On August 14, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 840mg [generic name: atezolizumab (genetical recombination)] for an additional indication as adjuvant treatment for adults and pediatric patients with microsatellite instability-high (MSI-High) colon cancer.

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"Colorectal cancer is the most commonly diagnosed cancer in Japan, and recurrence after adjuvant chemotherapy remains a significant challenge in patients with pathological Stage III disease. In the ATOMIC trial, the addition of Tecentriq to standard adjuvant chemotherapy demonstrated a reduction in the risk of disease recurrence or death. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients with MSI-High colon cancer as a new standard of care," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the investigator-initiated global Phase III ATOMIC trial (Alliance A021502) in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection1,2. The trial evaluated the efficacy and safety of adding Tecentriq to standard adjuvant mFOLFOX6 chemotherapy. dMMR is known to lead to MSI-High status in tumor cells.
For the primary endpoint of disease-free survival (DFS), three-year DFS rates were 86.3% (95% CI: 81.8-89.8) in the Tecentriq combination arm and 76.2% (95% CI: 70.9-80.6) in the mFOLFOX6 arm.
The Tecentriq combination arm demonstrated a statistically significant improvement compared with mFOLFOX6 alone, reducing the risk of disease recurrence or death (stratified hazard ratio: 0.50, 95% CI: 0.35-0.73; p<0.001). The most common adverse events were hepatic dysfunction (43.9%), skin disorders (33.8%), and hypothyroidism (18.8%). The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines for patients and healthcare professionals.

About the ATOMIC (NCT02912559/Alliance A021502) trial
ATOMIC is an investigator-initiated overseas Phase III trial being conducted by the Alliance for Clinical Trials in Oncology, a research group supported by the U.S. National Cancer Institute (NCI), in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection. The trial is being conducted as an open-label, randomized trial evaluating the efficacy and safety of a standard adjuvant mFOLFOX6 treatment arm (administered for six months) and a combination treatment arm in which mFOLFOX6 plus Tecentriq is administered for six months, followed by Tecentriq monotherapy for an additional six months (12 months in total). The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026.

About Colorectal Cancer with Deficient Mismatch Repair (dMMR) or Microsatellite Instability-High (MSI-High)
Colorectal cancer is the most commonly diagnosed cancer in Japan, with approximately 154,000 new cases reported in 2023 (approximately 102,000 cases of colon cancer and 52,000 cases of rectal cancer) and approximately 54,000 deaths reported in 2024 (approximately 38,000 cases of colon cancer and 16,000 cases of rectal cancer)3. Among colorectal cancer cases in Japan, approximately 6-7% are reported to have deficient mismatch repair (dMMR)4,5. dMMR refers to a condition in which the DNA mismatch repair system is impaired, resulting in the development of microsatellite instability-high (MSI-High) tumors. Most tumors with dMMR exhibit MSI-High status. Because these tumors accumulate large numbers of somatic mutations and are therefore highly immunogenic, they are considered likely to respond to treatment with immune checkpoint inhibitors6,7. However, clinical evidence supporting the use of immune checkpoint inhibitors in the adjuvant treatment of colorectal cancer has been limited to date.
Adjuvant chemotherapy is recommended for patients with pathological Stage III colorectal cancer; however, recurrence is still observed in approximately 30% of patients following treatment8,9. Furthermore, prognosis remains poor once recurrent colorectal cancer progresses to an unresectable stage. Therefore, there remains a need for new adjuvant treatment options that can help reduce the risk of recurrence following curative resection.

About Tecentriq
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

(Press release, Chugai, AUG 14, 2026, View Source [SID1234670122])

On August 14, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter of 2026 and provided a business update.

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"At Caribou, we are redefining what patients and physicians should expect from allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, president and CEO of Caribou. "The data presented at EHA (Free EHA Whitepaper) 2026 continue to demonstrate that a single dose of vispa-cel can produce durable responses on par with autologous CAR-T cell therapies in patients with second-line large B cell lymphoma, and a single dose of CB-011 results in deep, durable responses in high-risk patients with relapsed or refractory multiple myeloma. With our off-the-shelf approach, these programs have the potential to dramatically expand CAR-T cell therapy access for patients."

