On November 4, 2026 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the third quarter of 2026 and raised full year 2026 guidance for Portfolio Receipts.

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"Royalty Pharma delivered excellent third quarter 2026 results and we again raised our financial guidance," said Pablo Legorreta, Royalty Pharma’s Chief Executive Officer and Chairman of the Board. "We delivered 9% growth in Royalty Receipts for the quarter and double-digit growth year-to-date. We continued to strengthen our portfolio by adding royalties on three innovative therapies in the third quarter. We have also seen tremendous clinical and regulatory progress across our portfolio, including FDA approvals of Revolution Medicines’ Rasonque and Teva’s Weltruza and positive Phase 3 results for Amgen’s Imdelltra. Lastly, we remain excited by the potential for R&D co-funding with global biopharma – where we have announced $1 billion of transactions so far this year – which represents an important new opportunity for our business. Looking ahead, with a robust deal pipeline and strong fundamental tailwinds supporting our business, we remain well positioned as a premier capital allocator in life sciences to deliver consistent, compounding growth."

Strong growth in Royalty Receipts in the third quarter of 2026
•Royalty Receipts grew 9% to $883 million, driven by Tremfya, Voranigo, Evrysdi and Imdelltra.
•Portfolio Receipts increased by 9% to $890 million, reflecting higher milestones and other contractual receipts.
Continued healthy transaction activity
•Acquired a royalty on Arcutis Biotherapeutics’ Zoryve for $100 million and on Takeda’s Mimrylo for $100 million.
•Announced value of transactions of $1.9 billion and Capital Deployment of $1.6 billion as of November 3, 2026.
Positive regulatory and clinical updates across royalty portfolio
•FDA approvals for Revolution Medicines’ Rasonque (daraxonrasib) for metastatic pancreatic cancer, Teva’s Weltruza (olanzapine LAI) for schizophrenia and Jazz and BeOne’s Ziihera for HER2+ metastatic gastric cancer.
•Positive Phase 3 results for Amgen’s Imdelltra as a first-line maintenance therapy for small cell lung cancer and Pharvaris’ deucrictibant XR for prophylaxis of hereditary angioedema attacks.
Raising financial guidance for full year 2026 (excludes contribution from future transactions)
•Royalty Pharma now expects 2026 Portfolio Receipts to be between $3,500 million and $3,550 million (previously $3,400 million to $3,500 million), representing expected Royalty Receipts growth of 10% to 11%.

Financial & Liquidity Summary
Three Months Ended September 30,
($ and shares in millions; unaudited)
2026 2025 Change
Portfolio Receipts 890 814 9%
Net cash provided by operating activities 686 703 (2)%
Adjusted EBITDA (non-GAAP)* 840 779 8%
Portfolio Cash Flow (non-GAAP)* 673 657 2%
Weighted average Class A ordinary shares outstanding – diluted 557 560 (0)%

*See "Liquidity and Capital Resources" section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement.

2026 Financial Outlook
Royalty Pharma has provided guidance for full year 2026, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided November 4, 2026
Previous
Portfolio Receipts
$3,500 million to $3,550 million
$3,400 million to $3,500 million
Payments for operating and professional costs
5.5% to 6.0% of Portfolio Receipts
5.5% to 6.5% of Portfolio Receipts
Interest paid
$350 million to $360 million
$350 million to $360 million

Portfolio Receipts is defined as the sum of Royalty Receipts and Milestones and other contractual receipts. The above Portfolio Receipts guidance provided on November 4, 2026 includes expected Royalty Receipts growth of 10% to 11% in 2026.
Royalty Pharma’s full year 2026 guidance reflects an estimated foreign exchange impact of approximately +1% to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2026.
Payments for operating and professional costs in 2026 are expected to decrease as a percentage of Portfolio Receipts, compared to 8.9% in 2025, primarily due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025.
Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedules for the term loan assumed as part of the internalization transaction and borrowings under our revolving credit facility. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 million to $360 million. Interest paid is anticipated to be a de minimis amount in the fourth quarter of 2026. These projections assume no additional debt financing in 2026. In the third quarter of 2026, Royalty Pharma collected interest of $6 million on its cash and cash equivalents, which partially offset interest paid.
Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Portfolio Receipts Highlights
Three Months Ended September 30,
($ in millions; unaudited)
2026 2025 Change
Products: Marketers: Therapeutic Area:
Cystic fibrosis franchise Vertex Rare disease 225 222 1%
Trelegy GSK Respiratory 89 96 (6)%
Tremfya Johnson & Johnson Immunology 80 49 61%
Evrysdi Roche Rare disease 71 52 38%
Tysabri Biogen Neuroscience 67 68 (1)%
Voranigo Servier Oncology 55 33 65%
Xtandi Pfizer, Astellas Oncology 51 50 3%
Imbruvica AbbVie, Johnson & Johnson Oncology 31 41 (24)%
Cabometyx/Cometriq Exelixis, Ipsen, Takeda Oncology 24 21 13%
Imdelltra Amgen Oncology 19 — n/a
Trodelvy Gilead Oncology 16 12 30%
Spinraza Biogen Rare disease 14 14 0%
Amvuttra Alnylam Rare disease 10 — n/a
Promacta Novartis Hematology 9 38 (75)%
Other products(5)
121 114 6%
Royalty Receipts 883 811 9%
Milestones and other contractual receipts 7 3 138%
Portfolio Receipts 890 814 9%

Amounts shown in the table may not add due to rounding.
Royalty Receipts was $883 million in the third quarter of 2026, an increase of 9% compared to $811 million in the third quarter of 2025. The increase was primarily driven by Tremfya, Voranigo, Evrysdi and Imdelltra, partially offset by declines from Promacta due to U.S. generic competition and from Imbruvica. Royalty Receipts from Evrysdi included the benefit of the additional royalties acquired in December 2025.
Portfolio Receipts was $890 million in the third quarter of 2026, an increase of 9% compared to $814 million in the third quarter of 2025, primarily driven by the same Royalty Receipts increases noted above, in addition to higher Milestones and other contractual receipts.

