Category: Health

Release – Cadrenal Therapeutics to File for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease

Posted on by [email protected]

Research News and Market Data on CVKD

Company to present Phase 3-ready pipeline, 12-LOX platform, and pediatric rare-disease expansion to global pharmaceutical partners at the 2026 BIO International Convention in San Diego

Kawasaki disease is the leading cause of acquired heart disease in children in developed nations. Patients are at risk of forming blood clots in coronary arteries and may require lifelong treatment

If the designation is granted and tecarfarin is approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher-recent open-market valuations for these vouchers have reached into the ~$200 million range

PONTE VEDRA, Fla., June 18, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration (FDA) for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop coronary artery aneurysms (CAAs) and require chronic oral anticoagulation.

The announcement comes ahead of the BIO International Convention, June 22-25, 2026, in San Diego, California. Cardenal’s executive leadership team will highlight this rare pediatric initiative and its Phase 3-ready CAD-1005 platform during one-on-one partnering meetings with global and regional pharmaceutical companies.

KD is an acute inflammatory illness and the leading cause of acquired heart disease in children in developed nations. Up to 25% of untreated children with KD develop enlarged coronary arteries or CAAs. Patients with large CAAs are at risk for forming blood clots in those blood vessels – with a continuing lifelong risk for subsequent heart attacks and sudden cardiac death – and require chronic, precise anticoagulation therapy to reduce their higher risk of clot formation.

Tecarfarin is a novel, next-generation Vitamin K antagonist (VKA) that offers a number of potential advantages over warfarin, the current standard VKA in clinical use. Specifically, tecarfarin is designed to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin.

“Children with large or giant aneurysms due to KD represent an important underserved orphan population,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “The current standard of care – warfarin – is notoriously unstable in children because of dietary variations, concurrent medications, and genetic differences in liver metabolism. Tecarfarin is metabolized in a completely different way than warfarin, and is being developed to offer a highly stable, predictable alternative. We believe tecarfarin can potentially improve time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events.”

The FDA’s RPDD program targets serious or life-threatening diseases that primarily affect fewer than 200,000 people in the United States from birth through age 18. If the FDA grants the designation and tecarfarin is subsequently approved for this indication, Cadrenal would be eligible to receive a Priority Review Voucher (PRV). These transferable vouchers can be used to accelerate the FDA review of a future drug or sold to another pharmaceutical manufacturer. Following Congress’s extension of the pediatric PRV program through September 30, 2029, recent open-market valuations for these vouchers have reached record highs, with recent sales ranging from $180 million to $205 million.

At the upcoming BIO International Convention, Cadrenal will present a dual-track portfolio strategy designed to maximize value for potential partners:

  • The Global Pharma Track: Focusing on CAD-1005, a first-in-class 12-LOX inhibitor. CAD-1005 is Phase 3-ready for Heparin-Induced Thrombocytopenia (HIT) and is advancing into a Phase 2a trial for Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), addressing a combined, multi-billion-dollar dual-indication acute hospital care market.
  • The Regional & Rare Disease Track: Focusing on tecarfarin for Kawasaki disease. This program offers an efficient clinical trial design and strong geographic synergy, particularly for Japanese and East Asian pharmaceutical companies, where the incidence of Kawasaki disease is historically 10 to 15 times higher than in Western nations.

“Our presence at BIO 2026 centers on executing capital-efficient development strategies,” added Mr. Pham. “If we are successful in advancing tecarfarin toward a RPDD, we will create a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing our core internal resources toward our blockbuster CAD-1005 critical care franchise.”

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics is a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions. The company’s pipeline includes CAD-1005, a novel first-in-class 12-LOX inhibitor targeting multiple critical care indications, and tecarfarin, a late-stage oral anticoagulant designed to avoid CYP450 metabolism. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency, for the treatment of Heparin-Induced Thrombocytopenia (HIT). CAD-1005 is also being developed for use in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), and second-generation 12-LOX oral therapeutics are in development for chronic indications.

About Tecarfarin

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices. Tecarfarin has also received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.

