UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On September 8, 2020, Arcutis Biotherapeutics, Inc. (the “Company”) issued a press release announcing its plans to advance its program to develop ARQ-151 (topical roflumilast cream) for the treatment of atopic dermatitis into Phase 3 clinical trials following its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, without conducting the previously planned Phase 2b atopic dermatitis trial. The Company anticipates initiating pivotal Phase 3 clinical trials in late 2020 or early 2021.
The foregoing contains “forward-looking” statements, including, among others, statements regarding the expected timing of the initiation of pivotal Phase 3 clinical trials in late 2020 or in early 2021. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to the Company’s business, see the “Risk Factors” section of its Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on August 11, 2020, as well as any subsequent filings with the SEC. The Company undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ARCUTIS BIOTHERAPEUTICS, INC. | ||||||
| Date: September 9, 2020 | By: | /s/ John W. Smither | ||||
| John W. Smither | ||||||
| Chief Financial Officer | ||||||