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Neurelis Presents Studies on Seizure Clusters at the American Epilepsy Society Annual Meeting
San Diego, CA – December 6, 2024 – Neurelis, Inc., today announced details of its presentations at the American Epilepsy Society (AES) Annual Meeting to be held December 6-10 in Los Angeles. The collection of ten posters highlights analyses of immediate-use seizure medication for treatment of seizure clusters. A wide
Neurelis to Join Epilepsy Community at 12th Annual Sofie’s Journey Epilepsy Awareness Day and Education Expo at Disneyland® Resort
San Diego, CA – November 18, 2024 – Neurelis, Inc., today announced it will participate in the 12th Annual Sofie’s Journey Epilepsy Awareness Day & Education Expo at Disneyland (EADDL), one of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners. The event was established to help
Neurelis Enters $208 Million Agreement to Monetize Intravail Royalties
San Diego, CA – November 14, 2024 – Neurelis, Inc. (“Company”), today announced a transaction with OrbiMed for the sale of the Company’s rights, royalty interests, and related sales milestone payments on global net sales of neffy® (nasal epinephrine) (the “Neffy Receivables”). Neurelis, through its subsidiary Aegis Therapeutics, LLC (“Aegis”),
NEURELIS TO SHARE CLINICAL STUDY DESIGN INSIGHTS FOR INVESTIGATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 AT CHILD NEUROLOGY SOCIETY ANNUAL MEETING
San Diego, CA – November 11, 2024 – Neurelis, Inc., today announced a presentation on insights into study design from the enrollment process for the new Stellina study investigating VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2 to 5 years. This age
NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE 76TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
San Diego, CA – [April 11, 2024] – Neurelis, Inc. will present a poster on VALTOCO® (diazepam nasal spray) for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 years, describing the time to treatment across different subpopulations. A second
Neurelis Pipeline Update – Advancements to Address Unmet Needs in Neuroscience – Replay
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 link here.
NEURELIS ANNOUNCES NEW ROLES FOR TOP EXECUTIVES TO ADVANCE CLINICAL AND STRATEGIC INITIATIVES AND POSITION FOR FUTURE GROWTH
Dr. Rabinowicz and Dr. Carrazana have been instrumental in synergistically advancing novel therapies to address unmet needs in the epilepsy and broader central nervous system (CNS) communities SAN DIEGO, CA — May 15, 2023 — Neurelis, Inc., announced today the promotion of Adrian L. Rabinowicz, MD, to Chief Medical Officer
NEURELIS ANNOUNCES FOUR POSTER PRESENTATIONS AT THE 75TH ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
Quality of life and overall duration of seizures data with use of VALTOCO® (diazepam nasal spray) CIV to be presented at AAN SAN DIEGO, CA — April 25, 2023 — Neurelis, Inc. will present four posters from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of
NEURELIS ANNOUNCES FIRST HEALTHY SUBJECTS DOSED IN INVESTIGATIONAL STUDY OF NRL-1049, A RHO KINASE (ROCK) INHIBITOR WITH POTENTIAL TO TREAT CEREBRAL CAVERNOUS MALFORMATIONS
First in human study will evaluate safety, tolerability, and pharmacokinetic parameters of NRL-1049, a Rho kinase (ROCK) inhibitor SAN DIEGO, CA — March 24, 2023 — 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
NEURELIS WINS 2023 PM360 PHARMA CHOICE MULTICHANNEL GOLD AWARD FOR ‘GIVE SEIZURES THE SPRAYER’ MARKETING CAMPAIGN
‘Give Seizures the Sprayer’, marketing campaign led by Beth Henriksen, Director of Marketing, Neurelis, Inc., wins the 2023 PM360 Pharma Choice Multichannel Gold Award SAN DIEGO, CA — March 2, 2023 — Neurelis, Inc. is proud to announce the ‘Give Seizures the Sprayer’ marketing campaign for VALTOCO® (diazepam nasal spray)
NEURELIS ANNOUNCES FILING OF ITS INVESTIGATIONAL NEW DRUG APPLICATION FOR NRL-1049, A RHO KINASE (ROCK) INHIBITOR WITH POTENTIAL TO TREAT CEREBRAL CAVERNOUS MALFORMATIONS
Pre-clinical data recently presented at Society for Neuroscience’s annual meeting demonstrates NRL-1049 potential safety, Neurelis to advance further studies SAN DIEGO, CA — January 9, 2023 — 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
NEURELIS CONGRATULATES INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, FOR FDA ACCEPTANCE OF INTRANASAL EPINEPHRINE NDA
neffy® (epinephrine nasal spray), is developed with Neurelis’ proprietary Intravail® Absorption-Enhancing Technology SAN DIEGO, CA — December 8, 2022 — 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
