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SLNO Soleno Therapeutics

Filed: 8 Mar 21, 4:01pm

 

 

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): March 8, 2021

 

 

SOLENO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 001-36593 77-0523891

(State or other jurisdiction

of incorporation)

 

(Commission

File No.)

 

(IRS Employer

Identification Number)

203 Redwood Shores Pkwy, Suite 500

Redwood City, CA 94065

(Address of principal executive offices)

(650) 213-8444

(Registrant’s telephone number, including area code)

 

 

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:

 

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

symbols

 

Name of each exchange

on which registered

Common Stock, $0.001 par value SLNO NASDAQ

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 March 8, 2021, Soleno Therapeutics, Inc. (the “Company”) issued a press release discussing recent guidance from the U.S. Food and Drug Administration that an additional controlled clinical trial will be necessary to support an NDA submission for the Company’s once-daily DCCR (diazoxide choline) extended release tablets for the treatment of Prader-Willi Syndrome (PWS).

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

ITEM 9.01

Financial Statements and Exhibits

 

(d)

Exhibits

 

Exhibit
No.

  

Description

99.1  Press release issued by Soleno Therapeutics, Inc. dated March 8, 2021
104  Cover Page Interactive Data File (embedded within the Inline XBRL document)


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.

 

  SOLENO THERAPEUTICS, INC.
Date: March 8, 2021   
  By: 

/s/ Anish Bhatnagar

   Anish Bhatnagar
   Chief Executive Officer