Harmony Biosciences Holdings Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On June 11, 2025, Harmony Biosciences Holdings, Inc. (the Company) issued a press release announcing the Company’s new preclinical pharmacological effect data for BP1.15205, an investigational, highly potent, and potentially best-in-class orexin 2 receptor (OX2R) agonist, which demonstrated significant wake-promoting and cataplexy-suppressing effects in a standard transgenic mouse model of narcolepsy type 1. The full text of the press release in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Additionally, on June 11, 2025, the Company will present this new preclinical pharmacological effect data for BP1.15205 in a presentation during the 39th Annual Meeting of the Associated Professional Sleep Societies.
The Company also announced that an Investigational Medicinal Product Dossier application with the European Medicines Agency is being completed for BP1.15205. A first-in-human study is planned to begin in the second half of 2025 with topline data anticipated in 2026. Additionally, an Investigational New Drug application for BP1.15205 will be filed with the U.S. Food and Drug Administration.
The information contained in Item 7.01 of this Current Report (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
| |
No. | Description | |
99.1* | ||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
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.
HARMONY BIOSCIENCES HOLDINGS, INC. | ||
Date: June 11, 2025 | By: | /s/ Christian Ulrich |
Christian Ulrich | ||
SVP and General Counsel | ||