Nitisinone

Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

Retrieved on: 
Thursday, May 9, 2024
FDA, Research and development, NDA, Food, Research, Carglumic acid, Administration, Patient, Physician, PKU, Nitisinone, Phenylketonuria, Growth, Pharmaceutical industry

DEER PARK, Ill., May 09, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • •  Q1 2024 revenue of $8.0 million, representing 50% growth over Q1 2023 and the 13th straight quarter of sequential product sales growth
    •  Acquired PKU GOLIKE®, launched Nitisinone, and submitted a new drug application (NDA) for product candidate ET-400
    DEER PARK, Ill., May 09, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended March 31, 2024.
  • We also launched Nitisinone and submitted an NDA for our highly anticipated ET-400 product candidate,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Eton reported first quarter 2024 product sales of $8.0 million, representing 50% growth over the prior year, driven primarily by the ongoing momentum of ALKINDI SPRINKLE® and Carglumic Acid.
  • As previously announced, Eton Pharmaceuticals will host a its first quarter 2024 conference call as follows:

Eton Pharmaceuticals Announces Acquisition of PKU GOLIKE® for Phenylketonuria

Retrieved on: 
Friday, March 22, 2024
Brain, Taste, Nitisinone, Partnership, Education, Patient, PKU, Phenylalanine, DSM-IV codes, Insurance, Protein, APR, Diet, Homocystinuria, Patent, OTCQB, FDA, Practitioner, Pharmaceutical industry

After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market.

Key Points: 
  • After extensive discussions with metabolic geneticists, dieticians, and PKU patients, we believe PKU GOLIKE is the best product in the estimated $100 million U.S. PKU medical formula market.
  • PKU GOLIKE’s taste-masked, odor-free coating technology is designed to provide a better taste and a superior experience compared to alternative PKU medical formulas.
  • Relief launched PKU GOLIKE Granules in the United States in the fourth quarter of 2022 and the PKU GOLIKE Tropical Bar in the second quarter of 2023.
  • Eton plans to promote PKU GOLIKE with its existing metabolic sales force, which currently promotes Eton’s Carglumic Acid, Betaine, and Nitisinone products.

Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Administration, Growth, Nitisinone, Patent, Patient, NDA, Orange Book, Trial of the century, Diurnal, Carglumic acid, Research and development, FDA, Endocrinology, Physician, Pharmaceutical industry

Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.

Key Points: 
  • Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.
  • Eton generated $0.4 million of operating cash during the fourth quarter of 2023, with total cash and cash equivalents of $21.4 million as of December 31, 2023.
  • Total net revenues were $7.3 million for the fourth quarter of 2023, compared to $8.5 million for the fourth quarter of 2022.
  • As previously announced, Eton Pharmaceuticals will host its fourth quarter 2023 conference call as follows:

Eton Pharmaceuticals Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 9, 2023
NDA, Betaine, Carglumic acid, Nitisinone, Administration, Patient, Research, FDA, Marketing, Hand, R, Research and development, Growth, Hydrocortisone, Pharmaceutical industry, Video game

Product sales and royalty revenue of $7.0 million up 118% from Q3 2022, representing the eleventh straight quarter of sequential product sales and royalty revenue growth

Key Points: 
  • Product sales and royalty revenue of $7.0 million up 118% from Q3 2022, representing the eleventh straight quarter of sequential product sales and royalty revenue growth
    Generated $0.9 million in positive cash flow from operations; ended quarter with $22.1 million of cash on hand
    DEER PARK, Ill., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the quarter ended September 30, 2023.
  • Eton reported third quarter 2023 product sales and royalty revenue of $7.0 million, representing 118% growth over the prior year period and 8% growth over the second quarter of 2023.
  • Product sales and royalty revenue for the third quarter of 2023 were up 8% over the second quarter of 2023.
  • As previously announced, Eton will host its third quarter 2023 conference call as follows:

Eton Pharmaceuticals Announces Acquisition of FDA-Approved Ultra-Rare Disease Product Nitisinone

Retrieved on: 
Wednesday, October 4, 2023
Insurance, Cornea, Keratitis, US Foods, Tyrosine, Diet, Medicine, Tell, Face, Chapter 11, Title 11, United States Code, Erythroderma, Skin, Light, DSM-IV codes, Inflammation, Carglumic acid, Mouth ulcer, Rash, Phenylalanine, Intellectual disability, Eton, Plasma, Vitamin, Hair, Photophobia, Allergy, Patient, Leukopenia, Blood, Itch, Immune system, Cover My Eyes (Pain and Heaven), Ageing, Rare, FDA, Conjunctivitis, Nosebleed, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Thrombocytopenia, Tongue, Food, Breast milk, Pharmaceutical industry, Nursing, Dietary supplement, Medical imaging, Birth control, Nitisinone

DEER PARK, Ill., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced it has entered into an agreement to acquire an abbreviated new drug application for Nitisinone Capsules via Oakrum Pharma, LLC’s Chapter 11 bankruptcy proceeding. The transaction has been approved by the bankruptcy court and is expected to be effective on October 12, 2023. The acquired product was approved by the U.S. Food and Drug Administration (FDA) in May of 2023 for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. It is estimated that less than 500 patients in the United States suffer from this ultra-rare condition.

