Rigel(RIGL)
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Why Teradata Shares Are Trading Higher By Around 15%; Here Are 20 Stocks Moving Premarket - Akari Therapeutics (NASDAQ:AKTX), Applied Digital (NASDAQ:APLD)

Benzinga· 2025-11-05 10:09
Core Insights - Teradata Corp reported better-than-expected third-quarter financial results, with earnings of 72 cents per share, surpassing the analyst consensus estimate of 54 cents per share [2] - The company also reported quarterly sales of $416 million, exceeding the analyst consensus estimate of $406.228 million [2] - Following the positive results, Teradata shares rose 14.6% to $23.73 in pre-market trading [2] - Additionally, Teradata raised its FY25 EPS guidance above estimates and issued fourth-quarter EPS guidance above estimates [1] Financial Performance - Teradata's quarterly earnings were 72 cents per share, beating the expected 54 cents per share [2] - Quarterly sales reached $416 million, surpassing the forecast of $406.228 million [2] Market Reaction - Teradata shares experienced a significant increase of 14.6%, reaching $23.73 in pre-market trading following the earnings report [2]
Rigel Pharmaceuticals (RIGL) Tops Q3 Earnings and Revenue Estimates
ZACKS· 2025-11-04 23:26
Core Insights - Rigel Pharmaceuticals (RIGL) reported quarterly earnings of $1.46 per share, exceeding the Zacks Consensus Estimate of $0.93 per share, and showing an increase from $0.7 per share a year ago, resulting in an earnings surprise of +56.99% [1] - The company achieved revenues of $69.46 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 12.80% and up from $55.31 million year-over-year [2] - Rigel's stock has increased by approximately 82.2% since the beginning of the year, significantly outperforming the S&P 500's gain of 16.5% [3] Earnings Outlook - The future performance of Rigel's stock will largely depend on management's commentary during the earnings call and the company's earnings outlook, including current consensus earnings expectations for upcoming quarters [4] - The current consensus EPS estimate for the next quarter is $0.87 on revenues of $64.23 million, and for the current fiscal year, it is $5.49 on revenues of $280.85 million [7] Industry Context - The Medical - Drugs industry, to which Rigel belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - The performance of Rigel's stock may also be influenced by the overall industry outlook, as empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions [5][8]
Rigel(RIGL) - 2025 Q3 - Earnings Call Transcript
2025-11-04 22:30
Financial Data and Key Metrics Changes - The company reported total revenue of $69.5 million for Q3 2025, including record net product sales of $64.1 million, a 65% year-over-year increase [4][27] - Net income for the third quarter was $27.9 million, compared to $12.4 million for the same period in 2024 [29] - Cash balance increased to $137.1 million, up from $77.3 million at the end of 2024 [29] Business Line Data and Key Metrics Changes - TAVALISSE generated $44.7 million in net product sales, a 70% increase year-over-year [11][27] - GAVRETO achieved $11.1 million in net product sales, reflecting a 56% increase compared to Q3 2024 [12][27] - REZLIDHIA reported $8.3 million in net product sales, a 50% increase year-over-year [12][27] Market Data and Key Metrics Changes - The company has expanded access to TAVALISSE in Japan, Europe, Canada, Israel, and South Korea, with ongoing regulatory approvals in new markets [13] - The commercial portfolio has shown strong year-over-year growth, with net product sales exceeding $200 million on a trailing 12-month basis [11] Company Strategy and Development Direction - The strategic objectives focus on growing the hematology and oncology business through commercial performance and pipeline expansion [4] - The company is pursuing additional in-licensing deals or asset acquisitions to achieve significant growth [7] - The 2025 revenue guidance has been raised to $285-$290 million, reflecting anticipated growth of 55%-59% compared to 2024 [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve significant long-term growth through strong commercial execution and financial discipline [9][32] - The company aims to continue driving sales of commercial products while funding key development programs in its internal pipeline [31][32] Other Important Information - The company is advancing its development pipeline, including the ongoing phase 1b study of R289 and collaborations for olutasidenib in various cancer studies [5][16] - The company has received fast-track designation and orphan drug designation from the FDA for R289, indicating a promising regulatory pathway [19] Q&A Session Summary Question: Competitive positioning of R289 in lower-risk MDS versus Rytelo - Management indicated it is too early to speculate on competitive positioning and plans for a registrational study [34] Question: Data needed for potential priority review of R289 - Management noted that the fast-track designation opens potential for priority review, but further data from the dose expansion study is needed [38] Question: Expectations for updated data at ASH for R289 - Management confirmed that updated data will include 16 weeks of follow-up on all patients, providing a robust data set for presentation [40]
