Eton Pharmaceuticals has gained 108% over six months, driven by 99% Q2 product sales growth and successful Hemangeol relaunch. The company raised 2026 revenue guidance to above $145 million with 35%+ adjusted EBITDA margins. Pipeline expansion including new launches and late-stage candidates like ASN-001 provide additional growth opportunities.

Eton Pharmaceuticals announced record Q2 2026 revenue with product sales of $37.6 million, representing 99% year-over-year growth. The company reported GAAP EPS of $0.35 and non-GAAP EPS of $0.43, with EBITDA of $14.1 million. Additionally, Eton expanded its infantile hemangioma franchise by acquiring U.S. rights to ASN-001, a late-stage product candidate targeting moderate infantile hemangiomas, complementing its existing HEMANGEOL product.

Eton Pharmaceuticals has licensed U.S. rights to ASN-001 (timolol topical gel) from Auson Pharmaceuticals for treating moderate infantile hemangiomas. Phase II/III trial results showed 56% elimination rates at week 24 with twice-daily dosing versus 15% for placebo. The company plans to submit an NDA in H2 2027 with potential approval and launch in 2028, targeting an estimated 20,000-30,000 patients annually and positioning ASN-001 as a complementary product to its existing HEMANGEOL therapy.

Eton Pharmaceuticals announced it will report second quarter 2026 financial results on August 13, 2026, with a conference call at 4:30 p.m. ET. The company also announced a Prior Approval Supplement submission to expand KHINDIVI's indication for a larger pediatric patient population and expanded its rare disease portfolio through commercialization rights to IMPAVIDO®.

Eton Pharmaceuticals announced the acquisition of U.S. commercialization rights to HEMANGEOL® (propranolol hydrochloride) oral solution from Pierre Fabre Medicament. HEMANGEOL is the only FDA-approved treatment for infantile hemangiomas requiring systemic therapy. The acquisition marks Eton's achievement of ten commercial products and is expected to be accretive to 2026 earnings. Commercialization begins May 1st with distribution through Eton's patient support program offering $0 co-pay assistance.

Eton Pharmaceuticals announced FDA approval of DESMODA (desmopressin acetate) Oral Solution for central diabetes insipidus treatment. The product, launching March 9th, is the first FDA-approved oral liquid formulation enabling precise dosing without tablet splitting. Eton projects peak annual sales of $30-50 million with patent protection through 2044, targeting over 13,000 U.S. patients including 3,000-4,000 pediatric patients.

•  Q1 2024 revenue of $8.0 million, representing 50% growth over Q1 2023 and the 13th straight quarter of sequential product sales growth•  Acquired PKU GOLIKE®, launched Nitisinone, and submitted a new drug application (NDA) for product candidate ET-400•  Management to hold conference call today at 4:30pm ET

DEER PARK, Ill., May 01, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced today that Sean Brynjelsen, Chief Executive Officer, and James Gruber, Chief Financial Officer, will present at the Citizens JMP Life Sciences Conference in New York as follows:

- Company anticipates 10-month review for potential approval in Q1 2025 -- Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than $50 million annually -- Product has patent protection through 2043 -

DEER PARK, Ill., April 29, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the "Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it will report first quarter 2024 financial results on Thursday, May 9, 2024. Management will host a conference call and live audio webcast to discuss the results at 4:30 p.m. ET (3:30 p.m. CT).

DEER PARK, Ill., March 22, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced that it has acquired U.S. rights to PKU GOLIKE® from RELIEF THERAPEUTICS Holding SA (“Relief”) (SIX: RLF, OTCQB: RLFTF, RLFTY).

Eton Pharmaceuticals, Inc. (ETON) delivered earnings and revenue surprises of -125% and 5.03%, respectively, for the quarter ended December 2023. Do the numbers hold clues to what lies ahead for the stock?