On May 4, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the presentation of updated pooled results from two first-in-human clinical trials of Alpha DaRT in pancreatic ductal adenocarcinoma (PDAC) at Digestive Disease Week (DDW) 2026, the world’s premier international gastroenterology conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract, entitled "Updated Results of Feasibility, Safety, and Tumor Control in Two First-In-Human Trials of a Novel Alpha-Emitting Radionuclide for Pancreatic Adenocarcinoma," was selected for podium presentation in the Pancreatic Cancer I: Diagnosis and Treatment session. The abstract is based on combined data from two clinical protocols conducted at Hadassah Medical Center in Jerusalem, Israel, and was presented by Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center. This marks the first time that Alpha DaRT clinical results have been selected for oral presentation at a major gastroenterology conference.

Clinical Results

The results were pooled from two clinical studies of Alpha DaRT treating localized unresectable and metastatic pancreatic cancers in a heterogeneous patient population, including those who were ineligible to receive chemotherapy as well as those who had undergone up to four prior lines of chemotherapy. Despite this breadth and complexity of clinical backgrounds, 100% local disease control was achieved across all 19 evaluable patients based on modified RECIST v1.1 criteria, as measured by best overall response, reflecting 15 (79%) with stable disease and 4 (21%) with partial response, a landmark result underscoring the potential of Alpha DaRT as a compelling intratumoral treatment regardless of prior treatment history.

The safety profile was also highly encouraging. Among 26 subjects treated, only 8 device-associated adverse events were observed in 7 subjects (27%), all of which resolved within two weeks, with the exception of one instance of lingering fatigue.

Uzi Sofer, CEO of Alpha Tau, stated: "These results represent a highly significant milestone for Alpha DaRT and for Alpha Tau’s strategic mission to establish intratumoral alpha-emitting radiotherapeutics as a meaningful option in oncology’s most challenging indications. What makes these data particularly compelling is not only the efficacy and safety signal – which are both exceptional – but also the fact that this treatment was designed to integrate naturally into the existing patient pathway and GI workflow. The ability to deliver Alpha DaRT via EUS, a procedure which gastroenterologists already perform routinely, makes this treatment highly attractive from a clinical adoption perspective. Furthermore, the combination of a localized treatment with systemic approaches represents a major advantage over combinations of other systemic therapies with chemotherapy regimens, which often carry significant toxicity burdens. We believe Alpha DaRT has the potential to fundamentally change how pancreatic cancer is treated, and these results bring us closer to realizing that potential."

"These are some of the most challenging, heavily pre-treated patients in oncology – patients for whom available options are extremely limited," commented Robert Den, MD, Chief Medical Officer of Alpha Tau. "Nevertheless, consistency of response across such a diverse cohort is a powerful signal of Alpha DaRT’s potential. Coupled with a very promising safety profile characterized by low rates of device-associated adverse events and rapid resolution, these results provide a strong foundation for the advancement of Alpha DaRT in pancreatic cancer and further reinforce the scientific basis for our ongoing U.S. multicenter pancreatic cancer IMPACT trial."

Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center, and presenter of the abstract, commented: "As a radiation oncologist and member of a multidisciplinary pancreatic cancer team, I see these results as potentially addressing a significant unmet need from several clinical perspectives. Pancreatic cancer has historically been relatively resistant to radiation therapy, and while modern techniques such as SBRT have improved our ability to deliver ablative doses, their use remains constrained by the close proximity of critical gastrointestinal structures. As a result, achieving meaningful local control without toxicity continues to be a major challenge. The ability to deliver intratumoral alpha-particle therapy via EUS, with consistent disease control across treated patients, hopefully represents an important advance in the radiotherapeutic management of this disease. Equally notable is the favorable toxicity profile. In a patient population already heavily burdened by aggressive systemic chemotherapy, a treatment that offers strong local efficacy with minimal added toxicity is highly compelling. This combination makes Alpha DaRT a treatment I am genuinely excited about for my patients."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, MAY 4, 2026, View Source [SID1234665043])

