Health Canada approves Iovance (NASDAQ: IOVA) Amtagvi for advanced melanoma

Rhea-AI Filing Summary

Iovance Biotherapeutics reported that Health Canada has approved its therapy Amtagvi (lifileucel) for patients with advanced melanoma who have already received anti-PD-1 and targeted therapies. This gives Canadian patients a new treatment option after other standard treatments have failed. The company shared this news through a press release, which is attached as an exhibit to the report.

Positive

• Health Canada approval of Amtagvi (lifileucel) for advanced melanoma after anti-PD-1 and targeted therapy expands the product’s regulatory footprint into Canada and opens a new treatment setting for patients with limited options.

Negative

• None.

Insights

Biotech regulatory and commercialization analyst

Health Canada approval of Amtagvi for advanced melanoma is a clearly positive milestone for Iovance.

The report states that Health Canada has approved Amtagvi (lifileucel) for advanced melanoma in patients previously treated with anti-PD-1 and targeted therapies. This expands formal regulatory recognition of the product into Canada, adding a new market for a therapy positioned for use after other treatments.

The indication focuses on a late-line setting where patients have limited options, which can support clinical relevance. While the disclosure does not provide details on pricing, reimbursement, or launch timing, gaining approval itself is a key de‑risking step for the product in another jurisdiction.

Future company communications and filings may clarify Canadian launch plans, commercial infrastructure, and early uptake for Amtagvi in advanced melanoma following anti-PD-1 and targeted therapy.

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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): August 18, 2025

IOVANCE BIOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware
(State of Incorporation)
001-36860		75-3254381
Commission File Number		(I.R.S. Employer Identification No.)
825 Industrial Road, Suite 100
San Carlos, California		94070
(Address of Principal Executive Offices)		(Zip Code)
(650) 260-7120
(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:

¨ 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)).

Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ¨

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.000041666 per share	IOVA	The Nasdaq Stock Market, LLC

Item 8.01. Other Events.

On August 18, 2025, Iovance Biotherapeutics, Inc. issued a press release announcing the approval of Amtagvi® (lifileucel) in Canada for advanced melanoma after anti-PD-1 and targeted therapy. The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release of Iovance Biotherapeutics, Inc., dated August 18, 2025.
104		Cover Page Interactive Data File (embedded as Inline XBRL document)

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.

Date: August 19, 2025	IOVANCE BIOTHERAPEUTICS, INC.
	By:	/s/ Frederick G. Vogt
		Frederick G. Vogt, Ph.D., J.D., Interim CEO and President, and General Counsel

FAQ

What did Iovance Biotherapeutics (IOVA) announce in this 8-K?

Iovance Biotherapeutics announced that Health Canada approved Amtagvi (lifileucel) for treating advanced melanoma after prior anti-PD-1 and targeted therapies, as described in an attached press release.

Which Iovance product was approved in Canada and for what condition?

Health Canada approved Amtagvi (lifileucel) for patients with advanced melanoma who have already been treated with anti-PD-1 and targeted therapies.

Is the full Amtagvi Canada approval announcement available?

Yes. The complete announcement is provided in a press release attached as Exhibit 99.1 to the report and incorporated by reference.

Does the 8-K mention any financial terms related to the Amtagvi approval?

The report focuses on Health Canada’s approval of Amtagvi (lifileucel) for advanced melanoma; it does not detail financial terms or commercial projections in this excerpt.

Who signed the Iovance Biotherapeutics 8-K related to the Amtagvi approval?

The report was signed on behalf of Iovance Biotherapeutics by Frederick G. Vogt, Ph.D., J.D., Interim CEO and President, and General Counsel.