|Over a week ago|
Eton receives FDA acceptance for NDA filing for zonisamide oral suspension » 08:3410/1510/15/20
Eton Pharmaceuticals announced the U.S. Food and Drug Administration has accepted for filing the company's new drug application for zonisamide oral suspension. The application has been assigned a Prescription Drug User Fee Act date of May 29, 2021. The application was submitted for the treatment of partial seizures in patients with epilepsy. Zonisamide is one of Eton's three neurology-focused oral liquid product candidates that have been submitted to the FDA, and all three product candidates are expected to be approved and launched in 2021.
Eton Pharmaceuticals up 4.6% at $7.25 after pricing secondary above prior close 08:3710/1410/14/20
Eton Pharmaceuticals 2.8M share Secondary priced at $7.00 » 08:3410/1410/14/20
The deal priced above the…
The deal priced above the last closing price of $6.93. National Securities is acting as sole book running manager for the offering.
Eton Pharmaceuticals files to sell common stock, no amount given » 16:0210/1310/13/20
National Securities Corporation, a wholly owned subsidiary of National Holdings is acting as the sole book-running manager of the offering.
Eton announces acceptance of NDA filing for dehydrated alcohol injection » 08:0210/0810/08/20
Eton Pharmaceuticals announced the U.S. Food and Drug Administration has accepted for filing the company's new drug application for dehydrated alcohol injection. The application has been assigned a Prescription Drug User Fee Act date of May 27, 2021. Eton's application previously received orphan drug designation for the treatment of methanol poisoning and is expected to receive seven years of market exclusivity upon its approval.
Fly Intel: After-Hours Movers » 18:3910/0610/06/20
LEVI, IART, SIRI, ETON, LNDC, NSTG, CLSK, GH
Check out this evening's…
Eton Pharmaceuticals submits NDA to FDA for topiramate oral solution » 16:1110/0610/06/20
Eton Pharmaceuticals announced that in tandem with its development and manufacturing partner Tulex Pharmaceuticals, it has submitted a new drug application, NDA, for topiramate oral solution to the U.S. Food & Drug Administration, FDA. The product candidate, formerly known as ET-101, was submitted for three indications, including: monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older; and as preventative treatment of migraine in patients 12 years of age and older. "Topiramate is one of the most widely compounded oral liquids, and our product addresses the unmet need for pediatric-friendly formulations of the molecule. We look forward to working with the FDA to bring a safe, effective, FDA-approved product to patients and caregivers as quickly as possible," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. Eton's product is expected to be the first and only FDA-approved liquid formulation of topiramate. The company's patent-pending liquid formulation addresses the significant unmet need for patients with dysphagia and patients that require the precision dosing that a liquid can offer. Topiramate is currently FDA-approved only in tablet and capsule form. Based on IQVIA data, the market for oral topiramate is more than $800M annually. ET-101 is Eton's third neurology-focused liquid product candidates to be submitted to the FDA. Eton expects all three of the neurology product candidates to be approved and launched in 2021.
Fly Intel: Pre-market Movers » 08:5309/3009/30/20
CZR, DUK, ETON, TH, SNX, PRGS, MU, OAS, DIS, RUN
Check out this morning's…
Eton Pharmaceuticals price target raised to $20 from $18 at H.C. Wainwright » 06:1509/3009/30/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju raised the firm's price target on Eton Pharmaceuticals to $20 from $18 and reiterates a Buy rating on the shares after the FDA approved Alkindi Sprinkle. Eton currently has three more product candidates under review at the FDA, Selvaraju tells investors in a research note.
|Over a month ago|
Eton Pharmaceuticals announces FDA approval of ALKINDI SPRINKLE » 18:5109/2909/29/20
Eton Pharmaceuticals announced that the U.S. FDA has approved ALKINDI SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency in children under 17 years of age. ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children.