On May 4, 2026 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the first quarter ended March 31, 2026, and provided recent operational updates.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the first quarter, we continued to build momentum across our ZYNLONTA program," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Looking ahead, we have multiple near-term catalysts, including topline results from LOTIS-5 anticipated in the second quarter, full results expected from both LOTIS-5 and LOTIS-7 by year-end, as well as additional updates from the investigator-initiated studies in indolent lymphomas ahead. We believe that we are well-positioned to expand ZYNLONTA’s role across B-cell malignancies, accelerating our expected growth trajectory starting in 2027."

First Quarter 2026 Operational Updates and Upcoming Milestones

LOTIS-5 topline results anticipated in 2Q 2026. The Company continues to expect to announce topline results from the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA (loncastuximab tesirine-lpyl) in combination with rituximab in the second quarter of 2026, with full results anticipated by year-end. If positive, the Company intends to submit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) before year-end, with potential compendia inclusion in the first half of 2027 and confirmatory approval in 2L+ diffuse large B-cell lymphoma (DLBCL) thereafter.

LOTIS-7 trial ongoing with data anticipated by year-end. The LOTIS-7 Phase 1b trial evaluating ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory (r/r) DLBCL is ongoing, with expected completion of enrollment at the selected 150 µg/kg dose in the first half of 2026. The Company plans to share full data at a medical meeting and through publication by the end of 2026. The Company also intends to evaluate potential regulatory and compendia pathways.

Investigator-Initiated trials (IITs) evaluating ZYNLONTA in additional B-cell malignancies progressing. The University of Miami Sylvester Comprehensive Cancer Center-led multi-center trials of ZYNLONTA in combination with rituximab to treat r/r follicular lymphoma (FL) and ZYNLONTA as a monotherapy to treat marginal zone lymphoma (MZL) are ongoing. The Company anticipates publication of data from both IITs between the end of 2026 and mid-2027. Assuming positive data, the Company intends to assess potential regulatory and compendia pathways.

First Quarter 2026 Financial Results

Product Revenues: Net product revenues were $20.0 million for the first quarter of 2026, as compared to $17.4 million for the first quarter of 2025. The increase in revenue versus the prior year was primarily driven by volume increase, which reflects the normal variability in customer ordering patterns as well as higher price.

License Revenues and Royalties: License revenue and royalties were $0.8 million for the first quarter of 2026, as compared to $5.6 million for the first quarter of 2025. The decrease was primarily driven by a prior year milestone received from our partner.

Cost of Product Sales: Cost of product sales was $3.6 million for the first quarter of 2026, as compared to $2.1 million for the first quarter of 2025. The increase in cost of product sales was primarily attributable to a $1.2 million increase in certain personnel costs, which includes a change in focus of these personnel from research and development clinical supply activities to commercial manufacturing activities.

Research and Development (R&D) Expense: R&D expense was $19.9 million for the first quarter of 2026, as compared to $28.9 million for the first quarter of 2025. The decrease was primarily driven by a $6.1 million decrease in external costs as a result of discontinued programs and completion of the IND-enabling activities for our PSMA-targeting ADC. The decrease was also driven by a shift of certain personnel costs totaling $2.1 million to cost of product sales ($1.2 million), inventory capitalization ($0.6 million), and selling and marketing expense ($0.3 million), reflecting a change in focus of these personnel from research and development activities toward commercial manufacturing and fulfillment activities.

Selling and Marketing (S&M) Expense: S&M expense was $12.7 million for the first quarter of 2026, as compared to $10.6 million for the first quarter of 2025. The increase was primarily due to higher wages and benefits, and marketing and advertising expenses.

General & Administrative (G&A) Expense: G&A expense was $9.9 million for the first quarter of 2026, as compared to $10.0 million for the first quarter of 2025.

