On May 21, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported the final data from the Phase 3 AcceleRET-Lung clinical trial of GAVRETO (pralsetinib) as first-line treatment of rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) will be presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Friday, May 29, 2026.

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In addition, the ASCO (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress will feature poster presentations that include additional data for pralsetinib and data for REZLIDHIA (olutasidenib) for the treatment of relapsed or refractory (R/R) isocitrate dehydrogenase-1 (mIDH1)-mutated acute myeloid leukemia (AML). The ASCO (Free ASCO Whitepaper) Annual Meeting is being held in Chicago, Illinois and virtually from May 29 to June 2, 2026 and the EHA (Free EHA Whitepaper)2026 Congress is being held in Stockholm, Sweden and virtually from June 11 to June 14, 2026.

"Having an oral presentation at ASCO (Free ASCO Whitepaper) as well as multiple additional data presentations at both upcoming medical conferences underscores the continued clinical relevance of our oncology portfolio. We’re pleased that data from the AcceleRET-Lung clinical study will be presented for the first time and the real-world outcome data for olutasidenib will be presented for patients with relapsed/refractory mIDH1 AML previously treated with venetoclax, further validating its role as a treatment option for these patients," said Raul Rodriguez, Rigel’s president and CEO. "Together, these data reinforce our ability to deliver targeted therapies that significantly improve the lives of patients with difficult-to-treat cancers. We look forward to sharing these data with the medical community."

Key highlights from the presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include:

In the Phase 3 AcceleRET clinical trial, pralsetinib met the primary progression-free survival (PFS) endpoint and had a significantly greater overall response rate and more durable response vs. standard of care, demonstrating the clinical utility of pralsetinib in RET fusion-positive NSCLC. In terms of safety, there were 32 (30.0%) and 26 (25.0%) deaths in the pralsetinib and standard of care groups, respectively, with 8 (7.4%) and 0 due to infection. Increased monitoring suggests severe infection risk can be effectively managed.
In the Phase 1/2 ARROW clinical study of pralsetinib in patients with RET altered thyroid cancer and medullary thyroid cancer, pralsetinib yielded clinically meaningful and durable responses with a manageable safety profile, consistent with prior reports.
In an analysis of the patient, disease and molecular characteristics of long-term (LT) complete remission (CR)/CR with partial hematologic recovery (CRh) (>12 months duration of response) in the registrational Phase 2 clinical trial evaluating olutasidenib in patients with R/R mIDH1 AML, olutasidenib enabled LT CR/CRh in half of patients with CR/CRh without transplant (longest response >54 months). Estimated 48-month overall survival was 74% (95% CI: 51%, 88%).
In a separate real-world assessment evaluating treatment patterns, safety and effectiveness of adults with R/R mIDH1 AML receiving olutasidenib following a venetoclax-based therapy in routine practice (73% of patients received olutasidenib as second-line therapy), a subgroup of patients that historically has very poor outcomes, 51 charts were collected from 18 physicians. Olutasidenib demonstrated robust real-world effectiveness with a CR/CRh rate of 60.8% and CR rate of 57% and a median response duration of 30.3 months. Substantial reductions in transfusion dependence further support olutasidenib as a viable post-venetoclax therapeutic option. These findings suggest that earlier sequencing of olutasidenib in the treatment paradigm may optimize patient outcomes.
ASCO Annual Meeting abstracts may be accessed online via View Source EHA (Free EHA Whitepaper)2026 Congress abstracts may be accessed online via the EHA (Free EHA Whitepaper) Library.

ASCO Presentations

Abstract Title

Lead Author / Presenter

Presentation Type / Abstract #

Session Title

Session Date / Time (CT)

GAVRETO (pralsetinib)

Efficacy and safety of pralsetinib as first-line treatment of RET fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC): The phase 3 AcceleRET-Lung study

Sanjay Popat, MBBS, FRCP, PhD

Oral presentation #8504

Lung Cancer—Non-Small Cell Metastatic

Friday, May 29, 2026 1:00pm – 4:00pm

Efficacy and safety of pralsetinib in advanced or metastatic RET-altered thyroid cancer (TC): Final analysis of the phase 1/2 ARROW study

