Release – MAIA Biotechnology Reports Strong Initial Efficacy Data in Third-Line Non-Small Cell Lung Cancer from Phase 2 THIO-101 Part C Expansion Trial

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Research News and Market Data on MAIA

July 08, 2026 9:45am EDT Download as PDF

90.5% interim disease control rate (DCR) observed with combination therapy

Initial Part C efficacy observations align with previously reported THIO-101 clinical activity despite a more heavily pre-treated patient population

CHICAGO, July 08, 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 positive initial efficacy data from its Phase 2 THIO-101 clinical trial expansion, Part C, evaluating its lead candidate, ateganosine, a dual mechanism of action drug incorporating telomere targeting and immunogenicity, as a third-line (3L) therapy for patients with advanced non-small cell lung cancer (NSCLC). 

Initial data from the THIO-101 Part C 3L studies1 show a disease control rate (DCR) of 90.5% (19 out of 21 patients) in the efficacy evaluable population who had at least one tumor scan after starting treatment. Patients are treated with ateganosine followed by cemiplimab (Libtayo®) in cycles of 21 days. Current chemotherapy treatments deliver an approximate 25-35% disease control rate.2

“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy treatment,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “Importantly, patients enrolled in Part C of our trial represent a more heavily pre-treated population, with all patients having previously received docetaxel in addition to demonstrating resistance to both immunotherapy and other chemotherapies.”

MAIA recently announced that it has completed international enrollment in Part C of the Phase 2 THIO-101 expansion trial. Treatment with ateganosine followed by cemiplimab has shown an acceptable safety profile to date in a heavily pre-treated population.

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]


1 As of July 06, 2026
2 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89

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Source: MAIA Biotechnology, Inc.

Released July 8, 2026

Release – Research Analyst Report on NanoViricides Rates Company “Outperform”; Separately, A “Fireside Chat” Interview of the Company’s President Dr. Anil Diwan Hosted by Mr. Dave Donlin was Published by StockInvestor Daily

Research Analyst Report on NanoViricides Rates Company "Outperform"; Separately, A "Fireside Chat" Interview of the Company's President Dr. Anil Diwan Hosted by Mr. Dave Donlin was Published by StockInvestor Daily

Research News and Market Data on NNVC

Wednesday, 08 July 2026 08:30 AM

Topic: 

Company Update

SHELTON, CT / ACCESS Newswire / July 8, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), a clinical stage leader developing antiviral drugs that viruses cannot escape, reports that a Coverage Initiating Research Report on the Company by an Independent Analyst has been published, dated as of July 6, 2026.

The report rates the Company with a rating of “Outperform” and has assigned a target price of $6.00, based on the analyst’s estimates. This research report provides a summary of the Company’s current programs, as well as additional longer term programs. The report was written by Mr. Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc. The report and additional coverage of the Company is available at channelchek.com. The report is also available at the Company’s website, nanoviricides.com .

The Company provided publicly available information to the Analyst, and also provided answers to questions of a technical nature, as is typical. All estimates of timelines, financial projections and modeling, etc. were made independently by the Analyst. The Company does not provide guidance on its timelines or revenues, profit or loss projections, nor does it review or have any input into the independent assessments.

The Company has retained Noble Capital as part of its investor outreach program. No part of the Analyst’s compensation was, is, or will be directly or indirectly related to any specific recommendations or views expressed in the public appearance and/or research report. All views expressed in this report accurately reflect the Analyst’s personal views about the subject securities or issuers. This report is intended to provide general securities advice, and does not purport to make any recommendation that any securities transaction is appropriate for any recipient particular investment objectives, financial situation or particular needs.

In a separate update, NanoViricides reports that Anil R. Diwan, PhD, the Company’s President and Executive Chairman was interviewed in a “Fireside Chat” by host Mr. Dave Donlin. This video interview was published by StockInvestor Daily under the IPO-Edge program on June 29, 2026 and is available at https://ipo-edge.com/replay-fireside-chat-with-nanoviricides-president-exec-chairman-anil-r-diwan/. The video is also available on the Company’s website (nanoviricides.com). The video provides information on the Company’s technology, how it is differentiated from current approaches, and the current programs.