Liquidity and Capital Resources
Royalty Pharma’s liquidity and capital resources are summarized below:
As of September 30, 2026, Royalty Pharma had cash and cash equivalents of $514 million and total debt with principal value of $8.8 billion. The reduction in total debt from $9.2 billion as of June 30, 2026 reflects payment of the $380 million term loan in July 2026.
In the third quarter of 2026, Royalty Pharma paid a quarterly dividend of $0.235 per share, equating to $135 million in dividends and distributions.
Royalty Pharma repurchased approximately 1.5 million Class A ordinary shares for $87 million in the third quarter and 3.5 million Class A ordinary shares for $183 million during the first nine months of 2026. The weighted-average number of diluted Class A ordinary shares outstanding for the third quarter of 2026 was 557 million as compared to 560 million for the third quarter of 2025.
Liquidity Summary
Three Months Ended September 30,
($ in millions; unaudited)
2026 2025
Portfolio Receipts 890 814
Payments for operating and professional costs (50) (34)
Adjusted EBITDA (non-GAAP) 840 779
Interest paid, net (167) (123)
Portfolio Cash Flow (non-GAAP) 673 657

Amounts may not add due to rounding.
•Adjusted EBITDA (non-GAAP) was $840 million in the third quarter of 2026. Payments for operating and professional costs were 5.6% of Portfolio Receipts. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.
•Portfolio Cash Flow (non-GAAP) was $673 million in the third quarter of 2026. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.
Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.
Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $362 million in the third quarter of 2026, consisting primarily of R&D funding for JNJ‑4804 and upfront payments for cliramitug, Zoryve and Mimrylo (see ‘Royalty Transactions’). Capital Deployment was $1.2 billion for the nine months ended September 30, 2026, with the announced value of transactions of $1.9 billion.
The table below details Capital Deployment by category:
Capital Deployment
Three Months Ended September 30, Nine Months Ended September 30,
($ in millions; unaudited)
2026 2025 2026 2025
Purchases of available for sale debt securities — — — (75)
Acquisitions of financial royalty assets (279) (962) (982) (964)
Development-stage funding payments (70) (51) (193) (402)
Milestone payments (13) — (63) (269)
Contributions from legacy non-controlling interests – R&D — (0) — 0
Capital Deployment (362) (1,013) (1,239) (1,709)

Amounts may not add due to rounding.

Royalty Transactions
As of November 3, 2026, Royalty Pharma has announced new transactions of up to $1.9 billion, which reflects the entire amount of potential capital committed for new transactions, including potential future milestones. In the third quarter of 2026, the following transactions were announced:
•In September 2026, Royalty Pharma acquired a royalty interest in Zoryve from AstraZeneca for $100 million upfront. Zoryve, marketed by Arcutis Biotherapeutics, is a topical phosphodiesterase type 4 (PDE4) inhibitor approved for atopic dermatitis, seborrheic dermatitis and plaque psoriasis.
•In August 2026, Royalty Pharma acquired a royalty interest in Mimrylo, formerly known as rusfertide, from Zealand Pharma for $100 million, consisting of $50 million paid upfront and the remaining $50 million payable on the first anniversary of the closing. Marketed by Takeda, Mimrylo is a first-in-class therapy approved for polycythemia vera, a rare and chronic blood disorder.
•In July 2026, Royalty Pharma acquired a portion of Neurimmune AG’s royalty interest in AstraZeneca’s cliramitug for up to $425 million, including $125 million upfront. Cliramitug is a Phase 3 first-in-class transthyretin (TTR)-fibril-depleting antibody designed to remove amyloid deposits in patients with TTR amyloidosis with cardiomyopathy, a progressive, degenerative and fatal disease caused by misfolded proteins that accumulate in the heart.
The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.
Key Developments Relating to the Portfolio
The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
pelabresib
In October 2026, Novartis announced that the regulatory submission for pelabresib in myelofibrosis was completed in the European Union, based on the positive Phase 3 MANIFEST-2 study.
Rasonque (daraxonrasib)
In October 2026, Revolution Medicines announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion of Rasonque for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
In October 2026, Royalty Pharma funded the required first $250 million tranche of the up to $750 million senior secured term loans to Revolution Medicines. Additionally, Revolution Medicines elected not to exercise its option for the third royalty funding tranche (which was up to $250 million). Up to an additional $500 million may be available at Revolution Medicines’ option under each of the senior secured term loan and royalty funding agreement, based on the achievement of certain milestones.
In August 2026, Revolution Medicines announced that the U.S. Food and Drug Administration (FDA) approved Rasonque for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
Niktimvo
In October 2026, Syndax Pharmaceuticals (Syndax) announced that the Phase 2 MAXPIRe trial of Niktimvo in idiopathic pulmonary fibrosis (IPF) did not meet its primary endpoint. Syndax does not plan to move forward with further development in IPF. The results do not affect ongoing trials of Niktimvo in other indications.
Weltruza (TEV-’749)
In October 2026, Teva Pharmaceuticals (Teva) announced that the FDA approved Weltruza for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults.
trontinemab
In September 2026, Roche announced that Phase 3 studies of trontinemab in early Alzheimer’s disease have fully enrolled, with data expected in the first half of 2028.
Imdelltra
In September 2026, Amgen announced positive results from the Phase 3 DeLLphi-305 study of Imdelltra in combination with Imfinzi as first-line maintenance treatment for extensive-stage small cell lung cancer. The study met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival, and also met secondary endpoints of progression-free survival and objective response rate.

