Eton Pharmaceuticals Stock Price, News & Analysis

Eton Pharmaceuticals (Nasdaq: ETON), a company focused on rare disease treatments, announced its inclusion in the Russell 2000® and Russell 3000® Indexes effective June 27, 2025. This addition marks a significant milestone for the company, reflecting its strong performance and shareholder value creation over the past year.

CEO Sean Brynjelsen highlighted this achievement as an opportunity to increase the company's visibility among investors while continuing their mission of developing treatments for ultra-rare conditions.

Eton Pharmaceuticals (ETON) has received FDA approval for KHINDIVI™, the first and only FDA-approved hydrocortisone oral solution for pediatric patients aged 5+ with adrenocortical insufficiency. The 1mg/ml solution offers precise dosing without the need to split tablets, requiring no refrigeration or mixing. Commercial launch is expected by June 2nd, with distribution through Anovo specialty pharmacy. KHINDIVI complements Eton's existing ALKINDI SPRINKLE® product line, with the company projecting combined peak sales exceeding $50 million. The U.S. market includes over 5,000 potential patients aged 5-17. The Eton Cares Program will provide prescription support and $0 co-pays for qualifying patients.

Eton Pharmaceuticals (Nasdaq: ETON), a pharmaceutical company specializing in rare disease treatments, announced its leadership team's participation in two upcoming investor conferences. CEO Sean Brynjelsen, CFO James Gruber, and CBO David Krempa will attend:

1. The 25th Annual B. Riley Securities Investor Conference on May 22, 2025, at 11:15am ET in Marina Del Rey, California, featuring a fireside chat

2. The 22nd Annual Craig-Hallum Institutional Investor Conference on May 28, 2025, in Minneapolis, Minnesota

One-on-one meetings can be arranged through B. Riley or Craig Hallum representatives. No webcasts will be available for either conference.

Eton Pharmaceuticals (NASDAQ: ETON) reported strong Q1 2025 financial results with revenue of $17.3 million, including product sales of $14.0 million - a 76% growth over Q1 2024. The company marked its 17th consecutive quarter of sequential product sales growth. Key highlights include: - Successful relaunch of INCRELEX for rare pediatric endocrinology condition - Out-licensed INCRELEX international rights to Esteve Pharmaceuticals for $4.3M upfront - Relaunched GALZIN for Wilson disease with Eton Cares support program - Submitted NDA for ET-600 following positive clinical study results - Preparing for potential ET-400 launch with PDUFA date of May 28th - Posted Q1 GAAP EPS of $(0.06) and Non-GAAP EPS of $0.07 - Generated $2.1M operating cash flow with $17.4M cash on hand The company expects to exit 2025 at approximately $80M annual revenue run rate.

Eton Pharmaceuticals (NASDAQ: ETON), a pharmaceutical company specializing in rare disease treatments, has scheduled its first quarter 2025 financial results announcement for Tuesday, May 13, 2025. The company will host a conference call and audio webcast at 4:30 p.m. ET (3:30 p.m. CT) to discuss the results.

Management will take live questions during the call and will also address emailed questions from investors 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 (ETON) has submitted a New Drug Application (NDA) to the FDA for ET-600, a proprietary oral solution of desmopressin designed to treat central diabetes insipidus. The company anticipates a 10-month FDA review period, targeting potential approval and launch in Q1 2026.

ET-600 would be the first FDA-approved oral liquid formulation of desmopressin, specifically developed to provide precise, titratable doses for pediatric patients. The drug has demonstrated pharmacokinetic equivalence to the FDA-approved reference product in a bioequivalence study involving 75 subjects.

Key highlights:

• Patent protection extends through 2044
• Target market: approximately 3,000 pediatric patients with central diabetes insipidus in the US
• Pre-launch commercial activities are already in progress

Eton Pharmaceuticals (ETON) has announced an out-licensing agreement with Esteve Pharmaceuticals for the commercialization of Increlex® in all markets outside the United States. The agreement grants Esteve licensing rights for up to ten years, along with a future acquisition option for international rights.

Under the partnership, Eton will supply the product to Esteve at a fixed transfer price. This strategic move allows Eton to concentrate on its U.S. growth opportunities, including three planned rare disease product launches in 2025, while avoiding significant international infrastructure investments. The company maintains its projection to reach an $80 million annual revenue run rate by the end of 2025.

Eton Pharmaceuticals (ETON) reported record Q4 2024 product revenue of $11.6 million, marking a 59% increase over Q4 2023 and the 16th consecutive quarter of sequential growth. The company achieved several major milestones:

Key developments include the acquisition and January relaunch of Increlex, a pediatric endocrinology biologic, and the acquisition and March relaunch of Galzin for rare diseases. The company also licensed U.S. rights to Amglidia and reported positive pivotal study results for ET-600, with NDA submission planned for April 2025.

Financial highlights: Gross profit reached $6.5 million in Q4 2024, up from $3.6 million in Q4 2023. The company reported a reduced net loss of $0.6 million ($0.02 per share) compared to $2.3 million ($0.09 per share) in the prior year period. Cash position stood at $14.9 million as of December 31, 2024.

Eton Pharmaceuticals (ETON) has announced positive results from its bioequivalence study for ET-600, a patented oral solution of desmopressin designed to treat central diabetes insipidus. The pivotal study, involving 75 human subjects, demonstrated pharmacokinetic equivalence to the FDA-approved reference product.

The study was conducted as an open label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover oral bioequivalence study. Following these successful results, Eton plans to submit a New Drug Application (NDA) to the FDA in April 2025.

If approved, ET-600 would become the only FDA-approved oral liquid formulation of desmopressin, particularly beneficial for pediatric patients requiring precise and titratable doses. The company anticipates a potential commercial launch in the first quarter of 2026.