NEW YORK, NY / ACCESS Newswire / March 31, 2025 / Levi & Korsinsky notifies investors that it has commenced an investigation of Nyxoah S.A. ("Nyxoah S.A.") (NASDAQ:NYXH) concerning possible violations of federal securities laws.

Nyxoah issued a press release on March 25, 2025, "announc[ing] that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system", which "means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations . . . , and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review." Following Nyxoah's announcement, analysts projected that Genio's commercial launch would be delayed pending further review by the FDA.

Following this news, Nyxoah's stock price fell over 21% on March 26, 2025. To obtain additional information, go to:

https://zlk.com/pslra-1/nyxoah-s-a-lawsuit-submission-form?prid=140030&wire=1

or contact Joseph E. Levi, Esq. either via email at jlevi@levikorsinsky.com or by telephone at (212)363-7500.

WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 17th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212)363-7500
Fax: (212)363-7171
https://zlk.com/

SOURCE: Levi & Korsinsky, LLP

View the original press release on ACCESS Newswire