Rigel Pharmaceuticals, Inc.

Rigel Pharmaceuticals Reports Strong Growth with TAVALISSE and REZLIDHIA in 2024, Expands Global Reach

3 months ago

• Rigel Pharmaceuticals achieved significant revenue growth in 2024, with TAVALISSE sales increasing 12% to $104.8 million and REZLIDHIA sales growing 118% to $23.0 million. • The company secured key regulatory approvals for TAVALISSE in South Korea and Mexico, while establishing a new partnership with Dr. Reddy's Laboratories for REZLIDHIA commercialization across multiple territories. • Rigel's R289 program for lower-risk MDS received FDA Fast Track designation, with promising Phase 1b data presented at ASH 2024 showing good tolerability and preliminary efficacy.

Rigel's Fostamatinib Enrolls First Patient in Phase I Sickle Cell Disease Trial

4 months ago

• Rigel Pharmaceuticals has announced the enrollment of the first patient in a Phase I clinical trial of fostamatinib for sickle cell disease (SCD). • The Phase I trial, sponsored by the NIH/NHLBI, will assess the safety and tolerability of fostamatinib in approximately 20 SCD patients. • Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, may reduce complications related to red blood cell sickling and thrombo-inflammation. • The study will explore fostamatinib's impact on red blood cell membrane integrity, sickling kinetics, and platelet and neutrophil activation in SCD.

NIH Launches Study of Fostamatinib for Sickle Cell Disease Treatment

4 months ago

The National Institutes of Health is investigating Rigel Pharmaceuticals' fostamatinib as a potential treatment for sickle cell disease (SCD). The drug, which is already approved for chronic immune thrombocytopenia, shows promise in addressing SCD's thromboinflammatory complications through SYK inhibition and could potentially improve red blood cell stability without increasing bleeding risks.

FDA Grants Orphan Drug Designation to Rigel's R289 for Myelodysplastic Syndromes

4 months ago

• The FDA has granted Orphan Drug designation to R289 for treating myelodysplastic syndromes (MDS), offering incentives for its development. • R289, a dual inhibitor of IRAK1 and IRAK4, is currently in a Phase 1b study for lower-risk MDS patients who have relapsed or are refractory to prior treatments. • The Orphan Drug designation provides Rigel with potential tax credits, exemptions from certain FDA fees, and seven years of market exclusivity upon drug approval. • R289 had previously received Fast Track designation from the FDA for transfusion-dependent lower-risk MDS, highlighting its potential as a new treatment option.

TAVALISSE® (Fostamatinib) Approved in Mexico for Chronic ITP Treatment

5 months ago

• Knight Therapeutics' Mexican affiliate receives regulatory approval for TAVALISSE® (fostamatinib) from COFEPRIS to treat thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP). • Fostamatinib, an orally administered spleen tyrosine kinase (SYK) inhibitor, offers a new therapeutic alternative for patients who have had an insufficient response to previous ITP treatments. • The approval marks a significant step in expanding treatment options for ITP patients in Latin America, with the launch of TAVALISSE® in Mexico expected in the first half of 2026.

FDA Grants Fast Track Designation to Rigel's R289 for Lower-Risk Myelodysplastic Syndrome

6 months ago

• The FDA has granted Fast Track designation to R289, Rigel Pharmaceuticals' IRAK1/4 inhibitor, for previously treated transfusion-dependent lower-risk myelodysplastic syndrome (MDS). • R289 is currently being evaluated in a Phase 1b study for safety, tolerability, pharmacokinetics, and preliminary activity in relapsed or refractory lower-risk MDS patients. • Fast Track designation aims to expedite the development and review of drugs addressing serious conditions with unmet medical needs, potentially allowing for accelerated approval. • R289 targets inflammatory signaling pathways implicated in the pro-inflammatory bone marrow environment of lower-risk MDS, offering a potential new therapeutic option.

Targeted Therapies Improve Outcomes in NSCLC Based on Molecular Profiling

6 months ago

• Comprehensive molecular testing, including NGS, is vital for identifying driver mutations in NSCLC, enabling precise targeted therapy and improved overall survival. • MET alterations, such as exon 14 skipping mutations, are effectively targeted by TKIs like crizotinib, capmatinib, and tepotinib, demonstrating significant response rates. • RET fusions, present in 1-2% of NSCLC cases, are successfully targeted by selpercatinib and pralsetinib, showing improved PFS and ORR compared to chemotherapy. • KRAS G12C mutations are now actionable with sotorasib and adagrasib, which have shown superior ORR and PFS compared to docetaxel in previously treated patients.