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EX-99.1 - EX-99.1 - scPharmaceuticals Inc.d85896dex991.htm

 

 

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): July 27, 2020 (July 27, 2020)

 

 

SCPHARMACEUTICALS INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

(State or other jurisdiction of

incorporation or organization)

 

001-38293   46-5184075

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

2400 District Avenue, Suite 310

Burlington, Massachusetts

  01803
(Address of principal executive offices)   (Zip Code)

Registrant’s 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):

 

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

 

  

 

  

 

Common stock, par value $0.0001    SCPH    The Nasdaq Global Select Market

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.

On July 27, 2020, scPharmaceuticals Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted the Company’s New Drug Application (“NDA”) resubmission for its product candidate, FUROSCIX® , a proprietary, subcutaneously delivered furosemide solution outpatient alternative for the treatment of worsening heart failure due to congestion. The FDA set a Prescription Drug User Fee Act target action date of December 30, 2020 for the completion of its review of the NDA. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01.

Exhibits

(d) Exhibits

 

99.1

Press release issued by the Company on July 27, 2020.


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.

 

  SCPHARMACEUTICALS INC.
Date: July 27, 2020   By:  

/s/ John H. Tucker

  Name:   John H. Tucker
  Title:   President, Chief Executive Officer, Principal Financial Officer and Principal Executive Officer