Eton Pharmaceuticals

81 articles with Eton Pharmaceuticals

• Eton Pharmaceuticals Announces Closing of Public Offering

  10/16/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the closing of its previously announced offering of 3,220,000 shares of common stock at a public offering price of $7.00 per share. The total offering included 420,000 shares sold as a result of the underwriter’s exercise of its overallotment option in full.

• Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Zonisamide Oral Suspension- Application Assigned a PDUFA Date of May 29, 2021

  10/15/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application (NDA) for zonisamide oral suspension. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of May 29, 2021. The application was s

• Eton Pharmaceuticals Prices Underwritten Public Offering of Common Stock

  10/14/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the pricing of an underwritten public offering of 2,800,000 shares of its common stock at a price to the public of $7.00 per share, for gross proceeds of $19.6 million. The Company has also granted the underwriters a 45-day option to purchase, at the same price

• Eton Pharmaceuticals Announces Proposed Public Offering of Common Stock

  10/13/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that it is offering to sell shares of its common stock in an underwritten public offering. The offering is expected to price on or about Wednesday, October 14, 2020. Eton Pharmaceuticals intends to use the net proceeds from the offering primarily for general

• Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection

  10/8/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s new drug application (NDA) for dehydrated alcohol injection

• Eton Pharmaceuticals Submits New Drug Application to the FDA for Topiramate Oral Solution (ET-101)

  10/6/2020

  - Application Submitted for the Treatment of Partial-Onset Seizures and Migraine - Eton’s Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Topiramate - Topiramate Oral Solution is Eton’s Third Neurology Product Candidate Submitted to the FDA DEER PARK, Ill., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric disea

• Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency

  9/29/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved ALKINDI® SPRINKLE (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

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  FDA Action Alert: Aquestive, Eton and Mesoblast

  9/28/2020

  The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.

• Eton Pharmaceuticals Announces Appointment of Ingrid Hoos as Senior Vice President of Scientific Affairs

  8/31/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it has appointed Ingrid Hoos as the company’s new Senior Vice President of Scientific Affairs.

• Eton Pharmaceuticals Announces Second Quarter 2020 Financial Results

  8/12/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today reported financial results for the second quarter ended June 30, 2020 and provided an update on business progress.

• Eton Pharmaceuticals Provides Update on the FDA Review of EM-100

  8/11/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, reported that its partner has not yet received a communication from the U.S. Food and Drug Administration (FDA) regarding its decision on the review of EM-100

• Eton Pharmaceuticals to Report Second Quarter Financial Results on Wednesday, August 12, 2020

  8/4/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it will report second quarter 2020 financial and operating results on Wednesday, August 12, 2020

• Eton Pharmaceuticals Submits New Drug Application to the FDA for Zonisamide Oral Suspension (ET-104)

  7/30/2020

  - Application Submitted for the Treatment of Partial Seizures in Epilepsy Patients - Eton’s Patent-Pending Product Addresses Significant Unmet Need for a Liquid Formulation of Zonisamide - Application is Eton’s Sixth Drug Application Under FDA Review

• Eton Pharmaceuticals Submits New Drug Application to the FDA for Orphan Drug Dehydrated Alcohol Injection (DS-100)

  7/27/2020

  -Granted Orphan Drug Designation by the FDA for the Treatment of Methanol Poisoning -Since the Start of COVID-19, the FDA has Recalled More Than 75 Contaminated Hand Sanitizers Due to Risk of Methanol Poisoning -DS-100 is Eton’s Fifth Drug Application Under FDA Review and Second Orphan Application DEER PARK, Ill., July 27, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products

• Eton Pharmaceuticals Announces First Quarter 2020 Financial Results

  5/14/2020

  Eton Pharmaceuticals, Inc, a specialty pharmaceutical company focused on developing and commercializing innovative drug products, reported financial results for the first quarter ended March 31, 2020 and provided an update on business progress.

• Eton Pharmaceuticals Confirms First-to-File Patent Challenge on Elcys (Cysteine Hydrochloride Injection)

  5/7/2020

  -Eton confirms first-to-file ANDA referencing Exela Pharma Sciences’ Elcys product -Eton plans to file Post Grant Reviews in the U.S. Patent & Trademark Office challenging the validity of Exela’s listed patents, which, if successful, could allow Eton to launch in 2021 -Eton believes Exela Pharma Sciences is improperly stifling competition on a decades-old drug

• Eton Pharmaceuticals to Report First Quarter Financial Results on Thursday, May 14, 2020

  5/6/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it will report first quarter 2020 financial and operating results on Thursday, May 14, 2020

• Eton Pharmaceuticals Announces Appointment of Paul Stickler as Senior Vice President of Sales and MarketingOrphan Drug Expert Paul Stickler to Lead Eton’s Commercialization of Alkindi® Sprinkle and Pediatric Neurology Franchise

  5/4/2020

  Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today announced that it has appointed Paul Stickler as the company’s new Senior Vice President of Sales and Marketing. Stickler brings more than twenty-five years of pharmaceutical sales and marketing experience with a primary focus in orphan and neurology products. In the new role, he will be responsi

• Eton Pharmaceuticals Announces Acquisition of U.S Marketing Rights to Pediatric Orphan Drug Alkindi® Sprinkle

  3/27/2020

  -Estimated Market Opportunity of Greater than $100 Million -Alkindi Sprinkle NDA has been Assigned a September 29, 2020 Prescription Drug User Fee Act Date -Alkindi Sprinkle has been Granted Orphan Drug Designation for Adrenal Insufficiency in Pediatric Patients -Eton Executed $7.8 Million Equity Financing and $2.0 Million Amended Credit Facility to Support Alkindi Sprinkle Transaction

• Eton Pharmaceuticals Reports Positive Study Results for ET-101 (Topiramate Oral Solution)

  3/17/2020

  Eton Pharmaceuticals, Inc today announced positive bioequivalence study results for ET-101, its proprietary oral solution formulation of topiramate. A bioequivalen