Press release
Eton Pharmaceuticals Reports First Quarter 2022 Financial Results
DEER PARK, Ill., May 12, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and
About this update from Eton Pharmaceuticals, Inc.
[{"type":"text","content":"DEER PARK, Ill., May 12, 2022 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today reported financial results for the first quarter ended March 31, 2022. “We are proud to report our fifth straight quarter of sequential growth in product sales. We expect this growth to continue for the foreseeable future as our commercial products are still in the early stages of launch, and we expect many additional product launches later this year,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals, “In addition to the strong commercial results, we have recently made significant progress on the development side with the approval of cysteine injection and the FDA submission for our Biorphen vial product candidate,” added Brynjelsen. Major Business Highlights Reported a fifth straight quarter of sequential growth in product sales and royalty revenue. For the first quarter of 2022, Eton reported revenue of $2.2 million from product sales and royalties, representing a 100% increase from the fourth quarter of 2021.Received final approval for cysteine injection. In April, the U.S. Food and Drug Administration (FDA) approved Eton’s abbreviated new drug application for cysteine injection. The product-related Paragraph IV trial occurred in March 2022, and a judge’s decision is expected by August 2022. If the outcome is successful, Eton plans to launch the product shortly after the judge’s decision. Submitted Prior Approval Supplement for Biorphen® vial. The supplement to add the vial container system was submitted in April 2022. The FDA has assigned an August 2022 target action date for the submission.Announcing development of Biorphen® (phenylephrine) premix bag. Eton announced the development of a Biorphen® premix bag. The product offering would address a significant unmet need in the market. Currently, many hospitals purchase premixed phenylephrine from compounding pharmacies. The product’s New Drug Application (NDA) is expected to be submitted in the third quarter of 2022. Commercial Update Eton’s carglumic acid product launched in late-December 2021 and has received a favorable reception from patients and physicians. Patients appreciate the product’s room-temperature stability compared to the competing product’s refrigeration ...