Safe Harbor Statement

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding plans to file for FDA Rare Pediatric Disease Designation for Tecarfarin in Kawasaki Disease; Cadrenal being eligible to receive a Priority Review Voucher and the value of the voucher; tecarfarin offering a number of potential advantages over warfarin, tecarfarin overcoming limitations of warfarin metabolism and potentially providing more reliable and more consistent anticoagulation than might be possible with warfarin; tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs while directing the Company’s core internal resources toward its CAD-1005 critical care franchise Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability for tecarfarin to receive a Rare Pediatric Disease Designation for treatment of Kawasaki Disease; the ability to monetize a priority review voucher if received, the ability to successfully design and complete a dual-track portfolio strategy and maximize value for potential partners; the ability of tecarfarin to overcome limitations of warfarin metabolism and potentially provide more reliable and more consistent anticoagulation than might be possible with warfarin; the ability of tecarfarin offering a highly stable, predictable alternative to warfarin; tecarfarin potentially improving time in therapeutic range for children with Kawasaki Disease, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events and the successful advancement of tecarfarin creating a high-value, de-risked regulatory pathway that aligns with regional partners’ portfolio needs; ; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission: and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Primary Logo

Release – MAIA Biotechnology Opens Enrollment for Phase 2 Expansion Trial of Novel Telomere-Targeting Agent at Winship Cancer Institute of Emory University

Posted on by [email protected]
Primary Logo

Research News and Market Data on MAIA

June 18, 2026 8:30am EDT Download as PDF

Georgia’s only National Cancer Institute (NCI)-designated Comprehensive Cancer Center; well recognized at the forefront of cancer innovation and discovery nationwide

CHICAGO, June 18, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the third U.S. clinical site in its Phase 2 THIO-101 expansion trial, Winship Cancer Institute of Emory University (“Winship”), is activated and now enrolling patients. The trial studies MAIA’s lead investigational telomere-targeting agent, ateganosine, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).

Matthew Failor, Director of Clinical Operations for MAIA, commented, “Winship is Georgia’s only National Cancer Institute (NCI)-designated Comprehensive Cancer Center and is recognized at the forefront of cancer innovation and discovery nationwide. Winship offers a renowned thoracic oncology clinical research program with a proven track record in clinical trial development and conduct. With its premier medical team and extensive body of research, this cancer center is well-suited for our U.S. Phase 2 trial of ateganosine.”

The principal investigator for the THIO-101 expansion trial at Winship is Ticiana Leal, M.D., a professor in the Department of Hematology and Medical Oncology at the Emory University School of Medicine. Dr. Leal’s clinical research focuses on trials involving chemotherapy and immunotherapy agents for lung cancer.

Dr. Leal commented, “At Winship, we serve the state of Georgia and surrounding states where innovation in lung cancer treatment is a broad, underserved need. In Georgia, lung cancer is the leading cause of cancer-related deaths, with over 7,300 new cases in 2025. MAIA’s novel ateganosine agent, if approved, could address a significant gap in clinical care for the advanced-stage NSCLC patient population where there are no FDA-approved options available for treatment.”

THIO-101 is an ongoing Phase 2, open-label trial evaluating ateganosine followed by cemiplimab for NSCLC patients resistant to checkpoint inhibitors and chemotherapy. Parts A and B of the trial have shown strong early efficacy, with some patients showing survival exceeding two years, and now MAIA continues to expand the trial in the U.S.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Primary Logo

Source: MAIA Biotechnology, Inc.

Released June 18, 2026

Release – GeoVax Highlights Strategic Implications of Recent Gedeptin(R) Findings for Checkpoint-Resistant Cancers

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Recent Publication and Growing Industry Focus on Immune-Priming Strategies Support Continued Evaluation of Gedeptin® as a Potential Complement to Checkpoint Inhibitor Therapy

ATLANTA, GA – June 17, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines for solid tumors and infectious diseases, today highlighted the broader oncology and strategic implications of recently published research supporting the potential of its Gedeptin® platform to enhance immune checkpoint inhibitor activity and address one of the most significant challenges in modern cancer treatment: improving responses in checkpoint-resistant tumors.

The update follows publication of the peer-reviewed article, “Broadening Activity of Checkpoint Blockade Agents by Intratumoral Nucleoside Cleavage,” in JCI Insight. The study reported findings supporting the potential for Gene-Directed Enzyme-Prodrug Therapy (GDEPT) to enhance checkpoint inhibitor responses, activate systemic anti-tumor immunity, and generate anti-tumor effects in both treated and distant untreated tumors in preclinical models of checkpoint-resistant triple-negative breast cancer.

While the publication focused on the underlying scientific findings, GeoVax views the results as further validation of broader trends shaping the future of cancer immunotherapy, including increasing industry emphasis on immune-priming approaches designed to improve checkpoint inhibitor responsiveness and overcome treatment resistance.

Addressing the Challenge of Checkpoint Resistance

Checkpoint inhibitors targeting pathways, such as PD-1 and PD-L1, have transformed treatment paradigms across multiple cancer types and now represent foundational therapies in modern oncology. Despite their success, many tumors remain poorly responsive to checkpoint blockade due to limited immune-cell infiltration, poor antigen presentation, and immunosuppressive tumor microenvironments.

