UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01 | Regulation FD Disclosure |
On October 27, 2023, the Company issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC”), and for toripalimab, as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information in this Item 7.01 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
The Company plans and projects payment of the $25.0 million milestone due to Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”) pursuant to the Exclusive License and Commercialization Agreement with Junshi Biosciences dated as of February 1, 2021 to occur in March 2024.
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) |
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.
Date: October 27, 2023 |
| COHERUS BIOSCIENCES, INC. | |
By: | /s/ McDavid Stilwell | ||
Name: | McDavid Stilwell | ||
Title: | Chief Financial Officer | ||