Total Operating Expenses and Adjusted Total Operating Expenses: Total operating expenses were $46.1 million for the first quarter of 2026, as compared to $51.5 million for the first quarter of 2025. On a non-GAAP basis, total adjusted operating expenses were $42.9 million for the first quarter of 2026, as compared to $49.1 million for the first quarter of 2025. The reduction in total adjusted operating expenses was primarily driven by lower R&D expenses.

Net Loss and Adjusted Net Loss: Net loss for the first quarter of 2026 was $33.0 million, or a net loss of $0.21 per basic and diluted share, as compared to a net loss of $38.6 million, or a net loss of $0.36 per basic and diluted share, for the first quarter of 2025. Adjusted net loss, which is a non-GAAP financial measure, was $19.7 million, or an adjusted net loss of $0.13 per basic and diluted share, for the first quarter of 2026, as compared to adjusted net loss of $24.0 million, or $0.22 per basic and diluted share, for the first quarter of 2025. The lower net loss and adjusted net loss were primarily due to lower operating expenses and on a per basic and diluted share basis, by a higher number of weighted average shares outstanding.

Cash and Cash Equivalents: As of March 31, 2026, cash and cash equivalents were $231.0 million, compared to $261.3 million as of December 31, 2025, a change primarily driven by cash used in operations and for annual bonus payments. The Company has an expected cash runway at least into 2028.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss first quarter 2026 financial results and provide a company update today at 8:30 a.m. EDT. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

(Press release, ADC Therapeutics, MAY 4, 2026, View Source [SID1234665042])

On May 4, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics, reported its attendance and presentations on its lead Radio-DARPin candidate MP0712 at upcoming scientific conferences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the events:

NIH National Cancer Institute 2026 Small Cell Lung Cancer Consortium Meeting
May 6–7, Rockville, MD, USA
Title: Molecular characteristics of MP0712, a clinical stage ²¹²Pb-based Radio-DARPin candidate for targeted anti-DLL3 radiotherapy of small cell lung cancer (SCLC)
Session: New Therapy Targets
Date & Time: 7 May 2026; 10:30–10:45 am local time

22nd Annual PEGS Boston
May 11–15, Boston, MA, USA
Title: Advancing Radio-DARPin therapeutics: from preclinical insights to clinical development
Session: Novel Platforms and Preclinical-to-Clinical Strategies
Date & Time: 13 May 2026; 2:40–3:10 pm local time

Antibody & Engineering Therapeutics
May 27–29, Basel, Switzerland Title: Radio-DARPins for targeted alpha therapy: first in human insights with MP0712 and opportunities for future candidates
Track: ADCs & Bioconjugates – Advancing ADCs to the Clinic
Date & Time: 29 May 2026; 4:45–5:15 pm local time

(Press release, Molecular Partners, MAY 4, 2026, View Source [SID1234665030])

On May 1, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported that it will present new data from the FLEX Study at the 27th Annual Meeting of the American Society of Breast Surgeons (ASBrS 2026), demonstrating that MammaPrint + BluePrint perform consistently across self-reported race in patients with genomically High-Risk, Basal-Type early-stage breast cancer who are receiving neoadjuvant chemotherapy. In multivariate analyses, pathological complete response (pCR) was driven by biological and treatment-related factors rather than race itself, supporting the robustness of genomic profiling across diverse patient populations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster #1062 | Friday, May 1, 6:00 p.m. – 7:00 p.m. PST | Presenter: Nathalie Johnson
Genomically Basal-Type tumors demonstrate distinct immune profiles and chemosensitivity across self-reported race among patients enrolled in FLEX receiving neoadjuvant chemotherapy

In this real-world cohort of 451 patients with BluePrint Basal-Type early-stage breast cancer treated with neoadjuvant chemotherapy, 46 percent achieved a pCR. While pCR rates varied across self-reported race, multivariate analyses demonstrated that pCR was significantly associated with MammaPrint index, patient age and receipt of platinum-based chemotherapy, rather than race itself.

