Current Report Filing (8-k)
October 03 2018 - 6:10AM
Edgar (US Regulatory)
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): October 2, 2018
Commission
file number 333-184948
PROCESSA
PHARMACEUTICALS, INC.
(Exact
name of Registrant as Specified in its Charter)
Delaware
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45-1539785
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(State
or Other Jurisdiction of
Incorporation
or Organization)
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(I.R.S.
Employer
Identification
Number)
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7380
Coca Cola Drive, Suite 106, Hanover, Maryland 21076
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(Address
of Principal Executive Offices, Including Zip Code)
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(443)
776-3133
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(Registrant’s
Telephone Number, Including Area Code)
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(Former
Name or Former Address, if Changed Since Last Report)
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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:
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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).
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Emerging
growth company [X]
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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.
[X]
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Item 8.01 Other Event.
On
October 2, 2018, Processa Pharmaceuticals, Inc. issued a press release announcing that the U.S. Food and Drug Administration (FDA)
has granted Processa clearance to proceed with a Phase 2 clinical trial of PCS-499 in patients with Necrobiosis Lipoidica under
a recently submitted Investigational New Drug (IND) application.
A
press release announcing the FDA clearance is filed as Exhibit 99.1 hereto.
Item
9.01 Exhibits and Financial Statements
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, on October 2, 2018.
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PROCESSA
PHARMACEUTICALS, INC.
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Registrant
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By:
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/s/
David Young
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David
Young
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Chief
Executive Officer
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