On May 12, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines for the treatment of cancer, reported that initial dose escalation data from its Phase 1/1b trial of BH-30236, a macrocyclic CDC-link kinase (CLK) inhibitor, in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) will be presented during a poster session on June 12, 2026, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. Additionally, BH-30236 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of AML.

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"We are highly encouraged by the initial safety data and early signs of anti-leukemic activity observed with BH-30236, both as a monotherapy and in combination with venetoclax," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "By modulating aberrant alternative mRNA splicing, our potential first-in-class CLK inhibitor, BH-30236, represents a novel approach for patients with relapsed or refractory AML and higher-risk MDS, who face a significant unmet medical need. We look forward to presenting additional data from more patients with longer follow-up at the meeting and to advancing BH-30236 in both monotherapy and combination settings."

BH-30236 was designed to target the CLK kinase family, leading to the modulation of aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors. Our Phase 1/1b trial evaluating BH-30236 was initiated following encouraging preclinical data, including evidence of synergistic activity between BH-30236 and venetoclax, a BCL-2 inhibitor and an established standard of care therapy for patients with AML. The trial is currently enrolling patients in dose escalation, evaluating BH-30236 as both a monotherapy and in combination with venetoclax.

As of the January 23, 2026 cutoff date for the EHA (Free EHA Whitepaper) abstract submission, 28 patients received BH-30236 monotherapy at 5-120 mg on a continuous daily administration schedule (QD) and 11 patients received BH-30236 at 20-60mg QD in combination with venetoclax. Initial findings demonstrated:

BH-30236 was generally well tolerated as both a monotherapy and in combination with venetoclax, with most treatment-related adverse events being low-grade and manageable, as well as one grade 3 DLT (diarrhea)
Dose escalation showed predictable pharmacokinetics without drug accumulation or reduction, and no significant drug-drug interactions were observed with venetoclax
Early signs of clinical activity were observed:
In the monotherapy cohort, 29% (n=5) of evaluable patients achieved at least a 50% reduction in bone marrow blast counts, including one HR-MDS patient treated at 60 mg with ongoing blast count reduction with duration of treatment 7.6 months.
In the combination cohort, 55% (n=5) of evaluable patients experienced at least a 50% blast reduction, including one patient refractory to all prior therapy including venetoclax, who achieved a minimal residual disease (MRD)-negative complete remission.
"In March of this year, the U.S. Food and Drug Administration granted Orphan Drug Designation to BH-30236 for the treatment of acute myeloid leukemia, underscoring the need for new therapies in this rare malignancy," said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. "This designation is an important milestone that reflects the potential of BH-30236 to address a significant unmet need and provides benefits that may support our ongoing clinical development, as well as potential market exclusivity upon approval."

Poster Session Details

Title: A First-in-Human Study of the Oral CLK Inhibitor BH-30236 in Adults with Relapsed/Refractory Acute Myeloid Leukemia or Higer-Rish Myelodysplastic Syndrome: Monotherapy and Venetoclax Combination
Presenting Author: Eytan M. Stein, MD, Chief of the Leukemia Service, Associate Attending Physician, Clinical Investigator and Director of the Program for Drug Development in Leukemia on the Leukemia Service at Memorial Sloan Kettering Cancer Center
Date & Time: Friday, June 12 from 12:45 to 1:45 ET / 18:45 – 19:45 CEST
Abstract Code: PF494
About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is designed to modulate aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine. BH-30236 is currently in clinical development for the treatment of relapsed or refractory AML (R/R AML) and HR-MDS.

BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, MAY 12, 2026, View Source [SID1234665580])

On May 12, 2026 Tevogen ("Tevogen Bio Holdings Inc." or "Company") (Nasdaq: TVGN) reported that it has entered into a securities purchase agreement for a private investment in public equity (the "PIPE") financing with existing investor The Patel Family, LLP for gross proceeds of $3 million. The Company intends to use the proceeds from the PIPE financing to support ongoing operations, advance strategic growth initiatives, and for general corporate purposes.

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Pursuant to the terms of the securities purchase agreement, Tevogen will issue 375,000 prefunded warrants each exercisable for the purchase of one share of the Company’s common stock. The PIPE financing was priced at $8.00 per prefunded warrant, which represents a 14% premium to the closing price of the Company’s stock on May 11, 2026. The PIPE financing is expected to close on or about May 13, 2026.

"Having The Patel Family, LLP continue to support Tevogen reflects a shared belief in both our mission and our long-term vision for building a more accessible and sustainable healthcare model," said Tevogen Bio founding CEO Ryan Saadi, MD, MPH. "We believe this financing along with an existing ATM offering and loan agreement, provides the company with access to adequate capital to reach revenue milestones."