In this Fireside Chat, Dr. Diwan discussed:

  • How NanoViricides’ broad-spectrum antiviral drugs like its lead drug NV-387 work alongside vaccines.
  • NanoViricides advancing a broad-spectrum antiviral approach that will be effective even against variants with its lead drug NV-387; how this differs from current antivirals in treating viral diseases like RSV and FLU.
  • The company’s Orphan Drug Designation granted by the FDA and its filing for Rare Pediatric Disease Designation for Measles; how the Company benefits from these designations and the upcoming potential funding benefits.
  • The resurgence of Measles despite having a vaccine in place and how it has caused epidemics in Europe, Canada, Mexico, and Bangladesh, while also making headlines in the U.S. Why this is happening and what this return tell us about current protection against viral diseases that are thought to be eliminated by vaccines.
  • The resurgence of several viral infections globally, like Monkeypox and Ebola, and the WHO declaring global alerts as diseases come back with new virus variants for which there is no vaccine or treatment, and how NanoViricides can help.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

SOURCE: NanoViricides, Inc.

Release – The Oncology Institute Completes Strategic Refinancing with OrbiMed, Repaying the Outstanding $86 Million Deerfield Convertible Note, Strengthening its Balance Sheet, and Improving Liquidity

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Research News and Market Data on TOI

Jul 07, 2026

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CERRITOS, Calif., July 07, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, announced today that it has repaid its $86 Million senior secured convertible note with Deerfield Partners through a debt refinancing that includes new credit facilities from OrbiMed.

This transaction is intended to increase liquidity, improve operating flexibility and extend debt maturities. Under the new financing arrangements with OrbiMed, TOI repaid the outstanding balance of its $86 million senior secured convertible note with a new $75 million term loan with OrbiMed maturing in 2031 as well as approximately $11 million of cash from the balance sheet without raising additional equity. Daniel Virnich, MD, CEO of TOI, commented, “I’m extremely excited about our new financing relationship with OrbiMed to support this next phase of TOI’s growth and business model refinement. In addition to providing the company with improved liquidity and financial flexibility, this important transaction significantly extends debt maturities and establishes committed funding from two leading healthcare financing institutions.” Dr Virnich also commented, “We are very pleased that we were able to complete these transactions without diluting our important existing shareholders, and would like to thank Deerfield Healthcare for their many years of support to TOI as both a creditor and existing shareholder.”

“We are pleased to support TOI in its next phase of growth,” said Matthew Rizzo of OrbiMed. ” We are excited to play a role in TOI’s expansion and development as it continues to scale and drive long term value for its patients and contracted payors.”

About The Oncology Institute  (www.theoncologyinstitute.com):

Founded in 2007, The Oncology Institute, Inc. (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 2.0 million patients including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 400 employed and network clinicians and over 100 clinics and network locations of care across five states and growing, TOI is changing oncology for the better. For more information visit www.theoncologyinstitute.com.

Forward Looking Statement

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or TOI’s future financial or operating performance and are often identified by words such as “believe,” “expect,” “anticipate,” “plan,” “intend,” “may,” “will,” “estimate,” “continue,” “project,” “target,” or similar expressions.

These forward-looking statements include, without limitation, statements regarding TOI’s growth strategy, liquidity, working capital needs, access to financing (including any asset-based credit facilities), expected operational and financial performance, and market opportunities. These statements are based on current expectations, assumptions, and information available to management and are not guarantees of future performance.

Actual results may differ materially from those expressed or implied in forward-looking statements due to a variety of risks and uncertainties, including, among others: changes in the healthcare regulatory environment; reimbursement and payor dynamics; competitive pressures; TOI’s ability to execute on its growth and value-based care strategy; access to capital and liquidity; and the impact of litigation, government investigations, or other proceedings.

Additional factors that could cause actual results to differ materially are described in TOI’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of TOI’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.

Forward-looking statements speak only as of the date made, and TOI undertakes no obligation to update or revise these statements to reflect events or circumstances occurring after the date of this communication, except as required by law.

