Neurelis: Latest Company News

Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society

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.

Neurelis Completes Pre-IND Meeting With FDA to Establish Clinical Development Program for NRL-4 in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar 1 Mania in Adults

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.

Neurelis Announces National Wholesale and Retailer Chains and Independent Pharmacies Are Now Stocking VALTOCO® (diazepam nasal spray)

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.

Neurelis Announces FDA Approval of Extended Expiration Dating for VALTOCO® (diazepam nasal spray)

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.

Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society

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.

Neurelis Announces Program to Investigate the Safety and Pharmacokinetics of VALTOCO® (diazepam nasal spray) in Children Aged 2 to 5

SAN DIEGO, CA – September 23, 2020 – Neurelis, Inc., announced today that it will be investigating the safety and pharmacokinetics 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.

NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY'S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY)

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.

NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS

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.

NEURELIS ANNOUNCES THAT INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS’ INTRANASAL EPINEPHRINE PRODUCT, DEMONSTRATES BIOEQUIVALENT EXPOSURE TO EPINEPHRINE INJECTORS

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.

NEURELIS ANNOUNCES COMMERCIAL AVAILABILITY OF VALTOCO® (DIAZEPAM NASAL SPRAY) FOR SEIZURE CLUSTER RESCUE

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.

NEURELIS TO PRESENT AT SVB LEERINK 9th ANNUAL GLOBAL HEALTHCARE CONFERENCE

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.

NEURELIS ANNOUNCES FDA APPROVAL FOR SEIZURE RESCUE TREATMENT VALTOCO® (DIAZEPAM NASAL SPRAY) THAT INCORPORATES THE SCIENCE OF INTRAVAIL® FOR CONSISTENT AND RELIABLE ABSORPTION

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.

NEURELIS ANNOUNCES NINE POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY

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.

NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY

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.

UPSHER-SMITH LABORATORIES ANNOUNCES THE LAUNCH OF TOSYMRA™ USING NEURELIS’ INTRAVAIL® TECHNOLOGY

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 migraine treatment option that delivers the efficacy of an injectable in a convenient nasal spray.

Neurelis Announces Two Poster Presentations At The Annual Meeting Of The American Academy Of Neurology

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.

NEURELIS ANNOUNCES COMPLETION OF SENIOR MANAGEMENT TEAM BUILDOUT TO SUPPORT THE ANTICIPATED COMMERCIAL LAUNCH OF VALTOCO™

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).

Neurelis Announces That Intravail® Licensee ARS Pharmaceuticals Intranasal Epinephrine Program Given Fast Track Designation

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.

Neurelis Announces First Product Approved Using The Company’s Intravail® Platform

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.

INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, SECURES $20M FINANCING FROM DEERFIELD MANAGEMENT

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.

Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology Company

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.

Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric, Adolescent And Adult Epilepsy Patients

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.

Neurelis Expands Worldwide Patent Portfolio with Latest Issuance in Japan

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

Neurelis Completes Series B Financing

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.

Neurelis Recieves FDA Fast Track Designation for NRL-1

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

Neurelis Finalizes Series A Financing to Advance Lead Program to NDA Filing

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.

Neurelis Initiates Pivotal Clinical Program for NRL-1 in the Treatment of Acute Repetitive Seizures

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.

Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures

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.

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