BioNTech SE Investigation Initiated: Levi & Korsinsky Investigates the Officers and Directors of BioNTech SE (BNTX)

By ACCESS Newswire

NEW YORK CITY, NY / ACCESS Newswire / October 16, 2026 / Levi & Korsinsky notifies investors that it has commenced an investigation into BioNTech SE ("BioNTech SE") (NASDAQ:BNTX) concerning potential violations of the federal securities laws.

BioNTech SE shares fell approximately 7.13% after the Company reported that its Phase 2/3 AHEAD-MERIT trial of BNT113 combined with pembrolizumab did not achieve its progression-free survival primary endpoint in HPV16-positive head and neck cancer. The stock decline was clinical-trial-driven, as the trial continues toward its second co-primary endpoint evaluating overall survival. In Form 6-K exhibits filed on August 4, 2026, the Company emphasized an "Advanced diversified pipeline now with 14 ongoing pivotal clinical trials and more than ten novel-novel combinations across major tumor types" while targeting "17+ Late-Stage and Pivotal Trial Readouts Informing Multiple Launch Opportunities." Earlier, during an earnings call on March 10, 2026, Chief Medical Officer Özlem Türeci stated, "Recruitment is ongoing and the Phase III interim analysis is expected in 2026." On August 4, 2026, Chief Medical Officer Özlem Türeci stated, "For BNT113, based on current event accrual projections, we expect a Phase III interim analysis for progression-free survival later this year." The investigation concerns whether BioNTech SE adequately disclosed the clinical trial status and progression-free survival results for BNT113 ahead of the public announcement.

If you suffered a loss on your BioNTech SE securities and would like to explore a potential recovery under the federal securities laws, Learn More About the Investigation or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212)363-7500 to speak to our team of experienced shareholder advocates.

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, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212)363-7500
Fax: (212)363-7171

SOURCE: Levi & Korsinsky, LLP



View the original press release on ACCESS Newswire

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