SAN DIEGO, CA – ARS Pharmaceuticals, Inc., a pharmaceutical company specializing in drug preparations, has amended its manufacturing agreement with Renaissance Lakewood, LLC, according to a recent 8-K filing with the Securities and Exchange Commission. The amendment, effective as of Monday, revises the terms of an agreement that was originally entered into on September 9, 2020, and subsequently amended on July 25, 2023.
The updated agreement includes changes to the duration of the contract and the conditions under which it may be terminated. Specifically, the initial term for the neffy nasal unit dose sprays, intended for commercial sale in the U.S., will now extend until December 31st following the five-year anniversary of the product's initial U.S. launch date. For products destined for the European Union market, a similar extension applies from the E.U. initial launch date.
Additionally, the termination provisions have been adjusted to allow either party to end the agreement under certain conditions, including an uncured material breach, insolvency-related events, legal contraventions in manufacturing, distribution, or sale, and specific regulatory setbacks such as withdrawal of FDA approval or a company decision to cease U.S. commercialization of the product.
The 8-K filing also contains forward-looking statements regarding the company's expectations about maintaining regulatory approval for neffy and the product's market acceptance and commercial success. These statements are subject to risks and uncertainties, and actual results may vary.
The company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, details the potential risks and uncertainties that could affect the commercialization of neffy and the company's business prospects.
The filing was made public on the same day, affirming ARS Pharmaceuticals' commitment to transparency and regulatory compliance. The company, formerly known as Silverback Therapeutics, Inc., is headquartered in San Diego, California, and is listed on The Nasdaq Stock Market LLC under the trading symbol SPRY.
In other recent news, ARS Pharmaceuticals has made significant progress with the FDA approval of Neffy, a needle-free epinephrine treatment for Type I Allergic Reactions. The company has also submitted a supplemental New Drug Application for Neffy 1 mg, aimed at pediatric patients. Cantor Fitzgerald initiated coverage of ARS Pharmaceuticals with an Overweight rating, indicating a positive outlook on the company's potential.
The European Commission approved EURneffy, a needle-free adrenaline nasal spray, marking a milestone in allergy treatment. ARS Pharmaceuticals' shareholders elected three Class I directors and ratified Ernst & Young LLP as the independent auditor for the current fiscal year, further solidifying the company's governance structure. These are recent developments in the company's operations.
The company is focused on expanding access to Neffy internationally, with EURneffy expected to be available in certain EU Member States by Q4 2024. The company aims to protect patients from severe allergic reactions leading to anaphylaxis.
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