These so-called “cold” tumors represent one of the most significant barriers to effective immunotherapy. Without sufficient immune recognition and engagement, even highly active therapies may struggle to generate durable clinical responses.

GeoVax recently explored this challenge in an Onco’Zine commentary authored by Chairman and Chief Executive Officer David Dodd entitled, “The Cold Tumor Barrier: Why Promising Oncology Therapies Fail In Vivo – and What It Will Take to Overcome It”. The article discussed the growing recognition that future advances in immuno-oncology may depend not only on developing new therapies, but also on improving the responsiveness of tumors to existing treatments through immune activation and tumor microenvironment modulation.

As a result, substantial research and development efforts across the oncology sector are increasingly focused on identifying therapies capable of converting immunologically cold tumors into more responsive tumors, potentially expanding the number of patients who may benefit from immunotherapy and improving outcomes with established checkpoint inhibitor regimens.

“One of the most significant challenges in oncology today is the cold tumor barrier,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “Checkpoint inhibitors can be highly effective when sufficient immune activity already exists within a tumor. However, many tumors remain largely invisible to the immune system. The next major opportunity may lie in therapies capable of activating immune recognition and making these tumors more responsive to existing immunotherapies.”

Positioning Gedeptin Within an Emerging Immunotherapy Paradigm

GeoVax sees potential for Gedeptin to play a differentiated role within this evolving treatment landscape. The recently published findings suggest that localized treatment may not only destroy targeted tumor cells, but also remodel the tumor microenvironment, promote immune activation, and enhance responsiveness to checkpoint inhibitors. These characteristics are increasingly viewed as important components of next-generation combination immunotherapy strategies.

The Company views Gedeptin’s combination of localized tumor destruction, strong bystander killing effects, tumor microenvironment remodeling, and immune activation as a potentially differentiated approach to addressing treatment resistance.

“Importantly, Gedeptin is not necessarily intended to directly compete with checkpoint inhibitors, but rather to complement them,” continued Mr. Dodd. “The medical proposition is to improve responses where checkpoint inhibitors alone have not achieved their full potential; also representing a significant commercial opportunity with multiple partnering avenues.”

Focus on Neoadjuvant Combination Strategies

GeoVax’s lead clinical development focus for Gedeptin is a planned neoadjuvant study in recurrent head and neck squamous cell carcinoma (HNSCC), evaluating intratumoral Gedeptin in combination with PD-1-based immunotherapy and standard of care, in patients with first recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) eligible for curative-intent surgery.

The Company considers recurrent head and neck cancer an attractive initial development setting because tumors are frequently accessible for direct injection, checkpoint inhibitors are already integrated into standard of care treatment paradigms, and substantial unmet need remains despite advances in immunotherapy.

GeoVax also views the neoadjuvant setting as particularly well suited for immune-priming approaches because the intact tumor can serve as a source of tumor antigens capable of stimulating broader anti-tumor immune responses prior to surgical resection.

“As checkpoint inhibitors continue moving earlier in the treatment paradigm, opportunities are emerging for therapies designed to improve immune responsiveness before surgery and potentially improve long-term outcomes,” said Mr. Dodd. “Gedeptin’s biologic profile appears well aligned with this evolving treatment strategy.”

Broader Platform Opportunities

Beyond head and neck cancer, GeoVax sees potential applicability for Gedeptin across multiple solid tumor settings where checkpoint inhibitors are established standard of care but response rates remain suboptimal.

“The oncology community is increasingly focused on improving response rates to existing immunotherapies and overcoming the cold tumor barrier,” added Mr. Dodd. “The emerging data support continued evaluation of Gedeptin as a differentiated immune-priming platform designed to complement existing immunotherapies and potentially broaden the impact of checkpoint blockade across multiple tumor settings.”

About Gedeptin®

Gedeptin® is GeoVax’s proprietary gene-directed enzyme prodrug therapy (GDEPT) platform under development for the treatment of solid tumors. The therapy utilizes a non-replicating adenoviral vector encoding purine nucleoside phosphorylase (PNP). Following administration of fludarabine, the PNP enzyme converts the prodrug into a potent localized cytotoxic compound within the tumor microenvironment.

