Rigel Reports First Quarter 2026 Financial Results

On May 5, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the first quarter ended March 31, 2026, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress.

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"Rigel entered 2026 with continued year-over-year growth from our commercial portfolio and financial discipline, driving another quarter of profitability. We are operating from a position of financial strength with a solid cash balance that can fund our development plans and allows for financial flexibility to pursue potential in-license opportunities," said Raul Rodriguez, Rigel’s president and CEO. "During the first quarter we also continued to advance our development pipeline, including our ongoing Phase 1b study of R289 in patients with lower-risk MDS, which may be a transformational opportunity for Rigel."

First Quarter 2026 Business Update

Commercial

First quarter net product sales were $54.9 million, an increase of 26% from the same period of 2025.
Corporate

In February, Michael P. Miller joined Rigel’s Board of Directors as an independent director and member of the Compensation Committee.
In April, Rigel received notification from Eli Lilly and Company that it will terminate the collaboration agreement with Rigel, which included the development of ocadusertib (previously R552 or LY3871801), an investigational, potent and selective receptor-interacting protein kinase 1 (RIPK1) inhibitor. The termination will become effective on June 15, 2026.
In early May, Rigel restructured its credit relationship with MidCap Financial to replace its existing term loan credit facility with a revolving credit facility for $40.0 million, with an option to increase to $60.0 million, subject to customary conditions. As part of the transaction, Rigel repaid the remaining outstanding term loan balance of $40.0 million and drew down $8.0 million on the new revolving credit facility.
Clinical Development

Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a potent and selective dual inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose expansion phase of the study is ongoing.
Rigel is on track to complete enrollment of the dose expansion phase of the Phase 1b study and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. The company anticipates sharing preliminary data from the dose expansion phase of the study by the end of 2026.
The first data release for pralsetinib from the TAPISTRY study (NCT04589845) was presented in a poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium (ASCO-GI) in January. The analysis reported results from the Phase 2 global, open-label, multicohort study, in which the efficacy and safety of pralsetinib was evaluated in a cohort of patients with rearranged during transfection (RET) fusion-positive solid tumors, including pancreatic, colorectal, and hepatobiliary cancers. Pralsetinib demonstrated robust and durable activity against RET fusion-positive solid tumors, including gastrointestinal (GI) tumors, and in the efficacy evaluable population showed an overall response rate (ORR) of 67% (26/39). These data supports RET fusions as a tissue-agnostic target with sensitivity to RET inhibition, suggesting the potential therapeutic utility of pralsetinib in these patients.
Key Publications

A paper titled "Matching-Adjusted Indirect Comparison of Olutasidenib and Ivosidenib in Isocitrate Dehydrogenase 1-Mutated Relapsed/Refractory Acute Myeloid Leukemia," was published in Advances in Therapy in February. The publication analysis used a well-accepted methodology called matching-adjusted indirect comparison (MAIC), which adjusts for between study differences in baseline characteristics to better estimate comparative efficacy. The analysis suggests that olutasidenib and ivosidenib achieve similar response rates in R/R isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukemia (AML), but responses achieved with olutasidenib may be more durable. The longer duration of complete remission (CR) plus CR with partial hematologic recovery (CR+CRh) observed with olutasidenib may be clinically meaningful in a setting where sustained remissions are difficult to achieve. While indirect and non-confirmatory, these findings may provide important comparative context for clinicians, medical affairs, and health-policy stakeholders in the absence of head-to-head data.
A paper titled "Final Efficacy and Safety Data From the Phase 1/2 ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)," was published in the Journal of Clinical Oncology in March. The publication reports the final data from the registrational trial evaluating pralsetinib for the treatment of patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The final data, which includes an additional 42 months of follow-up from data previously published, further support the robust, durable responses with a manageable toxicity profile seen in patients with RET fusion-positive NSCLC, and are consistent with previous reports from the ARROW study NSCLC cohort.
First Quarter 2026 Financial Update
For the first quarter ended March 31, 2026, total revenues were $58.8 million, consisting of $54.9 million in net product sales and $3.9 million in contract revenues from collaborations. Net product sales increased 26% compared to $43.6 million in the same period of 2025. TAVALISSE net product sales were $37.3 million, an increase of 31% compared to $28.5 million in the same period of 2025. GAVRETO net product sales were $9.6 million, an increase of 7% compared to $9.0 million in the same period of 2025. REZLIDHIA net product sales were $8.0 million, an increase of 31% compared to $6.1 million in the same period of 2025. Contract revenues from collaborations primarily consisted of $1.8 million of revenue from Grifols S.A. related to earned royalties, $1.8 million of revenue from Kissei Pharmaceutical Co., Ltd. related to delivery of drug supplies and $0.3 million of revenue from Medison Pharma related to earned royalties and delivery of drug supplies. Contract revenues from collaborations in the prior year period included a one-time $3.0 million regulatory milestone in connection with the approval of TAVALISSE in the Republic of Korea.

