Neurelis®: The Neu News (2024)

Findings include analysis of seizure cluster treatment patterns with use of VALTOCO® (diazepam nasal spray) CIV and characterization of a diazepam dosing regimen in an animal model

Neurelis hosted an investor call to highlight updates on two of its neuroscience product development candidates, NRL-1004 for acute agitation episodes and NRL-1049 for cerebral cavernous malformations (CCMs). A replay can be found at the linkhere.

Investor call to feature presentations from Leslie Lucien Citrome, MD, MPH, Issam Awad, MD, FACS and Connie Lee, PsyD

New analyses from phase 3, long-term, open-label, repeat-dose study of VALTOCO® (diazepam nasal spray) CIV will be presentedAdditional presentations explore anticipatory anxiety of seizures, short-term impacts of seizures on daily life and comparison of treated versus untreated seizure clusters

Sixth patent together with growing clinical evidence of the safety and effectiveness of VALTOCO reinforce clinical and commercial potential

Neurelis, Inc., a company focused on epilepsy and orphan neurologic disorders, today announced that corporate leadership will participate in and host one-on-one investor meetings at the 6th Annual Evercore ISI HealthCONx Conference

• Largest gathering of people with epilepsy, their care partners, and health care providers • Epilepsy and care partner testimonials from Neurelis Ambassadors• Seizure alert and response puppy-in-training from Little Angels Service Dogs

Neurelis, Inc., today announced additional findings from the post hoc analysis of the long-term phase 3 safety study of VALTOCO® (diazepam nasal spray) in a pediatric population, aged 6-17 years, as well as an analysis of real-world data on impact of administration of rescue medication on seizure timing.

Company recognized for culture that fosters a highly engaged and passionate team dedicated to improving lives through innovation.

Neurelis, Inc. will present additional clinical findings from the complete long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in people with epilepsy for ages 6 to 65 at the 35th International Epilepsy Congress (IEC) in Dublin, Ireland, September 2 to 6. The congress is organized by the International League Against Epilepsy (IBE).

Neurelis, Inc., announced today the promotion of Adrian L. Rabinowicz, MD, to Chief Medical Officer and the establishment of a new leadership position of Senior Vice President, Strategic Initiatives for Enrique Carrazana, MD. This enhanced and expanded leadership team will serve a critical function to Neurelis, as the company continues to seek and leverage novel scientific approaches to improve the lives of people around the world with CNS disorders.

Neurelis, Inc. will present four posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 years.

Neurelis, Inc., announced the first two cohorts dosed in the investigational clinical trial of NRL-1049, a Rho kinase (ROCK) inhibitor, a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord. This is a first-in-human study designed to establish safety, tolerability, and pharmaco*kinetic parameters of NRL-1049.

'Give Seizures the Sprayer’, marketing campaign led by Beth Henriksen, Director of Marketing, Neurelis, Inc., wins the 2023 PM360 Pharma Choice Multichannel Gold Award

Neurelis, Inc., announced the successful filing of its investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NRL-1049, a Rho kinase (ROCK) inhibitor with a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord.

ARS Pharmaceuticals, Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted its New Drug Application (NDA) for neffy (previously referred to as ARS-1), for the emergency treatment of severe type I allergic reactions in children and adults who weigh 30 kilograms (66 pounds) or more. In accordance with FDA guidelines, an anticipated target action date of mid-2023 has been set for the PDUFA (Prescription Drug User Fee Act).

Neurelis, Inc., announced the company will present nine posters at the 76th American Epilepsy Society Annual Meeting (AES), December 2 – 6, 2022, Nashville, TN. Poster presentations will occur on Monday, December 5, 2022, 12:00 – 1:45 PM CT.

Neurelis, Inc. today announced that corporate leadership will participate in a fireside chat and one-on-one investor meetings at the 5th Annual Evercore ISI HealthCONx Conference, to be held virtually from November 29 – December 1, 2022.

Neurelis is a proud supporter of the 10th Annual Sofie’s Journey Epilepsy Awareness Day and Education Expo at Disneyland Resort (EADDL), the largest worldwide gathering of people with epilepsy, their families/care partners, and healthcare providers.

