On May 29, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that the Canadian Intellectual Property Office (CIPO) has issued Notices of Allowance for two patent applications spanning the Company’s Actimab-A and Iomab-ACT programs. The allowances broaden Actinium’s intellectual property protection across both hematologic malignancies and next-generation conditioning for gene-edited cell-based therapies in Canada, an important market within the Company’s growing global patent estate. These Canadian allowances build on protection already secured in other major markets, including a previously granted Japanese patent for the Actimab-A program and an issued U.S. patent for the Iomab-ACT program, with additional applications pending in the United States, Europe and China.

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The Notices of Allowance follow examination by CIPO, with issuance of the patents expected in the ordinary course. The allowances deepen Actinium’s intellectual property protection across two of its priority franchises and reinforce a global patent estate of approximately 250 issued and pending patents and patent applications.

"These two allowances reflect the breadth and depth of the innovation across our radiotherapy platform and our commitment to protecting it in every key market," said Adeela Kamal, Ph.D., EVP-R&D of Actinium Pharmaceuticals. "Securing coverage for both our Actimab-A CLAG-M combination in AML and our Iomab-ACT conditioning approach for gene-edited cell-based therapies underscores the strength of our science and the durability of the franchises we are building. We will continue to expand and defend our intellectual property worldwide as we advance these programs toward patients."

Actimab-A + CLAG-M Combination for AML

The allowed application covers the use of Actimab-A in combination with the CLAG-M chemotherapy regimen for the treatment of AML. Actimab-A is one of Actinium’s most advanced clinical-stage candidates and may serve as a therapeutic backbone for myeloid malignancies. The Canadian allowance complements a counterpart patent already granted in Japan, with applications pending in the United States and Europe. The Canadian patent issuing from Application No. 3,087,346 titled "Combination Immunotherapy and Chemotherapy for the Treatment of a Hematological Malignancy" will have a patent term running into January 2039.

Iomab-ACT for Gene-Edited Cell-Based Therapies

The allowed application covers Actinium’s targeted CD45 conditioning approach used to prepare patients for gene-edited cell-based therapies. Iomab-ACT is designed as a targeted conditioning agent intended to enable adoptive cell therapies. The Canadian allowance builds on a patent already granted in the United States, with additional applications pending in the United States, Europe and China. The Canadian patent issuing from Application No. 3,078,963 titled "Anti-CD45-Based Conditioning Methods and Uses Thereof in Conjunction with Gene-Edited Cell-Based Therapies" will have a patent term running into October 2038.

(Press release, Actinium Pharmaceuticals, MAY 29, 2026, View Source [SID1234666205])

On May 29, 2026 Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, will present two poster presentations of pivotal research abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. This research delivers advanced intelligence to accelerate oncology trials by optimizing patient-centric breast cancer protocols and definitively validating tocilizumab’s efficacy for CAR T–induced Cytokine Release Syndrome (CRS).

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The research (abstracts #11027 and #7027 at booth #30099), conducted by the Medidata Research Alliance, provides valuable insights for oncologists and clinical trial sponsors to refine studies with foresight and strengthen patient outcomes.

"Oncology trials represent some of the most intricate and demanding work in clinical research," said Sheila Diamond, MS, CGC, director, Scientific Engagement, Medidata. "By leveraging decades of clinical research expertise, powered by one of the largest clinical trial datasets in the world, we are delivering the actionable intelligence needed to accelerate cancer breakthroughs. We are transforming trial execution by driving patient-centric protocol design to boost enrollment and, simultaneously, providing definitive clinical validation for treatments of CAR T–induced CRS."

Protocol Optimization in Breast Cancer Clinical Trials

Quantifying the impact of protocol design on enrollment and dropout rates in breast cancer clinical trials. Abstract #11027 (June 1, 2026, 09:00-12:00 CDT timezone)

The analysis by Medidata and Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health, validates a predictive algorithm that quantifies the impact of patient-centric protocol design on enrollment and retention rates in breast cancer trials. The research identified specific procedures that acted as barriers to entry and others that drove retention. Key findings were:

10-23% reduction in enrollment rates associated with the inclusion of Positron Emission Tomography (PET) Imaging in select protocols where PET imaging was considered a key driver of operational outcomes
Up to 6% enrollment increases associated with bone density imaging, abdominal and pelvic imaging, and tumor and biopsy procedures
Up to 10% reductions in dropout rates were seen with the use of blood cell analyses, biomarker testing, and assessment questionnaires overall
The analysis leverages Medidata Protocol Optimization, part of the Medidata Study Experience, which transforms trial design and execution by leveraging AI trained on proprietary, cross-industry data to evaluate planned protocols against how similar clinical studies have performed, helping sponsors identify and mitigate risks proactively.