Media
The Oncology Institute, Inc.
[email protected]

Investors
ICR Healthcare
[email protected]

Release – MariMed’s Nature’s Heritage Launches “The Nose Knows” Immersive, Science-Backed Consumer Education Campaign

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Research News and Market Data on MRMD

July 07, 2026 7:00am EDTDownload as PDF

NORWOOD, Mass., July 07, 2026 (GLOBE NEWSWIRE) — MariMed’s (“MariMed”) (CSE: MRMD) (OTCQB: MRMD) award-winning flower, vape and concentrate brand, Nature’s Heritage™, today announced the launch of ‘The Nose Knows,’ an immersive, science-backed consumer education campaign designed to help consumers better understand which cannabis products and strains align best to their preferences. The campaign aims to educate consumers about the critical role aroma plays in delivering desired cannabis experiences and organizes cannabis strains into six categorizes to make purchase decisions easier and more effective.

Developed in collaboration with Dr. Riley Kirk, a PhD-trained pharmaceutical scientist specializing in cannabis and pharmacology, ‘The Nose Knows’ campaign was inspired by feedback from cannabis consumers surveyed across Massachusetts, Maryland, and Illinois. The survey found that a product’s THC potency percentage is the primary factor influencing purchases. According to Dr. Kirk, research indicates that consumers would achieve a more desirable and personalized experience by focusing instead on their natural attraction to certain scents when making their flower purchase.

“Our sense of smell is intimately tied to our brain’s processing centers for emotions and memory,” said Dr. Kirk. “We want to encourage people to follow their nose to find cannabis that fits their needs and allows for a more personalized and nuanced experience. Terpene labels are a great resource, but they can be confusing to consumers. Following your nose is simple and intuitive for everyone.”

‘The Nose Knows’ campaign features immersive in-store activations, sensory-driven displays, and large-scale murals highlighting six aroma-and-effect-driven categories: Jacks & Haze, Tropical & Citrus, Floral & Earthy, Desserts & Sweets, OG, Gas & Chem, and Exotics. Utilizing local artists to visually depict each intended experience, the campaign transforms participating retail spaces into educational environments that encourage consumers to smell flower and concentrates and use their nose to help discover products that are right for them. Consumers can also explore the campaign through Nature’s Heritage’s online “Find Your Flower” quiz. The quiz helps guide consumers toward products aligned with their preferences and desired effects.

“Today’s cannabis consumer overwhelmingly purchases products based on THC percentage. Cannabis is meant to be experienced through one’s senses, and the science supports the fact that focusing on aroma rather than potency will enhance a consumer’s cannabis experience,” said Tami Kirlis, Brand Director for Nature’s Heritage. “We developed ‘The Nose Knows’ campaign to educate consumers and shift their purchasing behaviors using their sense of smell.”

To learn more about Nature Heritage, including options for flower, RSO, concentrates and vapes, visit www.naturesheritagecannabis.com.

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™, InHouse™, Nature’s Heritage™, and Vibations™, 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.

Media Contact:
Zach Galasso
DPA Communications 
Email: [email protected]
Phone: (978) 604-5423

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

Release – NeuroSense to Participate in Roth-Hosted KOL Webinar on the Future of ALS Treatment: “A Quest to Outrun ALS”

Research News and Market Data on NRSN

Featuring renowned ALS expert Prof. Jeremy Shefner, the discussion will address key unmet needs in ALS, trial endpoint design, and PrimeC’s path forward

CAMBRIDGE, Mass., July 6, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced its participation in a key opinion leader (KOL) webinar hosted by Roth Capital Partners titled “A Quest to Outrun Amyotrophic Lateral Sclerosis (ALS).” The webinar will bring together leading experts to discuss the current treatment landscape for ALS, persistent unmet medical needs, and emerging therapeutic approaches with the potential to change the course of the disease.