Vivek Subbiah, MD

Poster presentation #6028

Head and Neck Cancer

Saturday, May 30, 2026

1:30pm – 4:30pm

Efficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Data From the TAPISTRY Trial

Chia-Chi Lin, MD, PhD

Poster presentation #3144

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Saturday, May 30, 2026

1:30pm – 4:30pm

Clinical factors driving use of RET inhibitor pralsetinib and associated real-world outcomes in RET fusion–positive NSCLC: A retrospective chart review

Makenzi Evangelist, MD

Publication #e20731

Lung Cancer—Non-Small Cell Metastatic

REZLIDHIA (olutasidenib)

Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenib

Justin M. Watts, MD

Poster presentation #6523

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Monday, June 1, 2026

9:00am – 12:00pm

Real-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR Data

Yasmin Abaza, MD

Publication #e18514

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart Review

Pinkal Desai, MD, MPH

Publication #e18527

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Evaluating the cost per month of response for olutasidenib (OLU) versus ivosidenib (IVO) for patients with relapsed/refractory (R/R) mutant IDH1 (mIDH1) acute myeloid leukaemia (AML)

Yasmin Abaza, MD

Publication #e18504

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

EHA Presentations

Abstract Title

Lead Author / Presenter

Presentation Type / Abstract #

Session Date / Time (CEST)

REZLIDHIA (olutasidenib)

Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using Real-World Data from Chart Review

Pinkal Desai, MD, MPH

Poster presentation #PS1502

Saturday, June 13, 2026 (18:45 – 19:45 CEST)

Acute myeloid leukemia (AML) patient, disease, and molecular characteristics associated with a long-term (LT) response to olutasidenib

Stéphane de Botton, MD, PhD

Poster presentation #PS1625

Saturday, June 13, 2026 (18:45 – 19:45 CEST)

Delphi Consensus on Optimal Treatment Strategies Using IDH1 Inhibitors in Patients with R/R mIDH1 AML

Justin M. Watts, MD

Publication #PB2795

Real-World Treatment Patterns and Outcomes with Olutasidenib After Venetoclax in IDH1-Mutated AML Using EHR Data

Yasmin Abaza, MD

Publication #PB2610

TAVALISSE (fostamatinib disodium hexahydrate)

Health-Related Quality of Life (HRQoL) Among Patients With Immune Thrombocytopenia (ITP) Treated With Fostamatinib in the FORTE Study

Amber Afzal, MD, MSCI

Publication #PB4295

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

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 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 GAVRETO (pralsetinib)

INDICATIONS

GAVRETO (pralsetinib) is indicated for the treatment of:

Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS, INCLUDING OPPPORTUNISTIC INFECTIONS

GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.

WARNINGS AND PRECAUTIONS

Serious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.
Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.
Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.
Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
ADVERSE REACTIONS

Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
DRUG INTERACTIONS

Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.

Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.

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

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.

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

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.

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

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

(Press release, Rigel, MAY 21, 2026, View Source [SID1234665937])

On May 21, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported preliminary clinical data from the Phase 1 study of OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor. The data will be presented in a poster presentation on May 30, 2026 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois. Olema will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

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"We are pleased to share the initial Phase 1 data for OP-3136, which demonstrated acceptable tolerability and promising anti-tumor activity as a monotherapy across multiple dose levels in various advanced solid tumor types," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "The decreases in tumor size observed in over two-thirds of evaluable patients and evidence of on-target engagement reinforce our confidence in OP-3136 as a potential best-in-class KAT6 inhibitor and a potentially differentiated option for difficult-to-treat cancers. We look forward to progressing OP-3136 in development, particularly in combination with palazestrant in metastatic breast cancer."

The Phase 1 study evaluates dose escalation followed by dose expansion of OP-3136 in patients with ER+/HER2- advanced breast cancer (ABC), metastatic castration-resistant prostate cancer (mCRPC), and metastatic non-small cell lung cancer (mNSCLC). In Part 1A, OP-3136 monotherapy was administered orally once daily in 28-day cycles across dose levels from 2 mg to 45 mg. As of the March 2, 2026 data cut-off, 32 heavily pretreated patients who became resistant or intolerant to standard of care treatments were enrolled in this cohort.

