ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription […]
Neurelis Inc.
Neurelis closes $114M Series D for diazepam nasal spray
Neurelis announced today that it closed a $114 million Series D financing round to support its lead orphan drug product. San Diego-based Neurelis’ Valtoco (diazepam nasal spray) is a proprietary formulation incorporating the science of Intravail transmucosal absorption enhancement technology. The drug enables the noninvasive delivery of a range of drugs, while the company focuses […]
Neurelis wins FDA approval for seizure rescue nasal spray
Neurelis today said it won FDA approval for its Valoco seizure rescue nasal spray. Valtoco is approved to use by a care partner outside of a medical setting to treat intermittent, stereotypic episodes of seizure activity. It is designed for people with epilepsy aged 6 or older. Valtoco also uses the company’s Intravail formula for […]
Neurelis closes Series B for intranasal diazepam spray
Neurelis, Inc. said today that it closed a Series B financing round, led by HBM Healthcare Investments. Other investors included LYZZ Capital, which previously led a Series A funding round for the company. Neurelis will use the funds to complete clinical trials for its intranasal diazepam spray and prepare a new drug application to submit […]
Neurelis wins fast track designation from FDA for intranasal diazepam spray
Neurelis, Inc. said today that it won fast track designation from the FDA for its intranasal diazepam spray. The nasal formulation of diazepam, which is being developed for pediatric and adult epilepsy patients who experience repititive or cluster seizures, is in the final stage of clinical development, according to Neurelis. The company expects to submit […]