"Patient recruitment and retention is one of the greatest obstacles in clinical trials, directly impeding the speed at which patients receive potentially life-changing therapies," said Janna Andrews, MD, Chair of Radiation Oncology, Phelps Hospital, Northwell Health. "Our joint research with Medidata moves past simply identifying this challenge; it delivers quantifiable evidence that pinpoints the exact burdens and benefits of specific protocol steps. This data is critical for oncologists and sponsors to proactively design patient-centric trials, ensuring better enrollment, retention, and trial continuity."

Evaluating the Efficacy of Tocilizumab for CAR T–induced Cytokine Release Syndrome

Efficacy of tocilizumab in resolving CAR T–induced Cytokine Release Syndrome: A pooled clinical trial analysis of patients with B-cell lymphoma. Abstract #7027 (June 1, 2026, 09:00-12:00 CDT timezone)

The collaborative study by Medidata, Mayur Narkhede, MD of Mercy Cancer Institute and Sean Patrick Bliven, MD of the University of Alabama, Birmingham, examined data from multinational clinical trials spanning 2,300 patients with B-cell lymphoma on the Medidata Platform. This investigation verifies the effectiveness of tocilizumab for addressing CAR T–induced CRS (Chimeric Antigen Receptor T-cell induced Cytokine Release Syndrome) across a large patient population. This patient population was integrated from multiple multinational trials using AI-powered standardization pipelines. Key observations from the research were:

66% of the 680 patients achieved complete response with a median treatment time of four days
34% of patients did not meet the complete response criteria, highlighting a critical need for alternative rescue therapies to tocilizumab in more persistent cases
"This research is incredibly valuable in confirming that tocilizumab is a highly effective treatment for the majority of patients experiencing CAR T–induced CRS, although it also reinforces the need for further research into other treatment strategies for those who do not see clinical benefit," said Mayur Narkhede, MD, oncologist at Mercy Cancer Institute.

"It also demonstrates the power of industry collaborations such as the Medidata Research Alliance to combine knowledge of the treatment landscape and vast, robust historical clinical data sets to generate insights that may not have otherwise been researched," said Sean Patrick Bliven, MD, oncologist at University of Alabama, Birmingham.

(Press release, Medidata, MAY 29, 2026, https://www.globenewswire.com/news-release/2026/05/29/3303551/0/en/medidata-champions-collaborative-scientific-advancement-at-asco-with-new-research-on-oncology-protocol-optimization-and-car-t-efficacy.html [SID1234666236])

On May 29, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported it will provide a program update on its first-in-class Actinium-225 (225Ac) antibody radioconjugate, ATNM-400, highlighting new data that will be showcased across three presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, taking place May 30-June 2, 2026, in Los Angeles, California. Two of the presentations showcase ATNM-400’s differentiated profile across prostate cancer and non-small cell lung cancer (NSCLC), while a third demonstrates the importance of radioconjugate optimization for radiotherapies in the context of the Company’s pipeline candidates.

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With the SNMMI 2026 program now finalized, the Company is providing updated presentation details, including poster titles, presenters, dates, and times. The data to be presented reinforce the meaningful progress of the ATNM-400 program and its potential as a mutation-agnostic, pan-tumor therapy, while also demonstrating the strength of the underlying radioconjugate platform that supports Actinium’s broader pipeline. The Company anticipates multiple catalysts for ATNM-400, Actimab-A and Iomab-ACT in 2H:2026 that are expected to demonstrate the clinical potential of these programs.

ATNM-400 SNMMI 2026 Presentation Details

Poster Title: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models
Presenter: Sumit Mukherjee Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026 11:30am-12:15pm PT | Los Angeles, California

Poster Title: ATNM-400: A First-in-Class Actinium-225 Antibody Radioconjugate Demonstrating Durable, Mutation-Agnostic Anti-Tumor Activity in Non-Small Cell Lung Cancer Models
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: Oncology: Discovery & Translational Meet the Author Session
Date & Time: Tuesday, June 2, 2026, 11:30am-12:15pm PT | Los Angeles, California

Poster Title: Optimizing Chelator-to-Antibody Ratio Improves Tumor Targeting and Pharmacokinetics of 225Ac-Labeled Antibodies
Presenter: Shiva Kazerounian Ph.D., Actinium Pharmaceuticals, Inc.
Session: MTA05 RPSC/CMIIT POPs and Science Pavilion Mixer
Date & Time: Sunday, May 31, 2026, 7:30-8:00pm PT | Los Angeles, California

The posters will be available on the Company website shortly after the presentations at View Source

NYSE American Continued Listing Standards Notice
Actinium also announced today that it has received a notice (the "Notice") from the NYSE American LLC ("NYSE American") indicating that the Company is not in compliance with the continued listing standards set forth in Section 1003(a)(ii) of the NYSE American Company Guide (the "Company Guide"), which requires a listed company to maintain stockholders’ equity of $4.0 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. As of March 31, 2026, the Company reported stockholders’ equity of approximately $2.3 million and had net losses in its last five fiscal years ended December 31, 2025. The Notice also indicates that the Company is also not currently eligible for any exemption in Section 1003(a) of the Company Guide. The notice has no immediate effect on the listing or trading of the Company’s common stock on the NYSE American and the Company’s shares will continue to trade under the symbol "ATNM," subject to compliance with other listing requirements of the Company Guide.

