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Rigel Presents Updated Data from the Ongoing Phase 1b Study Evaluating R289 in Patients with Lower-Risk MDS at the 67th ASH Annual Meeting and Exposition
Prnewswire· 2025-12-07 14:30
Core Insights - Rigel Pharmaceuticals announced updated data from its ongoing Phase 1b study of R289, an oral prodrug of R835, targeting relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2] - The study results were presented at the 67th American Society of Hematology Annual Meeting, highlighting the potential of R289 as a treatment option for patients with transfusion-dependent lower-risk MDS [1][2] Study Overview - The Phase 1b study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed or refractory lower-risk MDS [2] - Enrollment in the dose escalation phase was completed in July 2025, with the dose expansion phase starting in October 2025, involving up to 40 patients [2] Key Data Highlights - As of October 28, 2025, 33 patients were enrolled, with a median age of 75 and a median of 3 prior therapies [4] - R289 was generally well tolerated, with 33% of evaluable transfusion-dependent patients achieving durable red blood cell transfusion independence (RBC-TI) [3][4] - The most common treatment-emergent adverse events included diarrhea (30%), constipation (27%), and fatigue (27%) [4] Efficacy Results - Among evaluable transfusion-dependent patients, 6 out of 18 (33%) achieved RBC-TI lasting more than 8 weeks, with a median time to onset of 1.9 months [4] - Peak hemoglobin increases ranged from 2.9 to 6.1 g/dL compared to baseline in patients achieving RBC-TI [4] Regulatory Designations - R289 has received Orphan Drug designation and Fast Track designation from the FDA for the treatment of previously-treated transfusion-dependent lower-risk MDS [5]
Rigel Pharmaceuticals (NasdaqGS:RIGL) Earnings Call Presentation
2025-12-07 12:00
Financial Performance & Guidance - Q3 2025 net product sales grew to $64.1 million, a 65% increase compared to Q3 2024[10, 158] - Rigel increased its 2025 net product sales guidance to $225 million - $230 million, up from $210 million - $220 million[12] - Rigel anticipates 2025 total revenue of ~$285 million to $290 million[162] - Cash, cash equivalents & short-term investments as of September 30, 2025, was $137.1 million compared to $77.3 million as of December 31, 2024[162] Product Performance - TAVALISSE Q3 2025 net product sales reached $44.7 million, a 70% increase compared to Q3 2024[16] - GAVRETO Q3 2025 net product sales reached $11.1 million, a 56% increase compared to Q3 2024[16] - REZLIDHIA Q3 2025 net product sales reached $8.3 million, a 50% increase compared to Q3 2024[16] R289 Clinical Development - In a Phase 1b study in R/R lower-risk MDS, 33% (6/18) of evaluable transfusion-dependent patients receiving ≥500 mg QD achieved RBC-TI >8 weeks[124, 131] - The median duration of RBC-TI was 22.9 weeks (9 - 104.3)[124] Strategic Collaborations - Contract revenues from collaborations were $5.4 million in Q3 2025[158]
Rigel Pharmaceuticals (RIGL) is a Great Momentum Stock: Should You Buy?
ZACKS· 2025-12-05 18:01
Core Insights - Momentum investing focuses on following a stock's recent price trends, with the aim of buying high and selling higher, capitalizing on established price movements [1] - Rigel Pharmaceuticals (RIGL) currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The Zacks Rank system, which complements the Style Scores, rates RIGL as 2 (Buy), suggesting potential for outperformance in the market [4] Price Performance - RIGL shares have increased by 9.25% over the past week, outperforming the Zacks Medical - Drugs industry, which rose by 4.43% during the same period [6] - Over the last quarter, RIGL shares have gained 25.28%, and over the past year, they have surged by 82.02%, while the S&P 500 has only increased by 5.77% and 13.9%, respectively [7] Trading Volume - The average 20-day trading volume for RIGL is 631,925 shares, which serves as a baseline for assessing price movements; rising prices with above-average volume are typically bullish [8] Earnings Outlook - In the past two months, three earnings estimates for RIGL have been revised upwards, while none have been lowered, leading to an increase in the consensus estimate from $5.49 to $6.54 [10] - For the next fiscal year, two estimates have moved up, while one has been revised down [10] Conclusion - Considering the strong momentum indicators and positive earnings outlook, RIGL is positioned as a 2 (Buy) stock with a Momentum Score of A, making it a potential candidate for near-term investment [12]
Rigel Pharmaceuticals (NasdaqGS:RIGL) FY Conference Transcript
2025-12-03 14:32