Rigel(RIGL) - 2025 Q3 - Earnings Call Presentation
2025-11-04 21:30
Financial Performance & Guidance - Rigel increased its 2025 net product sales guidance from approximately $210 million - $220 million to approximately $225 million - $230 million[15, 89] - Q3 2025 net portfolio sales grew by $25.2 million, a 65% increase compared to Q3 2024[24] - Q3 2025 net product sales were $64.1 million[84] - Rigel anticipates 2025 total revenue of approximately $285 million to $290 million, an increase from the previous guidance of approximately $270 million to $280 million[88] - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $137.1 million, compared to $77.3 million as of December 31, 2024[87] Product Sales Performance - TAVALISSE Q3 2025 net product sales were $44.7 million[27, 86] - GAVRETO Q3 2025 net product sales were $11.1 million[27, 86] - REZLIDHIA Q3 2025 net product sales were $8.3 million[27, 86] R289 Clinical Development - R289 is under evaluation in a Phase 1b study for patients with lower-risk MDS[14, 43] - The FDA granted Fast Track designation for R289 for previously-treated transfusion-dependent lower-risk MDS and Orphan Drug designation for MDS[42, 43] Strategic Collaborations - Grifols collaboration revenues were $3.1 million in Q3 2025[34, 86] - Kissei collaboration revenues were $1.8 million in Q3 2025[34, 86] - Medison collaboration revenues were $0.2 million in Q3 2025[34, 86]
Rigel(RIGL) - 2025 Q3 - Quarterly Results
2025-11-04 21:11
Financial Performance - Total revenue for Q3 2025 was approximately $69.5 million, including record net product sales of $64.1 million, a 65% increase from $38.9 million in Q3 2024[5][8] - Net product sales of TAVALISSE reached $44.7 million, a growth of 70% compared to $26.3 million in the same period of 2024[8][6] - GAVRETO net product sales were $11.1 million, reflecting a 56% increase from $7.1 million in Q3 2024[8][6] - REZLIDHIA net product sales amounted to $8.3 million, a 50% increase from $5.5 million in Q3 2024[8][6] - The company generated a net income of $27.9 million, or $1.55 basic and $1.46 diluted per share, compared to $12.4 million, or $0.71 basic and diluted per share, for the same period of 2024[10] - For the nine months ended September 30, 2025, total revenues were $224.5 million, with net product sales growing 69% compared to $98.4 million in the same period of 2024[12] - Total revenues for Q3 2025 reached $69,462,000, a 25.5% increase from $55,307,000 in Q3 2024[32] - Product sales for Q3 2025 were $64,067,000, up 64.5% compared to $38,927,000 in Q3 2024[32] - Net income for the nine months ended September 30, 2025, was $98,959,000, significantly higher than $3,144,000 for the same period in 2024[32] Guidance and Expectations - Rigel updated its 2025 revenue guidance to approximately $285 to $290 million, up from the previous range of $270 to $280 million[15] - The company anticipates continued growth in its commercial business and ongoing enrollment in the R289 study[29] - Rigel expects to develop and commercialize TAVALISSE, GAVRETO, and REZLIDHIA in domestic and international markets[29] Costs and Expenses - Total costs and expenses for Q3 2025 were $41.0 million, slightly down from $41.3 million in Q3 2024[9] - Research and development expenses for Q3 2025 were $7,353,000, compared to $6,182,000 in Q3 2024, reflecting a 19% increase[32] - Selling, general and administrative expenses for the nine months ended September 30, 2025, totaled $85,908,000, slightly up from $83,539,000 in the same period of 2024[32] Cash and Equity - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $137.1 million, compared to $77.3 million as of December 31, 2024[14] - Cash, cash equivalents, and short-term investments increased to $137,143,000 as of September 30, 2025, compared to $77,321,000 as of December 31, 2024[34] - Stockholders' equity rose to $117,609,000 as of September 30, 2025, a substantial increase from $3,288,000 as of December 31, 2024[34] Research and Development - The ongoing Phase 1b study evaluating R289 for lower-risk MDS has completed enrollment in the dose escalation phase and initiated the dose expansion phase[5][6] Risks and Challenges - Forward-looking statements indicate potential risks related to regulatory approvals and market competition affecting future performance[29]
