Impel Neuropharma Inc. (IMPL) stock prices surged by 21.15% shortly after market trading commenced on September 3rd, 2021. This brought the price per share up to USD$28.01 early on in the trading day.
FDA Approval for IMPL Stock
September 3rd, 2021 saw IMPL stock announce that the United States Food and Drug Administration approved TRUDHESA. TRUDHESA nasal spray has been approved for the acute treatment of migraine with or without aura in adults. The treatment was previously known as INP104. TRUDHESA makes use of Impel’s proprietary Precision Olfactory Delivery (POD) technology, thereby facilitating the gentle delivery of DHE to the bloodstream. The proven, well-established therapeutic access the bloodstream through the vascular-rich upper nasal space.
About TRUDHESA
TRUDHESA bypasses the gut and potential absorption issues, facilitating rapid, sustained, and consistent symptom relief. This is without the need for injection or infusion, even when administered several hours after the onset of a migraine attack. The commercial launch of the treatment is scheduled for early October 2021.
Scope of TRUDHESA
The company is keen to leverage the approval of TRUDHESA as it offers millions of Americans with migraines a non-oral, acute treatment option. This solution is hoped to provide rapid, sustained, and consistent relief, even when administered late into a migraine attack. The treatment’s approval marks the culmination of more than a decade of research and advanced engineering that has resulted in the pairing of the proven efficacy of DHE with our innovative POD technology.
IMPL Stock’s STOP 301 study.
IMPL stock’s New Drug Application for TRUDHESA included the results of STOP 301. The Phase 3 open-label, pivotal safety study is the largest longitudinal study ever conducted with DHE using nasal spray delivery. The study saw 5,650 migraine attacks being treated over 24 or 52 weeks. The primary objective of the study is to assess the safety and tolerability of TRUDHESA. Exploratory objectives were comprised of efficacy assessments of migraine measures and a patient acceptability questionnaire. TRUDHESA was generally well tolerated during the trial, with exploratory efficacy findings showing the facilitating rapid, sustained, and consistent symptom relief.
Future Outlook for IMPL Stock
The company reported a strong quarter, as evidenced by the strength of its financial reports for the quarter. IMPL stock is poised to capitalize on the opportunities presented to it as it gears up for the second half of the fiscal year. Current and potential investors are hopeful that management will be able to usher in organic growth over the long term.