deucrictibant
In September 2026, Pharvaris announced positive results from the CHAPTER-3 pivotal Phase 3 study evaluating deucrictibant extended-release for the prevention of hereditary angioedema (HAE) attacks. The primary endpoint and all secondary efficacy endpoints were met with statistical significance.
In July 2026, Pharvaris announced that the FDA accepted its New Drug Application (NDA) for deucrictibant immediate-release for the on-demand treatment of HAE attacks and assigned a Prescription Drug User Fee Act (PDUFA) date of April 23, 2027.
pelacarsen
In September 2026, Novartis announced that the Phase 3 Lp(a)HORIZON trial of pelacarsen did not meet its primary endpoint of reducing the risk of cardiovascular events in the overall study population compared to placebo. In the third quarter of 2026, Royalty Pharma recorded a non-cash impairment charge of $150 million related to pelacarsen.
TEV-’408
In September 2026, Teva announced positive topline results from an ongoing Phase 2a study of TEV-’408, an anti-IL-15 antibody, in adults with celiac disease. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8, and was well tolerated, with no safety signals observed to date.
In July 2026, Teva announced plans to advance TEV-’408 into a Phase 2b study in patients with non-segmental vitiligo, following positive Phase 1b results.
Mimrylo (rusfertide)
In August 2026, Takeda announced that the FDA approved Mimrylo, a hepcidin mimetic peptide, for the treatment of erythrocytosis in adults with polycythemia vera.
Ziihera
In August 2026, Jazz Pharmaceuticals announced that the FDA approved Ziihera in combination with chemotherapy, with or without tislelizumab, for the first-line treatment of adults with metastatic human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal adenocarcinoma.
Trodelvy
In August 2026, Gilead announced that the European Commission approved Trodelvy in combination with Keytruda as a first-line treatment for PD-L1-positive metastatic triple-negative breast cancer.
ecopipam
In August 2026, Teva announced that the FDA accepted its NDA for ecopipam for the treatment of pediatric Tourette syndrome and granted the application Priority Review with a PDUFA date late in the first quarter of 2027.
obexelimab
In August 2026, Zenas BioPharma announced that the FDA accepted for review its Biologics License Application for obexelimab for the treatment of immunoglobulin G4-related disease (IgG4-RD) and assigned a PDUFA target action date of May 27, 2027.
Jideytro (zidesamtinib) and neladalkib
In July 2026, GSK announced that the FDA approved Jideytro, a ROS proto-oncogene 1 (ROS1)-selective inhibitor, for the treatment of adult patients with metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.
In July 2026, GSK announced that it completed the acquisition of Nuvalent for approximately $10.6 billion, including Jideytro and neladalkib, two highly selective ROS1 and anaplastic lymphoma kinase inhibitors for the treatment of non-small cell lung cancer.

Financial Results Call
Royalty Pharma will host a conference call and simultaneous webcast to discuss its third quarter of 2026 results today at 8:00 a.m. Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

(Press release, Royalty Pharma , NOV 4, 2026, View Source [SID1234674181])

On November 4, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that data from the ongoing Phase 1b clinical study of R2891, a potent and selective inhibitor of interleukin receptor-associated kinases 1 and 4 (IRAK1/4), in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed or refractory (R/R) to prior therapies will be presented in an oral session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Saturday, December 12, 2026. In addition, the ASH (Free ASH Whitepaper) Annual Meeting will feature three poster presentations for TAVALISSE (fostamatinib disodium hexahydrate) in patients with immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). The ASH (Free ASH Whitepaper) Annual Meeting is taking place from December 12-15, 2026, in New Orleans, Louisiana and virtually.

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"Data from the dose escalation phase of the ongoing Phase 1b study of R289 in patients with relapsed or refractory lower-risk MDS was presented at an oral session at last year’s ASH (Free ASH Whitepaper)," said Alison L. Hannah, M.D., Rigel’s chief medical officer. "This year the data from our randomized dose expansion phase will also be presented at an oral session, providing an update on both efficacy, including the reduction of transfusion dependence, and safety. We continue to be encouraged by our evolving data in this heavily pretreated patient population."