Key Points: 
  • Nitisinone is our fourth FDA-approved product, and further advances us toward our goal of having ten commercial rare disease products on the market by the end of 2025.
  • Eton expects to launch the product in the first quarter of 2024 and plans to offer its Eton Cares support program to all patients.
  • Nitisinone is a prescription medicine used to treat adults and children with a hereditary disease called tyrosinemia type 1 (HT-1).
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Analog Pharma and Dipharma announce US FDA approval of abbreviated new drug application (ANDA) of 20 mg generic Nitisinone capsules (temperature stable)

Retrieved on: 
Wednesday, May 31, 2023
Cornea, Tyrosine, Analog, Hair loss, Pharmacy, Skin, Scar, Immunity, Nitisinone, Temperature, Liver transplantation, Cataract, Inflammation, Cell, Rash, Phenylalanine, Capsule, Patient, ANDA, Cover My Eyes (Pain and Heaven), Rare, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

PRINCETON, N.J. and CHIASSO, Switzerland, May 31, 2023 (GLOBE NEWSWIRE) -- Analog Pharma (member of Duchesnay Pharmaceutical Group, hereafter “Analog”) and Dipharma S.A. (“Dipharma”) are pleased to announce that their 20 mg nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration.

Key Points: 
  • PRINCETON, N.J. and CHIASSO, Switzerland, May 31, 2023 (GLOBE NEWSWIRE) -- Analog Pharma (member of Duchesnay Pharmaceutical Group, hereafter “Analog”) and Dipharma S.A. (“Dipharma”) are pleased to announce that their 20 mg nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration.
  • Nitisinone Capsules are a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin®, and are now available in 2, 5, 10 and 20 mg capsules.
  • Analog currently distributes the 2, 5, and 10 mg products through specialty pharmacies and now has available the 20 mg capsules for distribution.
  • Tanya Carro, Executive Vice President, Analog Pharma, commented, “With the approval of the 20 mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone.

Cycle Pharmaceuticals Secures $25 Million Debt Financing

Retrieved on: 
Monday, September 7, 2020
Oncology, Health, Genetics, Research, Science, Pharmaceutical, Biotechnology, Health, Articles, Medicine, Herbicides, Nitisinone, Nitrobenzenes, Tyrosinemia type I, Tyrosinemia, Medication, Disease, Pharmaceutical industry in China

This strategic financing allows Cycle to build on the success of NITYR (nitisinone) Tablets , which treats patients with the rare genetic metabolic disease, hereditary tyrosinemia type 1.

Key Points: 
  • This strategic financing allows Cycle to build on the success of NITYR (nitisinone) Tablets , which treats patients with the rare genetic metabolic disease, hereditary tyrosinemia type 1.
  • We are delighted to become a key financing partner for Cycle Pharmaceuticals and look forward to working closely with the company in the future.
  • Separately, Varsity Pharmaceuticals is incorporated as an independent business, receiving financing from the above transaction.
  • Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering best-in-class drug treatments and services to the under-served rare disease patient community.

Guided by CRISPR, Prenatal Gene Editing Shows Proof-of-Concept in Treating Congenital Disease before Birth

Retrieved on: 
Monday, October 8, 2018
Rare diseases, Medicine, Type I tyrosinemia, Health, Chemistry, Tyrosinemia, Birth defect, Nitisinone, Metabolic disorder

PHILADELPHIA, Oct. 8, 2018 /PRNewswire/ -- For the first time,scientists have performed prenatal gene editing to prevent a lethal metabolic disorder in laboratory animals, offering the potential to treat human congenital diseases before birth.

Key Points: 
  • PHILADELPHIA, Oct. 8, 2018 /PRNewswire/ -- For the first time,scientists have performed prenatal gene editing to prevent a lethal metabolic disorder in laboratory animals, offering the potential to treat human congenital diseases before birth.
  • They also used prenatal gene editing to improve liver function and prevent neonatal death in a subgroup of mice that had been engineered with a mutation causing the lethal liver disease hereditary tyrosinemia type 1 (HT1).
  • HT1 in humans usually appears during infancy, and it is often treatable with a medicine called nitisinone and a strict diet.
  • Prenatal treatment could open a door to disease prevention, for HT1 and potentially for other congenital disorders.

Investigation launched into certain nitisinone capsules from Sweden

Retrieved on: 
Friday, September 21, 2018
Chemistry, Herbicides, Health, Nitisinone, Nitrobenzenes, Pharmacology, Type I tyrosinemia, Borders of Canada, Tyrosinemia, Canada Border Services Agency, Capsule

OTTAWA, Sept.21,2018 /CNW/ - The CanadaBorderServicesAgency(CBSA) announced today that it is launching an investigation into whether or not certain nitisinone capsules originating in or exported from Sweden are being sold at unfair prices in Canada.

Key Points: 
  • OTTAWA, Sept.21,2018 /CNW/ - The CanadaBorderServicesAgency(CBSA) announced today that it is launching an investigation into whether or not certain nitisinone capsules originating in or exported from Sweden are being sold at unfair prices in Canada.
  • The initiation of this investigation does not prevent these goods from being imported into Canada and being made available to users.
  • The subject goods are nitisinone capsules supplied in certain dosages.
  • Nitisinone capsules are orally administered drugs used in the treatment of hereditary tyrosinemia type 1 (HT1).