Current Report Filing (8-k)
January 09 2023 - 12:16PM
Edgar (US Regulatory)
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2023-01-09 2023-01-09 iso4217:USD xbrli:shares iso4217:USD
xbrli:shares
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):
January 9, 2023
Gamida Cell Ltd.
(Exact name of registrant as specified in its Charter)
Israel |
|
001-38716 |
|
Not
Applicable |
(State or other jurisdiction
of incorporation)
|
|
(Commission File Number)
|
|
(IRS Employer
Identification No.)
|
116 Huntington Avenue, 7th Floor
Boston,
MA
|
|
02116 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(617)
892-9080
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last
report)
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 (see General Instruction A.2.
below):
|
☐ |
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(s)
|
|
Name
of each exchange on which registered |
Ordinary Shares, NIS 0.01 par value |
|
GMDA |
|
The
Nasdaq Stock Market LLC |
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 January 9, 2023, Gamida Cell Ltd. (the “Company”) posted an
updated corporate presentation on the Company’s website. To access
the presentation, investors should visit the “Investors &
Media” section of the Company’s website at www.gamida-cell.com.
The information furnished under this Item 7.01 shall not be deemed
“filed” for 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, nor shall such information be
deemed incorporated by reference in any filing under the Securities
Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such a filing.
Item 8.01 Other Events.
In the fourth quarter of 2022, the Israeli Ministry of Health and
the United States Food and Drug Administration (the “FDA”)
completed physical inspections of the Company's Kiryat Gat, Israel
manufacturing facility. The Company will commercially manufacture
omidubicel for sale in the United States at such facility if
omidubicel is approved for marketing by the FDA.
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.
|
GAMIDA
CELL LTD. |
|
|
|
January
9, 2023 |
By: |
/s/
Josh Patterson |
|
|
Josh
Patterson |
|
|
General
Counsel |
2
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