Eton Pharmaceuticals Stock Price, News & Analysis

Eton Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (NDA) for dehydrated alcohol injection, with a PDUFA date set for May 27, 2021. The drug, which is crucial for treating methanol poisoning, has received orphan drug designation, ensuring seven years of market exclusivity upon approval. The U.S. market for this injection is estimated to exceed $100 million annually, currently supplied by only one manufacturer. Eton focuses on developing innovative treatments for rare pediatric diseases and has multiple products in its late-stage pipeline.

Eton Pharmaceuticals has submitted a new drug application (NDA) for its topiramate oral solution to the FDA. This formulation addresses the unmet need for a pediatric-friendly liquid version of topiramate, targeting partial-onset seizures and migraines. It is anticipated to be the first FDA-approved liquid formulation of topiramate, which could tap into a market exceeding $800 million annually. Eton aims for approval and launch of this candidate in 2021, marking its third neurology-focused product submission.

Eton Pharmaceuticals announced FDA approval for ALKINDI SPRINKLE, the first granular hydrocortisone formulation for pediatric adrenocortical insufficiency. Designed for children under 17, it provides flexible dosing with strengths of 0.5mg, 1mg, 2mg, and 5mg, addressing prior dosing challenges. Expected availability is in Q4 2020, aiding an estimated 5,000 to 11,000 affected children in the U.S. This product allows caregivers to avoid splitting tablets, enhancing treatment precision and safety.

Eton Pharmaceuticals has announced the FDA approval of ALKINDI SPRINKLE, the first granular hydrocortisone formulation designed specifically for treating adrenocortical insufficiency in children under 17. This product enables precise dosing to meet the specific needs of pediatric patients, addressing significant dosing challenges faced by caregivers. Expected to be available by Q4 2020, ALKINDI SPRINKLE offers doses of 0.5mg, 1mg, 2mg, and 5mg, enhancing flexibility in treatment. Pediatric adrenocortical insufficiency affects between 5,000 and 11,000 children in the U.S.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) announced that its partner has yet to receive any communication from the FDA regarding the review of EM-100, with a Generic Drug User Fee Act (GDUFA) target action date of September 15, 2020. The company is optimistic about a forthcoming decision and reports no outstanding information requests. Eton focuses on developing innovative drug products, particularly in hospital injectables and pediatric rare diseases, with past successes including Biorphen, an FDA-approved ready-to-use formulation launched in December 2019.

Eton Pharmaceuticals (Nasdaq: ETON) has appointed Ingrid Hoos as the new Senior Vice President of Scientific Affairs. Hoos, previously Vice President of Regulatory Affairs at Horizon Therapeutics, brings substantial experience, having overseen the growth of Horizon's FDA-approved products from one to ten during her tenure. Eton CEO Sean Brynjelsen expressed confidence in Hoos's track record with complex product approvals and her potential to contribute to the company’s growth. Eton's focus remains on developing pediatric rare disease products, including its lead product, Alkindi® Sprinkle, currently under FDA review.

Eton Pharmaceuticals (Nasdaq: ETON) has submitted a new drug application (NDA) for its product DS-100, aimed at treating methanol poisoning, which has seen increased cases during the COVID-19 pandemic. The FDA has granted orphan drug designation for DS-100, promising seven years of market exclusivity upon approval. The urgency in the market arises from the recall of over 75 hand sanitizers containing methanol. This NDA marks Eton's second orphan drug submission and fifth overall under FDA review, which also includes other candidates like Alkindi® Sprinkle.

Eton Pharmaceuticals reported its Q1 2020 financial results, noting revenue of $0.1 million from Biorphen sales, impacted by COVID-19. The company acquired U.S. marketing rights for Alkindi Sprinkle and secured $9.8 million in liquidity through a $7.8 million equity raise and credit facility amendments. Eton achieved first-to-file status on its cysteine hydrochloride injection ANDA, allowing potential generic exclusivity. Despite challenges faced during Biorphen's launch, Eton remains optimistic about future product introductions in 2020.

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has been confirmed as the first filer of an Abbreviated New Drug Application (ANDA) for cysteine hydrochloride injection, referencing Exela Pharma Sciences' Elcys. Eton plans to challenge the validity of Exela's patents in the U.S. Patent & Trademark Office, aiming for a potential product launch in November 2021 if successful. The cysteine injection market is valued at over $50 million annually, and Eton aims to provide a lower-cost alternative to patients.