Eton Pharmaceuticals Stock Price, News & Analysis

Eton Pharmaceuticals (Nasdaq: ETON) reported strong Q2 2025 financial results, with product sales reaching $18.9 million, marking a 108% growth over Q2 2024 and the 18th consecutive quarter of sequential growth. The company posted a GAAP EPS of $(0.10) and non-GAAP EPS of $0.03.

Key highlights include the FDA approval and launch of KHINDIVI™, their eighth commercial product, reaching 100 active INCRELEX® patients ahead of schedule, and strong performance of ALKINDI SPRINKLE® and GALZIN. The company expects to achieve an $80 million annual revenue run rate in Q3 2025, one quarter ahead of previous guidance.

Financial metrics show gross profit of $11.9 million (75% adjusted margin) and Adjusted EBITDA of $3.1 million. The company maintains a strong cash position of $25.4 million and generated $8.0 million in operating cash flow during the quarter.

Eton Pharmaceuticals (Nasdaq: ETON), a pharmaceutical company specializing in rare disease treatments, has scheduled its second quarter 2025 financial results announcement for Thursday, August 7, 2025.

The company will host a conference call and audio webcast at 4:30 p.m. ET to discuss the results. Investors can participate via phone using the dial-in numbers (800) 715-9871 or (646) 307-1963 with Conference ID 5899895, or through the webcast available on Eton's investor relations website. Management will address both live questions and emailed inquiries sent to investorrelations@etonpharma.com.

Eton Pharmaceuticals (Nasdaq: ETON) announced that the FDA has accepted its New Drug Application (NDA) for ET-600, a proprietary desmopressin oral solution. The FDA has assigned a PDUFA target action date of February 25, 2026 for the review.

ET-600 aims to address unmet needs in pediatric endocrinology by providing a liquid formulation alternative to fractional tablets and compounded suspensions. The product has patent protection through 2044 and, if approved, would be the only oral liquid option available in the market. Eton is preparing for a potential commercial launch in Q1 2026.

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