Key Findings
Safety and Tolerability

OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed across the evaluated daily dose range up to 45 mg per day orally.
Most treatment-related adverse events (TRAEs) were grade 1 or 2; no grade 4 or 5 TRAEs were observed. TRAEs were manageable with dose modifications; no treatment discontinuations occurred due to TRAEs.
The most common TRAEs were dysgeusia (81% any grade; 56% grade 1, 25% grade 2), anemia (38% any grade; 6% grade 3), and neutropenia (34% any grade; 28% grade 3).

Efficacy and Target Engagement

Among 19 response-evaluable patients across dose levels and tumor types, tumor shrinkage was observed in 13 patients; partial responses (PR) were observed in 3 patients with measurable disease, with 2 confirmed PRs and 1 unconfirmed PR.
The longest duration of treatment is 62 weeks.
11 patients remain on treatment, including 9 with ABC and 2 with mCRPC.
Across all doses tested, OP-3136 demonstrated rapid, sustained, and significant reduction in levels of lysine 23 of histone H3, a direct target of KAT6, consistent with on-target KAT6 inhibition.

Pharmacokinetics

OP-3136 exhibited predictable, dose-proportional plasma exposure across all doses tested.
At doses of 6 mg and above, steady-state concentrations exceeded efficacy targets based on preclinical models.

"These initial results from the Phase 1 study of OP-3136, including confirmed and durable responses and a manageable safety profile in a heavily pretreated population, underscore the potential of KAT6 inhibition as a therapeutic strategy in different solid tumor types," said Amita Patnaik, MD, FRCPC, Principal Investigator, Co-Founder, and Co-Director of Clinical Research at the START Center for Cancer Research. "Supported by evidence of target engagement and predictable pharmacokinetics across all doses evaluated to date, I am excited to further evaluate this novel therapy, both as a monotherapy and in combination with multiple agents, as Phase 1 development continues."

OP-3136 Poster Presentation Details
Title: A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2- advanced breast cancer: preliminary results
Abstract Number: 3088
Poster Number: 225
Date/Time: May 30, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET

OPERA-02 Trial-in-Progress Poster Presentation Details
Olema will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.

Title: OPERA-02: A phase 3 study of palazestrant plus ribociclib as first-line treatment of ER+, HER2- advanced breast cancer
Abstract Number: TPS1152
Poster Number: 261b
Date/Time: June 1, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET

Copies of these posters will be available on the Publications page of Olema’s website in alignment with the ASCO (Free ASCO Whitepaper) embargo. Additional information, including abstracts, is available on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

(Press release, Olema Oncology, MAY 21, 2026, View Source [SID1234665936])

On May 21, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – "Nanobiotix" or the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the pricing of its previously announced global follow-on offering, consisting of (i) a public offering of 225,373 American Depositary Shares ("ADSs"), each ADS representing one ordinary share, €0.03 nominal value per share (each an "Ordinary Share"), of the Company, in the United States (the "U.S. Offering") at an offering price of $38.98 per ADS, and (ii) an offering of (a) 1,959,289 Ordinary Shares and (b) 345,099 pre-funded warrants to subscribe for one Ordinary Share each (the "PFW"), exclusively to "qualified investors" in Europe (including France) within the meaning of Article 2(e) of Regulation (EU) 2017/1129, as amended (the "Prospectus Regulation"), and certain other countries (excluding the United States and Canada) (the "International Offering", together with the U.S. Offering, the "Global Offering"), at an offering price of €33.60 per Ordinary Share and €33.57 per PFW.

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The subscription price of €33.60 per Ordinary Share, corresponding to the offering price of $38.98 per ADS based on an exchange rate of €1.00 = $1.16 as published by the European Central Bank on May 20, 2026, is equal to the volume weighted average price of the Ordinary Shares on the regulated market of Euronext in Paris ("Euronext") over the last three trading sessions preceding the pricing of the Global Offering (i.e. May 18, May 19 and May 20, 2026), less a discount of 14.92% and has been determined by the Company pursuant to the 29th resolution of the Company’s combined shareholders’ meeting held on May 19, 2025 (the "Shareholders’ Meeting"). The subscription price of each PFW is equal to the subscription price per Ordinary Share issued in the International Offering minus €0.03.