Rigel(RIGL) - 2025 Q3 - Quarterly Report
2025-11-04 21:06
Revenue Performance - TAVALISSE net product sales for the nine months ended September 30, 2025, were $113.3 million, an increase of $39.5 million or 54% compared to $73.8 million in the same period in 2024[128]. - REZLIDHIA net product sales for the nine months ended September 30, 2025, were $21.4 million, an increase of $5.9 million or 38% compared to $15.6 million in the same period in 2024[129]. - GAVRETO net product sales for the nine months ended September 30, 2025, were $31.9 million, compared to $9.0 million in the same period in 2024[130]. - For the three months ended September 30, 2025, total revenues were $69.462 million, an increase of 25.6% compared to $55.307 million for the same period in 2024[205]. - Product sales for the three months ended September 30, 2025, were $64.067 million, up 64.5% from $38.927 million in the same period of 2024[205]. - TAVALISSE net product sales for the three months ended September 30, 2025, were $44.7 million, a 70% increase compared to $26.3 million for the same period in 2024[206]. - REZLIDHIA net product sales for the three months ended September 30, 2025, were $8.3 million, reflecting a 50% increase from $5.5 million in the same period of 2024[206]. - GAVRETO net product sales for the three months ended September 30, 2025, were $11.0 million, compared to $7.1 million for the same period in 2024, following its commercialization in late June 2024[207][208]. Clinical Trials and Drug Development - R289 is currently in a Phase 1b study with an expected enrollment of approximately 86 patients, focusing on safety, tolerability, and preliminary efficacy in lower-risk MDS[132]. - The FDA granted R289 Orphan Drug designation for myelodysplastic syndromes in January 2025 and Fast Track designation for previously-treated transfusion dependent lower-risk MDS in November 2024[135]. - A strategic collaboration with MDACC was established to evaluate olutasidenib in AML and other hematologic cancers, with $15.0 million in milestone payments over five years[136]. - A collaboration with CONNECT aims to conduct a Phase 2 trial evaluating olutasidenib in combination with temozolomide for HGG, with funding up to $3.0 million[137]. - Lilly is advancing ocadusertib in a Phase 2a clinical trial for rheumatoid arthritis, with a notice received on October 1, 2025, regarding the termination of the CNS disease program[139]. - The Phase 1b study of R289 is expected to enroll approximately 86 patients, with the first patient dosed in December 2022[191]. - As of July 15, 2025, 33 patients were enrolled in the dose escalation part of the R289 study, with a median age of 75 and 61% classified as high transfusion burden[193]. - The collaboration with MDACC includes five studies evaluating olutasidenib in various hematologic cancers, with ongoing enrollment[196]. - The company has strategic collaborations with CONNECT to evaluate olutasidenib in combination with temozolomide for HGG, with the first patient enrolled in October 2025[198]. Regulatory Approvals and Designations - TAVALISSE is approved for chronic ITP treatment in adult patients, with an estimated 81,300 affected individuals in the US[143]. - Fostamatinib received FDA approval in April 2018 and was launched in the US in May 2018[146]. - Olutasidenib, granted orphan drug designation by the FDA, is designed to selectively inhibit mIDH1 and has the potential for durable remissions[161]. - The FDA approved REZLIDHIA for R/R AML with IDH1 mutation in December 2022, with a recommended dosage of 150 mg taken orally twice daily[164]. - R289 was granted Fast Track designation by the FDA in November 2024 for the treatment of previously-treated transfusion dependent lower-risk MDS[194]. Financial Performance and Expenses - Research and development expenses for the three months ended September 30, 2025, increased to $7.4 million from $6.2 million in 2024, reflecting a $1.2 million increase due to clinical trial expenses and personnel-related costs[217]. - Selling, general and administrative expenses for the three months ended September 30, 2025, rose to $28.9 million from $27.0 million in 2024, primarily due to a $1.6 million increase in personnel-related costs[229]. - Interest income for the three months ended September 30, 2025, was $1.1 