"Our continued investment emphasizes our conviction in Tevogen, its leadership and novel technology, and we look forward to being long-term holders," said investor Dr. Manmohan Patel, MD, on behalf of The Patel Family, LLP.

The securities issued in the PIPE financing have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. In connection with the private placement, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares issuable upon exercise of the prefunded warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Tevogen Bio, MAY 12, 2026, View Source [SID1234665579])

On May 12, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported financial results for the first quarter ended March 31, 2026, and provided a business update, including highlights of pipeline progress.

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BBOT’s portfolio of late-stage RAS-pathway inhibitors is designed to enable direct dual inhibition of KRAS in both its ON and OFF states, pan-KRAS coverage across major KRAS mutations, and disruption of RAS-driven PI3Kα activation. Together, these assets uniquely position BBOT to achieve safe, concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly owned internal combination strategy.

"In the first quarter, we reported meaningful progress across all three clinical programs, including encouraging preliminary antitumor activity and a potentially differentiated safety profile for BBO-8520 in lung cancer; anti-tumor activity and a partial response (PR) in pancreatic cancer with BBO-11818 as monotherapy; and confirmation of full target engagement without hyperglycemia for BBO-10203," said Pedro J. Beltran, PhD, Chief Executive Officer of BBOT. "In addition, we announced the publication of BBO-11818 in Cancer Discovery, highlighting its role as a potent and selective pan-KRAS inhibitor. These results and our cash runway into 2028 position us well as we continue advancing our differentiated pipeline to provide new treatment options for patients with limited choices."

Key Clinical Highlights & Upcoming Milestones

BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRAS.

On January 7, 2026, BBOT announced new clinical data from the ongoing Phase 1 ONKORAS-101 trial (NCT06343402).
As of November 15, 2025, BBO-8520 monotherapy in patients with KRASG12C non-small cell lung cancer (NSCLC) showed a 65% objective response rate (ORR) and a 68% 6-month progression-free survival (PFS), with 83% of patients eligible for 6-month follow-up remaining on treatment for ≥6 months, alongside a potentially differentiated safety profile.
BBO-8520 in combination with pembrolizumab demonstrated promising efficacy data and a distinct safety profile at active dose levels, including a potentially differentiated liver toxicity profile.
An internal combination study with BBO-10203 opened in April 2026.
Updated clinical data from the combination trial with pembrolizumab are expected in the second half of 2026.

BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states.

On January 7, 2026, BBOT announced preliminary clinical data from the ongoing Phase 1 KONQUER-101 trial (NCT06917079) for advanced solid tumors. BBO-11818 demonstrated encouraging early anti-tumor activity across dose levels and tumor types, including a PR in a patient with pancreatic ductal adenocarcinoma (PDAC) with a 56% tumor reduction. BBO-11818 monotherapy appeared generally tolerable with no dose-limiting toxicities (DLTs).
On March 6, 2026, BBOT announced the publication of preclinical data describing the discovery and characterization of BBO-11818 in Cancer Discovery, a peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The paper, titled "Discovery of BBO-11818, a Potent and Selective Non-covalent Inhibitor of (ON) and (OFF) KRAS with Activity Against Multiple Oncogenic Mutants," details the foundational science underlying BBOT’s pan-KRAS inhibitor program.
Updated clinical data are expected in the second half of 2026. An internal combination study with BBO-10203 is anticipated to open later in 2026.

BBO-10203: An orally bioavailable small molecule with a novel mechanism of action designed to block the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors.

On January 7, 2026, BBOT announced preliminary clinical data from the ongoing Phase 1 BREAKER-101 trial (NCT06625775).
BBO-10203 demonstrated a differentiated safety profile with no hyperglycemia in patients without restrictions on baseline HbA1c and glucose levels.
In addition, BBO-10203 achieved target systemic exposure and rapid full target engagement.
Clinical benefit was observed in patients with colorectal cancer (CRC) (>80% 3L+) and hormone receptor positive breast cancer (HR+ BC) who were previously heavily treated and tumor reductions were observed in some patients.
Updated clinical data are expected in the second half of 2026 and internal combination studies are anticipated to open in 2026.

Other Key Corporate Updates

In March 2026, Peter F. Lebowitz, MD, PhD, was appointed to BBOT’s Board of Directors. Dr. Lebowitz is Chief Executive Officer and Chief Medical Officer at Third Arc Bio. Previously, he served as Global Head of Oncology R&D at Johnson & Johnson (J&J), where he delivered 13 new drugs to market with over 60 approvals and 12 FDA Breakthrough Therapy Designations. Prior to J&J, he held senior oncology leadership roles at GlaxoSmithKline, where he filed 10 IND applications and advanced two medicines through global registration trials.
Subsequent to the end of the quarter, BBOT announced the appointment of Pedro J. Beltran, PhD, as Chief Executive Officer and Idan Elmelech as Chief Operating Officer, effective April 20, 2026. In addition, Neil Kumar, PhD, was appointed as the Executive Chairman of the Board of Directors and former CEO, Eli Wallace, PhD, will serve as a Senior Adviser to BBOT.