The aggregate gross proceeds of the Global Offering are expected to be approximately $98.6 million, equivalent to approximately €85.0 million, of which approximately €73.4 million in respect of the U.S. Offering and the International Offering and €11.6 million in respect of the PFW, before deduction of underwriting commissions in respect of the Global Offering and estimated expenses related to the Global offering, assuming no exercise of the Over-Allotment Option (as defined below) in respect of the Global Offering. If all of the PFW are exercised, the aggregate gross proceeds are expected to be approximately $12k, equivalent to approximately €10k.

Jefferies, TD Cowen and Stifel are acting as global coordinators and joint bookrunners for the Global Offering.

The Global Offering is subject to an underwriting agreement, which was entered into on May 21, 2026. The underwriting agreement does not constitute a performance guarantee (garantie de bonne fin) within the meaning of Article L. 225-145 of the French Commercial Code (Code de commerce).

Type of Offering

The issuance of 2,184,662 Ordinary Shares (including in the form of ADSs) and 345,099 PFW in the Global Offering has been decided on the date hereof by the Company’s Executive Board, without preferential subscription rights for existing shareholders, pursuant to the delegation granted to it by the Shareholders’ Meeting in its 29th resolution.

Main Terms of the Pre-Funded Warrants

The subscription price of each PFW is €33.57 (corresponding to $38.94), which equal to the subscription price per Ordinary Share issued in the Global Offering minus €0.03.

Each PFW will allow its holder to subscribe to one Ordinary Share at a price of €0.03.

The PFW are exercisable in cash from their date of issue until May 26, 2036.

The PFW are securities giving access to the capital within the meaning of Article L. 228-91 of the French Commercial Code. They will be issued in dematerialized form and held in pure registered form (au nominatif pur) in the securities account opened in the name of the holder thereof in the books of the Company’s account keeper.

No fractional shares shall be issuable upon the exercise of PFW, provided that the number of shares to be delivered in respect of any exercise of one or more PFW pursuant to any exercise notice shall be rounded down to the nearest whole multiple of one share.

If the Company carries out any of the transactions referred to in Articles L. 228-99 and L. 228-101 of the French Commercial Code, the rights of holders of the PFW will be maintained in accordance with said articles.

The PFW will not be admitted to trading on Euronext or on any domestic or foreign securities exchange or nationally recognized trading system. The shares issued upon the exercise of PFW (the "PFW Shares") will be held, at the option of the holder, in registered form (au nominatif) or in bearer form (au porteur). As soon as they are issued, the PFW Shares will be automatically assimilated to the Company’s ordinary shares and will be admitted to trading on Euronext under the same ISIN number.

The PFW holders will be grouped automatically for the defense of their common interests in a masse. The masse will act, in part, through a representative and, in part, through collective decisions of the holders.

Expected Closing

The Global Offering is expected to close on May 26, 2026, subject to the satisfaction of customary closing conditions.

Option to Purchase Additional Shares

In connection with the Global Offering, the Company has granted the underwriters for the Global Offering a 30-day option to purchase additional ADSs, in an amount of up to 15% of the total number of ADSs issued in the Global Offering, on the same terms and conditions as in the Global Offering, in accordance with the delegation granted by Shareholders’ Meeting in its 36th resolution (the "Over-Allotment Option"). The Company will announce the exercise of the Over-Allotment Option and the number ADSs to be issued in connection therewith, if any, as soon as practicable thereafter in a subsequent press release.

Stabilization

In connection with the Global Offering, Jefferies LLC, acting as stabilization agent, may effect transactions with a view to supporting, stabilizing, or maintaining the market price of such securities at a level higher than which might otherwise prevail in the Company’s ADS market. However, there is no assurance that the stabilization agent will take any stabilization action and, if begun, such stabilization action may be ended at any time without prior notice. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the Nasdaq Global Select Market.