Neurelis, Inc., is pleased to announce it was ranked third among medium-size employers on the Best Places to Work in SoCal 2022 list by Best Companies Group (BCG), a BridgeTower Media Company.

Neurelis, Inc., today announced findings from a novel, investigational analysis of the time between seizure clusters in pediatric patients using VALTOCO^® (diazepam nasal spray). Findings indicate a significant increase in these intervals, or SEIzure interVAL (SEIVAL) data, over a 12-month period.

Neurelis, Inc., a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need, today announced it will present an analysis of a Phase 3 safety study of VALTOCO^® (diazepam nasal spray) CIV at the 2022 Annual Meeting of the Academy of Managed Care Pharmacy (AMCP NEXUS), Oct. 14 to 22, in National Harbor, MD.

Building on a transformative year of growth and success, Neurelis, Inc., announced today that it promoted former CFO Brittany Bradrick to COO and CFO.

Neurelis, Inc., announced the recent online publication of a novel data analysis, evaluating the time interval between seizure clusters, or SEIzure interVAL (SEIVAL) in Epilepsia that indicates a significant increase in time between seizure clusters treated with VALTOCO^® (diazepam nasal spray) CIV

Neurelis and Little Angels Service Dogs are proud to present the “Barks ‘n Blues Music & More” concert for epilepsy awareness at the Quartyard, 1301 Market St., San Diego, Thursday, Aug. 25 at 5 p.m. PT

Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies Group (BCG), a BridgeTower Media Company. This distinction is based on responses from a detailed and comprehensive survey of its employees.

Neurelis, Inc., announced the publication of a study recently available online in the peer-reviewed, scientific journal Epilepsia.

Neurelis, Inc., announced findings from a novel, investigational analysis of VALTOCO^® (diazepam nasal spray) CIV. The data indicate that patients using the therapy had a statistical and clinically significant increase in the time between their seizure clusters, or SEIzure cluster interVAL (SEIVAL) over a 12-month period.

Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO^® (diazepam nasal spray), an acute therapy for episodes of frequent seizure activity (seizure clusters), at the 16^th EILAT Conference on New Antiepileptic Drugs and Devices, Madrid Spain, May 22-25, 2022.

Neurelis, Inc., today announced findings from a novel, exploratory analysis of VALTOCO^® (diazepam nasal spray). The data indicates that patients using the therapy had a significant increase in the time between their seizure clusters, or SEIzure InterVAL data (SEIVAL) over a 12-month period.

Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs in managing central nervous system (CNS) disorders, announced that it has secured the issuance of United States Patent No. 11,241,414 (the ‘414 Patent) for VALTOCO (diazepam nasal spray) CIV for acute treatment of episodes of frequent seizure activity in adult and pediatric patients age six and older.

Neurelis, Inc., will present three posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 at the 73rd Annual Meeting of the American Academy of Neurology (AAN), April 2 to 7, in Seattle, Wash.

Neurelis, Inc. announced that it has signed an exclusive licensing agreement with Aculys Pharma, Inc. for the development and commercialization of VALTOCO® (diazepam nasal spray) in Japan and the Asia-Pacific region.

Neurelis, Inc., announced today that it is partnering with epilepsy education advocate Rick Harrison, star of TV’s “Pawn Stars,” to raise awareness of epilepsy and the need for more education regarding seizure emergencies.

Neurelis, Inc. will present a collection of 16 posters describing safety, tolerability and effectiveness results observed in trials evaluating VALTOCO^® (diazepam nasal spray), and clinical trials designed to evaluate VALTOCO as a potential rescue therapy in patient groups with unmet needs at the annual meeting of the American Epilepsy Society December 3-7 in Chicago.

Neurelis, Inc., announced today that it has made the following additions to its leadership team.

Neurelis, Inc. announced today that it is presenting two posters at the 50th Annual Meeting of the Child Neurology Society in Boston from September 29 through October 2.

Neurelis, Inc. announced today that it has initiated a clinical program to investigate the use of VALTOCO (diazepam nasal spray) in children with epilepsy aged two to five as a treatment for seizure clusters.

