Eton Pharmaceuticals reports successful bioequivalence of ET-600 and plans NDA submission in April 2025 for diabetes insipidus treatment.
Quiver AI Summary
Eton Pharmaceuticals, Inc. announced positive results from its pivotal bioequivalence study of ET-600, a patented oral solution of desmopressin aimed at treating central diabetes insipidus. The study, involving 75 human subjects, showed that ET-600 has pharmacokinetic equivalence to the FDA-approved reference product. Eton plans to submit a New Drug Application (NDA) to the FDA in April 2025, with ET-600 potentially becoming the only FDA-approved oral liquid formulation of desmopressin if approved. The company recognizes the need for precise dosing options for pediatric patients with this condition. Eton has initiated pre-launch preparations and expects a potential launch in the first quarter of 2026.
Potential Positives
- Company's ET-600 oral solution successfully passed pivotal bioequivalence study, demonstrating pharmacokinetic equivalence to FDA-approved reference product.
- Anticipated submission of New Drug Application (NDA) to the FDA in April 2025, signaling progress in the regulatory process.
- ET-600 would become the only FDA-approved oral liquid formulation of desmopressin, addressing a significant market need for pediatric patients.
- Company has initiated pre-launch commercial readiness activities, indicating proactive planning for potential product launch in the first quarter of 2026.
Potential Negatives
- The expected New Drug Application (NDA) submission in April 2025 indicates a lengthy timeline before potential market entry, delaying benefits for patients and potential revenue for the company.
- The reliance on forward-looking statements introduces uncertainty regarding the company's ability to meet its projected timelines and objectives, which could negatively impact investor confidence.
- The statement that actual results may differ materially from forward-looking expectations highlights inherent risks that could affect the company's development programs and financial position.
FAQ
What is ET-600 by Eton Pharmaceuticals?
ET-600 is a proprietary oral solution of desmopressin developed for treating central diabetes insipidus in pediatric patients.
When does Eton plan to submit the NDA for ET-600?
Eton Pharmaceuticals expects to submit the New Drug Application (NDA) for ET-600 in April 2025.
What were the results of ET-600's bioequivalence study?
ET-600 demonstrated pharmacokinetic equivalence to the FDA-approved reference product in a study involving 75 human subjects.
How is ET-600 different from existing desmopressin medications?
If approved, ET-600 would be the only FDA-approved oral liquid formulation of desmopressin available on the market.
What is the significance of ET-600 for pediatric patients?
ET-600 can accommodate precise and titratable doses necessary for pediatric patients suffering from central diabetes insipidus.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ETON Insider Trading Activity
$ETON insiders have traded $ETON stock on the open market 7 times in the past 6 months. Of those trades, 7 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $ETON stock by insiders over the last 6 months:
- MANAGEMENT INC. OPALEYE has made 7 purchases buying 72,070 shares for an estimated $513,950 and 0 sales.
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$ETON Hedge Fund Activity
We have seen 51 institutional investors add shares of $ETON stock to their portfolio, and 20 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ECOR1 CAPITAL, LLC added 1,263,528 shares (+223.2%) to their portfolio in Q4 2024, for an estimated $16,830,192
- ACUITAS INVESTMENTS, LLC removed 394,136 shares (-68.0%) from their portfolio in Q4 2024, for an estimated $5,249,891
- CANNELL CAPITAL LLC added 381,323 shares (+inf%) to their portfolio in Q4 2024, for an estimated $5,079,222
- CONNOR, CLARK & LUNN INVESTMENT MANAGEMENT LTD. added 149,864 shares (+230.5%) to their portfolio in Q4 2024, for an estimated $1,996,188
- ACADIAN ASSET MANAGEMENT LLC added 142,551 shares (+134.5%) to their portfolio in Q4 2024, for an estimated $1,898,779
- MILLENNIUM MANAGEMENT LLC added 138,887 shares (+inf%) to their portfolio in Q4 2024, for an estimated $1,849,974
- GOLDMAN SACHS GROUP INC added 129,879 shares (+inf%) to their portfolio in Q4 2024, for an estimated $1,729,988
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
- Company’s patented desmopressin oral solution successfully passed pivotal bioequivalence study -
- Company expects to submit New Drug Application (NDA) in April 2025 -
DEER PARK, Ill., March 14, 2025 (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 positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.
In a bioequivalence study conducted in 75 human subjects, ET-600 demonstrated pharmacokinetic equivalence to the U.S. Food and Drug Administration (FDA)-approved reference product of the same active ingredient. Healthy adults enrolled in the study were randomly assigned to receive the test and reference drug in an open label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover oral bioequivalence study. Based on these successful trial results, Eton anticipates submitting an NDA to the FDA for ET-600 in April 2025. If approved, ET-600 would be the only FDA-approved oral liquid formulation of desmopressin.
“We are pleased to see ET-600 pass its pivotal study and move one step closer to reaching patients. Through our deep relationships in the pediatric endocrinology community, we've come to appreciate the significant need for a desmopressin medication that can accommodate the precise and titratable doses necessary for pediatric patients. We expect to submit the NDA shortly and have begun pre-launch commercial readiness activities in anticipation of a potential launch in the first quarter of 2026,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
About ET-600
ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidus. The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under revise by the United States Patent and Trademark Office. Central diabetes insipidus is estimated to impact approximately 3,000 pediatric patients in the United States.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E:
lwilson@insitecony.com
Source: Eton Pharmaceuticals, Inc.
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