Total costs and expenses were $46.9 million compared to $40.6 million for the same period of 2025. The increase in costs and expenses was primarily driven by increased research and development costs driven by the timing of clinical activities, including continued progress in our R289 program, as well as increased commercial-related expenses and personnel-related costs.

Income before income taxes was $11.7 million.

Rigel reported net income of $8.7 million, or $0.47 basic and $0.44 diluted per share, compared to $11.4 million, or $0.64 basic and $0.63 diluted per share, for the same period of 2025.

Cash, cash equivalents and short-term investments as of March 31, 2026 was $146.7 million, compared to $155.0 million as of December 31, 2025.

2026 Outlook
Rigel reaffirms its 2026 total revenues guidance of approximately $275 to $290 million, including:

Net product sales of approximately $255 to $265 million.
Contract revenues of approximately $20 to $25 million.
The company also continues to anticipate it will report positive net income for the full year 2026, while funding existing and new clinical development programs.

Conference Call and Webcast with Slides Today at 4:30 p.m. Eastern Time
Rigel will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,720 new cases in the United States, most in adults, in 2026.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow. 5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About TAVALISSE
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and 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 (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for GAVRETO.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE, GAVRETO and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, MAY 5, 2026, View Source [SID1234665129])

AVEO Oncology, an LG Chem company, Announces Two Poster Presentations at ASCO 2026 Annual Meeting

On May 5, 2026 AVEO Oncology, an LG Chem company ("AVEO"), reported that two abstracts were accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 annual meeting this May 29-June 2, 2026, in Chicago, IL.

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Presentation Details

Title: Final analysis of the TiNivo-2 phase 3 trial: Long-term outcome of tivozanib (Tivo) in patients with metastatic renal cell carcinoma (mRCC)
First Author: Robert Motzer, MD, Memorial Sloan Kettering Cancer Center
Abstract Number: 4555
Poster Session: Genitourinary Cancer—Kidney and Bladder
Poster Board: 34
Date and Time: Sunday, May 31, 2026, 9:00am – 12:00 PM CDT

Title: FIERCE-HN: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of ficlatuzumab (HGF/cMET mAb) in combination with cetuximab in participants with recurrent or metastatic (R/M) HPV negative head and neck squamous cell carcinoma (HNSCC)
First Author: Julie E. Bauman, MD, MPH, George Washington University Cancer Center
Abstract Number: TPS6132
Poster Session: Head and Neck Cancer
Poster Board: 585b
Date and Time: Saturday, May 30, 2026, 1:30 PM – 4:30 PM CDT

(Press release, AVEO, MAY 5, 2026, View Source [SID1234665148])

Disc Medicine Reports First Quarter 2026 Financial Results and Provides Business Update

On May 5, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the first quarter ended March 31, 2026, and provided a review of recent program and corporate developments.