million, up from $0.4 million in 2024, indicating improved cash and investment balances[232]. - The cost of product sales for the three months ended September 30, 2025, was $4.8 million, down from $8.0 million in 2024, primarily due to a decrease in product costs related to drug supply deliveries[211]. - Research and development expenses for the nine months ended September 30, 2025, totaled $22.6 million, an increase from $17.7 million in 2024, driven by clinical trial activities[218]. - The company anticipates significant increases in selling, general and administrative expenses as it expands commercial activities and engages with healthcare providers[231]. - As of September 30, 2025, the company had approximately $137.1 million in cash, cash equivalents, and short-term investments, compared to $77.3 million as of December 31, 2024, reflecting an increase of 77.5%[240]. - Net cash provided by operating activities for the nine months ended September 30, 2025, was $53.7 million, a significant increase from $17.0 million in the same period of 2024[241]. - Net cash used in investing activities for the nine months ended September 30, 2025, was $67.0 million, primarily due to net purchases of short-term investments[242]. Collaborations and Agreements - The company entered into a collaboration agreement with Kissei for the development and commercialization of olutasidenib in Japan, Korea, and Taiwan in September 2024[175]. - The company paid an upfront fee of $2.0 million for the licensing of REZLIDHIA, with potential additional payments of up to $67.5 million upon achieving development milestones[163]. - The total potential future contingent payments under existing collaboration agreements amount to approximately $1.1 billion, factoring in the impact of Lilly's notice to terminate the CNS disease program[246]. - The company has contractual commitments for potential milestone payments and tiered royalty payments under its agreements with Forma and Blueprint, including unpaid purchase price consideration[258][259]. Market and Competitive Landscape - The AML market is estimated to have an incidence of approximately 22,000 cases in the US in 2025, with 1,000 adult patients identified as having mIDH1 R/R AML[160]. - REZLIDHIA achieved a complete remission (CR) plus complete remission with partial hematologic recovery (CRh) rate of 35% in patients with R/R AML, with over 90% of responders in complete remission[162]. - The Phase 2 registrational trial showed an overall response rate (ORR) of 46% and a median duration of overall response of 11.7 months[165]. - REZLIDHIA demonstrated a median duration of complete response of 28.1 months, significantly longer than standard care[167]. - The National Comprehensive Cancer Network (NCCN) included REZLIDHIA as a recommended targeted therapy for adult patients with R/R AML with IDH1 mutation in January 2023[166]. - GAVRETO, an oral kinase inhibitor for RET fusion-positive NSCLC, became commercially available in June 2024, following the transfer of the NDA[182]. - GAVRETO received FDA exclusivity until September 2025 for metastatic RET fusion-positive NSCLC and until December 2027 for advanced thyroid cancer indications[184]. - GAVRETO is recommended as a preferred first-line treatment option for RET+ patients in the NCCN Guidelines for NSCLC[183]. Future Outlook and Funding - The company expects future revenues to include product sales from both existing and new commercial products, influenced by customer demand and rebate programs[210]. - The company expects its existing capital resources to be sufficient to support current and projected funding requirements for at least the next 12 months[244]. - The company may consider raising additional funds through public and/or private offerings of equity securities or debt financing to support ongoing operations and corporate development activities[250]. - As of September 30, 2025, the company has a potential cancellation fee obligation of approximately $22.6 million related to a contract manufacturing agreement, with $3.0 million due in the remainder of 2025 and $10.5 million due in 2026 and 2027[256]. - The company released a $40.0 million remaining cost share liability after deciding not to exercise its opt-in right for co-funding development costs under the Lilly Agreement[257]. - As of September 30, 2025, the outstanding principal amount of the company's loan with MidCap was $60.0 million, with $30.0 million principal payments due within 12 months[260]. - The company has a lease commitment of $1.3 million related to its lease agreement with 611 Gateway, with $0.7 million payable in the next 12 months[261].
