudhesa’s New Drug Application (NDA) included the results of the Phase 3 safety study, STOP 301. The trial demonstrated that the nasal spray was generally well-tolerated and provided rapid, sustained and consistent symptom relief. (See Impel stock chart on TipRanks)
Trudhesa also showed consistent efficacy even when administered late into a migraine attack, compared to other oral acute treatments that need to be taken within an hour of the onset of the attack. Furthermore, there were no serious Trudhesa-related treatment-emergent adverse events (TEAEs) observed during the trial.
The Associate Professor in the Department of Neurology, and Program Director of the Headache Medicine Fellowship Program at Thomas Jefferson University, Stephanie J. Nahas-Geiger, said, “Trudhesa upper nasal delivery circumvents the GI tract and common phenomena associated with migraines, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using Trudhesa within a certain timeframe.”
Following the approval of Trudhesa, Cowen analyst Ken Cacciatore maintained a Buy rating on the stock and raised the price target to $55 from $35 (upside potential of 194.9%). In a research note to investors, the analyst said, “Trudhesa’s differential delivery should provide a much-needed acute migraine option into this extremely large market.”
Overall, the stock has a Moderate Buy consensus rating based on 1 Buy. The average Impel NeuroPharma price target of $55 implies 194.9% upside potential. Shares of the company have gained 24.3% over the past year.
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