First Quarter 2026 Financial Results

Cash Position: As of March 31, 2026, BBOT had cash, cash equivalents and marketable securities totaling $388.9 million, which is expected to provide cash runway into 2028.
Research and development (R&D) expenses: R&D expenses were $39.8 million for the first quarter of 2026 compared to $20.6 million for the first quarter of 2025. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for BBO-8520, BBO-11818, and BBO-10203.
General and administrative (G&A) expenses: G&A expenses were $6.4 million for the first quarter of 2026 compared to $2.5 million for the first quarter of 2025. Changes in G&A expenses reflect the initiation of BBOT’s standalone operations and de-SPAC transaction.
Net Loss: Net loss was $42.1 million for the first quarter of 2026 compared to $22.1 million for the first quarter of 2025.

(Press release, BridgeBio Oncology Therapeutics, MAY 12, 2026, View Source [SID1234665578])

On May 12, 2026 Mirai Bio, the innovation delivery partner for companies developing next generation nucleic acid medicines, reported new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting 2026 demonstrating the rapid advancement of its CD8-targeted lipid nanoparticle (LNP) platform from novel particle design to functional non-human primate (NHP) proof-of-concept in only 10 months. T cells are a high-value delivery frontier because of their central role in immune biology and relevance across autoimmune diseases, oncology, and other immune-mediated conditions. The two poster presentations show how Mirai’s integrated platform addresses the core requirements for in vivo T-cell targeting, including T-cell specificity, reduced liver-directed delivery, scalable production, tolerability, and functional activity in relevant models, creating a cargo-ready foundation for partner programs.

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"Nucleic acid medicine programs can only move as fast as their delivery systems allow," said Jagesh V. Shah, Ph.D., SVP, Head of Platform at Mirai Bio. "These data show that Mirai can help partners move from delivery concept to functional NHP proof-of-concept with the speed and translational relevance needed to make confident development decisions. For in vivo T-cell programs, that means generating the proof points that matter, including functional activity, tolerability, and a clear path toward the clinic."

In the first poster, Mirai described the discovery and evaluation of novel ionizable lipids and long-circulating LNP compositions designed to support extrahepatic, targeted mRNA delivery to T cells. Using a modular lipid discovery platform, Mirai generated structurally diverse ionizable lipid libraries and screened LNPs with dual mRNA cargoes to assess both liver expression and tissue distribution. Lead particles were reformulated into long-circulating compositions that reduced hepatic expression and supported extrahepatic delivery in mice. These optimized base particles were then converted into CD8-targeted LNPs, which showed selective CD8+ T-cell expression with minimal CD4+ T-cell or B-cell transfection and, when loaded with CD20 CAR mRNA, produced dose-dependent CAR expression and B-cell depletion in CD34+ humanized mice, connecting particle design to functional immune-cell activity.

In the second poster, Mirai extended the CD8-targeted LNP platform into NHP-scale production and functional in vivo evaluation. Mirai generated CD8-targeted LNPs encapsulating mRNA encoding a second-generation human and cynomolgus cross-reactive anti-CD20 CAR and administered the particles systemically in NHPs. A single dose generated CAR-expressing endogenous CD8+ T cells and drove rapid depletion of circulating CD20+ B cells out to seven days post-dose, with reduced CD20+ cells also observed in the spleen at 72 hours. The data also showed a tolerability profile supportive of continued translational development, with cytokine and clinical chemistry findings that were monitored and controlled across studies and no major clinical observations in NHPs through the end of study.

The data were presented at the ASGCT (Free ASGCT Whitepaper) Annual Meeting 2026 in two poster presentations:

Abstract 2008: "Mirai Bio’s CD8-targeted lipid nanoparticle delivery platform enables in vivo generation of CD20 CAR T cells and B cell depletion" was presented by Brian Duke, Ph.D., Principal Scientist, Translational Science at Mirai Bio, on May 12 from 5:00 p.m. to 6:30 p.m. ET.
Abstract 1073: "Novel ionizable lipids and long-circulating LNP compositions designed for extrahepatic delivery to enable targeted mRNA delivery to T cells," was presented by Chelsea Martinez, Ph.D., Senior Scientist I at Mirai Bio, on May 13 from 5:00 p.m. to 6:30 p.m. ET

(Press release, Mirai Bio, MAY 12, 2026, View Source [SID1234665577])

On May 12, 2026 Incyte (Nasdaq:INCY) reported that data from key programs in its Hematology and Oncology franchises will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, to be held June 11 – 14, 2026, in Stockholm, Sweden.