Rigel Reports Third Quarter 2025 Financial Results and Provides Business Update
Prnewswire· 2025-11-04 21:01
Core Insights - Rigel Pharmaceuticals reported strong third-quarter performance, leading to an increase in full-year 2025 revenue guidance due to outstanding commercial execution and pipeline development [2][10]. Financial Performance - Total revenues for Q3 2025 were $69.5 million, comprising $64.1 million in net product sales (up 65% from $38.9 million in Q3 2024) and $5.4 million in contract revenues [4][10]. - Net product sales for TAVALISSE reached $44.7 million (70% growth), GAVRETO at $11.1 million (56% growth), and REZLIDHIA at $8.3 million (50% growth) compared to the same period in 2024 [4][11]. - For the nine months ended September 30, 2025, total revenues were $224.5 million, with net product sales growing 69% year-over-year [7]. Costs and Expenses - Total costs and expenses for Q3 2025 were $41.0 million, slightly down from $41.3 million in Q3 2024, primarily due to lower costs of product sales [5][10]. - Research and development costs increased due to clinical activities related to olutasidenib and R289, along with higher personnel-related costs [5][8]. Net Income - Rigel reported a net income of $27.9 million for Q3 2025, compared to $12.4 million in Q3 2024, translating to $1.55 basic and $1.46 diluted earnings per share [6][10]. Cash Position - As of September 30, 2025, cash, cash equivalents, and short-term investments totaled $137.1 million, up from $77.3 million at the end of 2024 [9][10]. Clinical Development - Rigel is advancing its Phase 1b study of R289 for lower-risk MDS, with enrollment completed in the dose escalation phase and the first patient enrolled in the dose expansion phase [2][11]. - Updated data from the R289 study will be presented at the ASH Annual Meeting in December [10][11]. 2025 Outlook - The company updated its 2025 revenue guidance to approximately $285 to $290 million, an increase from the previous estimate of $270 to $280 million [12][24]. - Rigel anticipates reporting positive net income for the full year 2025 while funding existing and new clinical development programs [12].
