Rigel Announces R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2024
0mins
Should l Buy RIGL?
Source: Newsfilter
FDA Fast Track Designation: Rigel Pharmaceuticals has received Fast Track designation from the FDA for R289, a treatment aimed at patients with previously-treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS), highlighting the significant unmet medical need in this patient population.
Potential Impact of R289: R289 is a dual inhibitor targeting inflammatory signaling pathways, which may improve outcomes for elderly patients suffering from progressive cytopenias, particularly anemia, associated with LR-MDS.
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Analyst Views on RIGL
Wall Street analysts forecast RIGL stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 31.920
Low
38.00
Averages
52.00
High
71.00
Current: 31.920
Low
38.00
Averages
52.00
High
71.00
About RIGL
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing therapies for patients with hematologic disorders and cancer. It focuses on products that address signaling pathways that are critical to disease mechanisms. Its products include TAVALISSE, REZLIDHIA, and GAVRETO. TAVALISSE is an oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia. REZLIDHIA is used for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions. It is used for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Rigel Pharmaceuticals to Present at RBC Capital Markets Global Healthcare Conference
- Conference Presentation: Rigel Pharmaceuticals' CFO Dean Schorno will present a company overview at the RBC Capital Markets Global Healthcare Conference on May 19, 2026, at 9:30 a.m. ET in New York, highlighting its innovative therapies for hematologic disorders and cancer.
- Webcast Access: Investors can access the live webcast and archived recording through the Investor Relations section of Rigel's website, ensuring they connect prior to the start of the live event for any necessary software downloads to enhance participation.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on discovering and developing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer, showcasing its expertise and market potential in the biotechnology sector.
- Investor Contact Information: Investors and media can reach out through the provided contact details for timely inquiries, ensuring transparency and effective communication, which strengthens the interaction between the company and its investors.
See More
Rigel Partners with Arvinas and Pfizer for Breast Cancer Treatment
- FDA Approval: Vepdegestrant, branded as Veppanu, received FDA approval earlier this month, becoming the only FDA-approved oral PROTAC therapy, which is expected to drive Rigel's cancer treatment portfolio expansion and enhance market competitiveness.
- Financial Gains from Agreement: Rigel will receive $70 million upfront and an additional $15 million upon completion of transition activities, along with potential future milestone payments of up to $320 million, significantly improving the company's financial outlook and investor confidence.
- Positive Stock Reaction: Rigel's shares surged over 15% following the announcement of the agreement, reflecting investor optimism regarding the new drug's market potential and indicating the company's growth prospects in oncology.
- Clinical Data Support: Veppanu demonstrated a 43% reduction in disease progression risk in Phase 3 studies, with a median progression-free survival of five months compared to 2.1 months for the comparator drug Fulvestrant, highlighting its significant therapeutic advantage.
See More
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- Agreement Reached: Arvinas (ARVN) and Pfizer (PFE) have finalized an agreement to sell global licensing rights for their jointly developed breast cancer therapy, Veppanu, to Rigel (RIGL), marking a significant advancement in breast cancer treatment.
- Cash Inflow: Rigel (RIGL) will provide $70 million upfront to Arvinas (ARVN) and Pfizer (PFE), along with an additional $15 million contingent on specific development and manufacturing milestones, significantly enhancing the funding capabilities for ongoing R&D activities.
- Milestone Payments: The agreement includes up to $320 million in milestone payments and tiered royalties on net sales ranging from the mid-teens to mid-20s, indicating substantial market potential for the therapy and promising long-term revenue for the partners.
- Global Market Expansion: Rigel (RIGL) will receive global rights to Veppanu, including sublicensing rights in overseas territories, which not only broadens market reach but also provides Arvinas (ARVN) and Pfizer (PFE) with additional revenue streams, further solidifying their positions in the global biopharmaceutical market.
See More
Rigel Pharmaceuticals Q1 2026 Earnings Call Insights
- Sales Growth: In Q1 2026, Rigel Pharmaceuticals reported net product sales of nearly $55 million, reflecting a 26% increase year-over-year, despite seasonal impacts, with expectations for sequential growth resuming in Q2, thereby boosting market confidence.