Estimated Proceeds from the Global Offering

The aggregate gross proceeds from the Global Offering are expected to be approximately $98.6 million, equivalent to approximately €85.0 million, of which approximately €73.4 million in respect of the U.S. Offering and the International Offering and €11.6 million in respect of the PFW, before deducting underwriting commissions in respect of the Global Offering and estimated offering expenses payable by the Company, assuming no exercise of the Over-Allotment Option in connection with the Global Offering. If all of the PFW are exercised, the estimated gross proceeds received by the Company from the Global Offering would be expected to be approximately $12k, equivalent to approximately €10k. If the Company issues additional ADSs pursuant to the exercise in full of the Over-Allotment Option in connection with the Global Offering, the estimated gross proceeds received by the Company from the Global Offering would be expected to be approximately $100 million, equivalent to approximately €87.8 million, before deducting underwriting commissions in respect of the Global Offering and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds from the Global Offering as follows:

less than 10% to support the development and advancement of JNJ-1900 (NBTXR3);
between 50-60% to advance our Nanoprimer and other platforms; and
between 30-40% for general corporate purposes.
The expected use of proceeds represents the Company’s intentions based upon its current plans and business conditions. The Company cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of Global Offering or the amounts that the Company will actually spend on the uses set forth above. The amounts and timing of the Company’s actual expenditures and the extent of clinical development may vary significantly depending on numerous factors, including the progress of the development efforts, the status of and results from preclinical studies and any ongoing clinical trials or clinical trials the Company may commence in the future, as well as any collaborations that the Company may enter into with third parties for its product candidates and any unforeseen cash needs. As a result, the Company’s management will retain broad discretion over the allocation of the net proceeds.

The Company believes that the net proceeds from the Global Offering, together with its cash and cash equivalents, will be sufficient to meet its working capital requirements for operations into 2029, consistent with the Company’s currently contemplated cash burn rate.

The Company’s estimates of the period of time through which its financial resources are expected to be adequate to meet its working capital requirements are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, as described under "Special Note Regarding Forward-Looking Statements."

Lock-up

In connection with the Global Offering, the Company’s executive board members and supervisory board members are subject to a contractual lock-up for a period of 90 days after the date hereof, subject to customary exceptions, including an exception for the purpose of financing the exercise price of stock options and/or satisfying any applicable taxes due in connection with such exercise. The Company has also agreed to be bound by a contractual lock-up for a period of 90 days after the date hereof, subject to customary exceptions.

Dilution

The transaction was supported by existing shareholders including Qatar Holding LLC and Invus, as well as other healthcare specialist investors.

On an indicative basis, assuming the full exercise of the Over-Allotment Option and of the PFW and, based on the number of outstanding Company’s shares and the Company’s shareholder structure as of 31 December 2025,, the Company’s shareholder structure would, to its knowledge, be as follows:

Shareholders

Before the Global Offering After the Global Offering excluding full exercise of the Over-Allotment Option After the Global Offering and full exercise of the Over-Allotment Option After the Global Offering and full exercise of the Over-Allotment Option and the PFW
Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights Number of Shares % of share capital % voting rights
Invus (A) 5 844 592 12.07% 11.67% 6 095 038 12.05% 11.66% 6 095 038 12.04% 11.65% 6 440 137 12.63% 12.23%
JJDC (B) 5 623 816 11.62% 11.23% 5 623 816 11.12% 10.76% 5 623 816 11.11% 10.75% 5 623 816 11.03% 10.68%
Qatar Holding LLC (C) 4 298 507 8.88% 8.58% 4 526 185 8.95% 8.66% 4 526 185 8.94% 8.65% 4 526 185 888% 8.60%
Total (A) + (B) + (C° 15 766 915 32.57% 31.48% 16 245 039 32.11% 31.08% 16 245 039 32.09% 31.06% 16 590 138 32.55% 31.72%
Laurent Levy 1 394 292 2.88% 4.47% 1 394 292 2.76% 4.28% 1 394 292 2.75% 4.28% 1 394 292 2.74% 4.25%
Bart Van Rhijn 356 747 0.74% 0.71% 356 747 0.71% 0.68% 356 747 0.70% 0.68% 356 747 0.70% 0.68%
Anne-Juliette Hermant 241 708 0.50% 0.76% 241 708 0.48% 0.73% 241 708 0.48% 0.73% 241 708 0.47% 0.72%
Other managers and employees 253 585 0.52% 0.66% 253 585 0.50% 0.63% 253 585 0.50% 0.63% 253 585 0.50% 0.63%
Total Management & Employees 2 246 332 4.64% 6.66% 2 246 332 4.44% 6.33% 2 246 332 4.44% 6.32% 2 246 332 4.41% 6.32%
Free Float 30 374 703 62.74% 61.92% 32 081 241 63.41% 62.60% 32 115 046 63.43% 62.62% 32 165 152 63.00% 62.21%
Treasury Shares 22 118 0.05% 22 118 0.04% 22 118 0.04% 22 118 0.04%
TOTAL 48 410 068 100.00% 100.00% 50 594 730 100.00% 100.00% 50 628 535 100.00% 100.00% 51 023 740 100.00% 100.00%