GeoVax is advancing development plans evaluating Gedeptin in combination with checkpoint inhibitors, including pembrolizumab-based regimens, with the goal of improving anti-tumor immune responsiveness across multiple solid tumor indications.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

Release – MariMed Presents Fourth Annual Bob Fireman Entrepreneur of the Year Award to Weldon Angelos

Posted on by [email protected]
Primary Logo

Research News and Market Data on MRMD

June 16, 2026 7:00am EDTDownload as PDF

Award Honors the Legacy of MariMed’s Late Co-Founder

NORWOOD, Mass., June 16, 2026 (GLOBE NEWSWIRE) — Leading multi-state cannabis operator MariMed Inc. (“MariMed”) (CSE: MRMD) (OTCQB: MRMD) proudly presented the Fourth Annual Bob Fireman Entrepreneur of the Year Award at a ceremony held June 15th during the 2026 IgniteIt Cannabis Capital Conference in Chicago. The recipient of this year’s award is Weldon Angelos, Founder of cannabis brand REEFORM and one of the nation’s leading advocates for criminal justice reform.

The Bob Fireman Entrepreneur of the Year Award honors the legacy of MariMed’s co-founder and CEO, who passed away in 2022. Fireman was a pioneer and visionary of the legal cannabis industry. He entered the industry in 2008 with his best friend and business partner, current MariMed CEO Jon Levine, through an investment in a California cannabis business. In 2014, they began building and leading MariMed, initially as an advisor to license holders before strategically transitioning into a vertically integrated multi-state operator. The Company also owns a portfolio of top-selling cannabis brands, including Betty’s Eddies™ fruit chews, the #1- selling edibles brand across its core states.

The award is presented annually to a cannabis industry executive who embodies Fireman’s entrepreneurial spirit and success, as well as his staunch advocacy for legal access to cannabis and social justice reform.

In 2003, Angelos’s low-level cannabis case resulted in a 55-year federal sentence. He became a symbol for justice reform over the years that followed before he was finally released from prison after receiving clemency from President Obama in 2016. Through his Mission [Green] initiative, Angelos is dedicated to helping free people incarcerated for cannabis, advocating for policy reform, and ending the war on drugs. Most recently, he played a key role in persuading the current Administration to reclassify cannabis to Schedule III of the Controlled Substances Act. His successful cannabis brand REEFORM exists as a platform to advocate for the release of those unjustly incarcerated and to help them rebuild their lives post release.

“Bob worked tirelessly as an advocate and an executive to improve people’s lives through cannabis. In fact, that remains MariMed’s mission today,” said MariMed CEO Jon Levine. “Weldon is the embodiment of everything Bob believed in and supported, both as a change-agent for reform and as the builder of a successful business. Bob would be extremely pleased that we are honoring Weldon with this year’s award.”

“I’m incredibly proud to be named this year’s recipient of the Bob Fireman Entrepreneur of the Year Award,” said Weldon Angelos. “From everything I have learned, Bob was the type of leader who understood what it means to do right while doing good. I’ve dedicated my life to cannabis reform and social injustice. Receiving this award means my efforts are making an impact. I am deeply honored but also know that our work is far from being done.”

About MariMed:
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Company Contact:
Howard Schacter
Chief Communications Officer
Email: [email protected]
Phone: (781) 277-0007

Primary Logo

Source: MariMed Inc.

Released June 16, 2026

Cadrenal Therapeutics (CVKD) – Phase 2a Trial For New CAD-1005 Indication Announced

Posted on by [email protected]


Tuesday, June 16, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Trial Planned In Cardiac Surgery-Associated Acute Kidney Injury. Cadrenal announced plans for a Phase 2a trial in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKD). The trial is designed to demonstrate proof of concept and generate data on safety, measures of renal injury, and biomarkers of the 12-LOX inflammatory pathway. This would provide data on CAD-1005 in CSA-AKD as well as its other indications in development.

Trial Design. The trial is expected to test CAD-1005 using its intravenous formulation in Intensive Care Unit (ICU) settings later in FY2026. This data could be used in several development indications for CAS-1005, including the HIT (heparin-induced thrombocytopenia) indication, which is planned to begin Phase 3 later in FY2026-27. At this time, Cadrenal plans to use the data to form a development partnership for the CSA-AKI indication.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – Cadrenal Therapeutics Advances Multi-Indication Strategy for CAD-1005; Launches Phase 2a Acute Kidney Injury (CSA-AKI) Clinical Plan to Accelerate Pharma Partnering at Upcoming BIO 2026

Posted on by [email protected]