- Revenue Guidance Maintained: The company maintains its 2026 revenue guidance at $275 million to $290 million, with net product sales projected between $255 million and $265 million, indicating management's confidence in future performance despite challenges from the termination of a collaboration.
- Improved Financial Position: The first quarter net income was $8.7 million, with cash and short-term investments totaling $146.7 million, demonstrating robust financial management that supports future R&D and market expansion initiatives.
- Collaboration Termination Impact: The termination of the collaboration with Eli Lilly effective June 15, 2026, introduces uncertainty regarding the RIPK1 program; however, management indicated plans to reassess the strategic direction of the project, showcasing adaptability to market changes.
See More
Rigel Pharmaceuticals Reports Q1 Earnings Decline
- Earnings Decline: Rigel Pharmaceuticals reported a first-quarter net income of $8.65 million, translating to an EPS of $0.44, which represents a significant decline of 24.5% and 30.2% from last year's $11.45 million and $0.63 per share, indicating a notable weakening in profitability.
- Revenue Growth: Despite the drop in earnings, the company's revenue increased by 10.3% year-over-year to $58.82 million from $53.33 million last year, suggesting resilience in sales performance potentially driven by new product launches.
- Full-Year Guidance: Rigel has provided a full-year revenue guidance of $275 million to $290 million, reflecting a cautiously optimistic outlook for future performance, aiming to achieve growth despite current earnings challenges.
- Market Reaction: The decline in earnings may lead to a negative market response towards Rigel, prompting investors to closely monitor how the company addresses profitability challenges and its strategies for future growth.
See More
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- Disappointing Earnings: Rigel Pharmaceuticals reported a Q1 GAAP EPS of $0.44, missing expectations by $0.28, indicating pressure on profitability that may affect investor confidence.
- Lackluster Revenue Growth: The company generated $58.8 million in revenue for the quarter, a 10.3% year-over-year increase, yet fell short of expectations by $3.6 million, reflecting intensified market competition and sales challenges.
- Cash Flow Concerns: As of March 31, 2026, Rigel's cash and short-term investments totaled $146.7 million, down from $155.0 million as of December 31, 2025, suggesting potential liquidity issues.
- 2026 Outlook: Rigel reaffirms its revenue guidance for 2026 at approximately $275 to $290 million, and while it anticipates reporting positive net income for the full year, ongoing funding for clinical development programs remains a critical concern.
See More
Rigel Pharmaceuticals to Present at RBC Capital Markets Global Healthcare Conference
- Conference Presentation: Rigel Pharmaceuticals' CFO Dean Schorno will present a company overview at the RBC Capital Markets Global Healthcare Conference on May 19, 2026, at 9:30 a.m. ET in New York, highlighting its innovative therapies for hematologic disorders and cancer.
- Webcast Access: Investors can access the live webcast and archived recording through the Investor Relations section of Rigel's website, ensuring they connect prior to the start of the live event for any necessary software downloads to enhance participation.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on discovering and developing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer, showcasing its expertise and market potential in the biotechnology sector.
- Investor Contact Information: Investors and media can reach out through the provided contact details for timely inquiries, ensuring transparency and effective communication, which strengthens the interaction between the company and its investors.
See More
Rigel Partners with Arvinas and Pfizer for Breast Cancer Treatment
- FDA Approval: Vepdegestrant, branded as Veppanu, received FDA approval earlier this month, becoming the only FDA-approved oral PROTAC therapy, which is expected to drive Rigel's cancer treatment portfolio expansion and enhance market competitiveness.
- Financial Gains from Agreement: Rigel will receive $70 million upfront and an additional $15 million upon completion of transition activities, along with potential future milestone payments of up to $320 million, significantly improving the company's financial outlook and investor confidence.
- Positive Stock Reaction: Rigel's shares surged over 15% following the announcement of the agreement, reflecting investor optimism regarding the new drug's market potential and indicating the company's growth prospects in oncology.