On an indicative basis, the impact of the Global Offering on the shareholding of a shareholder holding 1% of the Company’s share capital prior to the Global Offering and not subscribing to it, and on the Company’s equity per share, is as follows (based on 48,410,068 Company’s shares outstanding and equity of €-84.483 million as of December 31, 2025):

Shareholding Equity per share
Non-diluted basis Diluted basis* Non-diluted basis Diluted basis*
Before the Global Offering 1.0000% 0.9066% -1.75 -1.58
After the Global Offering 0.9568% 0.8710% -1.67 -1.52
After the Global Offering (assuming the full exercise of the Over-Allotment Option) 0.9562% 0.8705% -1.67 -1.52
After the Global Offering (assuming the full exercise of the Over-Allotment Option and of the PFW) 0.9497% 0.8651% -1.66 -1.51

* including the 4,985,304 new ordinary shares issuable upon the exercise of founders’ warrants (BSPCE), warrants (BSA), and stock options (OSA) as of December 31, 2025.

Risk Factors

Potential investors should carefully consider the risks described under "Risk Factors" in the Preliminary Prospectus Supplement (as defined below), including the following risks:

shareholders not participating in the Global Offering may see their participation in the Company’s share capital diluted due to the issuance of new securities;
the volatility and liquidity of the Company’s Ordinary Shares and ADSs may experience significant fluctuation (mainly downwards), and there may be differences on Nasdaq and Euronext; and
sales of the Company’s Ordinary Shares and ADSs, in particular by its significant shareholders, could occur on the market and have an adverse impact on the Company’s trading prices.
Settlement and Delivery – Documentation

The Company’s ADSs are listed on the Nasdaq Global Select Market under the ticker symbol "NBTX". The Company’s Ordinary Shares are listed on Euronext under the symbol "NANO." The Company does not intend to list the PFW on any domestic or foreign securities exchange or nationally recognized trading system.

The Ordinary Shares are expected to be admitted to trading on Euronext on May 26, 2026.

Ordinary Shares (including those underlying ADS) issued in the Global Offering will be subject to an application for admission to trading on Euronext on the same trading line as the existing Ordinary Shares of the Company currently listed on Euronext, under the same ISIN code FR0011341205. The trading of Nanobiotix’s Ordinary Shares on Euronext is suspended today until the opening of trading of Nanobiotix’s ADSs on the Nasdaq Global Select Market at approximately 3:30 pm (Paris time) / 9:30 a.m. (New York time) today.

The ADSs and Ordinary Shares issued in the Global Offering are being offered pursuant to an effective shelf registration statement on Form F-3 (Registration No. 333-285604), which was filed with the Securities and Exchange Commission (the "SEC") on March 6, 2025 and subsequently declared effective on March 14, 2025. The Global Offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the Global Offering (the "Preliminary Prospectus Supplement") has been filed with the SEC on May 20, 2026 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to the Global Offering will be filed with the SEC. When available, copies of the final prospectus supplement (and accompanying prospectus) relating to the Global Offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388 or by email at [email protected]; from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; or from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected].

(Press release, Nanobiotix, MAY 21, 2026, View Source [SID1234665935])

On May 21, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that an abstract featuring pooled cardiac safety data for its lead drug candidate Annamycin (also known as "L-Annamycin" or "naxtarubicin"), has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. Access the abstract here.