In connection with the non-compliance with Sections 1003(a)(ii) and (iii) of the Company Guide, the Company must submit a compliance plan by June 26, 2026, advising of actions the Company has taken or will take to regain compliance with the continued listing standards by November 27, 2027 (the "Plan Period Deadline"). If the NYSE American determines to accept the plan, the Company will be notified in writing and will be subject to periodic reviews, including quarterly monitoring, for compliance with the plan.

If the Company does not submit a plan or if the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan is accepted but the Company is not in compliance with the continued listing standards by the Plan Period Deadline which is eighteen months from the receipt of the notice or November 27, 2027, or if the Company does not make progress consistent with the plan during the plan period, Exchange staff will initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide.

Actinium currently intends to submit a plan to regain compliance within the required timeframe. There can be no assurance that the Company will be able to achieve compliance with the NYSE American’s continued listing standards within the required timeframe of eighteen months from date of receipt of the notice or November 27, 2027.

(Press release, Actinium Pharmaceuticals, MAY 29, 2026, View Source [SID1234666206])

On May 29, 2026 Alaw Therapeutics, Inc. ("Alaw"), a clinical-stage biotechnology company developing precision oncology therapeutics designed to control oncogenic proliferation, tumor survival, and therapeutic resistance, reported two major pipeline milestones advancing its next-generation cyclin-dependent kinase (CDK) inhibitor portfolio.

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The announcements include:

Dosing of first patients in its Phase 1a/b clinical trial evaluating AL-605, Alaw’s selective, brain-penetrant CDK2 inhibitor, in patients with CCNE1-amplified solid tumors
Drug candidate nomination of AL-433, Alaw’s selective, brain-penetrant CDK4 inhibitor, with first-in-human clinical entry planned for Q4 2026
"These milestones represent an important inflection point for Alaw and for CDK-directed oncology," said Idean Marvasty, President and CFO of Alaw. "The inability to achieve meaningful CNS exposure has remained a fundamental limitation, leaving patients with brain metastases and primary CNS tumors underserved by targeted cell-cycle therapies. AL-605 and AL-433 were specifically engineered to address that challenge through enhanced selectivity of CDK inhibition combined with robust brain penetration."

AL-605: Phase 1a/b Study Initiated for Selective Brain-Penetrant CDK2 Inhibitor

Alaw has initiated a Phase 1a/b clinical trial evaluating AL-605 in patients with cyclin E (CCNE1)-amplified solid tumors. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, while incorporating prospective biomarker-based patient selection strategies intended to enrich for tumors dependent on CDK2 signaling.

The trial is enrolling two biomarker-defined populations:

Patients with hormone receptor-positive breast cancer that has progressed following CDK4/6 inhibitor therapy and exhibits CCNE1 amplification or overexpression, a setting strongly associated with CDK2-mediated resistance
Patients with CCNE1-amplified solid tumors more broadly, including ovarian, endometrial, gastric, esophageal, and triple-negative breast cancers
The Phase 1a portion follows a standard dose-escalation design, while Phase 1b expansion cohorts are intended to confirm the recommended Phase 2 dose and evaluate early clinical activity. Interim data are anticipated in the second half of 2026.

Addressing a Critical CNS Limitation in CDK2 Therapy

CDK2 inhibition is increasingly recognized as a central strategy for overcoming resistance to CDK4/6 inhibitors, which have transformed the treatment landscape for hormone receptor-positive breast cancer but are ultimately limited by the emergence of CDK2-driven bypass signaling.

However, currently available and emerging CDK2 inhibitors demonstrate limited blood-brain barrier penetration, leaving the CNS as a pharmacologic sanctuary where resistant tumor cells can survive and proliferate. By achieving robust and selective CNS CDK2 inhibition, AL-605 is designed to address both systemic disease and intracranial tumor progression, including brain metastases arising from CDK2-dependent tumors.

Preclinical studies have demonstrated that AL-605 achieves CNS exposure exceeding leading comparator CDK2 inhibitors and produces meaningful antitumor activity in intracranial tumor models, including glioblastoma and triple-negative breast cancer brain metastases.

