On June 12, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. Food and Drug Administration (FDA) approval for determining PTEN protein loss, also known as PTEN deficiency, in tumours of patients with prostate adenocarcinoma. These patients may now be eligible for treatment with AstraZeneca’s targeted therapy TRUQAPⓇ (capivasertib).

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"Prostate cancer is one of the leading cancer diagnoses for men in the United States," said Matt Sause, CEO of Roche Diagnostics. "The FDA approval of our new companion diagnostic will provide clinicians with a vital tool to identify patients with PTEN loss and potentially provide new therapeutic options."

PTEN is a tumour suppressor protein and loss of PTEN is commonly observed in a variety of cancers.2 Roche’s test enables patients with PTEN-deficient prostate cancer to potentially benefit from a combination treatment with TRUQAP. TRUQAP provides a new, first-line treatment option for patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC).3

Metastatic hormone-sensitive prostate cancer is an aggressive form of prostate cancer and treatments specifically targeting the PTEN protein loss biology were previously not available. The average length of survival after new, metastatic prostate cancer diagnosis is about 5 to 6 years.4 About 25% of patients with metastatic hormone-sensitive prostate cancer have PTEN-deficient tumors as evaluated by immunohistochemistry (IHC).1

Foundation Medicine, an independent affiliate of the Roche Group, is one laboratory using the VENTANA PTEN (SP218) RxDx Assay companion diagnostic kit to help healthcare providers identify patients with PTEN protein loss.

About the VENTANA PTEN (SP218) RxDx Assay
The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument. The assay is indicated as an aid in identifying patients with prostate adenocarcinoma who may be eligible for treatment with TRUQAP in combination with abiraterone acetate in accordance with the approved therapeutic product labeling.

The approval of the VENTANA PTEN (SP218) RxDx Assay is based on the results of the CAPItello-281 clinical study where it was used as the enrollment assay to identify patients whose tumours exhibited PTEN deficiency. The clinical cutoff for PTEN protein loss status is ≥ 90% of viable malignant cells with no specific cytoplasmic staining. PTEN protein loss status is based on the pathologist’s observation of an absence or presence of PTEN expression within prostate adenocarcinoma.5 Patients who received combination therapy with TRUQAP experienced a statistically significant and clinically meaningful reduction in disease progression.

(Press release, Hoffmann-La Roche, JUN 12, 2026, https://www.globenewswire.com/news-release/2026/06/12/3311289/0/en/roche-receives-fda-approval-for-the-first-companion-diagnostic-to-assess-pten-protein-in-people-living-with-prostate-cancer.html [SID1234666614])

On June 12, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported new safety data from the ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) in the second-line (2L) and third- and later-line (3L+) settings and new translational data for ronde-cel. The new data will be presented today in two poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

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"The clinical data presented today reinforce the differentiated profile of ronde-cel in more than 100 patients with relapsed or refractory large B-cell lymphoma," said Lynn Seely, M.D., President and Chief Executive Officer of Lyell. "The updated safety profile, with no Grade 3 or higher CRS and low rates of Grade 3 or higher ICANS, supports outpatient administration. The translational data extend our understanding of ronde-cel’s durable clinical responses. Our data indicate they are achieved through next-generation dual-antigen targeting and production of CD62L-enriched CAR T-cells with enhanced memory phenotype."

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis (Poster: PF962)

A total of 108 patients with R/R LBCL (43 2L and 65 3L+) were treated with ronde-cel in the ongoing Phase 1/2 trial as of the data cutoff date of May 5, 2026. The population reflected high-risk disease: median age 64 years (range, 20 to 87), 67% (72/108) with primary refractory disease, and 28% (30/108) had an International Prognostic Index score of 3 or 4. Of the patients treated, 59% (64/108) received dexamethasone prophylaxis, 10 mg daily for three days at the time of CAR T-cell administration.

Key Safety Findings:

Cytokine Release Syndrome (CRS): There were no reports of Grade ≥ 3 events in patients treated with or without dexamethasone prophylaxis. Grade 1 CRS events were reported in 56% (36/64) and Grade 2 in 13% (8/64) of patients receiving prophylaxis, compared with cases of Grade 1 CRS reported in 30% (13/44) or Grade 2 in 39% (17/44) of patients who did not receive prophylaxis.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Grade ≥ 3 events of ICANS occurred in 8% (5/64) of patients receiving prophylaxis vs. 16% (7/44) of patients who did not receive prophylaxis. Grade 1 events were reported in 6% (4/64) and Grade 2 in 2% (1/64) of patients receiving prophylaxis vs. 11% (5/44) or 5% (2/44) who did not receive prophylaxis.
With over 100 patients treated, ronde-cel continues to show a consistent and manageable safety profile, supporting the potential for outpatient administration. Notably, dexamethasone prophylaxis did not change ronde-cel cell expansion and pharmacokinetics. Manufacturing has also proven reliable to date, with a 97% success rate across these patients.

Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) Are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products (Poster: PF1097)

The purpose of this study was to explore the roles of CD62L+ enrichment and CD19/CD20
dual-targeting in ronde-cel infusion products on clinical response observed in patients with R/R LBCL.

Single-cell RNA sequencing was conducted on ronde-cel infusion products to assess memory potential of cytotoxic effector cells compared to FDA-approved CD19 CAR T-cell therapies. Cluster analysis identified a population of cytotoxic effector cells (defined by high GZMB, IFNG, CCL4, CCL5, KLRD1 gene expression) that had higher expression of memory-associated genes (CD62L, IL7R, LEF1) compared to an analogous cytotoxic cluster from FDA-approved CD19 CAR T-cell therapies. These cells co-expressing cytotoxic genes and memory-associated genes are referred to as Cytotoxic T cells with Memory Potential (Tcmp) in this study.

Key Translational Findings:

Tcmp cells were more abundant in the ronde-cel products of patients with durable responses (>12 months) than in patients with progressive disease
Ronde-cel drug product Tcmp cells have a stronger memory potential compared to
axicabtagene ciloleucel’s cytotoxic effector cells
Ronde-cel Tcmp cells following CD62L enrichment also had higher survival and expansion in vitro compared to cytotoxic effector cells with CD4/CD8 enrichment.
Ronde-cel CAR+ T cells collected from patients two months after infusion sustained the capacity to proliferate, kill tumor cells, and secrete cytokines
Durable complete responses > 12 months observed in patients with LBCL with low CD19 or CD20 antigen expression on tumor biopsies at baseline
Collectively, these data offer a potential biological rationale for the benefits of CD62L+ enrichment during manufacturing and CD19/CD20 dual-targeting, which are thought to underpin the high rates of durable complete responses previously reported with ronde-cel.

Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in the second half of 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

(Press release, Lyell Immunopharma, JUN 12, 2026, View Source [SID1234666615])

On June 12, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the Phase III part of the ESLIM-02 study of sovleplenib in patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China were presented on Thursday, June 11, 2026 during the European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") Congress in Stockholm, Sweden.

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Supported by data from the ESLIM-02 study, a New Drug Application ("NDA") for sovleplenib for the treatment of adult patients with wAIHA who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration ("NMPA") in April 2026. The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of wAIHA in March 2026. The ESLIM-02 presentation was selected for the official EHA (Free EHA Whitepaper) Press Program.

Professor Bing Han of Peking Union Medical College Hospital, and co-leading Principal Investigator of the ESLIM-02 study, said: "The wAIHA treatment paradigm has remained stagnant for decades, with patients often trapped in a cycle of high-dose steroids and frequent relapses. The ESLIM-02 data are transformative as they demonstrate that targeting the Syk pathway can achieve both rapid and durable control of hemolysis. We are particularly encouraged by the robust data across all patient subgroups, regardless of their prior treatments. Sovleplenib’s ability to significantly reduce the need for rescue therapies and blood transfusions represents a major step forward in restoring the quality of life for these patients."

ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment (NCT05535933). Results from the Phase II part of the study were published in The Lancet Haematology in January 2025. In Phase III part of the study, 90 patients were randomized 1:1 to receive either sovleplenib (n=44) or placebo (n=46) at a dose of 300 mg once daily for 24 weeks.

The study met its primary endpoint, with sovleplenib demonstrating a significantly higher durable response rate during weeks 5–24 compared to placebo (66% vs 15%, p<0.0001). During the 24-week double-blind treatment period, sovleplenib demonstrated superior efficacy across several key metrics; specifically, the overall response rate—defined as hemoglobin (Hb) ≥100 g/L with an increase of ≥20 g/L from baseline without rescue therapy—was significantly increased (70% vs 22%, p<0.0001). The use of protocol-defined rescue therapy was significantly reduced with sovleplenib (16% vs 54%, p=0.0001), fewer patients received red blood cell transfusion (11% vs 43%) and higher patients with tapering or discontinuation of glucocorticoids or other baseline concomitant anti-wAIHA therapies (50% vs 15%, p=0.003​).

Median time to response was 3.1 weeks for sovleplenib versus 6.3 weeks for placebo, while the median cumulative duration of response among overall responders was 16.1 versus 6.1 weeks, respectively. Additionally, an improvement in hemolytic markers was observed with sovleplenib compared with placebo, showing an alleviation of active hemolysis.

These efficacy findings remained consistent across all sensitivity analyses, and all subgroup analyses further supported the primary endpoint results. Notably, in patients who had received prior rituximab therapy, the durable response rate continued to favor sovleplenib over placebo (69% vs 16%, p=0.0022).

