Eton Pharmaceuticals Stock Price, News & Analysis

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced it will release its third quarter 2021 financial results on November 15, 2021. A conference call and live webcast will follow at 4:30 p.m. ET, where management will discuss the results and provide a business update. Participants can ask questions during the call or submit them via email. Eton is focused on developing treatments for rare diseases and currently has five FDA-approved products along with five additional submissions pending.

Eton Pharmaceuticals has acquired U.S. marketing rights for carglumic acid tablets, a generic alternative to the high-cost treatment Carbaglu®. The FDA approved the Abbreviated New Drug Application on October 13, 2021. This move is expected to provide significant savings for patients, with Carbaglu® costing over $1 million annually. Eton plans to utilize its existing commercial framework for orphan drugs to enhance distribution and support for patients, aiming to save millions for both individuals and the U.S. healthcare system.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced its second quarter financial results for 2021, reporting revenues of $3.1 million, including $2.5 million from licensing. The company achieved FDA approval for Rezipres®, its fourth product, and acquired rights to the ZENEO® Hydrocortisone autoinjector. Despite a net loss of $2.0 million, Eton improved diluted earnings per share to ($0.08) from ($0.23) in the prior year. The company maintains a strong cash position of $25.8 million as of June 30, 2021.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced it will report its second quarter 2021 financial and operating results on August 16, 2021. A conference call will be held at 4:30 p.m. ET to discuss these results and provide a business update. Interested parties can access the live audio webcast on Eton's investor website. Eton is focused on developing treatments for rare diseases and currently has four FDA-approved products while five additional products await FDA review.

Eton Pharmaceuticals has acquired U.S. and Canadian rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector, designed for emergency treatment of adrenal crisis. This innovative device, covered by 24 U.S. patents, is expected to be the first hydrocortisone autoinjector. Eton plans to submit a New Drug Application to the FDA in 2023 and is targeting orphan drug designation, addressing a market of around 100,000 patients at risk of adrenal crisis. The deal includes up to $11 million in milestone payments and a 10% royalty on net sales.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced the FDA's approval of Rezipres (ephedrine hydrochloride injection) for treating clinically significant hypotension during anesthesia as of June 15, 2021. This marks Eton's second FDA-approved ready-to-use injectable product, enhancing hospital efficiency and safety by reducing reliance on compounded products. The sulfite-free formulation, previously successful in Europe, is set for U.S. market availability soon. Eton currently holds four FDA-approved products and has submitted five more to the FDA.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application for dehydrated alcohol injection used in treating methanol poisoning. The FDA's review concluded the application cannot be approved in its current form. A Pre-Approval Inspection of the European manufacturer is pending due to COVID-related travel restrictions. Eton anticipates addressing all FDA queries in a forthcoming response.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) reported Q1 2021 revenue of $11.9 million, a significant increase from $0.1 million in the prior year, marking its first profitable quarter with operating income of $5.4 million and EPS of $0.19. The company has three commercial products generating revenue and anticipates additional launches from four upcoming PDUFA dates in the next three months. Eton's strong cash position of $25.1 million supports its growth strategy, including the recent successful launch of Alaway Preservative Free and ongoing development of pipeline products.

Eton Pharmaceuticals (Nasdaq: ETON) will release its first quarter 2021 financial and operating results on May 13, 2021. A conference call and audio webcast to discuss these results will be held at 4:30 p.m. ET. Investors can access the live webcast on the company’s investor relations website and listen by dialing specific numbers for domestic and international calls. Eton develops treatments for rare diseases and owns or earns royalties from three FDA-approved products while advancing six additional products submitted to the FDA.