Research News and Market Data on CVKD

  • New high-value indication for Phase 3-ready asset with data intended to support clinical development and strategic partnering discussions
  • Additional billion-dollar target- Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI), a serious complication affecting 35,000 U.S. patients annually, with no approved FDA-approved targeted therapies
  • Dual-Purpose Synergy – Planned Phase 2a proof-of-concept trial expected to generate safety, renal injury signals, and 12-LOX pathway biology in high-risk cardiac surgery patients, while generating high-value data potentially relevant to the Company’s lead HIT indication
  • Capital-Efficient Development: Leverages shared in-hospital ICU infrastructure and an intravenous (IV) formulation to offer a turnkey critical care franchise for a global pharmaceutical partner
  • Maximizes 12-LOX Platform Valuation – Strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026

PONTE VEDRA, Fla., June 15, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced that it plans to initiate a Phase 2a proof-of-concept clinical trial of its lead drug candidate, CAD-1005, being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery. The trial is expected to begin later this year.

“The addition of a CSA-AKI indication further expands CAD-1005’s potential as a multi-billion-dollar critical care platform,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “CAD-1005’s potent, selective 12-LOX inhibition interrupts inflammatory and cell-death cascades frequently associated with cardiac surgery – a mechanism built for success in this population. This dual-indication program offers a turnkey franchise opportunity for pharmaceutical companies seeking to dominate hospital critical care applications and we believe creates a high-value inflection point for Cadrenal to secure a well-capitalized strategic partner and fund our pipeline expansion through non-dilutive collaborations.”

The planned study is intended to expand the clinical evaluation of CAD-1005 into a high-unmet-need acute-care setting while generating data that may be relevant to Cadrenal’s lead Phase 3-ready program in heparin-induced thrombocytopenia (HIT). HIT is a condition caused by an immune response to the widely used hospital blood thinner, heparin, resulting in blood clots that can cause death, amputation, stroke, and significantly increase healthcare costs. The Company expects to discuss the CSA-AKI clinical plan, its implications for CAD-1005’s broader development strategy, and potential non-dilutive collaboration opportunities at the BIO International Convention.

Cardiac surgery remains a cornerstone of cardiovascular care, but it is often complicated by CSA-AKI, which affects roughly 35,000 U.S. patients each year. CSA-AKI represents a potential treatment market estimated at $1 billion annually, a subset of the broader AKI market. CSA-AKI is associated with an approximately 8-fold increase in hospital mortality and significantly increases the risk of progressive, permanent kidney failure. There are currently no FDA-approved targeted pharmacologic therapies to prevent CSA-AKI. Cardiac surgery patients are also at risk for the potentially catastrophic complication of HIT. The planned Phase 2a trial builds on encouraging preclinical data in multiple animal models for CAD-1005 in AKI, as well as existing Phase 1 safety data. Moreover, it leverages the clinical overlap between AKI and HIT in cardiac surgery, enabling Cadrenal to efficiently collect dual-purpose validation data. Thus, in addition to potentially establishing proof of concept in the multi-billion-dollar AKI market, the trial will also generate key safety and mechanistic data that could help to de-risk the pivotal Phase 3 registration path for HIT.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a first-in-class 12-LOX therapeutic platform focused on thrombosis, inflammation, and the prevention of ischemia-reperfusion-related organ and tissue damage. The Company’s lead asset, CAD-1005, is a selective 12-LOX inhibitor designed to address diseases driven by immune-mediated platelet activation, oxidative stress, and inflammatory tissue injury. CAD-1005 is being developed for heparin-induced thrombocytopenia (HIT), with additional development opportunities in acute kidney injury (AKI) and other critical-care indications characterized by ischemia-reperfusion injury and inflammatory organ damage.

Cadrenal is advancing its 12-LOX platform because this target is suspected to represent a central biological pathway across a broad range of acute and chronic diseases, creating the potential for a differentiated therapeutic pipeline targeting a common disease mechanism. The Company’s plans include developing next-generation oral 12-LOX inhibitors for larger chronic disease opportunities.

Cadrenal’s broader pipeline includes tecarfarin, a late-stage anticoagulant for patients requiring chronic anticoagulation, and frunexian, a Factor XIa inhibitor for acute hospital use.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

About CAD-1005

CAD-1005 is an investigational therapy under evaluation for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms that drive HIT. Unlike existing therapies for HIT, which are directed only at preventing thrombotic complications, this approach targets the primary underlying cause of HIT. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency.

About Acute Kidney Injury (AKI)

AKI is one of the most common and serious complications of cardiac surgery, affecting 20-30% of patients after cardiopulmonary bypass (CPB) and requiring renal replacement therapy (RRT) in approximately 1-5% of cases. It significantly increases morbidity, mortality, ICU length of stay, and the long-term risk of chronic kidney disease. There are currently no drugs approved for the prevention of AKI.