NEURELIS TO PRESENT NINE POSTERS AT THE 76th AMERICAN EPILEPSY SOCIETY ANNUAL MEETING
Investigational Phase 3 study of VALTOCO® (diazepam nasal spray) CIV shows double the time between seizure clusters when administered over a 12-month period Poster addresses myths associated with rescue therapy for seizure clusters Additional poster highlights investigational non-surgical treatment option for cerebral cavernous malformations SAN DIEGO, CA — December 2,
Neurelis, Inc. to Participate in the 5th Annual Evercore ISI HealthCONx Conference
SAN DIEGO, CA — November 28, 2022 — 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 that corporate leadership will participate in a fireside chat and one-on-one
NEURELIS SUPPORTS SOFIE’S JOURNEY EPILEPSY AWARENESS DAY AND EDUCATION EXPO AT DISNEYLAND® RESORT
Largest, worldwide epilepsy community gathering will feature a physician presentation on VALTOCO® (diazepam nasal spray) CIV for frequent seizure activity Little Angels Service Dogs’ seizure alert and response puppies-in-training to appear at Neurelis booth and for onstage demonstrations SAN DIEGO, CA — October 31, 2022 — Neurelis is a proud
NEURELIS RANKED THIRD BEST PLACE TO WORK IN SoCAL 2022
SAN DIEGO, CA — October 24, 2022 — 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. This distinction is based on responses from a detailed and
NEURELIS PRESENTS NOVEL, INVESTIGATIONAL ANALYSIS OF VALTOCO® (DIAZEPAM NASAL SPRAY) CIV DEMONSTRATING INCREASED TIME BETWEEN SEIZURE CLUSTERS AT THE 51ST CHILD NEUROLOGY SOCIETY ANNUAL MEETING
Two posters highlight findings from a long term safety study of VALTOCO in a pediatric population The first features investigational data indicating a doubling of time between VALTOCO treated seizure clusters across 12 months The second summarizes a sub-analysis showing no long-term safety differences for VALTOCO in patients with Lennox-Gastaut
NEURELIS ANNOUNCES PRESENTATION OF ANALYSIS OF TIME BETWEEN SEIZURE CLUSTERS WITH VALTOCO® (DIAZEPAM NASAL SPRAY) CIV AT THE 2022 ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY
Analysis of 12-month, Phase 3 study shows 2-fold increase in time between VALTOCO treated seizure clusters, or SEIzure interVAL (SEIVAL) SAN DIEGO, CA — October 12, 2022 — Neurelis, Inc., a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic
NEURELIS STRENGTHENS LEADERSHIP TO FURTHER ENHANCE GROWING MOMENTUM IN SEIZURE-RESCUE MARKET
Company promotes Brittany Bradrick to Chief Operating Officer (COO) and Chief Financial Officer (CFO) SAN DIEGO, CA — October 6, 2022 — Building on a transformative year of growth and success, Neurelis, Inc., announced today that it promoted former CFO Brittany Bradrick to COO and CFO. Ms. Bradrick’s impact both
STUDY PUBLISHED IN EPILEPSIA SHOWS SIGNIFICANT PROLONGATION OF TIME INTERVALS BETWEEN SEIZURE CLUSTERS TREATED WITH NEURELIS’ VALTOCO® (DIAZEPAM NASAL SPRAY) CIV
Novel clinical data highlights the potential for future research into additional benefits of rescue medications in treating individual seizure clusters SAN DIEGO, CA — September 7, 2022 — Neurelis, Inc., announced the recent online publication of a novel data analysis, evaluating the time interval between seizure clusters, or SEIzure interVAL
Neurelis, Inc., Little Angels Service Dogs Present Aug. 25 “Barks ‘n Blues Music & More” Concert to Build Epilepsy Awareness at Local Community Event
SAN DIEGO, CA — August 19, 2022 — 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. Featured performers include five-time San Diego
NEURELIS, INC., NAMED TO LIST OF BEST PLACES TO WORK IN SoCAL 2022
Company culture cultivates passioned innovation and purpose in employees to empower those impacted by epilepsy and other rare disorders SAN DIEGO, CA — August 18, 2022 — Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies
NEURELIS STUDY PUBLISHED IN EPILEPSIA, A WORLD-CLASS JOURNAL DEDICATED TO EPILEPSY
SAN DIEGO, CA – June 9, 2022 — Neurelis, Inc., announced the publication of a study recently available online in the peer-reviewed, scientific journal Epilepsia. Epilepsia is the world’s leading journal of original scientific research on multiple aspects of epilepsy. Epilepsia publishes reviews, opinion pieces, and guidelines that foster understanding
NEURELIS PRESENTED CLINICAL DATA SUPPORTING SEIZURE CLUSTER INTERVAL ANALYSIS AT THE EPILEPSY FOUNDATION PIPELINE CONFERENCE
