UPSHER-SMITH LABORATORIES ANNOUNCES THE LAUNCH OF TOSYMRA™ USING NEURELIS’ INTRAVAIL® TECHNOLOGY
Neurelis Announces Two Poster Presentations At The Annual Meeting Of The American Academy Of Neurology
— Neurelis’ lead product candidate for seizures, VALTOCO™ (diazepam nasal spray), currently under FDA review 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 […]
NEURELIS ANNOUNCES COMPLETION OF SENIOR MANAGEMENT TEAM BUILDOUT TO SUPPORT THE ANTICIPATED COMMERCIAL LAUNCH OF VALTOCO™
— Neurelis’ lead product candidate for seizures, VALTOCO™ (diazepam nasal spray), currently under FDA review — Company’s team members are all seasoned pharmaceutical industry executives with vast experience in CNS and epilepsy SAN DIEGO, CA – April 22, 2019 – Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing, and commercializing product candidates […]
Neurelis Announces That Intravail® Licensee ARS Pharmaceuticals Intranasal Epinephrine Program Given Fast Track Designation
— ARS Pharmaceuticals announced that ARS-1, an intranasal epinephrine spray in development to treat severe allergic reactions, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) SAN DIEGO, CA – February 20, 2019 – Neurelis, Inc. announced today that its Intravail® licensing partner, ARS Pharmaceuticals, Inc., received Fast Track designation from […]
Neurelis Announces First Product Approved Using The Company’s Intravail® Platform
— Dr. Reddy’s Laboratories and its U.S. subsidiary, Promius Pharma, announced U.S. FDA approval on January 28 for its migraine treatment TOSYMRA™ (sumatriptan nasal spray 10 mg) in the United States — This is the first FDA approval of an investigational drug utilizing the science of Intravail® — Neurelis’ lead product candidate for seizures, VALTOCO™, […]
INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, SECURES $20M FINANCING FROM DEERFIELD MANAGEMENT
Neurelis Announces Acquisition Of Aegis Therapeutics, A Leading Drug Delivery Technology Company
Aegis’ Intravail® drug delivery technology utilized in Neurelis’ VALTOCO™ Nasal Spray, a novel investigational treatment for epilepsy patients 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 […]
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 VALTOCOTM (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as […]
Neurelis Expands Worldwide Patent Portfolio with Latest Issuance in Japan
Neurelis, Inc. today announced that the Japan Patent Office (JPO) recently allowed JP Application No. 2014-515967 related to Neurelis’ NRL-1 intranasal diazepam formulation. The patent, when issued, will be in force at least until 2032. NRL-1’s formulation incorporates the unique combination of a Vitamin E-based solvent and Intravail® absorption enhancement with the goal of obtaining unparalleled absorption, […]
Neurelis Completes Series B Financing
Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which led the Series A funding for Neurelis, has participated in the Series B round. The company will utilize the funds to complete clinical trials for NRL-1 (intranasal diazepam), prepare the planned New Drug […]