ATOSSA THERAPEUTICS, INC. 8-K

What Happened
On January 6, 2026, Atossa Therapeutics, Inc. (NASDAQ: ATOS) announced that the U.S. Food and Drug Administration issued a "Study May Proceed" letter for the company’s planned clinical study of metastatic breast cancer. The company filed a press release regarding the letter as Exhibit 99.1 to its Form 8-K (Item 8.01). The filing was signed by Mark J. Daniel, Chief Financial Officer.

Key Details

• FDA issued a "Study May Proceed" letter for Atossa’s metastatic breast cancer study (announcement dated January 6, 2026).
• Press release announcing the FDA letter is filed as Exhibit 99.1 to the Form 8-K.
• Form 8-K reports the event under Item 8.01 (Other Events) and includes the standard exhibits under Item 9.01.
• The filing was signed by CFO Mark J. Daniel (Principal Financial and Accounting Officer).

Why It Matters
A "Study May Proceed" letter indicates the FDA has cleared the company to initiate the planned clinical study, removing a key regulatory hurdle for starting patient enrollment. For investors, this is a clinical development milestone—watch for subsequent updates on trial initiation, enrollment progress, and clinical data releases that could affect the company's development timeline and valuation.