Results of a post hoc analysis of Phase 3 clinical trial data may support a previously unrecognized effect of intermittent rescue therapy SAN DIEGO, CA – June 7, 2022 — Neurelis, Inc., announced findings from a novel, investigational analysis of VALTOCO® (diazepam nasal spray) CIV. The data indicate that patients
NEURELIS TO HIGHLIGHT VALTOCO (DIAZEPAM NASAL SPRAY) CIV DEVELOPMENT PROGRAM Updates AT 16TH EILAT CONFERENCE
Company to provide an overview of studies and publications for VALTOCO® in treating episodes of frequent seizure activity (seizure clusters) SAN DIEGO, CA ̶ May 31, 2022— Neurelis, Inc., today announced it will provide highlights of its clinical development program for VALTOCO® (diazepam nasal spray), an acute therapy for episodes
DATA FROM NOVEL, EXPLORATORY ANALYSIS OF INTERMITTENT VALTOCO® (DIAZEPAM NASAL SPRAY) CIV USE INDICATES MORE THAN TWO-FOLD INCREASE IN MEAN INTERVAL BETWEEN SEIZURE CLUSTERS
Neurelis presents two posters at the 2nd North American Epilepsy Congress (NAEC) highlighting new analysis of change in timing between seizure clusters across 12 months, and final effectiveness and safety data from the Phase 3, open-label, repeat-dose study of VALTOCO SAN DIEGO, CA — May 5, 2022— Neurelis, Inc., today
NEURELIS EXPANDS INTELLECTUAL PROPERTY ESTATE FOR VALTOCO®, A PATIENT-CENTRIC NASAL SPRAY FOR ACUTE TREATMENT OF EPISODES OF FREQUENT SEIZURE ACTIVITY
Fifth patent combined with a growing body of clinical data demonstrate safety and effectiveness of VALTOCO in this patient population, enhancing potential to expand clinical and commercial value. SAN DIEGO, CA — April 26, 2022 — Neurelis, Inc., a neuroscience-based company dedicated to enhancing therapeutic benefits and addressing significant unmet needs
NEURELIS ANNOUNCES THREE POSTER PRESENTATIONS AT THE 2022 ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
Final results from long-term, open-label, repeat-dose Phase 3 study of VALTOCO® (diazepam nasal spray) for episodes of frequent seizure activity include findings on ease of dosing and quality of life Investigational analysis on timing of a second dose of VALTOCO® SAN DIEGO, CA — April 4, 2022 — Neurelis, Inc., will
NEURELIS SIGNS EXCLUSIVE LICENSING AGREEMENT WITH ACULYS PHARMA FOR THE DEVELOPMENT AND COMMERCIALIZATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN JAPAN AND THE ASIA-PACIFIC REGION
SAN DIEGO, CA — January 25, 2022 — 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 which includes Australia, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand,
NEURELIS ANNOUNCES PARTNERSHIP WITH RICK HARRISON, HOST OF TV’S “PAWN STARS” AND EPILEPSY ADVOCATE, TO RAISE AWARENESS OF EPILEPSY AND NEED FOR MORE EDUCATION REGARDING SEIZURE EMERGENCIES
SAN DIEGO, CA — December 3, 2021 — 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. Harrison was diagnosed at age 8 with focal onset
NEURELIS ANNOUNCES 16 POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN EPILEPSY SOCIETY
Subgroup analyses from the long-term safety study of VALTOCO® (diazepam nasal spray) demonstrated favorable safety and tolerability results in children (6-11 years of age), adolescents (12-17 years of age) and adults who experience seizure clusters Safety and effectiveness results for VALTOCO remained consistent in subgroups of patients, including subgroups of
NEURELIS ANNOUNCES ADDITION OF BRITTANY BRADRICK AS CFO AND EXPANSION OF LEADERSHIP TEAM AND BOARD OF DIRECTORS
Corporate finance veteran David Smith named to company’s Board of Directors SAN DIEGO, CA — October 18, 2021 — Neurelis, Inc., announced today that it has made the following additions to its leadership team: • Brittany Bradrick has been named Chief Financial Officer at Neurelis • David Smith has been
NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS AT THE ANNUAL MEETING OF THE CHILD NEUROLOGY SOCIETY
Subgroup analyses from the long-term safety study of VALTOCO® (diazepam nasal spray) produced favorable safety and tolerability results in children (6-11 years of age) and adolescents (12-17 years of age) who experience seizure clusters A post-hoc analysis also showed that 89% of children and adolescents with epilepsy used one dose
NEURELIS INITIATES STUDY OF VALTOCO® (diazepam nasal spray) IN CHILDREN WITH SEIZURE CLUSTERS AGED TWO TO FIVE
VALTOCO is currently approved by the FDA as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters or acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in patients with epilepsy 6 years of age and older SAN DIEGO, CA — September
NEURELIS SECURES SENIOR TERM LOAN FACILITY OF UP TO $150 MILLION FROM ORBIMED
