Current Report Filing (8-k)
May 25 2021 - 9:36AM
Edgar (US Regulatory)
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2021-05-25
2021-05-25
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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): May 25, 2021
PROVENTION
BIO, INC.
Commission
File Number: 001-38552
Delaware
(State
or other jurisdiction
of
incorporation)
|
|
81-5245912
(IRS
Employer
Identification
No.)
|
55
Broad Street, 2nd Floor
Red
Bank, New Jersey
(Address
of principal executive offices)
|
|
07701
(Zip
Code)
|
(908)
336-0360
(Registrant’s
telephone number, including area code)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐
|
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
|
☐
|
Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
|
☐
|
Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
|
☐
|
Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
|
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
|
|
Trading
Symbol
|
|
Name
of each exchange on which registered
|
Common
Stock, $0.0001 par value per share
|
|
PRVB
|
|
The
Nasdaq Global Select Market
|
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
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:
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.
|
|
|
|
|
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By:
|
/s/
Andrew Drechsler
|
|
|
|
Andrew
Drechsler
|
|
|
|
Chief
Financial Officer
|
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