Welcome to our dedicated page for Eton Pharmaceutcials news (Ticker: ETON), a resource for investors and traders seeking the latest updates and insights on Eton Pharmaceutcials stock.
Eton Pharmaceuticals, Inc. (NASDAQ: ETON) is a Deer Park, Illinois-based specialty pharmaceutical company dedicated to developing and commercializing innovative pharmaceutical products, particularly those aimed at treating rare diseases. The company's mission is to advance healthcare by introducing affordable and accessible medicines to patients in need.
Eton utilizes the U.S. Food and Drug Administration’s (FDA) 505(b)(2) regulatory pathway to develop its products. Currently, Eton has four commercial rare disease products: ALKINDI SPRINKLE® for pediatric adrenocortical insufficiency, Carglumic Acid for hyperammonemia, Betaine Anhydrous for homocystinuria, and Nitisinone for hereditary tyrosinemia type 1 (HT-1). The recent addition of Nitisinone further advances Eton's goal of having ten commercial rare disease products by the end of 2025.
Beyond these, Eton has several promising candidates in late-stage development. These include ET-400, a liquid formulation of hydrocortisone for adrenocortical insufficiency, the ZENEO® hydrocortisone autoinjector for adrenal crisis, and ET-600 for diabetes insipidus. Eton's ET-400 product recently received a new U.S. patent with an expiration date in 2043, and it is expected to significantly complement the existing ALKINDI SPRINKLE product.
Financial Performance and Recent Achievements
- The company has reported eleven consecutive quarters of growth in product sales and royalty revenue, achieving cash flow break-even ahead of schedule.
- Third quarter 2023 net revenue reached $7.0 million, marking a 118% increase from the prior year period.
- Gross profit for the same quarter more than doubled year-over-year, underscoring the company's strong commercial execution.
Eton's strategic acquisitions further bolster its portfolio. The recent acquisition of U.S. rights to PKU GOLIKE® from Relief Therapeutics positions the company to address the needs of patients with phenylketonuria (PKU), a rare metabolic disorder. Eton also aims to leverage its strong relationships within the metabolic community to drive adoption and market penetration for both existing and new products.
Patient Support and Community Initiatives
Eton is committed to supporting patients and their families through initiatives like the Eton Cares program, which provides comprehensive support services including prescription fulfillment, insurance benefits investigation, educational support, and financial assistance for qualified patients. The program aims to make treatments like Nitisinone more accessible to those who need them the most.
Looking Ahead
With a robust pipeline, strategic acquisitions, and a strong financial footing, Eton Pharmaceuticals is well-positioned for continued growth and success. The company's focus on rare diseases and commitment to patient care make it a valuable player in the pharmaceutical industry.
For more detailed information, please visit the company's website at www.etonpharma.com.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. announced the commercial launch of Rezipres® (ephedrine hydrochloride) injection, approved for treating hypotension during anesthesia. The ready-to-use formulation aims to replace unapproved compounded options, enhancing safety for hospitals. The ephedrine injection market saw a 24% growth in 2021, reaching $86 million. Rezipres is supplied in a 5mL ampule and can be ordered through major wholesalers. Eton retains ownership of the FDA New Drug Application.
Eton Pharmaceuticals, Inc (Nasdaq: ETON) announced its fourth quarter 2021 financial results will be reported on March 16, 2022. Management will host a conference call and live audio webcast for investors at 7:00 p.m. ET due to ongoing litigation regarding their cysteine product. Investors can submit questions via email prior to or during the call. Eton currently holds six FDA-approved products and has four others submitted for approval, emphasizing their focus on rare diseases.
Eton Pharmaceuticals has launched Carglumic Acid tablets, the first FDA-approved generic version of Carbaglu®. Available exclusively through Anovo specialty pharmacy, this product treats acute and chronic hyperammonemia due to NAGS deficiency. Carglumic Acid is stable at room temperature, unlike Carbaglu®, and includes a patient support program offering $0 co-pays for eligible patients. The FDA has granted this product Competitive Generic Therapy designation, allowing for 180 days of exclusivity. Eton aims to improve patient access and reduce healthcare costs by providing a more affordable alternative.
Eton Pharmaceuticals, Inc (Nasdaq: ETON) reported its Q3 2021 financial results, achieving $0.8 million in revenue compared to no revenue in Q3 2020. The company made significant strides, gaining FDA approvals for EPRONTIA and carglumic acid, expected to launch in Q4 2021. Eton also partnered with Tolmar Pharmaceuticals to expand the commercial footprint of ALKINDI SPRINKLE®. Despite a net loss of $6.1 million, down from $6.5 million year-over-year, Eton anticipates these developments will bolster revenue and aim for profitability in 2022.
Eton Pharmaceuticals has entered a multi-year agreement with Tolmar Pharmaceuticals to co-promote ALKINDI SPRINKLE®, an FDA-approved treatment for adrenal insufficiency in children. Tolmar's sales force, consisting of 62 representatives, will leverage their existing relationships in pediatric endocrinology to enhance the product's adoption. The collaboration aims to improve face-to-face interactions with physicians, significantly increasing outreach and accelerating market penetration. The promotional efforts are set to begin in December 2021, coinciding with a digital marketing campaign aimed at raising awareness among patients and caregivers.
Eton Pharmaceuticals has announced the FDA approval of EPRONTIA™, the first ready-to-use liquid formulation of topiramate, for treating various types of seizures and migraine prevention in patients aged 2 years and older. The product serves both as a monotherapy and adjunctive therapy, offering significant benefits for adherence and dosing precision. Azurity Pharmaceuticals will commercialize EPRONTIA™, with availability expected by year-end. Eton stands to receive a $5 million milestone payment upon launch, plus royalties on net sales.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced it will release its third quarter 2021 financial results on November 15, 2021. A conference call and live webcast will follow at 4:30 p.m. ET, where management will discuss the results and provide a business update. Participants can ask questions during the call or submit them via email. Eton is focused on developing treatments for rare diseases and currently has five FDA-approved products along with five additional submissions pending.
Eton Pharmaceuticals has acquired U.S. marketing rights for carglumic acid tablets, a generic alternative to the high-cost treatment Carbaglu®. The FDA approved the Abbreviated New Drug Application on October 13, 2021. This move is expected to provide significant savings for patients, with Carbaglu® costing over $1 million annually. Eton plans to utilize its existing commercial framework for orphan drugs to enhance distribution and support for patients, aiming to save millions for both individuals and the U.S. healthcare system.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced its second quarter financial results for 2021, reporting revenues of $3.1 million, including $2.5 million from licensing. The company achieved FDA approval for Rezipres®, its fourth product, and acquired rights to the ZENEO® Hydrocortisone autoinjector. Despite a net loss of $2.0 million, Eton improved diluted earnings per share to ($0.08) from ($0.23) in the prior year. The company maintains a strong cash position of $25.8 million as of June 30, 2021.
Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced it will report its second quarter 2021 financial and operating results on August 16, 2021. A conference call will be held at 4:30 p.m. ET to discuss these results and provide a business update. Interested parties can access the live audio webcast on Eton's investor website. Eton is focused on developing treatments for rare diseases and currently has four FDA-approved products while five additional products await FDA review.
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