Financing to fund commercialization of Neurelis’ lead product, VALTOCO® (diazepam nasal spray), and to advance its product pipeline while allowing the company to explore certain additional strategic opportunities SAN DIEGO, CA — August 11, 2021 — Neurelis, Inc., announced today that it has completed a senior term loan facility of
NEURELIS ANNOUNCES ACQUISITION OF RIGHTS TO PORTFOLIO OF NEW CHEMICAL ENTITY (NCE) COMPOUNDS TARGETING CEREBRAL CAVERNOUS MALFORMATIONS, A RARE CNS DISORDER
Adds to Neurelis’s growing pipeline of innovative neuroscience programs There are no currently FDA-approved treatments for Cerebral Cavernous Malformations (CCMs) Neurelis intends to submit an Investigational New Drug (IND) application with the FDA on BioAxone’s lead compound, BA-1049, in 2022 SAN DIEGO, CA — June 21, 2021 — Neurelis, Inc.,
NEURELIS ANNOUNCES FIVE POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
Data from clinical studies continue to support effectiveness, tolerability and safety profile for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older Survey data presented at AAN shows that nearly
NEURELIS ANNOUNCES TWO POSTER PRESENTATIONS FOR THE ANNUAL MEETING OF THE ACADEMY OF MANAGED CARE PHARMACY
Clinical studies support effectiveness and safety profile for Neurelis’ lead product, VALTOCO®(diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older Data presented at AMCP shows that just a single dose of VALTOCO was needed
NEURELIS ANNOUNCES CLOSE OF $114 MILLION SERIES D FINANCING ROUND TO ADVANCE NEUROSCIENCE FOCUS
2021 financing will be a catalyst to further establish Neurelis as a best-in-class epilepsy company Funds will enhance growth and commercial penetration of company’s lead orphan drug product, VALTOCO® (diazepam nasal spray), and support pipeline development and expansion Company also announces appointment of healthcare industry expert Alexander Kwit to its
Neurelis Announces 12 Poster Presentations for the Annual Meeting of the American Epilepsy Society
— Abstracts continue to demonstrate the safety and unique clinical attributes of Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for episodes of frequent seizure activity in pediatric patients 6 years of age and older, adolescents, and adults — Data also highlight the ability
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
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
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,
Neurelis Announces Four Poster Presentations for the Joint Meeting of the International Child Neurology Association and Child Neurology Society
— Data continue to support the unique clinical attributes for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults — Data also highlight that 88 percent of treated seizure
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
NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY’S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY)
— More than 176 million lives in the U.S. now covered by payers/managed care/insurance plans within months of FDA approval of VALTOCO, the first and only nasal spray treatment of seizure clusters in patients 6 years of age and older — Neurelis’ patient assistance program supports eligible patients who have
NEURELIS ANNOUNCES TOTAL OF NINE POSTER PRESENTATIONS FOR THE AANN, AMCP, AND AAN ANNUAL MEETINGS
— Data supports pharmacokinetic and safety profile for Neurelis’ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in pediatric patients 6 years of age and older, adolescents, and adults — Data also further highlights the permeation enhancer potency of Intravail® for
NEURELIS ANNOUNCES THAT INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS’ INTRANASAL EPINEPHRINE PRODUCT, DEMONSTRATES BIOEQUIVALENT EXPOSURE TO EPINEPHRINE INJECTORS
— ARS Pharmaceuticals’ lead product, ARS-1 (epinephrine nasal spray) to treat severe allergic reactions, has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) — Neurelis’ lead product, VALTOCO® (diazepam nasal spray), approved by the FDA for seizure cluster rescue, also utilizes Intravail® as a
NEURELIS ANNOUNCES COMMERCIAL AVAILABILITY OF VALTOCO® (DIAZEPAM NASAL SPRAY) FOR SEIZURE CLUSTER RESCUE
— VALTOCO is the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older — Copay and patient assistance program to be provided by Neurelis for eligible VALTOCO patients SAN DIEGO, CA – March 2, 2020 – Neurelis, Inc.,
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 9th 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