About 12-LOX
Lipoxygenases are lipid-metabolizing enzymes that catalyze the conversion of fatty acids into key components of cellular signaling pathways. One of these, 12-Lipoxygenase (12-LOX), plays a key role in the pathogenesis of AKI, immune-mediated platelet activation, and HIT. CAD-1005 is a selective inhibitor of 12-LOX and the only one in clinical-stage development. It has promising preclinical data in AKI and more recent preliminary Phase 2 data in HIT. Genetic depletion or pharmacological inhibition of 12-LOX has been shown to be protective against disease development and/or progression in animal models of diabetes, pulmonary, cardiovascular, and metabolic diseases.

About Heparin-Induced Thrombocytopenia (HIT)

Heparin is the most widely used in-hospital anticoagulant, with more than 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening, immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, markedly lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding the plans for a Phase 2a proof-of-concept clinical trial of CAD-1005 being studied to prevent Acute Kidney Injury (AKI) in high-risk patients undergoing cardiac surgery; enrollment to begin later this year; data intended to support clinical development and strategic partnership discussions; CAD-1005’s potential as a multi-billion-dollar critical care platform; the dual-indication program creating a high-value inflection point for Cadrenal to secure a well-capitalized strategic partner and fund its pipeline expansion through non-dilutive collaborations; being strongly positioned for upcoming strategic collaboration and licensing meetings at BIO 2026; potential to establish proof-of-concept in the multi-billion-dollar AKI market and the trial generating key safety and mechanistic data that could help to de-risk the pivotal Phase 3 registration path. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 2a study and derive the results needed for further clinical development; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Primary Logo

Release – NeuroSense Granted South Korean Patent Covering PrimeC Composition for ALS

Posted on by [email protected]

Research News and Market Data NRSN

  • Patent claims cover PrimeC’s proprietary formulation, manufacturing process and use in ALS
  • Expands intellectual property protection in one of the world’s leading pharmaceutical markets, following recent patent advancements in Japan, Brazil, Australia and the United States
  • Further strengthens global patent portfolio as NeuroSense prepares to initiate Phase 3 development of PrimeC

CAMBRIDGE, Mass., June 11, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”  or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Korean Intellectual Property Office (KIPO) has issued Korean Patent Number 10-2969898 covering the composition of PrimeC, the Company’s lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS).

The granted patent claims cover key aspects of PrimeC, including its proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for the treatment of ALS.

The patent is expected to provide patent protection for such aspects of PrimeC in South Korea through 2042.

“This patent grant further strengthens our growing global intellectual property estate surrounding PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “South Korea is an important pharmaceutical market, and this milestone reflects the continued recognition of the novelty and proprietary nature of PrimeC as we advance toward Phase 3 development.”

The South Korean patent grant follows patent grants received in other major jurisdictions, further expanding NeuroSense’s global intellectual property portfolio and supporting the long-term development and commercialization strategy for PrimeC.

PrimeC is a novel oral therapy designed to simultaneously target multiple biological mechanisms associated with ALS progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense previously reported compelling results from its Phase 2b PARADIGM study, including meaningful slowing of disease progression, significant biological activity across multiple ALS-related biomarkers, including microRNAs, and long-term data demonstrating a meaningful survival benefit. The Company has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 PARAGON study in ALS.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements, including statements regarding the benefits of the Korean patent, development, regulatory progress and potential commercialization of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding the benefits of the Korean patent; outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

SOURCE NeuroSense

For further information: For further information: Email: [email protected], Tel: +972 (0)9 799 6183

Release – MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial

Posted on by [email protected]

June 10, 2026 9:15am EDT

Additional data from MAIA’s THIO-101 expansion may further support an accelerated approval filing with the FDA

Potential breakthrough therapy holds substantial commercial opportunity in a projected $70 billion global non-small cell lung cancer market by 20301

CHICAGO, June 10, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has activated the second U.S. clinical site in its Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates MAIA’s lead investigational therapy, ateganosine, a dual-action molecule incorporating telomere targeting and immunogenicity, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy.

Parts A and B of the Phase 2 THIO-101 Phase 2 trial provided key inputs for MAIA’s market strategy by identifying optimal dosing for a well-defined patient population. The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA.

“Adding our second U.S. site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “Broadening our site footprint enables more efficient patient enrollment as we advance the program under the FDA Fast Track designation and work toward upcoming interim data milestones.”

David J. Mooney, M.D., oncology physician at Central Alabama Research and principal investigator for THIO-101 in Alabama commented, “We look forward to bringing ateganosine treatment to our cancer center. There’s a large regional patient pool across the Southeast, including underserved and rural populations, that can greatly benefit from a novel therapy in this hard-to-treat NSCLC setting with very limited treatment options.”

