Vertex Pharmaceuticals Incorporated filed SEC Form 8-K: Other Events
$VRTX
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 31, 2026
Vertex Pharmaceuticals Incorporated
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(Address of principal executive offices) (Zip Code)
(617 ) 341-6100
(Registrant's telephone number, including area code)
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Item 8.01. Other Events.
Vertex Pharmaceuticals Incorporated (the “Company”) has completed the submission to the U.S. Food and Drug Administration (the “FDA”) of its rolling Biologics Licensing Application (“BLA”) for potential accelerated approval of povetacicept for the treatment of immunoglobulin A nephropathy (“IgAN”) in adults. The Company used a priority review voucher and therefore expects the FDA review of the povetacicept BLA to be expedited to six months from the date of the FDA’s acceptance of the BLA versus the typical ten-month review.
Special Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are subject to risks, uncertainties and other factors including statements regarding the expected duration of the FDA review of the povetacicept BLA and potential for accelerated approval of povetacicept for the treatment of IgAN. While the Company believes the forward-looking statements contained in this communication are accurate, these forward-looking statements represent the beliefs of the Company only as of the date of this communication, and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements due to a number of risks and uncertainties. Forward-looking statements in this communication should be evaluated together with the many risks and uncertainties that affect the Company's business. Those risks and uncertainties include, among other things, that we may be unable to obtain or be delayed in obtaining regulatory approval and other risks listed under the heading “Risk Factors” and the other cautionary factors discussed in the Company's periodic reports filed with the Securities and Exchange Commission (the “SEC”), including the Company's annual report on Form 10-K for the year ended December 31, 2025, its quarterly reports on Form 10-Q, and its current reports on Form 8-K, all of which are available for free through the Company's website at www.vrtx.com and on the SEC’s website at www.sec.gov. You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to the Company, and the Company disclaims any obligation to update the information contained in this communication as new information becomes available, except as required by law.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
VERTEX PHARMACEUTICALS INCORPORATED | |||||
(Registrant) | |||||
Date: March 31, 2026 | /s/ Joy Liu | ||||
Joy Liu | |||||
Executive Vice President, Chief Legal Officer | |||||