Neurelis, Inc., announced today that it has completed a senior term loan facility of up to $150 million from OrbiMed, one of the leading investors in the healthcare industry, to help fuel the company’s future growth.

Neurelis, Inc., announced today that it has acquired from BioAxone Biosciences, Inc. a portfolio of novel ROCK-2 Inhibitors that target cerebral cavernous malformations (CCMs), a rare disorder of the central nervous system (CNS) that currently have no pharmacologic treatments available.

SAN DIEGO, CA — April 19, 2021 — Neurelis, Inc., announced today that it is presenting five posters at the American Academy of Neurology (AAN) Annual Meeting being held virtually from April 17 through April 22.

SAN DIEGO, CA — April 12, 2021 — Neurelis, Inc., announced today that it is presenting two posters at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting being held virtually from April 12 through April 16.

SAN DIEGO, CA – March 10, 2021 – Neurelis, Inc., announced today that it has closed a $114 million round of Series D preferred stock financing to support the commercialization of the company’s lead orphan drug product, VALTOCO^® (diazepam nasal spray), and to continue the development and expansion of the company’s neuroscience pipeline.

SAN DIEGO, CA – December 4, 2020 – Neurelis, Inc., announced today the company has 12 posters being presented at the American Epilepsy Society Annual Meeting being held virtually from December 4 through December 8.

SAN DIEGO, CA – November 23, 2020 – Neurelis, Inc., announced today that it has concluded a pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding NRL-4. The FDA provided direction for the clinical development pathway for the investigational treatment. NRL-4 is being investigated as a noninvasive, easy-to-administer rescue therapy to address the escalation of acute agitation symptoms outside the medical setting. Acute agitation is associated with several psychiatric disorders, including schizophrenia and bipolar mania 1 in adults.

SAN DIEGO, CA – November 9, 2020 – Neurelis, Inc., announced today that the company's lead product, VALTOCO^® (diazepam nasal spray), is now available through pharmacies nationwide. VALTOCO was approved by the FDA earlier this year for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as the basis for granting Orphan Drug Exclusivity.

SAN DIEGO, CA – October 19, 2020 – Neurelis, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO^® (diazepam nasal spray). VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as part of the Orphan Drug Exclusivity designation.

SAN DIEGO, CA – October 16, 2020 – Neurelis, Inc., announced today the company has four posters being presented at the 16^th annual International Child Neurology Association Congress/49^th annual Child Neurology Society Meeting. Due to the COVID-19 pandemic, posters are available online during the organizations' virtual meetings.

SAN DIEGO, CA – September 23, 2020 – Neurelis, Inc., announced today that it will be investigating the safety and pharmaco*kinetics of the company's lead product, VALTOCO^® (diazepam nasal spray), in children with epilepsy aged two to five. VALTOCO is currently available for adults and pediatric patients 6 years of age and older. This is an investigational program for a patient population not included in the current U.S. Food and Drug Administration-approved (FDA) VALTOCO label. VALTOCO was approved by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern.

SAN DIEGO, CA – June 8, 2020 – Neurelis, Inc., announced today that insurers and managed care plans now provide coverage for more than 176 million lives for the company's lead product, VALTOCO^® (diazepam nasal spray). VALTOCO was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in adult and pediatric patients 6 years of age and older.

SAN DIEGO, CA – May 20, 2020 – Neurelis, Inc., announced today the company has nine total posters accepted for the annual meetings of the American Association of Neuroscience Nurses (AANN), the Academy of Managed Care Pharmacy (AMCP) and the American Academy of Neurology (AAN). The posters are all available for review online due to the cancellation of the organizations' annual meetings because of the COVID-19 pandemic.

SAN DIEGO, CA – May 4, 2020 – Neurelis, Inc., announced today that the American Academy of Allergy, Asthma & Immunology (AAAAI) presented promising results for ARS Pharmaceuticals' lead asset, ARS-1, a 1-mg intranasal epinephrine product utilizing the Intravail^® technology.

SAN DIEGO, CA – March 2, 2020 – Neurelis, Inc., announced today the commercial availability of VALTOCO^® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.