Key highlights from the ASH (Free ASH Whitepaper) abstracts include:

In the ongoing Phase 1b study of R289 in patients with R/R lower-risk MDS, there were 64 patients enrolled as of July 16, 2026, including 33 patients in the dose escalation phase and 31 patients in the dose expansion phase. At the data cut off, R289 continues to be generally well tolerated in this elderly, heavily pretreated lower-risk MDS patient population, the majority of whom were considered to have high transfusion burden (HTB) disease at baseline. Updated study data as of a planned mid-November data cut will be presented in the oral session, including preliminary efficacy data from the dose expansion phase of the study.
In a retrospective real-world analysis of 90 patients with ITP receiving fostamatinib plus a thrombopoietin receptor agonist (TPO-RA), combination treatment was associated with increased platelet counts. Among 38 patients with available measurements during months 7-12, 81.6% had platelet counts ≥50 × 10³/µL, an increase from 33.3% of 90 patients at baseline. These findings support a treatment approach targeting multiple mechanisms of disease through the combination of fostamatinib and TPO-RAs.
Data from an interim analysis investigating fostamatinib in 799 patients enrolled in the ongoing post-marketing surveillance in Japan will be presented. No new safety signals were detected. Platelet counts increased within two weeks of fostamatinib initiation, with responses maintained at 12 months in a subset of patients who continued treatment and had available follow-up data.
In an open-label long-term extension study enrolling 71 patients with wAIHA that were treated with fostamatinib, durable hemoglobin responses were observed in >50% of patients during follow-up through Week 104. The long-term safety profile was consistent with the established safety profile of fostamatinib, with no new safety signals identified. Fostamatinib remains investigational in this setting.
ASH Annual Meeting abstracts may be accessed online at www.hematology.org.

Abstract Title

Lead
Author / Presenter

Presentation
Type /
Publication #

Session Title

Session
Date /
Time (CT)

R289

Dose Escalating / Dose Expansion Study of R289, a Dual IRAK 1/4 Inhibitor,
in Patients with Relapsed/Refractory (R/R) Lower Risk Myelodysplastic
Syndrome (LR-MDS)

Guillermo Garcia-Manero, MD

Oral presentation Publication #251

637. Myelodysplastic Syndromes: Clinical and Epidemiological: Novel Therapeutic Strategies and Prognostic Stratification in MDS and MDS/MPN

Saturday, December 12, 2026
3:00pm – 3:15pm

TAVALISSE (fostamatinib disodium hexahydrate)

Platelet Responses with Combination Therapy of Fostamatinib and
Thrombopoietin Receptor Agonists in Immune Thrombocytopenia:
An Updated Real-World Analysis

David J. Kuter, MD, DPhil

Poster presentation Publication #1250

311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster I

Saturday, December 12, 2026
5:30pm – 7:30pm

Real-world safety, effectiveness, and predictors of responses to fostamatinib
in patients with ITP: interim analysis of a nationwide post-marketing
surveillance in Japan

Masataka Kuwana, MD

Poster presentation Publication #1252

311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster I

Saturday, December 12, 2026
5:30pm – 7:30pm

Hemoglobin Responses With Fostamatinib in a Long-Term Extension Trial in
Warm Autoimmune Hemolytic Anemia

David J. Kuter, MD, DPhil

Poster presentation Publication #4619

101. Red Cells and Erythropoiesis, Excluding Iron: Poster III

Monday, December 14, 2026

6:00pm – 8:00pm

REZLIDHIA (olutasidenib)

Efficacy of Olutasidenib After Venetoclax in IDH1-Mutated Relapsed/Refractory
Acute Myeloid Leukemia: A Systematic Literature Review and Meta-Analysis

Jorge E. Cortes, MD

Publication only

#7191

N/A

N/A

About R289
R289 is a prodrug of R835, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients.2

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 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 2026.3

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.4,5 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.6 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
Indication
TAVALISSE (fostamatinib disodium hexahydrate) 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.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to ≥3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Click here for Important Safety Information and Full Prescribing Information.

About REZLIDHIA

INDICATION
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.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include
dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.

Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.

Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

DRUG INTERACTIONS

Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.

HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.

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 and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, NOV 4, 2026, View Source [SID1234674180])

On November 4, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a global, commercial-stage oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2026, and provided an update on corporate progress.

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"The U.S. approval and launch of RASONQUE marked a monumental step forward for eligible patients with pancreatic cancer and a transformational quarter for Revolution Medicines, and the CHMP opinion sets the stage for potential approval in the European Union," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We are focused on delivering RASONQUE with urgency and supporting patients as they begin treatment while we rapidly scale our global commercialization capabilities in preparation for potential international approvals. We also continue to advance our broad, integrated portfolio of RAS(ON) inhibitors across common, difficult-to-treat RAS-addicted cancers."

Commercial Highlights

RASONQUE (daraxonrasib) U.S. Launch

On August 26, 2026, the U.S. Food and Drug Administration (FDA) approved RASONQUE (daraxonrasib), the company’s oral RAS(ON) multi-selective inhibitor, for adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Immediately following approval, the company launched RASONQUE in the U.S.

RASONQUE generated net product revenue of $197.6 million for the quarter ended September 30, 2026, reflecting approximately five weeks of commercial availability following FDA approval on August 26. From FDA approval through September 30, 2026, more than 5,000 unique patients received commercial RASONQUE in the U.S.

Initial net product revenue included patients transitioning from the U.S. Expanded Access Program (EAP), patients who had exhausted available treatment options and were awaiting an approved treatment option, and newly eligible patients initiating RASONQUE following its approval, as well as initial stocking of inventory into the channel. The EAP transition and initial cohort of waiting patients are finite early-launch dynamics, and third-quarter results should not be viewed as indicative of the launch’s longer-term trajectory.

Early physician engagement spanned academic cancer centers and community oncology practices. RASONQUE claims have been reimbursed across health plans collectively representing greater than 90% of U.S. PDAC covered lives while formal coverage policies continue to develop. The company’s field access and ON(Path)TM patient support services teams support benefits verification, coverage navigation, financial assistance and patient support.

