Eton Pharmaceuticals, Inc. (ETON) stock soared 9.67% in the pre-market trading session at the price of $4.66 following the FDA approval of cysteine hydrochloride injection.
FDA Approved Cysteine HCL Injection
On 11th April 2022, ETON announced receiving approval from the U.S. FDA for its cysteine HCL-based drug application. ETON had given generic exclusivity of 180 days following the submission of the first ANDA against the concerned product. This exclusivity time will start upon the commercial sale of the relevant product. Cysteine had devised to use as an amino acid additive to satisfy the nutrition needs of infants. Earlier in 2019, cysteine was being marketed in the U.S. as an unapproved or grandfathered product.
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ETON is an innovative and technology-based pharmaceutical firm that develops and commercializes therapies against rare conditions. The company presently owns or acquires royalties from several of its FDA-approved products including Carglumic Acid, Biorphen, Rezipres, Eprontia, and others. Besides, the stock has submitted an application to FDA for three more products.
ETON Market Outlook
Currently, ETON has partnered with Exela in section-IV litigation concerning the validity of cysteine patents. The clinical trial had earlier conducted in March 2022. The ETON stock expects a judicial decision to declare by Q3 of 2022. Established on IQVIA results, the current demand for cysteine HCL injection exceeded US$50M annually.
The earlier announced Q4 financial results demonstrate ETON’s strong business position. Besides, the company’s launch of carglumic acid is superseding its expectations. Moreover, the recently executed collaboration with Tolmar has revived the development of ALKINDI SPRINKLE, resulting in the launch of a new product named Rezipres. The stock has also submitted the NDA to the FDA for its four other products and continued towards the development stage. It will resultantly lead the stock towards more launches in the upcoming quarters of 2022.