Eton Pharmaceuticals Stock Price, News & Analysis

Eton Pharmaceuticals (Nasdaq: ETON) announced that the FDA has extended the PDUFA goal date for its New Drug Application (NDA) for ET-400 to May 28, 2025, from the original date of February 28, 2025. The three-month extension was implemented to allow the FDA additional time to review supplemental information provided in December in response to their request.

The company states it has fully addressed all FDA questions with no outstanding requests. CEO Sean Brynjelsen expressed confidence in the NDA package and indicated that this standard extension is not expected to significantly impact their 2025 revenue projections. The drug is intended as a therapy for pediatric rare diseases.

Eton Pharmaceuticals (NASDAQ: ETON) has announced the acquisition of Galzin® (zinc acetate), an FDA-approved maintenance treatment for Wilson Disease. The drug serves an ultra-rare patient population with less than 5,000 patients currently being treated in the United States.

The company plans to begin commercialization in the U.S. during Q1 2025 through its metabolic sales force. Patients will have access to the Eton Cares support program, offering $0 co-pay for qualified commercial patients, prescription fulfillment, insurance benefits investigation, and educational support.

The acquisition also includes European rights to the product, where it's marketed as Wilzin® through a third-party distributor. Eton will continue supplying the product while the third party manages European commercialization. Stifel acted as exclusive financial advisor for the transaction.

Eton Pharmaceuticals has completed its acquisition of Increlex® (mecasermin injection) from Ipsen S.A. Increlex® is a biologic treatment for pediatric patients aged 2+ with severe primary insulin-like growth factor 1 deficiency (SPIGFD). The product is approved in 41 territories, including the US and EU, and is the only FDA/EMA-approved treatment for SPIGFD, serving approximately 200 US patients and 900-1,000 European patients.

The medication is now available in the US through AnovoRx, a specialty pharmacy for rare conditions. The Eton Cares Program offers prescription fulfillment, insurance benefits investigation, and financial assistance, including $0 co-pays for qualifying patients. Outside the US, Ipsen will continue distribution during a six-month transition period before Eton takes over commercialization.

Eton Pharmaceuticals (ETON) announced compelling results from a clinical trial evaluating PKU GOLIKE for treating phenylketonuria (PKU) during prolonged fasting periods. The randomized, crossover study demonstrated that PKU GOLIKE, when administered as the last daily dose, significantly improved metabolic control compared to standard amino acid protein substitutes.

Key findings showed PKU GOLIKE achieved a 17.8% reduction in blood phenylalanine (Phe) levels and a 33.8% increase in blood tyrosine (Tyr) levels after overnight fasting. In contrast, standard treatments led to a 27.6% increase in Phe levels with no significant Tyr improvement. The study was conducted at Birmingham Children's Hospital, UK, on pediatric patients with classical PKU.

Eton Pharmaceuticals (Nasdaq: ETON) has appointed Ipek Erdogan-Trinkaus as Chief Commercial Officer. She brings extensive commercial leadership experience in pharmaceuticals, particularly in pediatric endocrinology. At Tolmar Pharmaceuticals, she led the successful launch of FENSOLVI® and served as General Manager of the Pediatric Endocrinology unit. The appointment comes ahead of two significant milestones: the anticipated closing of Increlex® in late-December and the expected launch of ET-400 in early 2025.

Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. The product, already approved by the European Medicines Agency since 2018, has received Orphan Drug Designation from the FDA. Amglidia is a patented liquid formulation targeting approximately 300 U.S. patients with neonatal diabetes mellitus, for which no FDA-approved oral treatments currently exist. The company plans to meet with FDA in Q1 2025 and aims to submit a New Drug Application in 2026, supported by five years of real-world safety and efficacy data from European patients.

Eton Pharmaceuticals reported strong Q3 2024 financial results with total revenue of $10.3 million and GAAP Net Income of $0.6 million ($0.02 per share). Product sales increased 40% year-over-year, marking the 15th consecutive quarter of sequential growth. The company generated $2.9 million in operating cash flow and achieved positive quarterly GAAP net income from product sales for the first time. Key highlights include an agreement to acquire Increlex, FDA acceptance of the ET-400 NDA with a PDUFA date of February 28, 2025, and strong growth in ALKINDI SPRINKLE (55% YoY) and Carglumic Acid sales.

Eton Pharmaceuticals has been granted its second patent (U.S. Patent No. 12,133,914) for ET-400, a proprietary liquid hydrocortisone formulation. The patent, extending protection through 2043, covers the method of using hydrocortisone oral liquid formulations. This follows the first patent received in February 2024, with an additional patent application under review. The FDA has accepted the New Drug Application for ET-400 with a PDUFA target action date of February 28, 2025. If approved, ET-400 would become the only FDA-approved liquid formulation of hydrocortisone.

Eton Pharmaceuticals (Nasdaq: ETON), a pharmaceutical company focused on rare disease treatments, has scheduled its third quarter 2024 financial results announcement for Tuesday, November 12, 2024. Management will host a conference call and audio webcast at 4:30 p.m. ET to discuss the results. The company will take live questions during the call and answer emailed investor questions sent to investorrelations@etonpharma.com. The webcast will be accessible through Eton's investor relations website and will remain available for 30 days after the event.