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 20, 2021 — Neurelis, Inc. […]
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 up to $150 million from […]
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., announced today that it has […]
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 80% of patients were comfortable […]
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 in 87.4% of seizure clusters […]
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 Board of Directors SAN DIEGO, […]
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 for patients to self-administer VALTOCO […]
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 […]
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 […]
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 […]