Current Report Filing (8-k)
April 08 2021 - 3:06PM
Edgar (US Regulatory)
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0001695357
2021-04-08
2021-04-08
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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): April 8, 2021
PROVENTION
BIO, INC.
Commission
File Number: 001-38552
Delaware
|
|
81-5245912
|
(State
or other jurisdiction
|
|
(IRS
Employer
|
of
incorporation)
|
|
Identification
No.)
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55
Broad Street, 2nd Floor
|
|
|
Red
Bank, New Jersey
|
|
07701
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(Address
of principal executive offices)
|
|
(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)
|
|
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☐
|
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
|
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Name
of each exchange on which registered
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Common
Stock, $0.0001 par value per share
|
|
PRVB
|
|
The
Nasdaq Global Select Market
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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
April 8, 2021, Provention Bio, Inc. (the “Company”) issued a press release regarding the matters set forth in Item
8.01 to this Current Report on Form 8-K. 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.
On
April 8, 2021, the Company issued a press release disclosing that: (i) the Company received a letter from the U.S.
Food and Drug Administration (“FDA”) stating that as part of its ongoing review of the Company’s Biologic New Drug
Application (“BLA”) for teplizumab, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing
requirements/commitments at this time; (ii) at an informal meeting with the Company to discuss the upcoming Advisory Committee, the FDA
indicated that, based on the data it has reviewed to date, it was taking the position that the drug pharmacokinetic profiles of the two
drug products evaluated in a pharmacokinetic/pharmacodynamic bridging study submitted by the Company for review by the FDA were not comparable,
and additional data would be required before the FDA’s concerns could be satisfied; (iii) the FDA is willing to discuss
these issues concurrently with its ongoing review and (iv) the FDA intends to continue the review of clinical data submitted
in the BLA and to conduct the Advisory Committee meeting on May 27, 2021 as planned.
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:
|
On
April 8, 2021
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Provention
Bio, Inc.
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|
|
|
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By:
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/s/
Andrew Drechsler
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Andrew
Drechsler
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|
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|
Chief
Financial Officer
|
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