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"The breadth of the data that will be showcased at the 2026 EHA (Free EHA Whitepaper) Congress highlights the continued advancement of our Hematology and Oncology pipeline and our focus on delivering differentiated medicines for patients with cancer and hematologic diseases," said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. "These presentations include findings from the frontMIND study, which support the U.S. and EU regulatory applications for tafasitamab (Monjuvi/Minjuvi) in patients with first-line diffuse large B-cell lymphoma (DLBCL). Additionally, data presentations for INCA033989, which support our Phase 3 trials, demonstrate the steady advancement of this molecularly targeted therapy that has the potential to revolutionize treatment for patients with myeloproliferative neoplasms (MPNs)."

Details on key data presentations at EHA (Free EHA Whitepaper) include:

Plenary Abstract Session

Tafasitamab

Tafasitamab Plus Lenalidomide and R-CHOP for Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results From the Phase 3 frontMIND Study
(Plenary Abstract Session. June 13, 6:00 – 7:30 a.m. ET [12:00-1:30 p.m. CEST]. Abstract #S101.)

Oral Presentations

INCA033989 (mutCALR)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Robust Spleen, Anemia, and Molecular Responses in Patients with Myelofibrosis
(Session: Myeloproliferative neoplasms – Clinical. June 13, 11:15 a.m. – 12:30 p.m. ET [5:15-6:30 p.m. CEST]. Abstract #S216.)

Poster Presentations

INCA033989 (mutCALR)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, Produces Clonal Molecular Responses that Correlate with Clinical Responses in Patients with MF
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF884)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Rapid and Sustained Hematologic and Molecular Responses in Patients with Essential Thrombocythemia (ET)
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1983)

INCA035784 (mutCALR)

Preclinical Evaluation of INCA035784, a Novel T-Cell–Redirecting Antibody for the Treatment of MutCALR-Driven Myeloproliferative Neoplasms (MPNs)
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF858)

INCA160058 (JAK2V617F)

INCB160058 Selectively Targets JAK2V617F-driven Hematopoiesis in Diverse and Drug-Resistant Models of Myeloproliferative Neoplasms (MPNs)
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF872)

Axatilimab

Assessments of Bone Health Among Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab in the AGAVE-201 Trial
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1151)

Axatilimab in Combination with Ruxolitinib in Patients with Newly Diagnosed Chronic Graft-Versus-Host Disease: Updated Safety Analysis of a Randomized, Phase 2 Study
​(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2243)

Ponatinib

Efficacy and Safety of Ponatinib in Pediatric Patients With BCR::ABL–Positive Chronic Phase Chronic Myeloid Leukemia (CP-CML): Preliminary Results From the INCB84344-102 Study
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF628)

Ruxolitinib

Longitudinal Analysis of Iron Deficiency Markers in Patients with Polycythemia Vera Enrolled in the Prospective Observational REVEAL Study
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF910)

Risk factors for Progressive Kidney Impairment Among Patients with Polycythemia Vera (PV) are Recapitulated and Treatable in Mouse Models of PV
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 CEST], Abstract #PF914)

AI-Quantified Bone Marrow Fibrosis and Megakaryocyte Features Correlate With Driver VAF and Outcomes in the MOST MPN Study
​(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1961)

Identification of Biomarkers to Predict Disease Progression Via Molecular Analysis of Patients (pts) with Low-Risk Myelofibrosis (MF) Enrolled in the MOST Study
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1970)

Tafasitamab

Phase 3 inMIND trial of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) in Relapsed/Refractory (R/R) Follicular Lymphoma (FL): Analyses of Biomarkers Predictive of Patient (pt) Response
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1075)

Phase 3 inMIND Study Of Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Clinical Characteristics and Outcomes of Patients Receiving Second-Line Treatment
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF948)

Phase 3 inMIND Study of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) for Relapsed or Refractory Follicular Lymphoma (R/R FL): Outcomes in Patients With or Without High-risk Factors
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2048)

Effectiveness and Safety of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy After Tafasitamab (Tafa) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): A Real-World Study
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2089)

More information regarding the EHA (Free EHA Whitepaper) 2026 Congress can be found at: View Source

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.

Jakafi is a registered trademark of Incyte.

About Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab)
Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

About Niktimvo (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Iclusig (ponatinib) tablets
Iclusig (ponatinib), targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved tyrosine kinase inhibitors.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

(Press release, Incyte, MAY 12, 2026, View Source [SID1234665576])