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines), which guide U.S. clinical practice, were updated to include RASONQUE as a Category 1 Preferred subsequent-therapy option for appropriate patients with locally advanced or metastatic pancreatic cancer, or with recurrent disease following prior systemic therapy. The NCCN Guidelines also list RASONQUE in treatment-naïve metastatic disease as "Useful in Certain Circumstances," with the applicable category linked to prescriber assessments of performance status. These guidelines do not change the FDA-approved indication.

Eligible patients with previously treated metastatic pancreatic cancer are receiving daraxonrasib through Global Named Patient Access (GNPA) in certain countries prior to local regulatory approval. Access follows physician-initiated, unsolicited requests and is subject to applicable local laws and regulations, and operational feasibility.

Positive CHMP Opinion Advances Path Toward Approval in the European Union

The company continues to build its global commercialization capabilities across priority European markets and Japan in preparation for potential international regulatory approvals.

In October, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of daraxonrasib as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, marking a major step toward bringing the medicine to eligible patients in the European Union.

The recommendation follows RASONQUE’s U.S. approval and is based on results from RASolute 302, the first Phase 3 trial in metastatic pancreatic cancer to demonstrate superior efficacy of a targeted medicine versus chemotherapy. The trial demonstrated an unprecedented survival benefit, with consistent benefit across the study population, providing a strong clinical foundation for European access and reimbursement discussions. The positive opinion follows an expedited phased review under the EMA’s Cancer Medicines Pathfinder project. A decision by the European Commission on the marketing application for RASONQUE is pending.

In parallel, Revolution Medicines is advancing its evidence package and preparing for country-specific pricing, reimbursement and access processes across European markets. Following potential European Commission approval, the timing of commercial availability will vary by country governed by the legal and regulatory frameworks within each country.

The company also continues commercial preparations in Japan, subject to regulatory approval.

Clinical Highlights

Pancreatic Adenocarcinoma (PDAC)

With RASONQUE’s U.S. approval establishing a foundation in metastatic pancreatic cancer, Revolution Medicines is advancing four additional global Phase 3 studies across first-line metastatic and adjuvant settings. This multi-asset strategy evaluates RAS(ON) inhibition as monotherapy, in combination with chemotherapy and through a novel RAS(ON) inhibitor doublet, with the aim of extending potential benefit to more patients and earlier stages of disease.

Daraxonrasib in PDAC

At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, the company presented additional exploratory subgroup analyses from the Phase 3 RASolute 302 trial as a late-breaking abstract. The analyses showed that RASONQUE consistently provided an overall survival (OS) benefit compared with chemotherapy across all evaluated RAS genotype subgroups among patients with previously treated metastatic PDAC, including those with no identified tumor RAS mutation. The OS benefit with RASONQUE was also maintained across preselected standard-of-care chemotherapy regimens and prior treatment settings, including early metastatic recurrence following perioperative therapy.

Longer-term follow-up from the ongoing Phase 1 trial evaluating daraxonrasib in combination with gemcitabine and nab-paclitaxel in treatment-naïve metastatic pancreatic cancer will be shared in a late-breaking oral presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium, building on findings previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026.

The company also announced that the FDA granted Breakthrough Therapy Designation (BTD) for the investigational combination of daraxonrasib with gemcitabine and nab-paclitaxel for the treatment of treatment-naïve metastatic pancreatic cancer. This marks the third BTD for daraxonrasib and fifth across the company’s portfolio of RAS(ON) inhibitors.

The company completed U.S. enrollment in RASolute 303, the global Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with chemotherapy in treatment-naïve metastatic pancreatic cancer. Global enrollment is expected to be completed in the first half of 2027.

The company continues to advance RASolute 304, the global Phase 3 trial evaluating daraxonrasib in the adjuvant setting.

Zoldonrasib in PDAC

The FDA granted Orphan Drug Designation (ODD) to zoldonrasib, the company’s oral RAS(ON) G12D-selective covalent inhibitor, for the treatment of pancreatic cancer. This marks the fifth ODD across the company’s portfolio of RAS(ON) inhibitors.

The company announced it has begun treating patients in RASolute 309, the global Phase 3 trial evaluating the novel RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib in patients with treatment-naïve metastatic RAS G12D pancreatic cancer.

The company continues to advance RASolute 305, the global Phase 3 trial evaluating zoldonrasib in combination with chemotherapy in treatment-naïve metastatic RAS G12D pancreatic cancer.

Non-Small Cell Lung Cancer (NSCLC)

Revolution Medicines continues to advance a broad RAS-targeted portfolio in NSCLC, with both clinical-stage RAS(ON) multi-selective and mutant-selective inhibitors designed to address a broad spectrum of RAS-driven malignancies. The clinical-stage portfolio includes mutant-selective inhibitors targeting RAS G12C, G12D and G12V, which together account for more than 70% of RAS mutant NSCLC.

Daraxonrasib in NSCLC

Development of daraxonrasib in previously treated RAS mutant NSCLC continues to advance. Global enrollment in RASolve 301, the Phase 3 trial evaluating daraxonrasib in this setting, is winding down with all sites expected to close enrollment by the end of November 2026, supporting an anticipated initial readout in 2027.

Previously reported Phase 1/2 clinical data evaluating daraxonrasib in RAS mutant NSCLC were published in The New England Journal of Medicine during the quarter.

