UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

Current Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 9, 2021

 

Seagen Inc.

(Exact name of Registrant as specified in its charter)

 

 

Delaware		0-32405		91-1874389
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S Employer Identification No.)

21823 30th Drive SE

Bothell, Washington 98021

(Address of principal executive offices, including zip code)

(425) 527-4000

(Registrant’s telephone number, including area code)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001		SGEN		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 8.01

Other Events

On July 9th, 2021, Seagen Inc. (the “Company”) and Astellas Pharma Inc. (“Astellas”) issued a press release announcing that the U.S. Food and Drug Administration had: 1) converted the accelerated approval of PADCEV^® (enfortumab vedotin-ejfv) to regular approval for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting; and 2) granted regular approval for a new PADCEV indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin containing chemotherapy and have previously received one or more prior lines of therapy. The press release issued by the Company and Astellas is attached as Exhibit 99.1 to this current report and is incorporated by reference herein.

 

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

 

99.1		Press Release of Seagen Inc. and Astellas Pharma Inc. dated July 9, 2021
104		Cover Page Interactive Data File (formatted as Inline XBRL)

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.

 

				SEAGEN INC.
Date: July 9, 2021				By:		/s/ Jean I. Liu
						Jean I. Liu
						Executive Vice President, Legal Affairs & General Counsel