Sovleplenib demonstrated a favorable safety profile. Grade ≥3 treatment-emergent adverse events ("TEAE") were reported in 43% patients in the sovleplenib arm and 59% patients in the placebo arm. The most common Grade ≥3 TEAEs, occurring in at least 10% of patients, were warm autoimmune hemolytic anemia (18% vs 43%) and upper respiratory tract infection (2% vs 11%). There were no TEAE-related deaths or treatment discontinuations reported in the sovleplenib group.

Details of the presentation are as follows:

Title:

A randomized, double-blind, placebo-controlled Phase 3 study of ESLIM-02 for efficacy and safety of sovleplenib (HMPL-523) in patients with warm autoimmune hemolytic anemia in China

Lead Author:

Bing Han, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China

Session:

Oral Session (Targeted therapies in rare red cell and metabolic disorders)

Presentation ID:

S301

Date & Time:

Thursday, 11 June 2026, 17:00 CEST

Location:

A13 Hall

About Sovleplenib and wAIHA

Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.

The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc-gamma receptor (FcγR) bearing macrophages is thought to be the pathogenic mechanism in wAIHA.1 Activated Syk mediates downstream signaling of the activated Fc receptors in phagocytic cells, resulting in phagocytosis of RBCs.2 In addition, activation of Syk through the B-cell receptor mediates activation and differentiation of B-lymphocytes into antibody secreting plasma cells.3 Inhibition of Syk may have potential effects in the treatment of wAIHA through inhibition of phagocytosis and reduction of antibody production.

In addition to wAIHA, sovleplenib is also being studied in immune thrombocytopenia ("ITP"). Positive results from ESLIM-01 (NCT05029635), a Phase III trial in China of sovleplenib in patients with primary ITP, have been published in The Lancet Haematology. The NMPA accepted for review the resubmitted NDA filing for the treatment of ITP and granted it priority review in February 2026. According to IQVIA, China has 430,000 existing patients with 41,000 new ITP patients each year. About half of ITP patients fail to have satisfactory results from currently approved treatments such as TPO (thrombopoietin) / TPO-RAs (thrombopoietin receptor agonists).

HUTCHMED currently retains all rights to sovleplenib worldwide.

(Press release, Hutchison China MediTech, JUN 12, 2026, View Source [SID1234666602])

On June 12, 2026 PharmaMar (MSE: PHM), reported top-line results from its Phase III LAGOON trial evaluating Zepzelca (lurbinectedin) in patients with relapsed (second line) metastatic small cell lung cancer (SCLC), which did not meet its primary endpoint of Overall Survival (OS) compared with control arm, nor did the exploratory combination with irinotecan. Safety for lurbinectedin monotherapy is better compared to the control group.

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The LAGOON study targeted a different population in a different setting of SCLC than the IMforte Phase III trial first line maintenance with atezolizumab (Tecentriq) and does not impact lurbinectedin approval in the first-line maintenance setting.

The full European Commission (EC) and U.S. approval of lurbinectedin is based on the Phase III IMforte trial, which evaluated lurbinectedin in combination with atezolizumab as first-line maintenance treatment for patients with extensive-stage SCLC. In the IMforte trial, the lurbinectedin and atezolizumab combination demonstrated a statistically significant improvement in the primary endpoints of OS and progression-free survival (PFS), as assessed by an independent review facility, compared to treatment with atezolizumab alone. The lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone.

PharmaMar and its partners will share the results with regulatory bodies as needed at appropriate time.

Key Results from the Phase III LAGOON Trial

The LAGOON trial included a broader patient population than the Phase 2 pivotal trial that supported the second-line approval, including patients with a history of CNS involvement.

The outcome of this trial may be impacted by the unexpected OS outperformance of the control arm by 30% (topotecan mOS 10.8) when compared to most recent phase III trials (topotecan 8.3m,)[1] in this setting.

Trial Population Lurbinectedin monotherapy Median OS Lurbinectedin+ irinotecan Median OS Control Median OS HR (95% CI)
Lurbinectedin vs Control HR (95% CI)
Lurbinectedin+irinotecan vs Control
Overall 8.7 (n=240) 10.9 (n=242) 10.7 (n=242) 1.190 (0.959, 1.476) 0.902 (0.729, 1.115)
Without CNS metastases 9.6 (n=182) 11.1 (n=189) 10.7 (n=186) 1.106 (0.875, 1.398) 0.922 (0.729, 1.166)
With CNS metastases 7.1 (n=58) 10.5 (n= 53) 10.3 (n=56) 1.791 (1.162, 2.760) 1.107 (0.724, 1.692)
The overall safety profile for lurbinectedin was favorable relative to the control arm. Treatment-related adverse events (TRAE) were 78.5% with lurbinectedin, 95% with lurbinectedin + irinotecan, and 93.8% with the control arm. TRAEs Grade ≥ 3 were 35% with lurbinectedin, 62.6% with lurbinectedin + irinotecan, and 64.4% with the control arm.