The NCCN Guidelines were updated to include RASONQUE as a Category 2A available targeted agent for patients with metastatic NSCLC harboring KRAS G12, G13 or Q61 mutations. Daraxonrasib remains investigational for the treatment of NSCLC.

Zoldonrasib in NSCLC

Zoldonrasib continues to advance across multiple treatment settings in NSCLC. The company announced it has begun treating patients in RASolve 308, the global Phase 3 trial evaluating zoldonrasib in combination with pembrolizumab and platinum doublet chemotherapy in patients with treatment-naïve metastatic RAS G12D NSCLC.

Elironrasib in NSCLC

The company initiated RASolve 307, a global Phase 3 trial in patients with treatment-naïve metastatic RAS G12C NSCLC. The trial is evaluating elironrasib, the company’s oral, RAS(ON) G12C-selective covalent inhibitor, in combination with pembrolizumab and platinum doublet chemotherapy.

Colorectal Cancer (CRC)

The company is initiating a global, randomized Phase 3 trial, RASonate 312, evaluating the combination of zoldonrasib, cetuximab and FOLFOX/FOLFIRI in patients with treatment- naïve metastatic RAS G12D CRC compared with standard of care. The trial is based on strong initial clinical activity observed with the zoldonrasib combination regimen, including encouraging objective response rates and disease control rates, along with an acceptable safety and tolerability profile generally consistent with what would be expected for cetuximab and FOLFOX.

Under the companies’ existing agreement, BeOne Medicines is funding and conducting the trial on Revolution Medicines’ behalf. Revolution Medicines expects to provide a clinical data update from its earlier phase CRC studies along with the RASonate 312 trial design in the first half of 2027.

Early-Stage Programs

RMC-5127

The company continues enrollment in the ongoing first-in-human trial evaluating RMC-5127, its oral RAS(ON) G12V-selective, noncovalent inhibitor, and is nearing selection of a candidate recommended Phase 2 dose. The company expects to report initial clinical monotherapy data in 2027.

Innovative New Class of RAS(ON) Inhibitors

The company remains on track to initiate a first-in-human clinical trial evaluating RM-055, a representative of its novel class of mutant-targeted catalytic RAS(ON) inhibitors, in the fourth quarter of 2026.

Collaborations

The company’s development efforts continue to include ongoing clinical collaborations evaluating its RAS(ON) inhibitors in combination with other targeted therapies, including Summit Therapeutics’ PD-1/VEGF bispecific antibody and MTA-cooperative PRMT5 inhibitors from Tango Therapeutics and Bristol Myers Squibb (BMS).

Since its last quarterly update, the company announced the following new collaborations:

•
In August, the company announced a multi-part collaboration with BeOne Medicines including a clinical development collaboration to explore combinations of its RAS(ON) inhibitors with select BeOne oncology assets, including the MTA-cooperative PRMT5 inhibitor BGB-58067 and the EGFR × MET × MET trispecific antibody BG-T187. Separately, the companies entered into a regional rights agreement granting BeOne exclusive development and commercialization rights to four clinical-stage RAS(ON) inhibitors in select Asian markets.
•
In October, the company entered into clinical collaborations with BMS to evaluate pumitamig, an investigational PD-L1/VEGF bispecific immunomodulator jointly developed by BioNTech and BMS, in four planned early-stage combination study cohorts across Revolution Medicines’ RAS(ON) inhibitor portfolio.

Other Corporate Updates

In support of the company’s growing global commercialization capabilities, the company has continued to build its international leadership team, with country general managers now in place across key European markets, Canada and Japan, supported by regional leadership in Europe and the Japan and Asia-Pacific (JPAC) region.

Royalty Pharma Funding Arrangement

RASONQUE’s U.S. approval triggered the mandatory first debt tranche of $250 million under the company’s funding arrangement with Royalty Pharma. The company received the proceeds in October 2026, which are not included in the September 30, 2026 cash, cash equivalents and marketable securities balance.

RASONQUE’s U.S. approval also triggered an optional third royalty tranche of $250 million under the funding arrangement. Given its strong financial position, the company elected not to draw the optional third royalty financing tranche, which would have required incremental future royalty payments. Up to an additional $1 billion in committed capital remains available under the funding arrangement, subject to achievement of specified milestones. All remaining draws are optional and at the company’s election.

Financial Highlights

Third Quarter Results

Net Product Revenue: RASONQUE net product revenue was $197.6 million for the quarter ended September 30, 2026, reflecting approximately five weeks of commercial availability following U.S. FDA approval on August 26, 2026, and initial stocking of product in the channel.

Cash Position: Cash, cash equivalents and marketable securities were $3.7 billion as of September 30, 2026. This balance excludes the $250 million in proceeds received in October associated with the first mandatory debt tranche under the company’s Royalty Pharma funding arrangement.

Cost of Sales: Cost of sales was $0.3 million for the quarter ended September 30, 2026. Product sold during the quarter included inventory manufactured before FDA approval for which manufacturing costs were previously expensed to research and development. Accordingly, cost of sales for the quarter is not representative of normalized cost of sales.

R&D Expenses: Research and development expenses were $417.1 million for the quarter ended September 30, 2026 compared to $262.5 million for the quarter ended September 30, 2025. The increase was primarily driven by higher clinical trial and manufacturing expenses for RASONQUE, zoldonrasib and RMC-5127, increased personnel-related costs due to additional headcount, and higher stock-based compensation expense.