Clinical highlights

Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•In June, long-term follow-up clinical data from the ANTLER phase 1 clinical trial were presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting. Data presented reinforced vispa-cel is the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line (2L) large B cell lymphoma (LBCL). Efficacy and safety data in 2L LBCL patients who had received a single dose of 80 million optimized vispa-cel CAR-T cells (N=27) included:
◦82% overall response rate (ORR)
◦67% complete response (CR) rate
◦17.1-month median progression-free survival (PFS)
◦Generally well-tolerated safety profile
•Optimized vispa-cel is defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen (HLA) alleles between patient and donor. The 27-patient subgroup best represents the treatment regimen and patient population for Caribou’s planned ANTLER-3 pivotal phase 3 clinical trial.
•Caribou previously reached alignment with the U.S. Food and Drug Administration (FDA) regarding its planned ANTLER-3 pivotal phase 3 clinical trial design, which is expected to be a randomized, controlled clinical trial enrolling approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the urgent need for therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•In June, longer follow-up dose escalation clinical data from the CaMMouflage phase 1 clinical trial were presented at the 2026 EHA (Free EHA Whitepaper) Annual Meeting. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Twelve BCMA-naïve patients were treated with the recommended dose for expansion (RDE) of 450 million CB-011 CAR-T cells after lymphodepletion. Efficacy and safety data for this cohort included:
◦92% ORR
◦83% CR or stringent CR (≥CR) rate
◦91% minimal residual disease (MRD) negativity in 10/11 evaluable patients
◦50% of patients in ≥CR at 15 months
◦Manageable safety profile
•Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a CR following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial. In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation.
Second quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $1.5 million for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025.

R&D expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2026, compared to $27.7 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities; expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; facilities and allocated expenses; and expenses related to licenses, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $7.9 million for the three months ended June 30, 2026, compared to $10.4 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; lower legal expenses; other service-related expenses; and other facilities and allocated expenses.

GAAP net loss and net loss per share, basic and diluted: Caribou reported a GAAP net loss of $24.3 million, or $0.24 per share, basic and diluted, for the three months ended June 30, 2026, compared to $54.1 million, or $0.58 per share, basic and diluted, for the same period in 2025, which included $21.3 million in non-cash impairment charges.

Cash, cash equivalents, and marketable securities: Caribou had $113.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026, compared to $142.8 million as of December 31, 2025. Caribou now expects that its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned ANTLER-3 pivotal phase 3 clinical trial for vispa-cel, to the end of 2027. Caribou is exploring multiple options to fully fund its planned ANTLER-3 clinical trial.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. Eighty-five patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40, 80, or 120 million CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Six patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, AUG 14, 2026, View Source [SID1234670121])

On August 14, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended June 30, 2026, and provided a corporate update highlighting clinical progress for Plinabulin and the Company’s leadership transition.

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"The second quarter was marked by additional clinical and scientific support for continuing Plinabulin development," said Min Qiu, Chief Executive Officer of BeyondSpring. "Updated Phase 2 data presented at ASCO (Free ASCO Whitepaper) 2026 continued to demonstrate an encouraging 58% two-year OS rate in metastatic NSCLC patients whose disease progressed after first-line immune checkpoint inhibitor (ICI) therapy. This encouraging prospective OS data strengthens our conviction in the DUBLIN-4 study, a confirmatory Phase 3 study with OS as the primary endpoint in non-squamous NSCLC post-ICI with no driver mutation, a severe unmet medical need with docetaxel as the standard of care. With our leadership transition now effective, our priorities are clear: advancing the regulatory, operational and financing preparations necessary to initiate DUBLIN-4."

Mr. Qiu continued, "The DUBLIN-4 study represents our lead clinical development priority for a potential path toward future regulatory submissions. We believe the published DUBLIN-3 results in The Lancet Respiratory Medicine, recent ASCO (Free ASCO Whitepaper) 2026 clinical data, and the AACR (Free AACR Whitepaper) 2026 ADC combination findings collectively reinforce Plinabulin’s differentiated potential as a potent dendritic cell maturation agent to improve survival benefits while mitigating treatment-limiting high-grade neutropenia in NSCLC and beyond."