SAN DIEGO, CA – February 24, 2020 – Neurelis, Inc., today announced that the company will be participating in the SVB Leerink 9^th Annual Global Healthcare Conference at Lotte New York Palace, New York City. Neurelis President and CEO Craig Chambliss will present at 2:15 pm EST on Tuesday, February 25.

SAN DIEGO, CA – January 13, 2020 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO^® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older. The unique formulation of VALTOCO incorporates Intravail^® for consistent and reliable absorption.

SAN DIEGO, CA – December 5, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system market, announced today that the company will have nine poster presentations at the annual meeting of the American Epilepsy Society being held December 6-10 in Baltimore, Maryland.

SAN DIEGO, CA – October 22, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company will have three poster presentations at the 48th annual meeting of the Child Neurology Society being held October 23-26 in Charlotte, North Carolina.

MAPLE GROVE, MN – October 2, 2019 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Tosymra™ (sumatriptan)Nasal Spray, 10 mg for the acute treatment of migraine with or without aura in adults. Tosymra is a fast-acting, easy-to-use acute migrainetreatment option that delivers the efficacy of an injectable in a convenient nasal spray.

SAN DIEGO, CA – April 29, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company will have two poster presentations at the 71st annual meeting of the American Academy of Neurology being held May 4-10, 2019 in Philadelphia.

SAN DIEGO, CA – April 22, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates for epilepsy and the broader central nervous system (CNS) market, announced today that the company has completed the buildout of its senior management team to support the anticipated launch of its lead product, VALTOCO™(diazepam nasal spray).

SAN DIEGO, CA – February 20, 2019 – Neurelis, Inc. announced today that its Intravail^® licensing partner, ARS Pharmaceuticals, Inc., received Fast Track designation from the FDA for ARS-1, its novel intranasal epinephrine spray.

SAN DIEGO, CA – January 29, 2019 -- Neurelis announced today that its Intravail^® licensing partner, Dr. Reddy’s Laboratories and its U.S. subsidiary, Promius Pharma, LLC, received U.S. Food and Drug Administration (FDA) approval of TOSYMRA™ (sumatriptan nasal spray 10 mg). TOSYMRA™ is indicated for the acute treatment of migraine with or without aura in adults.

SAN DIEGO, CA – December 19, 2018 -- ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, has raised $20 million in Series C financing led by Deerfield Management. The Company will use the funds to advance the clinical development of its novel intranasal epinephrine spray, ARS-1, which uses Intravail^®, a novel nasal absorption platform licensed from Neurelis.

SAN DIEGO, CA – December 3, 2018 -- Neurelis, Inc. today announced the acquisition of Aegis Therapeutics, a San Diego-based drug delivery technology company. Aegis Therapeutics’ proprietary portfolio includes Intravail^®, ProTek^® and Hydrogel™, three non-invasive drug delivery and stabilization technologies applicable to a wide-range of molecules including therapeutic proteins, peptides, non-peptide macromolecules and small molecules.

SAN DIEGO, CA – Sept. 25, 2018 -- Neurelis, Inc. today announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCO^TM (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures.

November 07, 2017 | Company developing NRL-1, a proprietary intranasal formulation of diazepam, for epilepsy patients who experience acute repetitive or cluster seizures

January 05, 2017 | Funds to be utilized to complete development work and begin commercialization preparations for NRL-1. Program has received Orphan Drug and Fast Track Designation from FDA.

January 04, 2017 | Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA

February 22, 2016 | The investment, led by LYZZ Capital, is intended to advance the company's lead program, NRL-1 (intranasal diazepam), through the remaining clinical work in preparation for FDA submission of a New Drug Application (NDA) in the US.

January 19, 2016 | Following the receipt of Orphan Drug Designation for their lead product, NRL-1 (intranasal diazepam), Neurelis, Inc. ("Neurelis") today announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1.

December 21, 2015 | The FDA's Orphan Drug Designation program provides orphan status to drugs intended for the safe and effective treatment of rare disorders that affect fewer than 200,000 people in the United States.