SG&A Expenses: Selling, general and administrative expenses were $153.3 million for the quarter ended September 30, 2026, compared to $52.8 million for the quarter ended September 30, 2025. The increase was primarily driven by higher personnel-related costs associated with additional headcount, higher commercial expenses due to the RASONQUE commercial launch, and higher stock-based compensation expense.

Net Loss: Net loss was $407.5 million for the quarter ended September 30, 2026, compared to net loss of $305.2 million for the quarter ended September 30, 2025. Net loss for the quarter ended September 30, 2026 included non-cash charges of $40.7 million related to a change in the fair value of warrants assumed as part of the company’s acquisition of EQRx, Inc.

Financial Guidance

Revolution Medicines is reiterating full-year 2026 GAAP operating expense guidance of $2.1 billion to $2.2 billion, including expected non-cash stock-based compensation expense of $270 million to $290 million.

Webcast

Revolution Medicines will host a webcast this afternoon, November 4, 2026, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About RASONQUE© (daraxonrasib)

RASONQUE (daraxonrasib) is an oral, RAS(ON) multi-selective, noncovalent, tri-complex inhibitor, approved by the U.S. FDA for the treatment of adult patients with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE is being investigated through a global Phase 3 registrational program in patients with PDAC and metastatic RAS mutant non-small cell lung cancer. Outside the U.S., RASONQUE is an investigational agent that has not been approved by any regulatory authority.

U.S. FDA APPROVED INDICATION

RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

IMPORTANT SAFETY INFORMATION FOR U.S. APPROVED INDICATION

RASONQUE is associated with the following Warnings and Precautions: Dermatologic and Soft Tissue Toxicity, Stomatitis and Oral Disorders, Diarrhea, Gastrointestinal Perforation, Interstitial Lung Disease (ILD)/Pneumonitis, and Embryo-Fetal Toxicity.

Serious adverse reactions occurred in 30% of patients treated with RASONQUE. Serious adverse reactions occurring in ≥ 2% of patients treated with RASONQUE were diarrhea (3.7%), pyrexia (3.3%), sepsis (2.9%), fatigue (2.1%), and hemorrhage (2.1%).

The most common (≥ 20%) adverse reactions in patients treated with RASONQUE were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.

Please see U.S. Full Prescribing Information for RASONQUE

(Press release, Revolution Medicines, NOV 4, 2026, View Source [SID1234674179])

On November 4, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported third quarter 2026 financial results and corporate updates.

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"This quarter, we are very pleased by the pace of enrollment of our ReDiscover-2 trial for second-line breast cancer and also look forward to sharing updated ReInspire data for vascular anomalies at ASH (Free ASH Whitepaper). In addition, we continue to prepare for our frontline breast cancer trial testing the selective-selective combination of zovegalisib and atirmociclib, and we were highly encouraged by the data we saw from Pfizer’s FourLight-1 trial, which we believe showed the potential advantage of a CDK4-selective approach," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. "As we move toward potential launches, we are excited to bring Shannon Campbell onto the Relay team, where she will bring decades of experience in helping companies like ours prepare for commercialization. All of this drives us toward our mission of bringing potentially life-changing therapies to patients across multiple PI3Kα opportunities."

Corporate Highlights

ReDiscover-2 Trial in Second-Line (2L) Breast Cancer Estimated to Complete Enrollment in Mid-2027

•
Continued execution of the Phase 3 ReDiscover-2 trial of zovegalisib + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer
•
The ReDiscover-2 trial is estimated to complete enrollment in mid-2027 based on current enrollment trajectory, approximately one year faster than recent benchmarks

Vascular Anomalies Data and Regulatory Update at ASH (Free ASH Whitepaper) Annual Meeting in December

•
Abstract accepted for the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition covering updated clinical data for zovegalisib in vascular anomalies
o
Oral presentation date: Monday, December 14, 2026
o
Presentation time: 4:00-4:15 pm E.T. / 3:00-3:15 pm C.T.
o
Abstract Number: 878

o
Title: Updated results from part 1 of the ReInspire study evaluating zovegalisib, a mutant-selective PI3Kα inhibitor, in adults and adolescents with PIK3CA-driven vascular malformations
o
Presenter: Dr. Bryan Sisk
o
Relay Therapeutics plans to host a corporate conference call on December 14 after the ASH (Free ASH Whitepaper) presentation to review the presented data, provide a regulatory update, and provide an overview of next steps (call details to be provided at a later date)
•
Continued enrollment of expansion cohorts for adults and adolescents ages 12+ and dose escalation for pediatric patients ages 6-11 in the Phase 1/2 ReInspire trial to further evaluate zovegalisib in patients with PIK3CA-driven vascular anomalies

Shannon Campbell Joins Relay Therapeutics as Head of Commercial

•
Ms. Campbell brings more than 30 years of commercial leadership experience across the pharmaceutical and biotechnology industries, with a track record of building commercial capabilities and preparing organizations for the transition to commercial-stage operations
•
Most recently, Ms. Campbell served as Executive Vice President and Chief Commercial Officer at Merus, where she led commercial-readiness and launch planning for zenocutuzumab and petosemtamab in oncology indications through Merus’ acquisition by Genmab
•
Previously, she held senior leadership roles at Novartis Pharmaceuticals, including U.S. franchise leadership across solid tumor oncology and rare diseases, where her responsibilities included breast cancer and vascular anomalies
•
Ms. Campbell also serves on the board of directors for Zentalis, Hansa Biopharma, and Black Diamond Therapeutics

