Eton Pharmaceuticals Stock Price, News & Analysis

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.

Eton Pharmaceuticals, Inc reported robust financial results for Q1 2024, with revenue of $8.0 million, a 50% increase over Q1 2023. The company achieved its 13th consecutive quarter of sequential product sales growth, acquired PKU GOLIKE®, launched Nitisinone, and submitted an NDA for product candidate ET-400. Eton anticipates strong growth in 2024, driven by existing products and new additions, positioning itself for a potential successful launch of ET-400 in early 2025.

Eton Pharmaceuticals, Inc (Nasdaq: ETON) will present at the Citizens JMP Life Sciences Conference in New York on May 13, 2024. Sean Brynjelsen, CEO, and James Gruber, CFO, will participate. For meeting requests, contact Citizens JMP.

Eton Pharmaceuticals submitted a New Drug Application (NDA) for ET-400, a hydrocortisone oral solution with patent protection through 2043. The company expects potential approval by Q1 2025, aiming for combined peak sales of over $50 million annually.

Eton Pharmaceuticals, Inc. will report its first quarter 2024 financial results on May 9, 2024. The company focuses on developing treatments for rare diseases. A conference call and webcast will discuss the results at 4:30 p.m. ET on the same day. Investors can email questions or access the webcast on Eton's website.