On April 28, 2026 Incyte (Nasdaq:INCY) reported financial results for the first quarter of 2026 and provided a business update.

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!

"Our first quarter represented a strong start to 2026, driven by 20% year-over-year net sales growth and strong commercial execution," said Bill Meury, Chief Executive Officer, Incyte. "At the same time, we are making significant progress toward building a more durable, growth oriented portfolio with four anticipated product approvals and launches over the next 12 months, positive registrational data for povorcitinib in vitiligo and a late stage pipeline that now includes 10 Phase 3 studies underway, including the initiation of a pivotal trial of our G12D inhibitor in first line pancreatic ductal adenocarcinoma."

First Quarter 2026 Results
•Total revenue: Total revenue was $1.27 billion, an increase of 21% compared to the first quarter of 2025, primarily driven by an increase in total net sales.
•Total net sales: Total net sales for the first quarter of 2026 were $1.10 billion, an increase of 20% compared to the first quarter of 2025. The increase was primarily related to demand for Jakafi (ruxolitinib) across all indications, Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo, Niktimvo (axatilimab-csfr) in chronic graft versus host disease (GVHD), Monjuvi (tafasitamab-cxix) in follicular lymphoma (FL) and Zynyz (retifanlimab-dlwr) in squamous cell carcinoma of the anal canal (SCAC).
•Cost of sales: GAAP and non-GAAP cost of sales were $104.5 million and $98.3 million, an increase of 43% and 47%, respectively, compared to the prior year period.
•Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $515.9 million and $476.7 million, an increase of 18% and 19%, respectively, compared to the prior year period.
•Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $328.1 million and $304.1 million, an increase of 1% for both, respectively, compared to the prior year period.
•Cash, cash equivalents and marketable securities position: As of March 31, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $4.0 billion and $3.6 billion, respectively.

Key Business Updates
Hematology

Monjuvi/Minjuvi (tafasitamab)
•Data from the pivotal Phase 3 frontMIND trial evaluating tafasitamab and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) for the treatment of patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
◦Abstract Title: frontMIND: Phase 3 study of tafasitamab (Tafa) plus lenalidomide (Len) and R-CHOP for patients (pts) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
◦Abstract Number: 7000
◦Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
◦Date and Time: May 30, 2026, 3:00-6:00 p.m. CDT

Niktimvo
•Data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026.

INCA033989 (mutCALR)
•The Company is on track to initiate a Phase 3 registrational study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy in mid-2026 following a successful end-of-phase meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026.
•Updated data from the ongoing Phase 1 trial in second-line ET and myelofibrosis (MF) patients are anticipated in mid-2026. Data from the cohort evaluating INCA033989 and INCA033989 in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026.
•A Phase 1 study evaluating the pharmacokinetics, safety and tolerability of INCA033989 as a subcutaneous (SC) administration in healthy adult participants was initiated and completed. The Company plans to initiate a Phase 1 study evaluating INCA033989 as a SC administration in mutCALR positive patients mid-year 2026.

INCB160058 (JAK2V617F)
•In the first quarter of 2026, the Company initiated dosing of the amorphous solid dispersion (ASD) formulation of INCB160058 in the Phase 1 trial. Data from the Phase 1 trial evaluating INCB160058 in patients with myeloproliferative neoplasms (MPNs) with a JAK2V617F mutation are anticipated in the second half of 2026.

Jakafi XR (ruxolitinib)
•The Company expects a regulatory decision in the U.S. and potential commercial launch in mid-2026.
Oncology
Zynyz
•In March, the Company announced that the European Commission (EC) approved Zynyz in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent SCAC. This marks the second indication in Europe for Zynyz, which was previously approved by the EC for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

INCB161734 (KRASG12D)
•The Company initiated a Phase 3 study (DAWN-303) evaluating INCB161734 as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) versus chemotherapy alone in the first quarter of 2026.
•Additional data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy as a first-line treatment in patients with metastatic PDAC are anticipated in the second half of 2026.