Newly Announced Research Program: Mutant-Selective TIE2 Inhibitor

•
TIE2 is a receptor tyrosine kinase that, when mutated, is among the most common drivers of venous malformations and other vascular anomalies; an estimated 50,000-60,000 people have TIE2-mutated venous malformations in the U.S.
•
There are currently no approved systemic therapies for venous malformations, and non-selective approaches, either in development or used off-label, inhibit the wild-type TIE2 protein or target other downstream parts of the pathway, which can lead to significant off-target toxicity and limit efficacy
•
Off-target inhibition of wild-type TIE2 is implicated in severe ocular toxicities
•
Relay Therapeutics has discovered a novel modulation hypothesis leading to the discovery of the first known mutant-selective TIE2 inhibitor, which has been designed to address the liabilities of non-selective approaches
•
The program is currently in late-stage preclinical development

First FDA Approval of Molecule Discovered by Relay Therapeutics: LYRFIGTU (Lirafugratinib)

•
The FDA granted full approval for LYRFIGTU (lirafugratinib) as a treatment option for patients with cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement. Relay Therapeutics entered into a global licensing agreement with Elevar Therapeutics (Elevar) in December 2024, granting Elevar worldwide rights to develop and commercialize lirafugratinib
•
This is the first approved medicine to emerge from Relay Therapeutics’ Dynamo platform

Anticipated Milestones:

Breast Cancer

•
Complete enrollment of Phase 3 ReDiscover-2 trial in 2L breast cancer estimated in mid-2027
•
Regulatory update to confirm design for planned Phase 3 trial in 1L endocrine-sensitive breast cancer by year-end 2026
•
Initiation of Phase 3 trial in 1L breast cancer in early 2027
•
Data update for Phase 1/2 ReDiscover trial triplet combination in 2027

Vascular Anomalies

•
Data and regulatory update at ASH (Free ASH Whitepaper) 2026

Third Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of September 30, 2026, cash, cash equivalents and investments totaled $848.6 million, as compared to $910.9 million as of June 30, 2026. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029.

R&D Expenses: Research and development expenses were $77.1 million for the third quarter of 2026, as compared to $68.3 million for the third quarter of 2025. The increase of $8.8 million was primarily due to increases in costs across ongoing clinical trials, as well as non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, partially offset by the impact from strategic choices made to streamline the research organization prior to 2026.

G&A Expenses: General and administrative expenses were $13.1 million for the third quarter of 2026, as compared to $12.1 million for the third quarter of 2025. The increase of $1.0 million was primarily due to non-recurring costs related to the termination of the company’s operating lease at One Kendall Square, as well as increases in other miscellaneous general and administrative costs.

Net Loss: Net loss was $81.7 million for the third quarter of 2026, or a net loss per share of $0.37, as compared to a net loss of $74.1 million for the third quarter of 2025, or a net loss per share of $0.43.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant-selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+/HER2- breast cancer with a PI3Kα mutation and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States, one of the largest patient populations for a precision medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a Phase 1/2 study designed to treat patients with PIK3CA (PI3Kα) mutation-driven vascular anomalies. For more information on zovegalisib, please visit here.

(Press release, Relay Therapeutics, NOV 4, 2026, View Source [SID1234674178])

On November 4, 2026 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported full results for the third quarter of 2026, with net sales and adjusted diluted earnings per share (EPS) ahead of the outlook.

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In line with preliminary results, Q3 2026 sales rose 3% to $548 million compared with Q3 2025, also increasing 3% at constant exchange rates (CER) and exceeding the outlook for about 1-2% CER growth. Consumables and related revenues rose 3% CER and were 91% of sales, while instrument sales rose 1% CER. Sales from the pillars rose 7% CER to $415 million, partly offset by a 7% CER decline in the rest of the portfolio.

Operating income increased to $132 million from $129 million in Q3 2025. Adjusted operating income, which excludes various charges and other items in both periods, rose 6% to $167 million over Q3 2025. The adjusted operating income margin was 30.4% of sales, an increase of 0.8 percentage points from 29.6% in Q3 2025, as sales growth, a growing contribution from higher-margin consumables and efficiency gains supported investments in Parse Biosciences after the late 2025 acquisition.

Diluted EPS was $0.51 in Q3 2026 compared with $0.60 in Q3 2025. Adjusted diluted EPS increased to $0.65 from $0.61, while results at CER of $0.65 were above the outlook for at least $0.62 CER.

Please find a PDF of the full press release at the top of this page.

Use of adjusted results

QIAGEN reports adjusted results and constant exchange rate (CER) measures, along with other non-GAAP financial metrics, to show underlying business performance. These include adjusted gross profit and margin, adjusted EBITDA, adjusted operating income and expenses, adjusted operating income margin, adjusted pre-tax and net income, adjusted tax rate and adjusted diluted EPS, net leverage and free cash flow. Adjusted results are non-GAAP measures that exclude items outside of ongoing core operations or that vary significantly between periods. CER results apply prior-year exchange rates. Free cash flow is defined as operating cash flow less purchases of property, plant and equipment. QIAGEN also uses these measures for planning, forecasting and compensation. They complement, but do not replace, GAAP results, are reconciled in the accompanying tables and may not be comparable to other companies’ measures.

(Press release, Qiagen, NOV 4, 2026, View Source [SID1234674177])