UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On May 25, 2021, Provention Bio, Inc. (the “Company” or “Provention Bio”) posted an updated corporate slide presentation in the “Investors” portion of its website at www.proventionbio.com.
On May 25, 2021, the Company issued a press release announcing that the U.S. Food and Drug Administration has posted briefing documents for the May 27, 2021 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review the Biologics License Application for teplizumab, Provention Bio’s investigational drug candidate for the delay of Clinical Type 1 Diabetes in at-risk individuals. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this report furnished pursuant to Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references the information furnished pursuant to Item 7.01 of this report.
| Item 9.01 | Financial Statements and Exhibits. |
(d) The following exhibit is furnished with this report:
| Exhibit No. | Description | |
| 99.1 | Press Release issued by Provention Bio, Inc. on May 25, 2021 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |
SIGNATURE
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.
| Date: | May 25, 2021 | Provention Bio, Inc. | |
| By: | /s/ Andrew Drechsler | ||
| Andrew Drechsler | |||
| Chief Financial Officer | |||