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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): March 27, 2025

 

RIGEL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

0-29889   94-3248524
(Commission File No.)   (IRS Employer Identification No.)
     
611 Gateway Boulevard
Suite 900
   
South San Francisco, CA    94080
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (650) 624-1100

 

Not Applicable

(Former name or former address, if changed since last report)

 

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))

 

Title of Each Class   Trading
Symbol(s)
  Name of Each Exchange on Which
Registered
Common Stock, par value $0.001 per share   RIGL   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 March 27, 2025, Rigel Pharmaceuticals, Inc., issued a press release titled “Rigel Announces Settlement Agreement Resolving TAVALISSE® (fostamatinib disodium hexahydrate) Patent Litigation,” a copy of which is attached as Exhibit 99.1 hereto and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.
   
(d) Exhibits.

 

Exhibit   Description
     
99.1   Press Release, dated March 27, 2025, titled “Rigel Announces Settlement Agreement Resolving TAVALISSE® (fostamatinib disodium hexahydrate) Patent Litigation.”
104   Cover Page Interactive Data File (embedded within the 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.

 

Dated: March 27, 2025 RIGEL PHARMACEUTICALS, INC.
   
  By: /s/ Raymond J. Furey                          
  Raymond J. Furey
  Executive Vice President, General Counsel, Chief Compliance Officer, and Corporate Secretary

 

 

EX-99.1 2 tm2510607d1_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

 

 

Rigel Announces Settlement Agreement Resolving TAVALISSE® (fostamatinib disodium hexahydrate) Patent Litigation

 

SOUTH SAN FRANCISCO, Calif., March 27, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has entered into a settlement agreement with Annora Pharma Private Ltd., Hetero Labs Ltd., and Hetero USA, Inc. (collectively “Annora”) resolving patent litigation related to Rigel’s product TAVALISSE® (fostamatinib disodium hexahydrate). The litigation resulted from submission by Annora of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of TAVALISSE in the United States. Under the terms of the settlement agreement, Annora will have a license to sell its generic product in Q2 2032 or earlier under certain circumstances. In accordance with the agreement, the parties terminated all ongoing litigation between Rigel and Annora regarding TAVALISSE patents pending in New Jersey.

 

“The resolution of this patent litigation underscores the strength of Rigel’s intellectual property protecting TAVALISSE, an innovative treatment for people with immune thrombocytopenia,” said Raul Rodriguez, Rigel’s president and CEO. “We remain committed to advancing our portfolio of novel therapies with the potential to improve the lives of patients with hematological disorders and cancer, and to continue to develop and enhance our intellectual property portfolio.”

 

About ITP

In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

 

About TAVALISSE®

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

 

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

 

To report side effects of prescription drugs to the FDA, www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

 

TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

 

 


 

About Rigel

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.

 

Forward Looking Statements

This press release contains forward-looking statements relating to, among other things, expected generic product market entry, the strength of our intellectual property portfolio and our ability to develop and enhance it, TAVALISSE as a treatment for immune thrombocytopenia, and expectations to grow and advance our commercial portfolio. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as “anticipates”, “plan”, “potential”, “may”, “look to”, “expects”, “will”, “initial”, “promising”, and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel’s current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of fostamatinib, olutasidenib and pralsetinib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding fostamatinib, pralsetinib or olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib or olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel’s product candidates; market competition; as well as other risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.

 

Contact for Investors & Media:

Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com

 

Media:
David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com