INCA33890 (TGFβR2xPD-1)
•The Phase 3 study evaluating INCA33890 in combination with standard-of-care chemotherapy and bevacizumab as a first-line treatment in patients with microsatellite stable colorectal cancer (MSS CRC) is ongoing.
•Additional data from the ongoing Phase 1 study evaluating INCA33890 in combination with bevacizumab and/or chemotherapy in patients with solid tumors is expected in the second half of 2026.
Inflammation and Autoimmunity (IAI)
Opzelura
▪The Company expects a regulatory decision in the second half of 2026 following the submission of a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the EU.
▪Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.
Povorcitinib
▪Today the Company announced positive results from the Phase 3 program evaluating povorcitinib (30mg) in adult patients with nonsegmental vitiligo. In both Phase 3 studies (STOP-V1 and STOP-V2), povorcitinib achieved the primary endpoint of >75% reduction in Facial Vitiligo Area Scoring Index (F-VASI75) from baseline at Week 52.
•In STOP-V1, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 6.8% of placebo-treated patients at Week 52 (p<0.001). In STOP-V2, 18.9% of povorcitinib-treated patients achieved a >75% reduction in F-VASI75 compared to 3.1% of placebo-treated patients at Week 52 (p<0.001). Across both studies, statistically significant and clinically meaningful differences were also observed in key secondary endpoint measures, including T-VASI50 at Week 52. The overall safety and tolerability profile of povorcitinib through 52 weeks is consistent with prior studies, with no new safety signals observed. We expect to share additional data from the Phase 3 program in the second half of 2026.

•The positive results from the Phase 3 STOP-V1 and STOP-V2 studies will support regulatory applications for povorcitinib in nonsegmental vitiligo planned for the first half of 2027.
▪The New Drug Application (NDA) submission for povorcitinib as a treatment for patients with moderate to severe HS was accepted by the FDA in the first quarter of 2026. The Company anticipates potential approval and launches in late-2026 in the EU and the first quarter of 2027 in the U.S.
▪In March, 54-week data from the Phase 3 clinical studies (STOP-HS1 and STOP-HS2) evaluating povorcitinib in patients with moderate to severe HS were presented during the late-breaking research session at the 2026 American Academy of Dermatology (AAD) Annual Meeting.
•In the studies, treatment with povorcitinib resulted in clinically meaningful and durable efficacy responses through Week 54. Across both STOP HS1 and STOP HS2, up to 71% of patients achieved HiSCR50, with improvements also observed at higher stringency thresholds, including up to 57% achieving HiSCR75 and up to 29% achieving HiSCR100. These responses were accompanied by consistent resolution across all three key types of inflammatory lesions including inflammatory nodules, abscesses and draining tunnels, as well as meaningful improvements in skin pain, fatigue and quality of life. The overall safety profile of povorcitinib through 54 weeks was consistent with previously reported data, and both doses were well tolerated.

▪Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.
▪Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026.

Corporate Updates

▪Today the Company announced the appointment of Suketu (Suky) Upadhyay to Chief Financial Officer, effective May 4, 2026. Mr. Upadhyay most recently served as Executive Vice President and Chief Financial Officer of Zimmer Biomet. Prior to joining Zimmer Biomet, Mr. Upadhyay served as Senior Vice President of Global Financial Operations at Bristol Myers Squibb, where he was responsible for strategic and operational initiatives across BMS’s supply chain, commercial operations, R&D and business development.

▪In March, the Company announced the appointments of Pablo J. Cagnoni, M.D. to President, Incyte and Global Head of Research and Development, Steven Stein, M.D. to Executive Vice President, Chief Medical Officer and Head of Late-State Development and Mohamed Issa, Pharm.D. to Executive Vice President and Head of U.S. Commercial.

2026 First Quarter Financial Results
The financial measures presented in this press release for the three months ended March 31, 2026 and 2025 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP

(Press release, Incyte, APR 28, 2026, View Source [SID1234664859])

On April 28, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported the successful completion of its previously announced acquisition of Arcellx, Inc. (Nasdaq: ACLX). Under the terms of the transaction, Gilead acquired Arcellx for $115 per share in cash, plus one non-transferable contingent value right (CVR) of $5 per share, representing a total implied equity value of approximately $7.8 billion at the time of closing.

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 acquisition builds on Kite, a Gilead Company, and Arcellx’s successful collaboration and provides Gilead with full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma. By consolidating ownership of anito-cel and eliminating future profit-share, milestone and royalty obligations, Gilead is positioned to accelerate development, streamline decision-making and maximize the long-term potential of the program.

