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Rigel Announces Conference Call and Webcast to Report First Quarter 2022 Financial Results and Business Update

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Rigel Pharmaceuticals (RIGL) will announce its Q1 2022 financial results on May 3, 2022, followed by an investor call at 4:30 PM ET. Dr. Caroline Piatek, a Key Opinion Leader and FORWARD trial investigator, will present insights on warm autoimmune hemolytic anemia (wAIHA) treatment and the potential role of fostamatinib. The ongoing Phase 3 trial evaluates fostamatinib against a placebo in 90 patients who have not responded to prior treatments. Topline data is expected mid-2022. Fostamatinib holds Orphan Drug and Fast Track designations from the FDA.

Positive
  • Ongoing Phase 3 trial for fostamatinib in wAIHA is fully enrolled, with topline data expected in mid-2022.
  • Fostamatinib has received Orphan Drug and Fast Track designations from the FDA.
Negative
  • No significant financial metrics or outcomes disclosed in the press release.

– Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., to join Rigel management to share experience and insight treating patients with wAIHA –

SOUTH SAN FRANCISCO, Calif., April 26, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022. Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

The conference call will also feature a presentation by Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., Associate Professor of Clinical Medicine, Jane Anne Nohl Division of Hematology at the Keck School of Medicine of the University of Southern California. Dr. Piatek will discuss the current treatment landscape, unmet medical need, patient journey, and how she may incorporate fostamatinib, if approved, into clinical practice in warm autoimmune hemolytic anemia (wAIHA).

Dr. Piatek's clinical focus is in non-malignant hematology. Her research interests include immune thrombocytopenia (ITP), wAIHA, cancer-associated thrombosis, and paroxysmal nocturnal hemoglobinuria.

Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About the FORWARD Phase 3 Study

Fostamatinib is currently being evaluated in a Phase 3 randomized, double-blind, placebo-controlled clinical study in 90 patients with wAIHA who have failed at least one prior treatment. The study will evaluate the efficacy of fostamatinib versus placebo in achieving a durable hemoglobin response, defined as a hemoglobin level ≥ 10 g/dL, with an increase from baseline and durability measure in hemoglobin level of ≥ 2 g/dL, with the response not being attributed to rescue therapy, on three consecutive available visits during the 24-week treatment period. Secondary endpoints include other measures of hemoglobin response, use of rescue medication, and safety. The pivotal trial is fully enrolled and topline data is expected in mid-2022.

The FDA has granted fostamatinib Orphan Drug and Fast Track designations for the treatment of patients with wAIHA.

Fostamatinib, commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) tablets, is the first and only FDA-approved SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

About Rigel

Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The product is also commercially available in Europe, the United Kingdom (TAVLESSE) and Canada (TAVALISSE) for the treatment of chronic immune thrombocytopenia in adult patients.  

Fostamatinib is currently being studied in a Phase 3 clinical trial (NCT03764618) for the treatment of warm autoimmune hemolytic anemia (wAIHA)1; a Phase 3 clinical trial (NCT04629703) for the treatment of hospitalized high-risk patients with COVID-191; an NIH/NHLBI-sponsored Phase 3 clinical trial (ACTIV-4 Host Tissue Trial, NCT04924660) for the treatment of COVID-19 in hospitalized patients, and a Phase 2 clinical trial (NCT04581954) for the treatment of COVID-19 being conducted by Imperial College London. 

Rigel's other clinical programs include its interleukin receptor-associated kinase (IRAK) inhibitor program, and a receptor-interacting serine/threonine-protein kinase (RIPK) inhibitor program in clinical development with partner Eli Lilly and Company. In addition, Rigel has product candidates in development with partners BerGenBio ASA and Daiichi Sankyo. 

For further information, visit www.rigel.com or follow us on Twitter or LinkedIn

Please see www.TAVALISSE.com for the full Prescribing Information.

1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.

Investor Contact: 
Jodi Sievers
Rigel Pharmaceuticals, Inc. 
Phone: 650.624.1232 
Email: ir@rigel.com

Rigel Pharmaceuticals Logo (PRNewsfoto/Rigel Pharmaceuticals, Inc.)

 

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SOURCE Rigel Pharmaceuticals, Inc.

FAQ

When will Rigel announce its Q1 2022 financial results?

Rigel will announce its Q1 2022 financial results on May 3, 2022.

Who is Dr. Caroline Piatek and what will she discuss during the conference call?

Dr. Caroline Piatek is a Key Opinion Leader and FORWARD trial investigator; she will discuss the treatment landscape and potential use of fostamatinib for wAIHA.

What is the status of the Phase 3 trial for fostamatinib?

The Phase 3 trial for fostamatinib in wAIHA is fully enrolled, with topline data expected in mid-2022.

What designations has fostamatinib received from the FDA?

Fostamatinib has received Orphan Drug and Fast Track designations from the FDA.

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