– 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
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SOURCE Rigel Pharmaceuticals, Inc.