We expect to submit the results to a medical meeting for presentation.

PharmaMar would like to thank all the patients, their families, and the medical staff involved in the study.

(Press release, PharmaMar, JUN 12, 2026, View Source [SID1234666603])

On June 12, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported updated data from multiple clinical programs to be presented at the EHA (Free EHA Whitepaper) Annual Meeting in Stockholm, Sweden. Data from the RALLY-MF trial of DISC-0974 in patients with MF and anemia, to be presented in an oral session today, demonstrate meaningful, durable overall anemia responses across all patient subgroups, regardless of baseline transfusion status or concomitant JAK inhibitor use. Updated data from the HELIOS open-label extension trial of bitopertin in EPP, to be presented in a poster session tomorrow, June 13, show sustained reductions in PPIX, significant improvement in light tolerance measures, and favorable longer-term safety in patients treated with bitopertin.

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"The updates at this year’s EHA (Free EHA Whitepaper) highlight continued progress across our portfolio heading into a catalyst-rich second half of the year," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "For DISC-0974 in MF anemia, our Phase 2 dataset continues to strengthen as we prepare for End of Phase 2 discussions with FDA by the end of this year. For bitopertin, continued durability of PPIX reduction and light tolerance improvement in HELIOS is encouraging leading up to the APOLLO Phase 3 readout in Q4, which, as confirmed in a recent Type A meeting with FDA, can serve as the basis for a response to the CRL and could potentially support a traditional approval if successful. We also look forward to sharing initial data from the RESTORE-PV Phase 2 trial of DISC-3405 in polycythemia vera in Q4 this year, setting up the potential for a third program in pivotal-stage development in 2027."

Management will host a call following the EHA (Free EHA Whitepaper) meeting to review highlights of the presented data and next steps for the company on Monday, June 15 at 8:00am EDT. Please register for the event on the Events and Presentations page of Disc’s website (View Source).

Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide.

Details of Presentations and Abstracts:

DISC-0974: RALLY-MF Oral Presentation

RALLY-MF, an ongoing Phase 2 open-label study, had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis (non-transfusion dependent receiving no transfusions (nTD, n=31), transfusion dependent with low transfusion burden (TD Low, n=11) and transfusion dependent with high transfusion burden (TD High, n=8)). The trial was comprised of both patients receiving concomitant JAK inhibitor therapy (n=25) and not receiving JAK inhibitor therapy (n=25). DISC-0974 was administered subcutaneously at 50 mg every 4 weeks for up to 6 treatments. The updated results demonstrated:

Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron
55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response)
64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response)
50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)
56% of patients receiving concomitant JAK inhibitor therapy achieved a major hematologic response across transfusion groups and 72% achieved an overall response, with similar response rates regardless of which specific JAK inhibitor the patient received
Dosing with DISC-0974 was associated with improvements in patient-reported outcomes:
Clinically significant improvements in FACIT-Fatigue scores in nTD and TD Low participants that were correlated with hemoglobin change
MPN-SAF TSS50 at EOS was achieved by 50% of nTD and TD low major responders
DISC-0974 was generally well-tolerated. Diarrhea, not considered serious, was the only adverse event (AE) that was reported as related to DISC-0974 and reported in two or more subjects. The majority of AEs were not considered related to DISC-0974.

Bitopertin: HELIOS update poster

HELIOS is an ongoing Phase 2, open-label, long-term extension trial that enrolled 86 adult and adolescent patients with EPP from the BEACON and AURORA trials. Patients were randomized to receive 20 mg or 60 mg bitopertin in BEACON and 20 mg or 60 mg bitopertin or placebo in AURORA, with all patients transitioning to a 60 mg daily dose of bitopertin in HELIOS.

Longer term treatment with bitopertin was associated with sustained reductions in the disease-causing toxin PPIX, with additional benefit for patients receiving the 60 mg dose continuously
Treatment with bitopertin was associated with sustained, significant improvement in average light tolerance and time to prodrome measures
Bitopertin exhibited a favorable longer-term safety profile with up to 2.5+ years of exposure and similar safety across adults and adolescents with EPP and XLP
DISC-3405: RESTORE-PV Trial-in-Progress poster

RESTORE-PV is a Phase 2 open-label study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DISC-3405 in patients with polycythemia vera. Initial data from the trial is expected in Q4 2026.

(Press release, Disc Medicine, JUN 12, 2026, View Sourcenews-releases/news-release-details/disc-medicine-presents-positive-clinical-updates-2026-european [SID1234668733])