Recent Clinical and Corporate Highlights of Plinabulin

ASCO 2026 (Phase 2 data): Plinabulin combination demonstrated durable response and survival benefit in post-ICI metastatic NSCLC

Presented updated efficacy and safety results from the investigator-initiated Phase 2 303 Study evaluating Plinabulin/docetaxel and pembrolizumab in 47 patients with metastatic NSCLC and acquired resistance following first-line immune checkpoint inhibitor therapy.
As of the February 28, 2026 data cutoff, median progression-free survival was 7.0 months, median duration of response was 9.3 months, disease control rate was 79.5%, and confirmed objective response rate was 18.2%.
The 12-month and 24-month overall survival rates were 78.1% and 58.0%, respectively, with median overall survival not reached after a median follow-up of 28.8 months.
The combination demonstrated a generally manageable safety profile and evidence of immune activation, including increased frequencies of activated CD4+ and CD8+ T cells as well as higher white blood cell, neutrophil, and platelet counts.
AACR 2026 (preclinical data): Improved complete response rate, overall survival and tolerability of certain antibody-drug-conjugates (ADCs)

Presented preclinical data showing that Plinabulin in combination with the approved topoisomerase I inhibitor (TOP1)-based ADCs enhanced complete tumor regression rates and/or survival of TROP-2-directed datopotamab deruxtecan or HER2-directed trastuzumab deruxtecan, with or without PD-1/PD-L1 inhibition.
Plinabulin improved tolerability in the preclinical combination models and increased the CD8+ T-cell-to-Treg ratio, supporting an immune-mediated mechanism for the enhanced anticancer activity.
The findings support Plinabulin’s potential to address limited durability and treatment-limiting hematologic toxicity associated with ADC-based therapy and broaden the scientific rationale for future ADC combination studies.
DUBLIN-4 Confirmatory Phase 3 Program

DUBLIN-4 is the Company’s planned, randomized, double-blind, 442-patient confirmatory Phase 3 study of Plinabulin plus docetaxel in non-squamous, EGFR wild-type NSCLC patients who have progressed on PD-1/PD-L1 inhibitor-containing therapies.
The program is designed to prospectively confirm the survival and tolerability benefits observed in the DUBLIN-3 Phase 3 study, which was published in The Lancet Respiratory Medicine in 2024.
BeyondSpring Leadership Transition and Corporate Execution

Effective July 1, 2026, Min Qiu was appointed Chief Executive Officer with a mandate focused on advancing DUBLIN-4, extending Plinabulin’s scientific optionality, and building BeyondSpring’s global partner and investor base. Dr. Jiangwen (Jen) Majeti was appointed Vice Chairman, strengthening Board-level governance continuity and strategic depth. Na Li was appointed Chief Financial Officer to support financial discipline, public-company reporting, financing activities, and capital markets engagement.
Dr. Lan Huang remains Co-Founder and Chairman of BeyondSpring, providing strategic vision and Board leadership, while devoting her executive focus to SEED Therapeutics, where she serves as Co-Founder, Chairman, and Chief Executive Officer.
Second Quarter Financial Results

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2026, compared to $1.0 million for the quarter ended June 30, 2025. R&D expenses remained relatively flat, as a $0.3 million increase in drug manufacturing activities to prepare for potential future study initiation was substantially offset by lower patent-related professional services and personnel expenses.
General and administrative (G&A) expenses were $0.8 million for the quarter ended June 30, 2026, compared to $0.9 million for the quarter ended June 30, 2025. The $0.1 million decrease was primarily due to lower legal and consulting expenses related to accounting advisory and business development.
Net loss was $1.8 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025.
Cash, cash equivalents, and short-term investments were $6.5 million as of June 30, 2026, compared to $12.6 million as of December 31, 2025.
Year-to-Date Financial Results

Continuing operations:

Research and development (R&D) expenses were $2.0 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The $0.1 million increase was primarily due to higher drug manufacturing expenses, partially offset by lower patent-related professional services, regulatory filing advisory and personnel expenses.
General and administrative (G&A) expenses were $1.9 million for the six months ended June 30, 2026, compared to $2.7 million for the six months ended June 30, 2025. The $0.8 million decrease was primarily due to lower incentive compensation and share-based compensation and lower professional services expenses related to legal advisory matters.
Net loss was $4.1 million for the six months ended June 30, 2026, compared to $4.5 million for the six months ended June 30, 2025.