"With the Arcellx acquisition, our focus turns to executing with speed and discipline as we prepare to bring anito-cel to patients," said Cindy Perettie, Executive Vice President and Global Head of Kite. "I want to thank the Arcellx team for their scientific leadership, close collaboration to date and deep expertise they bring as we advance anito-cel. With this acquisition, anito-cel and the differentiated D-Domain BCMA binder will advance within Kite, combining this science with our global manufacturing, regulatory and commercial capabilities to unlock the full value of this potentially transformative therapy for people living with multiple myeloma."

On April 28, 2026, Gilead successfully completed its tender offer for all outstanding shares of common stock of Arcellx and accepted for payment all shares validly tendered and not validly withdrawn as of the expiration time of the tender offer, which shares represented, together with shares already owned by Gilead, approximately 77.2% of Arcellx’s outstanding shares. Following completion of the offer, Gilead completed the acquisition of Arcellx through a merger of Gilead’s wholly owned subsidiary with and into Arcellx, in which shares of Arcellx common stock were cancelled and converted into the right to receive the same $115 per share in cash and one CVR of $5 per share as shares tendered in the offer.

The CVR is payable upon achievement of cumulative global net sales of anito-cel of at least $6.0 billion from launch through the end of 2029.

As a result of the completion of the merger, Arcellx has become a wholly owned subsidiary of Gilead and the common stock of Arcellx will be delisted from the Nasdaq Global Select Market.

This transaction is expected to be accounted for as an asset acquisition and reduce Gilead’s GAAP and non-GAAP 2026 diluted EPS by approximately $5.57 – $5.67. Excluding the impact of acquired in-process research and development expenses, Gilead expects the transaction to be modestly dilutive to earnings per share in 2026 and 2027, and accretive in 2028 and thereafter, subject to FDA approval of anito-cel.

About Anito-cel

Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes a novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Gilead Sciences, APR 28, 2026, View Source [SID1234664856])

On April 28, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present positive preclinical data on the Company’s diabetes gene therapy drug candidate at the upcoming 2026 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place May 11-15, 2026 in Boston, Mass. The collaborators will present preclinical data demonstrating that the diabetes gene therapy (Pdx1/MafA gene therapy, PM or GPX-002) can reverse hyperglycemia in Type 2 diabetic (T2D) mouse models.

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!

"Our collaborators’ preclinical data to be presented at ASGCT (Free ASGCT Whitepaper) 2026 demonstrate the ability of our diabetes gene therapy to reverse hyperglycemia in T2D models, representing a significant advancement toward a novel therapeutic paradigm for T2D patients," said Ryan Confer, President and Chief Executive Officer at Genprex. "The compelling evidence from the preclinical studies, which achieved complete rescue of HFD-induced hyperglycemia at four weeks post-treatment via direct intrapancreatic infusion, suggests the technical translatability of our diabetes gene therapy approach to human application, potentially through endoscopic retrograde cholangiopancreatography, offering a potentially promising avenue for long-term glycemic control in T2D."

The featured Genprex-supported abstract and poster at the 2026 ASGCT (Free ASGCT Whitepaper) Annual Meeting:

Title: "Pancreatic Delivery of AAV-Pdx1/MafA Reverses Hyperglycemia in a Preclinical Model of Type 2 Diabetes"
Abstract ID: 2419
Topic: Gene-Based Therapies in Pre-Clinical Models of Genetic Disease
Poster Presentation Date: Wednesday, May 13, 2026
Poster Presentation Time: 5-6:30 p.m. ET

In this study, eight-week-old male C57BL/6 mice were maintained on a regular diet (RD) or high fat diet (HFD) for 24 weeks. HFD mice then either remained unoperated or underwent intrapancreatic infusion of adeno-associated virus (AAV-8) encoding Pdx1 and MafA (PM) cassettes under the CMV promoter (global–islet cell targeting) or the rat insulin promoter (RIP) (β-cell–specific targeting) or received a control virus. The diet remained unchanged after surgery. At two and/or four weeks after surgery, researchers performed intraperitoneal glucose tolerance testing (IPGTT), insulin tolerance testing (ITT), glucose-stimulated insulin secretion (GSIS), calculated HOMA-IR and assessed glucagon secretion. Mice were then euthanized for pancreatic histology, quantification of β- and α-cell mass, electron microscopy (EM), and islets were isolated for ex-vivo glucose-stimulated insulin secretion (GSIS) and single-cell RNA sequencing. The results at four weeks showed major improvements in the control of diabetes.