AL-433: Selective Brain-Penetrant CDK4 Inhibitor Advances Toward First-in-Human Development

Alaw also announced the nomination of AL-433, its selective, brain-penetrant CDK4 inhibitor, as a development candidate, with first-in-human clinical studies planned for Q4 2026.

AL-433 targets tumors driven by dysregulation of the CDK4-cyclin D1-Rb-E2F axis, a central regulator of G1-to-S phase cell-cycle progression frequently altered across aggressive solid tumors.

The program is designed to address two fundamental limitations of the currently approved CDK4/6 inhibitor class:

Selective CDK4 Inhibition. AL-433 was engineered for high selectivity toward CDK4 over CDK6 with the goal of preserving antitumor efficacy while substantially improving tolerability. Reduced CDK6 inhibition may enable uninterrupted dosing and expand combination opportunities with immunotherapies and other targeted agents.
CNS Exposure and Brain Tumor Activity. Approved CDK4/6 inhibitors are substrates for efflux transporters at the blood-brain barrier and achieve minimal CNS exposure, limiting activity against glioblastoma, CDK4-amplified brain tumors, and brain metastases. AL-433 was specifically optimized for brain permeability and is designed to enable clinically meaningful CDK4 inhibition within the CNS.
Preclinical studies demonstrated that AL-433 achieves near-complete blood-brain barrier penetration, resulting in direct intracranial target engagement and antitumor activity in CDK4-dependent CNS tumor models.

AL-433 has been well tolerated in multi-species preclinical safety studies, and GLP toxicology studies are ongoing in support of clinical advancement. Planned clinical studies are expected to permit enrollment of patients with active CNS tumors or brain metastases, a population historically excluded from trials evaluating CDK4/6 inhibitors.

"The convergence of selectivity, brain penetrance, and rational combination strategy is what makes the pipeline fundamentally differentiated," added Marvasty. "We are not developing conventional next-generation CDK inhibitors. We are building the first CDK-directed therapies designed to follow the tumor wherever it goes, including the brain."

About AL-605

AL-605 is a selective, brain-penetrant CDK2 inhibitor designed for the treatment of CCNE1-amplified solid tumors and CDK2-mediated resistance to CDK4/6 inhibitors. The molecule achieves significant CNS exposure and has demonstrated antitumor activity in preclinical intracranial tumor models. AL-605 is currently being evaluated in a Phase 1a/b clinical study.

About AL-433

AL-433 is a selective, brain-penetrant CDK4 inhibitor designed to achieve highly selective inhibition of CDK4 over CDK6 while maintaining near-complete blood-brain barrier penetration. The program is intended to address both the hematologic toxicity and CNS limitations associated with approved CDK4/6 inhibitors and has demonstrated antitumor activity in preclinical CDK4-dependent CNS tumor models, including glioblastoma. Drug candidate nomination has been achieved, and first-in-human clinical studies are planned for Q4 2026.

(Press release, Alaw Therapeutics, MAY 29, 2026, View Source [SID1234666237])

On May 29, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.

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The open-label, multicenter, 24-week dose-finding trial evaluated once-daily tebapivat at 10 mg, 15 mg, and 20 mg in 65 patients with LR-MDS and anemia, representing a heavily pretreated, heterogeneous population. The primary endpoint was transfusion independence, defined as eight consecutive weeks without a transfusion during the 24-week treatment period. While tebapivat demonstrated evidence of biological activity, clinical benefit was not observed in a sufficient proportion of patients or subgroup of patients to meet the company’s predefined threshold for advancement in LR-MDS. Tebapivat was well tolerated across all dose levels, with no new safety signals identified.

"The results from the Phase 2b trial underscore the biological complexity of lower-risk myelodysplastic syndromes and the challenges of identifying patients most likely to benefit. On behalf of the entire Agios team, I want to extend our sincere gratitude to the patients, caregivers, investigators, and broader community who made this research possible," said Sarah Gheuens, M.D., Ph.D., Chief Medical Officer and Head of R&D, Agios. "PK activation remains a clinically validated mechanism, and we continue to see significant potential for tebapivat as a next-generation medicine in sickle cell disease. We look forward to sharing topline data from this Phase 2 trial in the second half of 2026."

About Tebapivat
Tebapivat is a next-generation oral pyruvate kinase (PK) activator designed to provide optimized clinical benefits for patients with rare hematologic diseases. It is structurally differentiated by its potent dual activation of the PKR and PKM2 isoforms (or variants) of the PK enzyme, which are expressed in red blood cells. Clinical pharmacology data supports once-daily dosing of tebapivat, without the need for a dose taper. Tebapivat is currently being evaluated in a Phase 2 trial for the treatment of sickle cell disease, with topline data anticipated in the second half of 2026.

(Press release, Agios Pharmaceuticals, MAY 29, 2026, View Source [SID1234666190])