Whole transcriptome analysis revealed immune active transcriptional profiles among tumors achieving pCR across all racial groups. Importantly, among patients who achieved pCR, significant differences in pathway activation and immune cell composition were observed across race, highlighting biological heterogeneity within chemotherapy-sensitive Basal-Type disease. These findings demonstrate how BluePrint Basal-Type classification captures shared biology associated with response to therapy, while whole transcriptome analysis enables deeper characterization of race-associated molecular and immune differences among responders.

"The FLEX Study provides a unique opportunity to evaluate tumor biology in a population that is more broadly representative than what is typically seen in clinical trials," said Nathalie Johnson, Medical Director of the Legacy Cancer Institute and the Legacy Breast Health centers in Portland, Oregon, and first author of the study. "By including patients from diverse racial backgrounds, FLEX allows us to understand that patient outcomes are tied to shared and distinct biological features. More robust genomic and transcriptomic analyses are crucial in patient selection and in determining therapies that will result in higher pCR in all patient populations. This will help move us closer to equity in treatment outcomes."

"These results align with findings from our recent publication in npj Breast Cancer, which highlight the strength of MammaPrint + BluePrint as biology-driven tools that perform consistently across self-reported racial groups and underscore the importance of identifying patients with High Risk Basal-Type tumors, which are twice as common among Black women compared to White women," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "By identifying tumors most likely to respond to therapy based on intrinsic biology, our assays support treatment decisions that are informed by molecular features rather than by demographic characteristics."

(Press release, Agendia, MAY 1, 2026, View Source [SID1234665014])

On May 1, 2026 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD," said Bill Meury, Chief Executive Officer, Incyte. "Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice."

FDA approval was based on a clinical study which demonstrated that a single 55 mg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg Jakafi tablet, the immediate-release (IR) dosage form, taken twice-daily (BID). This means that, based on key measures of steady-state drug exposure, it delivers the same active ingredient at comparable levels throughout the day, indicating the potential for similar clinical benefit.1

The safety of Jakafi XR has been established from adequate and well-controlled studies of Jakafi in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease. The most common adverse reactions associated with Jakafi in these studies include:

For certain patients with MF and PV: low platelet or red blood cell counts, bruising, dizziness, headache and diarrhea;
For patients with acute GVHD: low platelet counts, low red or white blood cell counts, infections and swelling;
And for patients with chronic GVHD: low red blood cell or platelet counts and infections, including viral infections.2
"Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions," said Naveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "Since its initial approval in 2011, ruxolitinib has helped transform the treatment landscape for patients with MPNs and GVHD. With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet." Researchers at UT MD Anderson have led several clinical trials in the development of ruxolitinib.

Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Jakafi XR have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering personalized patient support, including financial assistance and ongoing education and additional resources. More information about IncyteCARES is available by visiting www.incytecares.com or calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.

About Myelofibrosis
Myelofibrosis (MF) is a part of a group of rare, chronic blood cancers called myeloproliferative neoplasms, or MPNs. MF occurs when a bone marrow defect results in an abnormal production of blood cells, causing scar tissue to form, which can lead to severe anemia, weakness, fatigue and an enlarged spleen and liver. MF can result from a progression of other bone marrow diseases, including polycythemia vera and essential thrombocythemia, or it can occur on its own.3

About Polycythemia Vera
Polycythemia Vera (PV) is a part of a group of rare, chronic blood cancers called myeloproliferative neoplasms, or MPNs.3 PV occurs when bone marrow produces too many red blood cells, white blood cells and often platelets. Increased red blood cells and platelets can cause the blood to thicken, leading to an increased risk of blood clotting complications, including deep vein thrombosis, stroke or heart attack.4

About Graft-Versus-Host Disease
Graft-versus-host disease (GVHD) is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs after 100 days of transplant. Both forms can affect multiple organ systems, including the skin, gastrointestinal (digestive) tract and liver.5

About Jakafi XR (ruxolitinib) Extended-Release Tablets

Jakafi XR (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by the U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults; polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi XR is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi XR and the Jakafi XR logo are trademarks of Incyte.