Summary of Rigel Pharmaceuticals FY Conference Call Company Overview - **Company**: Rigel Pharmaceuticals (NasdaqGS:RIGL) - **Industry**: Biotechnology, specifically focusing on hematology and oncology Key Points and Arguments 1. **Business Growth**: Rigel has experienced significant growth in its hematology and oncology business, with a 65% year-over-year increase in U.S. net product sales, reaching $64.1 million in Q4 and totaling $166 million through Q3 [3][17] 2. **Product Performance**: - **Tavalisse (ITP Product)**: Generated $44.7 million, reflecting a 70% year-over-year growth. It is primarily used for adult chronic ITP patients who have not responded adequately to previous treatments [3][4] - **Gavreto**: Acquired from Blueprint Medicines, it has grown from $7 million per quarter to over $11 million, indicating strong commercial execution [3][4] - **Rezlidhia**: Indicated for IDH1 positive AML patients, showing a 50% year-over-year growth [4][5] 3. **Market Opportunity**: - **Chronic ITP**: Approximately 81,000 patients in the U.S. suffer from chronic ITP, with Rigel's products increasingly being utilized in second and third-line therapies, where there are larger patient populations [4][5] - **AML**: About 22,000 patients diagnosed annually in the U.S., with a significant portion having IDH1 mutations, presenting a targeted market for Rezlidhia [5][6] 4. **Clinical Development**: Rigel is focused on in-licensing differentiated assets in hematology and oncology, with ongoing clinical trials for IRAK1/4 inhibitors and other products [10][12] 5. **Strategic Collaborations**: Partnerships with organizations like Grifols, Kissei, and MD Anderson to enhance product reach and development [9][14] 6. **Financial Performance**: - **Net Income**: Approximately $28 million through Q3, with profitability in each quarter [17] - **Cash Balance**: Increased to $137 million, providing a strong financial foundation for future growth [17] - **Revenue Guidance**: Increased guidance to $285-$290 million total revenue, with net product sales projected at $225-$230 million [17][18] Additional Important Information - **Regulatory Support**: The IRAK1/4 program has received fast-track and orphan designations from the FDA, indicating a supportive regulatory environment [12] - **Market Dynamics**: Rigel faces competition in the RET fusion-positive therapeutic market but sees opportunities due to recent changes in practice guidelines favoring their products [8][9] - **Future Goals**: Rigel aims to continue expanding its product sales, advancing its development pipeline, and seeking in-license opportunities [18]
Rigel Pharmaceuticals, Inc. (RIGL) Hit a 52 Week High, Can the Run Continue?
ZACKS· 2025-11-27 15:16
Core Insights - Rigel Pharmaceuticals (RIGL) shares have increased by 73.3% over the past month and 203% since the beginning of the year, outperforming the Zacks Medical sector and the Zacks Medical - Drugs industry [1] - The company has consistently beaten earnings estimates, reporting an EPS of $1.46 against a consensus estimate of $0.93 in its last earnings report [2] - For the current fiscal year, Rigel is projected to achieve earnings of $6.54 per share on revenues of $290.75 million, reflecting a 560.61% increase in EPS and a 62.18% increase in revenues [3] Valuation Metrics - Rigel has a Value Score of B, with Growth and Momentum Scores both rated A, resulting in a combined VGM Score of A [6] - The stock trades at 7.8X current fiscal year EPS estimates, significantly lower than the peer industry average of 20.7X, while on a trailing cash flow basis, it trades at 47.2X compared to the peer group's average of 15.5X [6] Zacks Rank - Rigel holds a Zacks Rank of 2 (Buy), supported by favorable earnings estimate revisions from analysts, indicating potential for further gains [7] Competitive Landscape - Aurinia Pharmaceuticals Inc (AUPH), a peer in the industry, also shows strong performance with a Zacks Rank of 2 (Buy) and has gained 34% over the past month [8][10] - AUPH is expected to post earnings of $0.85 per share on revenues of $280.35 million for the current fiscal year, having beaten consensus estimates by 43.75% last quarter [9]
Rigel Pharma: Q3 Earnings Showcase Robust Growth
Seeking Alpha· 2025-11-26 13:15
Core Insights - The article highlights the background and expertise of Brendan, a key figure in the biotechnology sector, emphasizing his academic achievements and professional experience in both pharmaceutical and biotech industries [1]. Group 1: Background and Experience - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 [1]. - He worked for Merck, a major pharmaceutical company, from 2009 to 2013 [1]. - His experience includes roles in biotech startups such as Theravance and Aspira before joining Caltech [1]. - Brendan is a co-founder and the first employee of 1200 Pharma, which successfully spun out of Caltech and secured significant investment in the eight-figure range [1]. - He remains an active investor with a focus on market trends, particularly in biotechnology stocks [1].
