Welcome to our dedicated page for Impel Pharmaceuticals news (Ticker: IMPL), a resource for investors and traders seeking the latest updates and insights on Impel Pharmaceuticals stock.
Impel Pharmaceuticals Inc. (symbol: IMPL) is a Seattle-based biopharmaceutical company dedicated to providing groundbreaking therapies for central nervous system (CNS) diseases. Their innovative approach leverages a proprietary nasal drug delivery system known as the POD™ device, which ensures consistent and predictable drug administration to the upper nasal cavity.
Impel's diverse product portfolio is focused on addressing significant unmet medical needs.
- INP104 (POD™ DHE) is in development for the acute treatment of migraine headaches.
- INP103 (POD™ Levodopa) aims to offer relief for Parkinson's disease patients.
- INP105 (POD™ Olanzapine) targets agitation associated with schizophrenia and bipolar disorders.
- INP102 (POD™ Insulin) is being tested in an NIH-funded trial for Alzheimer's disease.
In September 2021, Impel received FDA approval for Trudhesa®, a nasal spray specifically designed for the acute treatment of migraine with or without aura in adults. This marks a significant milestone in their journey to provide effective therapies for CNS conditions.
Despite recent achievements, Impel has encountered financial challenges and has filed for Chapter 11 bankruptcy as part of a strategic decision to maximize value for stakeholders. The company is actively pursuing a sale and has entered into an agreement with JN BIDCO LLC as the 'stalking horse' bidder. Throughout this process, Impel aims to continue operating normally, ensuring minimal disruption to its customers, employees, and other key stakeholders.
For more details, visit Impel Pharmaceuticals Inc.
Impel NeuroPharma (NASDAQ: IMPL) has launched Trudhesa™, a nasal spray utilizing Precision Olfactory Delivery (POD®) technology, for treating acute migraines in adults. Approved by the FDA, Trudhesa offers rapid and consistent relief, bypassing gastrointestinal absorption issues. It comes with a patient savings program and is available through Trudhesa Direct™ for hassle-free delivery. In clinical trials, Trudhesa demonstrated high tolerability and effectiveness, with many patients achieving pain relief rapidly. The product aims to address unmet needs in migraine management.
Impel NeuroPharma (NASDAQ: IMPL) announced the pricing of a public offering of 3,000,000 shares of its common stock at $15.00 per share, aiming to raise $45.0 million in gross proceeds. The offering is scheduled to close on September 14, 2021, contingent upon customary conditions. The underwriters also have a 30-day option to purchase an additional 450,000 shares. Cowen and Guggenheim Securities are joint bookrunning managers for the offering, with a registration statement filed and effective as of September 9, 2021.
Impel NeuroPharma (NASDAQ: IMPL) has announced a public offering of 3,000,000 shares of its common stock, with an additional 450,000 shares available to underwriters. The offering is managed by Cowen and Guggenheim Securities, with Wedbush PacGrow as lead manager. The funds from this offering are aimed at supporting the company's development of therapies for central nervous system diseases. The registration statement has been filed with the SEC but is not yet effective, meaning no sales can occur until it is approved.
Impel NeuroPharma announces FDA approval for TRUDHESA (dihydroergotamine mesylate) nasal spray, a groundbreaking treatment for acute migraine in adults. Utilizing Precision Olfactory Delivery (POD) technology, it offers rapid and sustained relief, even when administered late in an attack. With over 5,650 migraine treatments in clinical trials, TRUDHESA demonstrated high tolerability and efficacy with 38% of patients achieving pain freedom at 2 hours. The commercial launch is slated for early October 2021.
Impel NeuroPharma (NASDAQ: IMPL) has submitted its TRUDHESA New Drug Application (NDA) to the FDA, with a target action date of September 6, 2021.
Impel anticipates a successful launch in Q4 2021, supported by a $50 million debt facility enhancing their cash position to $60.9 million, funding operations into 2022. The company reported a net loss of $15.5 million for Q2 2021, slightly up from $13.1 million YoY, with R&D expenses decreasing to $6.1 million. General and administrative expenses rose to $8.9 million due to pre-launch activities.
Impel NeuroPharma, Inc. (NASDAQ: IMPL) will host a live webcast on August 16, 2021, at 8:30 a.m. ET, to discuss second quarter 2021 financial results and provide a business update. Investors can access the webcast via the Investors section of the company's website. Impel focuses on developing transformative therapies for central nervous system diseases, with products like TRUDHESA™ for migraines and INP107 for Parkinson's disease. The company aims to advance its pipeline using its proprietary Precision Olfactory Delivery (POD®) system.
Impel NeuroPharma announced positive results from its pivotal Phase 3 study, STOP 301, for TRUDHESA™ (INP104) in treating acute migraine. The open-label study demonstrated that 38% of patients achieved pain freedom within two hours, with a low recurrence rate of only 7.1% at 24 hours. The FDA has accepted the new drug application for TRUDHESA, with a target action date of September 6, 2021. Overall, the results suggest TRUDHESA is well-tolerated and effective, presenting a new option for patients struggling with current therapies.
Impel NeuroPharma, a late-stage biopharmaceutical company (NASDAQ: IMPL), announced CEO Adrian Adams will participate in a panel discussion titled “For Headaches THIS Big – The Evolution of Migraine Therapeutic Landscape” at the 2021 Wedbush Pacgrow Virtual Healthcare Conference. The event is scheduled for August 10, 2021, from 8:00 to 8:30 a.m. ET. Impel focuses on developing transformative therapies for central nervous system diseases, leveraging its proprietary Precision Olfactory Delivery (POD®) system. Its notable products include TRUDHESA™ for migraine treatment and INP105 for autism-related agitation.
Impel NeuroPharma (NASDAQ: IMPL) will host a virtual key opinion leader (KOL) event on August 6, 2021, at 1:00 PM ET, to discuss the treatment landscape for acute migraines post-triptan failure. The event includes presentations from leading experts on non-oral migraine therapies and shares results from the STOP301 trial for TRUDHESA™, Impel's lead product candidate. A live webcast of the discussion can be accessed on Impel's website, with a replay available afterwards.
Impel NeuroPharma has closed a $50 million debt facility with Oxford Finance and Silicon Valley Bank, securing $20 million at closing. This financing bolsters the company's balance sheet as it prepares for the potential launch of TRUDHESA™ for acute migraine treatment, with FDA review underway. The initial funding extends cash runway through Q4 2022. Additional tranches are contingent on FDA approval and revenue milestones. The debt matures in July 2026, involving interest-only payments until September 2023. Impel aims to advance its proprietary POD® technology and product pipeline.
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