Rigel Announces One Oral and Four Poster Presentations at the 67th American Society of Hematology Annual Meeting and Exposition
Prnewswire· 2025-11-03 14:05
Core Insights - Rigel Pharmaceuticals is set to present data from its ongoing Phase 1b study of R289, a dual IRAK1/4 inhibitor, at the 67th American Society of Hematology (ASH) Annual Meeting on December 7, 2025, focusing on patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2][5] - The ASH Annual Meeting will also feature four poster presentations regarding REZLIDHIA (olutasidenib) for treating relapsed or refractory mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML) [1][5] R289 Study Details - The Phase 1b study of R289 has enrolled 33 patients as of July 15, 2025, with a median age of 75 and a median of 3 prior therapies; 61% of these patients had a high transfusion burden at baseline [6] - R289 was administered at doses ranging from 250 mg once daily to 500 mg twice daily, with the most common treatment-emergent adverse events being diarrhea (28.1%), constipation (25%), and increased creatinine/ALT (21.9%) [6] - Among evaluable transfusion-dependent patients receiving doses of at least 500 mg, 31% achieved durable red blood cell transfusion independence for over 8 weeks, with a median time to onset of 2.2 months and a median duration of 24.3 weeks [6] REZLIDHIA Data Highlights - In a pivotal cohort of the Phase 2 registrational study involving 147 patients with R/R mIDH1 AML, 24% maintained stable disease after two treatment cycles, with a subsequent response rate of 33% [9] - The median overall survival for late responders was reported at 23.9 months, indicating that patients with stable disease after two cycles may benefit from continued treatment [9][10] - The overall response rate in a real-world cohort of olutasidenib-treated patients was 50%, supporting its use as a viable therapeutic option in post-venetoclax treatment settings [9][10] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on developing therapies for hematologic disorders and cancer, founded in 1996 and based in South San Francisco, California [26]
Rigel Gears Up to Report Q3 Earnings: Here's What to Expect
ZACKS· 2025-10-31 19:21
Core Insights - Rigel Pharmaceuticals (RIGL) is set to report its third-quarter 2025 results on November 4, with revenue expectations at $61.6 million and earnings at 93 cents per share [1][6] Group 1: Revenue Drivers - The primary revenue sources for Rigel include sales from marketed products and contract revenues from collaborations [2] - The significant revenue growth in Q3 is anticipated to be driven by strong demand for Tavalisse, which treats chronic immune thrombocytopenia (ITP) [2][6] - Sales from other marketed products, Rezlidhia (olutasidenib) and Gavreto (pralsetinib), are also expected to contribute positively to Rigel's revenue in the upcoming quarter [3][6] Group 2: Stock Performance - Year-to-date, Rigel's shares have increased by 88%, significantly outperforming the industry average rise of 7.3% [3] Group 3: Pipeline Developments - Rigel is advancing its pipeline with R289, a dual IRAK1 and IRAK4 inhibitor, currently in early-stage studies for lower-risk myelodysplastic syndrome (MDS) [4] - The company is also exploring additional uses for Rezlidhia beyond its current approval for relapsed or refractory IDH1-mutated acute myeloid leukemia (AML) [7] Group 4: Earnings Surprise History - Rigel has a strong history of earnings surprises, having exceeded earnings expectations in the last four quarters with an average surprise of 1,840.49% [8] Group 5: Earnings Prediction Model - The current model does not predict a definitive earnings beat for Rigel, as the Earnings ESP stands at 0.00% with both the Most Accurate Estimate and the Zacks Consensus Estimate at 93 cents per share [9][10]
This biotech stock has jumped nearly 50% in 3 months. Its CEO says business is 'growing substantially'
CNBC· 2025-10-30 18:20
Core Insights - Rigel Pharmaceuticals has experienced substantial growth, with an average increase of 30% over the past four years and approximately 50% growth this year [1] - The company's stock has surged about 50% in the last three months, making it one of the top-performing stocks in San Francisco [1][2] Financial Performance - In the second quarter, Rigel reported earnings of $3.28 per share, exceeding analyst expectations of $2.58 per share [3] - Revenue for the quarter was $101.7 million, significantly higher than the consensus estimate of $88.9 million [3] - The company raised its full-year revenue guidance to a range of $270 million to $280 million, up from the previous forecast of $200 million to $210 million [3] Product Portfolio - Rigel has three drugs currently on the market: Tavalisse for chronic immune thrombocytopenia, Gavreto for lung cancer, and Rezlidhia for acute myeloid leukemia with IDH1 mutation [4] - The company is advancing two clinical programs, one in partnership with Eli Lilly for Ocadusertib and another for R835, targeting lower-risk myelodysplastic syndrome [5] Clinical Trials and Future Outlook - Rigel is expanding its clinical trials to include a larger patient population, with more definitive data expected by the end of next year [6] - The company plans to present data on R835 at the American Society of Hematology meeting in December [5][6] - The next quarterly results are anticipated to be announced on November 4 [6]