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EX-99.1 - EX-99.1 - scPharmaceuticals Inc.d59025dex991.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 7, 2020 (December 3, 2020)

 

 

scPharmaceuticals Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38293   46-5184075
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   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

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 to the registrant under any of the following provisions:

 

 

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 (§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 8.01. Other Events.

On December 7, 2020, scPharmaceuticals Inc. (the “Company”) issued a press release announcing that it had received a complete response letter (the “CRL”) from the U.S. Food and Drug Administration (the “FDA”) on December 3, 2020 for the Company’s New Drug Application (the “NDA”) for its product candidate, FUROSCIX®, a novel formulation of furosemide delivered via an on-body infusor under development for the treatment of congestion in patients with worsening heart failure. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated into this Item 8.01 by reference.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

 

Exhibit
No.

  

Description

99.1    Press Release issued by the registrant on December 7, 2020.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

December 7, 2020     SCPHARMACEUTICALS INC.
    By:  

/s/ John H. Tucker

      Name:   John H. Tucker
      Title:  

President, Chief Executive Officer,

Principal Financial Officer and Principal Executive Officer