BioNTech to buy $205M FDA priority review voucher
The voucher grants priority review for one application; BioNTech intends to use it for a future filing from its late-stage oncology pipeline.
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Form Type
6-K
Rhea-AI Filing Summary
BioNTech SE (BNTX) entered into an agreement to acquire a U.S. Food and Drug Administration Priority Review Voucher from Scholar Rock, Inc., for total cash consideration of $205 million.
The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. A Priority Review Voucher grants FDA priority review for a single application, reducing the target FDA review timeline and potentially leading to expedited approval. BioNTech intends to use the voucher to support a future filing of an asset in its late-stage oncology pipeline.
Key Figures
Cash consideration: $205 million
Applications eligible for priority review: 1 application
2 metrics
Cash consideration
$205 million
Agreement to acquire the Priority Review Voucher from Scholar Rock
Applications eligible for priority review
1 application
A Priority Review Voucher grants priority review for a single application
Key Terms
Priority Review Voucher, Hart-Scott Rodino Antitrust Improvements Act, customary closing conditions, late-stage oncology pipeline
4 terms
Priority Review Voucher regulatory
"acquire a US Food and Drug Administration (“FDA”) Priority Review Voucher"
A priority review voucher is a transferable regulatory incentive that lets a company move a future drug or device application to the front of the review line, shortening the review period by several months. For investors it matters because the voucher can speed up market access for a high-value product or be sold to other companies for significant cash, acting like a tradable fast-pass that can accelerate revenue or create immediate financial upside.
Hart-Scott Rodino Antitrust Improvements Act regulatory
"clearance under the Hart-Scott Rodino (“HSR”) Antitrust Improvements Act"
A U.S. law that requires companies to notify federal regulators and wait for clearance before completing certain large mergers or acquisitions, acting like a customs checkpoint for big business deals. It matters to investors because the required filing and review can delay or block transactions, create uncertainty around deal timing and value, and signal regulatory risk that can affect stock prices and strategic planning.
customary closing conditions regulatory
"subject to customary closing conditions"
"Customary closing conditions" are standard rules or checks that must be met before a business deal can be finalized, like making sure all paperwork is in order or that certain approvals are obtained. They matter because they help protect both parties, ensuring everything is in place and reducing the risk of surprises or problems after the deal is closed.
late-stage oncology pipeline medical
"an asset in its late-stage oncology pipeline"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much is BNTX paying for the Priority Review Voucher?
BioNTech agreed to acquire the voucher from Scholar Rock for $205 million in total cash consideration.
What does a Priority Review Voucher do?
A Priority Review Voucher grants FDA priority review for a single application, reducing the target FDA review timeline and potentially leading to expedited approval.
What conditions apply to BioNTech’s PRV agreement?
The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF NOVEMBER 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On November 10, 2026, BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced that it has entered into an agreement to acquire a US Food and Drug Administration (“FDA”) Priority Review Voucher (“PRV”) from Scholar Rock, Inc. (Nasdaq: SRRK, “Scholar Rock”) for a total cash consideration of $205 million. The statement is attached as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE | ||||||||||||||
By: | /s/ Ramon Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramon Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: November 10, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | BioNTech to Acquire US FDA Priority Review Voucher | ||||
Exhibit 99.1
BioNTech to Acquire US FDA Priority Review Voucher
MAINZ, Germany, November 10, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that it has entered into an agreement to acquire a US Food and Drug Administration (“FDA”) Priority Review Voucher (“PRV”) from Scholar Rock, Inc. (Nasdaq: SRRK, “Scholar Rock”) for a total cash consideration of $205 million.
A PRV grants FDA priority review for a single application, which reduces the target FDA review timeline and could lead to expedited approval. BioNTech intends to use the PRV to support a future filing of an asset in its late-stage oncology pipeline. The transaction is subject to customary closing conditions, including clearance under the Hart-Scott Rodino (“HSR”) Antitrust Improvements Act.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the parties’ ability to complete the contemplated transaction (including the parties’ ability to satisfy certain closing conditions); the benefits sought to be achieved in the proposed transaction; and BioNTech’s intentions regarding the use of the PRV. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational
medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended September 30, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
CONTACTS
Media Relations
Jasmina Alatovic
Media@BioNTech.de
Investor Relations
Douglas Maffei, Ph.D.
Investors@BioNTech.de