Eton Pharmaceuticals - ETON STOCK NEWS

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.

Eton Pharmaceuticals has announced an agreement to acquire Increlex® (mecasermin injection) from Ipsen S.A. The acquisition, expected to close near year-end 2024, aligns with Eton's mission to develop and distribute medicines for ultra-rare conditions. Increlex is a biologic product used to treat children and adolescents aged 2-18 with severe primary insulin-like growth factor 1 deficiency (SPIGFD).

Key points:

• Increlex is approved in 40 territories, including the U.S. and EU
• Approximately 200 patients in the U.S. and 900-1,000 in Europe live with SPIGFD
• Eton will immediately commercialize the product in the U.S. post-closing
• Ipsen will continue distribution outside the U.S. for a six-month transition period
• The transaction will be financed by Eton's cash and an expanded credit facility
• Ipsen reported global sales for Increlex of €17.3 million in 2023

Eton Pharmaceuticals (Nasdaq: ETON), a company focused on rare disease treatments, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York City. The company's CEO, Sean Brynjelsen, will deliver a presentation that will be available on demand starting September 9, 2024, at 7am ET.

Investors can access the presentation online, and those interested in in-person meetings with the company are encouraged to contact H.C. Wainwright's Corporate Access team. This event provides Eton Pharmaceuticals with an opportunity to showcase its innovative approach to developing and commercializing treatments for rare diseases to a global investment audience.

Eton Pharmaceuticals (ETON) reported strong Q2 2024 financial results, with product sales and royalty revenue reaching $9.1 million, a 40% increase year-over-year. This marks the 14th consecutive quarter of sequential growth. Key highlights include:

1. FDA acceptance of the New Drug Application (NDA) for ET-400, with a PDUFA date of February 28, 2025.
2. Q2 2024 Cash Flow from Operations of $1.3 million, despite a one-time $2.0 million NDA filing fee.
3. ALKINDI SPRINKLE® saw 63% year-over-year revenue growth.
4. Successful launch of PKU GOLIKE for phenylketonuria patients.
5. Anticipated initiation of ET-600 pivotal study in Q3 2024.

The company expects continued sequential quarter-over-quarter growth in product sales through 2024 and beyond, driven by its existing commercial products and pipeline advancements.

Eton Pharmaceuticals (Nasdaq: ETON), a company focused on developing and commercializing treatments for rare diseases, has announced it will report its second quarter 2024 financial results on Thursday, August 8, 2024. The company will host a conference call and live audio webcast at 4:30 p.m. ET (3:30 p.m. CT) to discuss the results.

Management will take live questions from call participants and answer emailed questions from investors. Investors can email their questions to investorrelations@etonpharma.com. The live webcast will be accessible on Eton's website, with an archived version available for 30 days after the event.

Eton Pharmaceuticals (Nasdaq: ETON) announced FDA acceptance of its New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution. The FDA assigned a PDUFA target action date of February 28, 2025. ET-400 is a room temperature stable formulation with patent protection through 2043.

CEO Sean Brynjelsen stated that ET-400's approval could allow Eton to capture a larger share of the oral hydrocortisone market. Combined with ALKINDI SPRINKLE®, the company anticipates peak sales exceeding $50 million annually. Eton is preparing for a potential launch in early 2025, pending FDA approval.