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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

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The abstract, titled "Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis," will be presented in a poster session focused on Symptom Science and Palliative Care.

Presentation Details:

Session Type: Poster Session – Symptom Science and Palliative Care
Presentation Date and Time: May 30, 2026, 1:30 PM – 4:30 PM CDT
Location: Poster Board #8
The abstract presents pooled cardiac safety analyses from sponsor- and investigator-initiated clinical trials evaluating Annamycin (also known as "L-Annamycin" or "naxtarubicin") in patients with acute myeloid leukemia (AML) and soft tissue sarcoma.

Key findings include:

Independent cardiac safety review conducted in 90 patients treated with L-Annamycin across five completed clinical trials
Source-verified pre-and-post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients
Median cumulative L-Annamycin dose of 660 mg/m2 (95% CI, 645-690; range, 210-2,970 mg/m2), with most cumulative doses exceeding conventional lifetime anthracycline limits
No statistically significant change in LVEF from baseline to final assessment (mean difference, -0.12%; 95% CI, -1.34 to 1.09; p = 0.84)
No correlation observed between cumulative L-Annamycin dose and change in LVEF (p = 0.12)
No correlation observed between patient age and change in LVEF (p = 0.73)
Independent review of serial ECGs, cardiac biomarkers, cardiac adverse events, and available global longitudinal strain measurements demonstrated no evidence of drug-induced cardiotoxicity
"Acceptance of these findings at ASCO (Free ASCO Whitepaper) highlights the growing body of evidence supporting the differentiated safety profile of Annamycin," said Walter Klemp, Chairman and CEO of Moleculin. "These data continue to support the potential for Annamycin to provide effective anthracycline therapy without the traditional cumulative dose limitations associated with cardiotoxicity. We believe these findings further strengthen the rationale for our ongoing pivotal Phase 2b/3 MIRACLE trial in AML patients."

Anthracyclines remain among the most widely used chemotherapy agents but are limited by cumulative dose-dependent cardiotoxicity. Annamycin is designed to avoid multidrug resistance mechanisms while potentially eliminating the cardiotoxicity commonly associated with currently prescribed anthracyclines.

Previously reported results from the Company’s Phase 1b/2 study evaluating Annamycin in combination with cytarabine as second-line therapy in AML demonstrated:

50% complete remission (CR) rate
60% composite complete remission (CRc) rate
Median overall survival of 12.39 months (95% CI, 2.07-13.96) in the intent-to-treat population
The ASCO (Free ASCO Whitepaper) Annual Meeting is one of the largest and most influential gatherings of oncology professionals worldwide, featuring cutting-edge research and advances in cancer treatment. For more information, please visit asco.org.

(Press release, Moleculin, MAY 21, 2026, View Source [SID1234665934])

On May 21, 2026 Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported new radiodiagnostic data to be presented at the 2026 Society of Nuclear Medicine and Medical Imaging (SNMMI) Annual Meeting, taking place May 30 – June 2, 2026 in Los Angeles, CA.

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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

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Presentation details are as follows:

Date & Time: Monday, June 1, 2026, 10:30 am – 11:15 am PT

Session Type: Poster
Session Title: Oncology Clinical Diagnosis and Therapy Scientific Session

Session Number: MTA06 – Screen 29
Title: Impact of PSMA-PET with Piflufolastat F18 on Prostate Cancer Management for Patients with Low or Ultra-low Prostate-Specific Antigen Levels after Definitive Treatment.
Presenter: Neal Shore, Carolina Urologic Research Center
Poster Number: #262453

Date & Time: Tuesday, June 2, 2026, 9:50 am – 10:00 am PT
Session Type: Oral Presentation

Session Title: Prognosis and Novel Imaging Techniques
Session Number: SS30

Location: SS Room 2

Title: Diagnostic performance of 18F-GP1 PET/CT for acute deep vein thrombosis of the lower extremities in symptomatic patients: a phase 2, open-label, non-randomized study
Presenter: Sangwon Han, Asan Medical Center, University of Ulsan College of Medicine

(Press release, Lantheus, MAY 21, 2026, View Source [SID1234665933])