About Jakafi (ruxolitinib)

Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi and the Jakafi logo are registered trademarks of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

IMPORTANT SAFETY INFORMATION

JAKAFI or JAKAFI XR can cause serious side effects, including:

Low blood counts: JAKAFI or JAKAFI XR may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking JAKAFI or JAKAFI XR and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start and regularly during your treatment. Your healthcare provider may change your dose or stop your treatment based on the results of your blood tests.

Tell your healthcare provider right away if you develop or have worsening symptoms such as:

unusual bleeding
bruising
tiredness
shortness of breath
a fever
Infection: You may be at risk for developing a serious infection during treatment with JAKAFI or JAKAFI XR. Tell your healthcare provider if you develop any of the following symptoms of infection:

chills
nausea
vomiting
aches
weakness
fever
painful skin rash or blisters
Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment.

Do not interrupt or stop treatment without talking to your healthcare provider. Tell your healthcare provider right away if you have any of the following after stopping treatment:

fever
trouble breathing
weakness
night sweats
feeling dizzy or lightheaded
pain in left upper stomach area or left shoulder
Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly check your skin during your treatment. Tell your healthcare provider if you develop any new or changing skin lesions during treatment.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking JAKAFI or JAKAFI XR and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis:
Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with JAKAFI or JAKAFI XR, including:

discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
weakness in one part or on one side of your body
slurred speech
Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening.

Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with JAKAFI or JAKAFI XR, including:

swelling, pain, or tenderness in one or both legs
sudden, unexplained chest or upper back pain
shortness of breath or difficulty breathing
Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of JAKAFI or JAKAFI XR include:

for certain types of polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea
for certain types of myelofibrosis (MF) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea
for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling
for chronic GVHD – low red blood cell or platelet counts and infections, including viral infections
These are not all the possible side effects. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking JAKAFI or JAKAFI XR, tell your healthcare provider about:

all the medications, vitamins, and herbal supplements you are taking
your medical conditions, including if you
have or had low white or red blood cell counts
have an infection
have or had tuberculosis (TB) or have been in close contact with someone who has TB
had shingles (herpes zoster)
have or had hepatitis B
have a high level of fat in your blood (high blood cholesterol or triglycerides)
have or have had a blood clot, heart attack, other heart problems, or stroke
are a current or past smoker
had cancer
have or had liver or kidney problems or are on dialysis. If you are on dialysis, JAKAFI or JAKAFI XR should be taken after your dialysis
have any other medical condition
Women should not take JAKAFI or JAKAFI XR while pregnant or planning to become pregnant. Do not breastfeed during treatment with JAKAFI or JAKAFI XR and for 2 weeks after the final dose.

How should I take JAKAFI or JAKAFI XR?

Take exactly as your healthcare provider tells you.
Do not change your dose or stop taking JAKAFI or JAKAFI XR without first talking to your healthcare provider. If you stop treatment, symptoms of your condition may return.
If you miss a dose, take your next dose at your regular time. Do NOT take 2 doses at the same time.
You may have regular blood tests during your treatment. Based on the results, your healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.
IF YOU ARE PRESCRIBED JAKAFI:
Take JAKAFI 2 times a day or exactly as your healthcare provider tells you, with or without food.
JAKAFI may also be given through certain nasogastric tubes.
Tell your healthcare provider if you cannot take JAKAFI by mouth. Your healthcare provider will decide if you can take JAKAFI through a nasogastric tube. Ask your healthcare provider to give you specific instructions on how to properly take JAKAFI through a nasogastric tube.
IF YOU ARE PRESCRIBED JAKAFI XR:
Take JAKAFI XR 1 time a day with or without food.
Swallow JAKAFI XR whole. Do not split, crush, or chew.
Please see the Full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with JAKAFI or JAKAFI XR at Jakafi.com.

(Press release, Incyte, MAY 1, 2026, View Source [SID1234665013])