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RIGL 資訊
RIGL 事件
Rigel Presents GAVRETO Clinical Data at ESMO 2026
Rigel announced analysis of the pooled efficacy and safety data from two clinical trials of GAVRETO, or pralsetinib, ARROW and TAPISTRY, in patients with rearranged during transfection, or RET, fusion-positive solid tumors will be presented in a rapid oral session at the European Society For Medical Oncology, or ESMO, Congress 2026 on Sunday, October 25. In addition, the ESMO Congress will feature two poster presentations and an ePoster with additional clinical and health-related quality of life data from the TAPISTRY clinical trial in patients with RET fusion-positive thyroid cancer and ARROW trial in patients with RET fusion-positive non-small cell lung cancer, or NSCLC. The ESMO Congress is being held in Madrid, Spain and virtually from October 23 to October 27. Key highlights from the presentations at ESMO include: In a pooled analysis of 49 patients with RET fusion-positive solid tumors from the ARROW and TAPISTRY studies excluding NSCLC and thyroid tumors, pralsetinib demonstrated robust and durable activity across a range of tumor types, including pancreatic and colorectal, with an overall response rate, or ORR, of 53% and median duration of response of 12.2 months. Notably, patients with previously-treated pancreatic tumors had an ORR of 88%. These data support the potential use of pralsetinib in a tumor-agnostic approach for RET fusion-positive solid tumors. In the TAPISTRY clinical trial cohort that evaluated pralsetinib in 16 response-evaluable thyroid cancer patients with RET fusion-positive tumors, pralsetinib demonstrated robust and durable activity against RET fusion-positive thyroid cancer with an ORR of 81.3% and manageable safety, results that are consistent with the ARROW study and further highlight its utility in this population. In patients with RET fusion-positive NSCLC enrolled in ARROW, patients treated with pralsetinib in the first-line setting had a higher investigator-assessed ORR than patients who had received standard of care first-line therapies before ARROW enrollment. Median times to progression, treatment discontinuation, and next treatment or death were also longer with first-line pralsetinib. These findings support pralsetinib as an effective first-line therapy and are consistent with treatment guidelines recommending selective RET inhibition for patients with RET fusion-positive advanced NSCLC. In the ARROW clinical trial, pralsetinib therapy was associated with clinically meaningful improvements in Health-Related Quality of Life among patients with advanced or metastatic RET fusion-positive NSCLC, with at least 75% of evaluable patients experiencing improved or stable scores across all assessed domains at Cycle 12 Day 1.
Rigel Pharmaceuticals Announces Veppanu Now Available in the U.S.
Rigel Pharmaceuticals announced Veppanu - vepdegestrant - is now available by prescription in the U.S. for the treatment of adults with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by a FDA-authorized test, with disease progression following at least one line of endocrine therapy. Veppanu is the first and only FDA-approved PROteolysis TArgeting Chimera, or PROTAC. PROTACs are a new class of heterobifunctional protein degraders designed to harness the body's natural machinery to selectively degrade, rather than inhibit, disease-causing proteins.
Rigel Reports Q2 Revenue of $78.7M, Beating Expectations
Reports Q2 revenue $78.7M, consensus $55.27M. "Rigel delivered a strong Q2, highlighted by record net product sales, continued profitability and the in-license of VEPPANU, the first and only FDA-approved PROTAC for patients with ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. We expect VEPPANU to be commercially available later this month, further expanding our commercial business in hematology and oncology," said Raul Rodriguez, Rigel's president and CEO. "We are also advancing the development of R289 in our ongoing Phase 1b study in patients with R/R lower-risk MDS, and remain on track to complete enrollment in the dose expansion phase of the study, select a recommended Phase 2 dose in the second half of 2026 and share preliminary data by year end."
FY26 Revenue Consensus at $278.89M
Consensus is for FY26 revenue $278.89M. Sees FY26 net product sales $255M-$265M; and contract revenues $30M, an increase from the prior range of approximately $20M-$25M.
Rigel Pharmaceuticals Appoints Alison L. Hannah as Chief Medical Officer
Rigel Pharmaceuticals announced the appointment of Alison L. Hannah, to the role of Executive Vice President and Chief Medical Officer. Hannah has resigned from Rigel's Board of Directors, effective July 1, in connection with her appointment. She succeeds Lisa Rojkjaer, as Chief Medical Officer. Alison L. Hannah has held the roles of Chief Medical Officer of CytomX Therapeutics, where she oversaw clinical development of conditionally activated protein therapeutics, and Senior Medical Director at SUGEN where she had oversight of clinical development, clinical operations, and pharmacovigilance, specializing in the development of tyrosine kinase inhibitors, including sunitinib approved for the treatment of kidney cancer and imatinib-refractory gastrointestinal stromal tumors. Hannah has served as a consultant to the pharmaceutical and biotechnology industry since 2000, directing the development of investigational cancer therapies. Hannah received her B.A. in biochemistry and immunology from Harvard University and her M.D. from the University of St Andrews. Rigel's leading pipeline asset, R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4, continues to be advanced in its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with relapsed or refractory lower-risk myelodysplastic syndrome.
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