Current Report Filing (8-k)
October 18 2018 - 7:47AM
Edgar (US Regulatory)
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 16, 2018
SCPHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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(State or other jurisdiction of
incorporation or organization)
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001-38293
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46-5184075
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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2400 District Avenue, Suite 310
Burlington, Massachusetts
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01803
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code: (617)
517-0730
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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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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))
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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 or Rule
12b-2
of the Securities Exchange Act of 1934.
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 8.01 Other Events.
As previously disclosed, on June 11, 2018, scPharmaceuticals Inc. (the Company) received a complete response letter (CRL) from the
U.S. Food and Drug Administration (the FDA) following the FDAs review of a New Drug Application submitted by the Company under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for FUROSCIX Infusor
(furosemide), 80 mg/10 mL, drug-device combination product. On September 24, 2018, a Type A Post-Action Meeting was held between the Company and the FDA to discuss the Companys proposed plan to address the CRL, and on
October 16, 2018, the Company received the official meeting minutes from the Type A Post-Action Meeting.
The Company issued a press release on
October 18, 2018 announcing its receipt of the official meeting minutes. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.
By filing this information, the Company makes no admission as to the materiality of any information in this report. The information contained in this
report is intended to be considered in the context of the Companys filings with the U.S. Securities and Exchange Commission (the Commission) and other public announcements that the Company makes, by press release or otherwise, from
time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be
made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.
This report
contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to
statements regarding the Companys plans to meet with the FDA to discuss validation study protocols; the Companys completion of human factors and dose delivery validation studies; the Companys plans to resubmit its NDA for FUROSCIX;
the potential timing and advancement of the Companys ongoing or planned clinical trials and investigator-sponsored studies; the announcement of data from these trials and studies; and the Companys financial condition and cash runway, are
forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, risks associated
with the Company conducting human factors studies or a dose delivery validation study, the ability of the Companys device to appropriately deliver therapy, whether the Company will be able to address the deficiencies raised in the CRL and the
receipt of regulatory approval for FUROSCIX, as well as other risks set forth under the caption Risk Factors in the Companys Annual Report on Form
10-K
for the year ended December 31,
2017 and its subsequent public filings with the Commission. The Company cautions investors not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company disclaims
any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
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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.
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SCPHARMACEUTICALS INC.
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Date: October 18, 2018
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By:
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/s/ John H. Tucker
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Name:
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John H. Tucker
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Title:
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President, Chief Executive Officer and Principal Executive Officer
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