Rigel to Present at the Piper Sandler 37th Annual Healthcare Conference
Prnewswire· 2025-11-26 13:05
Core Insights - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on hematologic disorders and cancer, and it will present an overview at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [1][3]. Company Overview - Rigel Pharmaceuticals was founded in 1996 and is based in South San Francisco, California [3]. - The company is dedicated to discovering, developing, and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer [3]. Event Details - Dean Schorno, the Chief Financial Officer of Rigel, will present at the conference at 8:30 am ET [1]. - Investors can access the live webcast or archived recording through the Investor Relations section of Rigel's website [2].
Rigel Pharmaceuticals: Behind The Huge Rally (NASDAQ:RIGL)
Seeking Alpha· 2025-11-25 23:01
Core Insights - Rigel Pharmaceuticals, Inc. (RIGL) has experienced a significant increase in share price over the past month, driven by better-than-expected Q3 results [1]. Company Performance - The Q3 results for Rigel Pharmaceuticals exceeded market expectations, contributing to the recent rally in its stock price [1]. Market Commentary - The Biotech Forum, led by an experienced market analyst, provides insights into high beta sectors and offers a model portfolio of 12-20 biotech stocks with high upside potential [1].
Rigel Pharmaceuticals (NasdaqGS:RIGL) 2025 Conference Transcript
2025-11-18 11:02
Summary of Rigel Pharmaceuticals Conference Call Company Overview - Rigel Pharmaceuticals is a hematology and oncology biotech company focused on expanding its commercial business and pipeline [2][3] Commercial Products - Rigel has three approved products: - **TAVALISSE**: Indicated for immune thrombocytopenia (ITP) with net sales of $44.7 million last quarter, a 70% increase year-over-year [6] - **REZLIDHIA**: Approved for mutant IDH1 relapsed and refractory acute myeloid leukemia (AML) with sales of $8.3 million, a 50% growth from the previous year [6] - **GAVRETO**: Approved for RET fusion positive non-small cell lung cancer and thyroid cancer, with sales increasing from $7 million to $11.1 million [6][12] Financial Performance - Rigel reported $64 million in net product sales last quarter, a 65% increase from the same quarter last year, and $166 million over three months, surpassing total sales for all of 2024 [5] - The company generated $60 million in cash this year and has maintained profitability [4][30] - Guidance for revenue is set at $285-$290 million, with net product sales expected to be $225-$230 million [30] Pipeline Development - Rigel is focused on developing transformational programs, particularly R289 for low-risk myelodysplastic syndromes (MDS) [4][17] - R289 has received fast-track and orphan designations from regulatory agencies, indicating its potential for significant improvement in treatment options [20] - The company plans to initiate a registration study for R289 in 2027 [24] Market Opportunities - The U.S. market for adult chronic ITP has approximately 81,000 patients, with Rigel targeting the second-line treatment population of about 24,000 patients [7] - The market for low-risk MDS is substantial, with current treatments showing limited efficacy, presenting an opportunity for R289 [18][19] Strategic Partnerships - Rigel has partnered with various companies for product distribution, including Grifols in Europe and Kissei in Asia for TAVALISSE [13] - Collaborations with MD Anderson and MyeloMatch are underway to explore additional indications for Olutasidenib and AML treatments [25][27] Future Outlook - Rigel aims to continue in-licensing differentiated assets in hematology and oncology to enhance its portfolio [14][16] - The company is committed to maintaining financial discipline while investing in its pipeline to drive growth [31][32] Key Takeaways - Rigel Pharmaceuticals is experiencing significant growth in its commercial products and is strategically positioning itself for future opportunities in hematology and oncology [5][32] - The focus on developing innovative treatments like R289 and expanding its product offerings through partnerships is central to Rigel's growth strategy [4][14][24]
Eli Lilly Partner And Cancer Treatment Maker Nears Buy Point
Investors· 2025-11-17 18:44
Core Insights - Rigel Pharmaceuticals has reported strong third-quarter earnings and raised its sales guidance, indicating positive momentum in its business performance [1][4] - The company's IBD SmartSelect Composite Rating has been upgraded from 94 to 96, placing it among the elite stocks with a rating above 95 [1][4] - Rigel Pharmaceuticals is nearing a buy point of a cup base, suggesting potential investment opportunities for traders [1] Financial Performance - Rigel Pharmaceuticals experienced a significant boost in its stock performance following the earnings report [1] - The company is part of the IBD 50 Growth Stocks To Watch, outperforming 94% of stocks tracked by Investor's Business Daily with a remarkable 152% increase [1] Market Position - The upgrade in Rigel's Composite Rating reflects its strong market position and investor confidence [4] - Other pharmaceutical stocks, such as Dianthus Therapeutics and PTC Therapeutics, have also seen improvements in their ratings, indicating a positive trend in the sector [4]