At four weeks after surgery, ex-vivo GSIS showed that islets isolated from HFD+CMV-PM-GFP treated mice had insulin secretion similar to islets from RD mice, and both groups had increased insulin secretion compared to islets from the control HFD groups, indicating improved β-cell function with PM treatment.

Similarly, and importantly, treatment of HFD mice with RIP-PM-GFP, which selectively targets β-cells, reversed hyperglycemia and improved ex-vivo GSIS. In addition, EM imaging showed that PM treatment in HFD mice increased the number of total and mature insulin granules and decreased the number of immature insulin granules compared with HFD controls. Furthermore, transcriptomic pseudotime analysis demonstrated a shift in β-cells from an immature state toward a more mature state after PM treatment.

PM gene therapy reverses hyperglycemia, likely in large part by specifically enhancing β-cell function and maturation. This approach is technically translatable to humans using endoscopic retrograde cholangiopancreatography to deliver PM gene therapy to the pancreas.

(Press release, Genprex, APR 28, 2026, View Source [SID1234664855])

On April 28, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported that the first patient has been dosed in the first-in-human, Phase 1/2a study of GLIX1 for the treatment of recurrent and progressive glioblastoma (GBM) and other high-grade gliomas. The GLIX1 program is being conducted under a collaboration between BioLineRx and Hemispherian announced in September 2025.

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 patient was dosed at NYU Langone Health under the supervision of Dr. Alexandra Miller, Chief of Neuro-Oncology & Co-Director of Brain and Spine Tumor Center, Perlmutter Cancer Center. Northwestern University, led by lead investigators Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffit Cancer Center, led by Dr. Patrick Grogan, will also be participating in the study.

GLIX1 is an oral, first-in-class, small molecule with a novel mechanism of action, designed to activate TET2 and drive tumor DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors. Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. GBM remains one of the most aggressive and treatment-resistant cancers, and there is an urgent need for breakthrough innovation and more effective treatment options.

In multiple pre-clinical models, including in-vivo GBM models, GLIX1 demonstrated potent anti-tumor activity, excellent blood-brain-barrier penetration, and a favorable safety profile.

"The dosing of the first patient in our Phase 1/2a study of GLIX1 is an important milestone for BioLineRx and, more importantly, for patients battling glioblastoma, a very challenging tumor where there has been very little innovation over the past 20 years," said Philip Serlin, Chief Executive Officer of BioLineRx. "We believe GLIX1 has the potential to offer a novel therapeutic approach in this cancer indication, as well as in multiple other cancer indications, where DNA damage repair is critical for cancer survival. We are excited to advance GLIX1 development into this first-in-human clinical trial and look forward to initial data in the first half of 2027."

Zeno Albisser, Chief Executive Officer of Hemispherian, added, "The initiation of patient dosing in this important study represents a watershed event for Hemispherian and GLIX1. This is the culmination of years of focused scientific and operational work, and an important step toward bringing a new therapeutic approach to patients with glioblastoma. We are encouraged by our preclinical data and look forward to generating initial clinical insights as the trial progresses."

Phase 1/2a clinical trial design (NCT07464925)

The Phase 1 part of the trial is a dose escalation part where patients receive GLIX1 daily as monotherapy. This part is expected to recruit up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The objective is to establish a maximum tolerated dose (MTD) and/or a recommended dose based on safety, PK/PD and preliminary efficacy. Data from the Phase 1 part of the trial are anticipated in H1 2027.

The Phase 2a expansion part of the trial is planned to include additional indications, including newly diagnosed GBM, as well as select cancers with/without standard of care (e.g., in combination with PARP inhibitors). These cohorts are expected to identify preliminary efficacy, PD assessments and dose optimization data, serving as the basis for a rapid and effective advanced clinical development plan.

(Press release, BioLineRx, APR 28, 2026, View Source [SID1234664852])

On April 28, 2026 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company plans to present at the following 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!

Bank of America Health Care Conference in Las Vegas on Tuesday, May 12, 2026, at 4:40 p.m. ET.
Jefferies Global Healthcare Conference in New York on Wednesday, June 3, 2026, at 3:45 p.m. ET.

Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at www.biocryst.com.

(Press release, BioCryst Pharmaceuticals, APR 28, 2026, View Source [SID1234664851])