In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

Eledon Pharmaceuticals (ELDN) – Updates To Islet Cell Transplant Data Show Continued Insulin Independence

Posted on by [email protected]


Wednesday, June 10, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Islet Cell Transplant Data Presented At ADA Meeting. Eledon presented data at the American Diabetes Association Annual Meeting from its trial testing tegoprubart as an immunosuppressive in patients with Type 1 diabetes (T1D) receiving pancreatic islet cell transplants. These data update earlier presentations with additional patients and longer follow-up periods. After treatment, the patients were able to become insulin independent with no rejection episodes or treatment-related side effects.

Study Design. The trial enrolled 12 patients with Type 1 diabetes and poorly controlled glucose levels. Patients had diabetes for a mean duration of 33 years and a mean HbA1C of 8.0% at baseline. All received allogeneic pancreatic islet cell transplants with tegoprubart as part of their immunosuppression regimen instead of tacrolimus, a calcineurin inhibitor that is the standard of care in transplantation.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

GSK Pays $10.6 Billion for Nuvalent in Its Largest Acquisition in Over a Decade

Posted on by [email protected]

The biotech acquisition market just recorded one of its most significant transactions of 2026. GSK (LSE/NYSE: GSK) announced Tuesday it has entered into a definitive agreement to acquire Nuvalent Inc. (Nasdaq: NUVL), a Cambridge, Massachusetts-based clinical-stage biopharmaceutical company focused on precision oncology, for $10.6 billion in an all-cash tender offer at $124 per share. The price represents a 40% premium to Nuvalent’s last closing price and a 26% premium to its 30-day volume-weighted average price. Net of cash acquired, GSK’s aggregate investment is approximately $9.4 billion.

Nuvalent shares surged nearly 40% in premarket trading. GSK shares slipped approximately 1.5% in London as the market processed the scale of the commitment.

The deal marks GSK’s largest acquisition in more than a decade and the first major transaction under the leadership of new CEO Luke Miels, who took over from Emma Walmsley in January 2026. It signals a deliberate strategic pivot — GSK is moving aggressively into oncology as it confronts patent expiration pressures on established products, including its blockbuster shingles vaccine Shingrix, and seeks to close the gap with rival AstraZeneca, whose oncology sales accounted for 44% of total revenue last year.

What GSK Is Actually Buying

Founded in 2017, Nuvalent has built its pipeline around precisely targeted therapies for non-small cell lung cancer, one of the largest and most commercially significant oncology indications globally. Its two lead assets are zidesamtinib, a ROS1 inhibitor, and neladalkib, an ALK inhibitor — both of which have received FDA Breakthrough Therapy Designation and Orphan Drug Status and are currently under active FDA review.

FDA target decision dates are September 18, 2026 for zidesamtinib and November 27, 2026 for neladalkib. Subject to approval, both drugs are expected to launch before year-end 2026, with combined peak annual sales potential estimated at $3 billion to $4 billion. The pipeline also includes NVL-330, a potential best-in-class HER2 inhibitor currently in Phase I trials for HER2-altered non-small cell lung cancer, adding a third growth platform beyond the two near-term approvals.

GSK expects the acquisition to be accretive to sales and core operating profit in 2027 and accretive to core earnings per share in 2029, inclusive of synergies and pipeline reprioritization. The company plans to complement Nuvalent’s lung cancer platform with its own Ris-Rez B7-H3 antibody-drug conjugate, creating an integrated oncology franchise in one of the sector’s highest-priority therapeutic areas.

The Small Cap Biotech Signal

GSK paying $10.6 billion for a clinical-stage company with no approved products and no commercial revenue carries a specific and powerful message for small and microcap biotech investors. The premium reflects the value of FDA Breakthrough Therapy Designation, validated mechanism of action, late-stage regulatory visibility, and a clearly defined commercial opportunity in a large patient population.

The broader biotech M&A environment is accelerating. Patent cliffs across major pharmaceutical companies are creating urgency to acquire external innovation, and the pipeline of clinical-stage companies with validated oncology assets in the sub-$2 billion market cap range remains deep. When large pharma assigns a $10.6 billion value to a pre-revenue biotech, it resets the reference point for how the market values similar-stage assets across the sector.

Upon completion of the tender offer and merger, Nuvalent common stock will be delisted from Nasdaq.