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"We continue to make strong progress across the portfolio, completing enrollment in our Phase 3 trial of bitopertin in EPP and remaining on track to report topline data in the fourth quarter of 2026. We were also pleased to have our Phase 2 data for DISC-0974 in MF anemia selected for oral presentation at ASCO (Free ASCO Whitepaper), while continuing to advance multiple additional clinical trials across our pipeline," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Together, these milestones reflect the strength of our execution and position us to deliver multiple important catalysts in the second half of this year."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Completed enrollment of Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026; study size was expanded to 183 patients due to patient and physician demand
Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027
Type A meeting with the US FDA to review approach for resubmission scheduled for Q2 2026
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared in an oral presentation at ASCO (Free ASCO Whitepaper) in June covering N=61 patients with data through April 27, 2026
Topline data from the RALLY-MF study to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study in patients with polycythemia vera and Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026
First Quarter 2026 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $730.2 million as of March 31, 2026, which are expected to fund operational plans into 2029.
Research and Development Expenses: R&D expenses were $45.9 million for the three months ended March 31, 2026, as compared to $27.8 million for the three months ended March 31, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 and DISC-3405 programs, and increased headcount.
Selling, General and Administrative Expenses: SG&A expenses were $23.6 million for the three months ended March 31, 2026, as compared to $12.2 million for the three months ended March 31, 2025. The increase in SG&A expenses was primarily due to increased headcount and establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $63.5 million for the three months ended March 31, 2026, as compared to $34.1 million for the three months ended March 31, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, MAY 5, 2026, View Source [SID1234665114])

Sana Biotechnology to Present at the BofA Securities 2026 Healthcare Conference

On May 5, 2026 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentation at the BofA Securities 2026 Healthcare Conference at 2:20 p.m. PT on Tuesday, May 12, 2026. The presentation will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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The webcast will be accessible on the Investor Relations page of Sana’s website at View Source A replay of the presentation will be available at the same location for 30 days following the conference.

(Press release, Sana Biotechnology, MAY 5, 2026, View Source [SID1234665130])

Senhwa Biosciences Launches Global Study, Targeting Breakthrough in Hard-to-Treat Cancers with CX-5461 and Tislelizumab Combination

On May 5, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company reported the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key milestone in Senhwa’s global clinical development.

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The study will evaluate Senhwa’s first-in-class investigational drug, Pidnarulex (CX-5461), in combination with BeOne Medicines’ marketed PD-1 inhibitor, tislelizumab, across multiple advanced or metastatic solid tumors, including pancreatic cancer, colorectal cancer, and melanoma—areas with significant unmet medical needs. The global multi-center design is expected to accelerate clinical validation while enhancing the asset’s visibility, supporting future out-licensing and commercialization opportunities.

The Company aims to leverage combination therapy approaches to enter the rapidly expanding immuno-oncology market and build sustainable long-term growth momentum.

CX-5461 features a differentiated dual mechanism of action. In addition to inhibiting ribosomal RNA synthesis and suppressing tumor cell proliferation, it stabilizes G-quadruplex structures, inducing DNA damage and activating the cGAS–STING pathway. This unique mechanism not only confers direct anti-tumor activity but also enhances tumor immunogenicity, creating strong synergy with immune checkpoint inhibitors. Preclinical and translational studies have demonstrated that CX-5461 can effectively remodel the tumor microenvironment, increase tumor-infiltrating lymphocytes (TILs), and upregulate PD-L1 expression. These findings suggest its potential to overcome resistance and improve response rates in patients with limited benefit from current immunotherapies, positioning CX-5461 as a promising backbone agent in combination immunotherapy strategies.

According to market research analyses, the global cancer immunotherapy market exceeded US$150 billion in 2025 and is projected to grow at a double-digit compound annual growth rate, potentially surpassing US$300 billion by 2035. Within this expanding landscape, combination therapies have emerged as a central focus for the pharmaceutical industry, serving as a key driver for lifecycle extension and next-generation revenue growth.

At the same time, the pharmaceutical sector is facing increasing pressure from patent expirations of blockbuster drugs, driving strong demand for innovative assets with differentiated mechanisms and clinical potential. Strategic licensing and M&A activities have become primary pathways for large pharmaceutical companies to secure high-value pipeline assets, intensifying competition for early-stage opportunities.

Against this backdrop, the current clinical trial is expected to serve as a critical validation point for CX-5461. Pending positive efficacy and safety outcomes, the asset has the potential to attract strong interest from global pharmaceutical companies for licensing or acquisition, significantly enhancing its commercial prospects and overall market value.

(Press release, Senhwa Biosciences, MAY 5, 2026, View Source [SID1234665149])