(Press release, BeyondSpring Pharmaceuticals, AUG 14, 2026, View Source [SID1234670120])

On August 14, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported advances across its Actimab-A program, including recently acquired patents adding to a broad suite of IP, and expansion of the Company’s manufacturing capacity, as the program approaches clinical milestones from the fourth quarter of 2026 and into 2027. The Company also provided an update on the status of its NYSE American listing.

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Actiniums holds a broad IP portfolio covering the manufacture of Actimab-A, as well as its use alone and in combination with other therapies in the treatment of myeloid hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in addition to solid tumor cancers via targeting of tumor-resident myeloid-derived suppressor cells (MDSCs). Actimab-A patent portfolio activity in the last twelve months:

Actimab-A targeting of myeloid-derived suppressor cells (MDSCs) for the treatment of solid tumors: Two United States patents issued — US 12,491,274 for the treatment of sarcoma, expiring 15 October 2043, and US 12,539,340 for the treatment of solid tumors generally, alone or with checkpoint therapy, expiring 31 October 2043. Together they extend the anti-CD33 franchise beyond hematologic malignancy into solid tumors by targeting the immunosuppressive myeloid cells of the tumor microenvironment rather than the tumor cells themselves. Applications remain pending in the United States, Canada and Europe.

Actimab-A treatment of low peripheral blast AML: US 12,410,249 issued, with a term to 12 October 2039, and Canadian application 3,022,802 entered pre-grant status, with a term to 25 May 2037. Additional patents in this family have already issued in the United States and Japan; applications remain pending in the United States and Europe.

Actimab-A venetoclax (BCL-2 inhibitor) combination therapy for the treatment of AML: Canadian application 3,059,752 entered pre-grant status, with a term to 26 April 2038, covering the use of Actimab-A together with venetoclax in AML. Three patents have already issued in the United States and one in Mexico; applications remain pending in the United States, Europe, Japan and China.

Actimab-A CLAG-M combination therapy for the treatment of AML: Canadian application 3,087,346 was allowed, with a term to 8 January 2039. A counterpart patent has already issued in Japan; applications remain pending in the United States, Europe and Japan.

Actinium has amended its Investigational New Drug (IND) application to add an additional manufacturer. The additional manufacturer will supply studies conducted under the Company’s Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), together with additional Company-sponsored studies, which carry clinical milestones expected from the second half of 2026 and throughout 2027. Establishing an additional manufacturing source is intended to expand capacity and supply flexibility as Actimab-A advances into a broader set of studies across hematologic malignancies and solid tumors.

NYSE American Listing Update

Actinium also announced today that NYSE Regulation has accepted the Company’s plan submitted June 18, 2026, to regain compliance with the NYSE American continued listing standards and granted the Company a plan period through November 27, 2027 (the "Plan Period") – the maximum period available under Section 1009 of the NYSE American Company Guide (the "Company Guide").

The Company’s common stock continues to be listed and traded on NYSE American under the symbol ATNM during the Plan Period, subject to the Company’s compliance with the terms of the compliance plan and the other continued listing standards of the NYSE American Company Guide. NYSE Regulation staff will periodically review the Company’s compliance with the initiatives outlined in the compliance plan.

As previously disclosed, the Company is not currently in compliance with Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide, and its listing is being continued pursuant to an extension through November 27, 2027.

(Press release, Actinium Pharmaceuticals, AUG 14, 2026, View Source [SID1234670119])

On August 13, 2026 Evotec reported Half-Year Interim Report 2026.

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(Presentation, Evotec, AUG 13, 2026, View Source [SID1234670282])