Release – NeuroSense Therapeutics Receives Japanese Patent Grant for PrimeC Novel Composition

Posted on by [email protected]

Research News and Market Data on NRSN

Patent Protection Extends Through 2042 following recent U.S., Australia and Brazil patents

CAMBRIDGE, Mass., June 9, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Japan Patent Office has issued a Japanese Patent 7857044 covering the Company’s lead drug candidate for the treatment of amyotrophic lateral sclerosis (ALS).

The patent, entitled “Compositions comprising ciprofloxacin and celecoxib,” includes 17 claims and provides protection through 2042 for the unique formulation and manufacturing process of PrimeC, including its synchronized delivery profile of celecoxib and ciprofloxacin, designed to target multiple key mechanisms underlying ALS progression.

“This patent grant further strengthens our global intellectual property estate around PrimeC and reinforces the novelty of our synchronized extended-release formulation,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Japan is a key pharmaceutical market, and this patent further supports our long-term commercialization strategy as we advance PrimeC toward a pivotal Phase 3 clinical trial.”

The patent is part of NeuroSense’s broader global IP portfolio protecting both the composition and formulation of PrimeC, which is designed to modulate multiple disease-relevant mechanisms, including neuroinflammation, iron dysregulation, autophagy, and miRNA pathways.

PrimeC has demonstrated consistent clinical, biomarker, and survival benefit in the Phase 2b PARADIGM study, including a significant survival benefit in extended follow-up analyses. The Company has received FDA’s clearance to proceed and is preparing for initiation of a Phase 3 pivotal study (PARAGON).

The Japanese patent is expected to provide long-term protection for PrimeC’s proprietary formulation in a key strategic market, subject to standard terms and potential extensions.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has generated compelling clinical data from its Phase 2b PARADIGM study in ALS, demonstrating meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action. Notably, long-term follow-up data indicated a meaningful survival benefit, representing a potentially important advancement in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements, including statements regarding the benefits of the Japanese patent, development, regulatory progress and potential commercialization of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding the benefits of the Japanese patent; outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

SOURCE NeuroSense

For further information: For further information: Email: [email protected], Tel: +972 (0)9 799 6183

Release – Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine

Posted on by [email protected]
Primary Logo

June 8, 2026

PDF Version

– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D

– All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline

– No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation in all enrolled patients

IRVINE, Calif., June 08, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The results were presented by trial investigator Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C (“HbA1c”) below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort.

While all patients enrolled reported recurrent severe hypoglycemic events pre-transplant, no severe hypoglycemic episodes were reported following transplantation. Severe hypoglycemia is a serious complication of type 1 diabetes that may require emergency medical intervention and can cause loss of consciousness, seizures, injury, or death. Recurrent severe hypoglycemic episodes can significantly impact patients’ daily activities and quality of life.

Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart-based immunosuppression regimen than in historical patients treated with a tacrolimus-based immunosuppression regimen at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Tegoprubart-based immunosuppression was generally well tolerated, with immunosuppression-related adverse events generally successfully treated by lowering the mycophenolic acid dose, if necessary. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors such as tacrolimus.

The investigator-initiated pilot study enrolled 12 adults with long-standing T1D undergoing allogeneic islet transplantation at UChicago Medicine with a median duration of diabetes of approximately 33 years and mean HbA1c of approximately 8.0% prior to transplantation. Participants received tegoprubart, as part of a calcineurin inhibitor-free immunosuppression regimen. Calcineurin inhibitors such as tacrolimus are commonly used to prevent transplant rejection but can be associated with kidney toxicity, hypertension, neurological side effects, and harm to insulin-producing islet cells, limiting their suitability for long-term use in patients with T1D receiving an islet cell transplant.

“T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

“Insulin independence without the burden of traditional immunosuppression has long been one of cell replacement therapy’s biggest goals,” said Aaron Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D. “Results like these show that this goal is becoming increasingly achievable. Breakthrough T1D is proud to fund this important study.”

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Eledon Announces Presentation of Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at American Diabetes Association (ADA) 2026 Scientific Sessions

Posted on by [email protected]
eledon logo

Research News and Market Data on ELDN

June 4, 2026

PDF Version

IRVINE, Calif., June 04, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated results from an investigator-initiated trial being conducted at the University of Chicago Medicine Transplant Institute will be presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

Details of the oral presentation are as follows:

Presentation Title: Anti-CD40L to Induce Graft Survival and Function in Islet Allotransplantation
Session: Immune Modulatory Strategies for Next-Generation Cell Therapies
Date: Sunday, June 7, 2026
Time: 2:30 p.m. – 3:00 p.m. CT
Room: 343 (Level 3)

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:
Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Primary Logo