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|ITEM 8.01|| |
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
|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)|
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|
|Chief Executive Officer|