- Clinical Data Support: Veppanu demonstrated a 43% reduction in disease progression risk in Phase 3 studies, with a median progression-free survival of five months compared to 2.1 months for the comparator drug Fulvestrant, highlighting its significant therapeutic advantage.
See More
Arvinas and Rigel Reach Licensing Agreement for Breast Cancer Therapy
- Agreement Reached: Arvinas (ARVN) and Pfizer (PFE) have finalized an agreement to sell global licensing rights for their jointly developed breast cancer therapy, Veppanu, to Rigel (RIGL), marking a significant advancement in breast cancer treatment.
- Cash Inflow: Rigel (RIGL) will provide $70 million upfront to Arvinas (ARVN) and Pfizer (PFE), along with an additional $15 million contingent on specific development and manufacturing milestones, significantly enhancing the funding capabilities for ongoing R&D activities.
- Milestone Payments: The agreement includes up to $320 million in milestone payments and tiered royalties on net sales ranging from the mid-teens to mid-20s, indicating substantial market potential for the therapy and promising long-term revenue for the partners.
- Global Market Expansion: Rigel (RIGL) will receive global rights to Veppanu, including sublicensing rights in overseas territories, which not only broadens market reach but also provides Arvinas (ARVN) and Pfizer (PFE) with additional revenue streams, further solidifying their positions in the global biopharmaceutical market.
See More
Rigel Pharmaceuticals Q1 2026 Earnings Call Insights
- Sales Growth: In Q1 2026, Rigel Pharmaceuticals reported net product sales of nearly $55 million, reflecting a 26% increase year-over-year, despite seasonal impacts, with expectations for sequential growth resuming in Q2, thereby boosting market confidence.
- Revenue Guidance Maintained: The company maintains its 2026 revenue guidance at $275 million to $290 million, with net product sales projected between $255 million and $265 million, indicating management's confidence in future performance despite challenges from the termination of a collaboration.
- Improved Financial Position: The first quarter net income was $8.7 million, with cash and short-term investments totaling $146.7 million, demonstrating robust financial management that supports future R&D and market expansion initiatives.
- Collaboration Termination Impact: The termination of the collaboration with Eli Lilly effective June 15, 2026, introduces uncertainty regarding the RIPK1 program; however, management indicated plans to reassess the strategic direction of the project, showcasing adaptability to market changes.
See More
Rigel Pharmaceuticals Reports Q1 Earnings Decline
- Earnings Decline: Rigel Pharmaceuticals reported a first-quarter net income of $8.65 million, translating to an EPS of $0.44, which represents a significant decline of 24.5% and 30.2% from last year's $11.45 million and $0.63 per share, indicating a notable weakening in profitability.
- Revenue Growth: Despite the drop in earnings, the company's revenue increased by 10.3% year-over-year to $58.82 million from $53.33 million last year, suggesting resilience in sales performance potentially driven by new product launches.
- Full-Year Guidance: Rigel has provided a full-year revenue guidance of $275 million to $290 million, reflecting a cautiously optimistic outlook for future performance, aiming to achieve growth despite current earnings challenges.
- Market Reaction: The decline in earnings may lead to a negative market response towards Rigel, prompting investors to closely monitor how the company addresses profitability challenges and its strategies for future growth.
See More
Rigel Pharmaceuticals Q1 Earnings Miss Expectations
- Disappointing Earnings: Rigel Pharmaceuticals reported a Q1 GAAP EPS of $0.44, missing expectations by $0.28, indicating pressure on profitability that may affect investor confidence.
- Lackluster Revenue Growth: The company generated $58.8 million in revenue for the quarter, a 10.3% year-over-year increase, yet fell short of expectations by $3.6 million, reflecting intensified market competition and sales challenges.
- Cash Flow Concerns: As of March 31, 2026, Rigel's cash and short-term investments totaled $146.7 million, down from $155.0 million as of December 31, 2025, suggesting potential liquidity issues.
- 2026 Outlook: Rigel reaffirms its revenue guidance for 2026 at approximately $275 to $290 million, and while it anticipates reporting positive net income for the full year, ongoing funding for clinical development programs remains a critical concern.
See More
