Item 7.01 Regulation FD.
On November 17, 2022, the Company issued a press release announcing that the
U.S. Food and Drug Administration (“FDA”) approved TZIELDTM (teplizumab-mzwv) to
delay the onset of Stage 3 type 1 diabetes (“T1D”) in adult and pediatric
patients aged 8 years and older with Stage 2 T1D. A copy of the press release is
furnished as Exhibit 99.1 hereto and shall not be deemed “filed” for the purpose
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be
deemed incorporated by reference in any filing under the Exchange Act or the
Securities Act of 1933, as amended, except as shall be expressly set forth by
specific reference in such a filing.
Item 8.01 Other Events.
On November 17, 2022, the Company issued a press release announcing that the FDA
approved TZIELDTM (teplizumab-mzwv) to delay the onset of Stage 3 T1D in adult
and pediatric patients aged 8 years and older with Stage 2 T1D.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibits are furnished with this report:
Exhibit No. Description 99.1 Press Release issued by Provention Bio on November 17, 2022 104 Cover Page Interactive Data File (formatted as Inline XBRL)
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