The live webinar will take place on Wednesday, July 8, 2026, at 11:00 a.m. Eastern Time and will be hosted by Boobalan Pachaiyappan, Ph.D., Managing Director and Senior Research Analyst at Roth Capital Partners, who covers the biotechnology sector. The discussion will feature Professor Jeremy Shefner, M.D., Ph.D., Chair of Neurology at Barrow Neurological Institute and Co-Founder of the Northeast ALS Consortium (NEALS), together with Alon Ben-Noon, Chief Executive Officer of NeuroSense.

To join the conversation, register in advance here.

The webinar will explore the most pressing questions in ALS drug development today – from the persistent unmet needs that continue to challenge patients and clinicians, to the clinical trial endpoints that may better capture disease progression. The discussion will also examine how NeuroSense’s PrimeC is positioned – mechanistically and clinically – relative to the current standard of care, what the pivotal Phase 3 PARAGON study will aim to demonstrate on the path toward potential FDA accelerated approval, and PrimeC’s longer-term commercial opportunity within an evolving ALS treatment landscape.

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 planned event, 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 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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

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

NanoViricides (NNVC) – Novel Technology With Broad-Spectrum Antiviral Applications In Development


Monday, July 06, 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.

We Are Initiating Coverage With An Outperform Rating. NanoViricides has a proprietary technology platform that it has used to formulate antivirals with a unique mechanism of action. These drugs, called nanoviricides, have been designed to carry a peptide sequence that the virus recognizes as a binding site on a host cell, effectively acting as decoys that the virus binds to instead of healthy cells. Once bound to the drug, the virus is trapped and neutralized.

NV-387 Addresses Viral Outbreaks and Pandemic Preparedness. The lead product, NV-387, is in development for MPox, Ebola, and smallpox. A Phase 2a trial evaluating NV-387 for treating MPox in the Democratic Republic of Congo (DRC) is expected to begin treatment in mid-2027, followed by a Phase 2a in Ebola. Initial data is expected to be available toward the end of 2027.


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This 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. 

NeuroSense Therapeutics Ltd. (NRSN) – Strong PrimeC Data Continues As Phase 2b PRAADIGM Study Meets Primary Endpoint In ALS With Reduction


Thursday, July 02, 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.

NeuroSense Reported Strong Phase 2b PARADIGM Data. Results of the Phase 2b PARDIDM study testing PrimeC in ALS met its primary endpoint of a statistically significant reduction in TDP-43 at six months. The reduction in neuron-derived TDP-43 in the treated group indicates that PrimeC affects an important mechanism of disease and the underlying cause of ALS. To our knowledge, this is the first clinical trial to show that a drug could reduce TDP-43 in people living with ALS.

Phase 2b PARADIGM Study Tested Functional and Biological Endpoints. The trial was a double-blind trial enrolling 68 patients with confirmed ALS. Patients were randomized 2:1 to receive either PrimeC or a placebo for 6 months. All patients then received PrimeC for the next 12 months (18 months total). The trial endpoints included TDP-43, safety, tolerability,  and biomarkers of disease.


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Release – Cadrenal Therapeutics Announces up to $8.8 Million Private Placement Priced At-The-Market Under Nasdaq Rules

PONTE VEDRA, Fla., June 30, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) (the “Company”), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 960,000 shares of its common stock (or pre-funded warrants in lieu thereof), series C-1 warrants to purchase up to an aggregate of 960,000 shares of common stock and series C-2 warrants to purchase up to an aggregate of 960,000 shares of common stock, at a combined purchase price of $3.125 per share (or pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The series C-1 warrants will have an exercise price of $3.00 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock issuable upon exercise of the series C-1 warrants (the “Stockholder Approval Date”) and will expire five years after the later of (i) the Stockholder Approval Date and (ii) the effective date of a resale registration statement registering for resale all of the shares of common stock underlying the series C-1 warrants. The series C-2 warrants will have an exercise price of $3.00 per share, will be exercisable immediately upon issuance, and will expire twenty-four months after the effective date of a resale registration statement registering for resale all of the shares of common stock and the shares of common stock underlying the series C-2 warrants.

The aggregate gross proceeds to the Company from the offering are expected to be $3 million, before deducting placement agent fees and other offering expenses. The potential additional gross proceeds to the Company from the series C-1 warrants and the series C-2 warrants, if fully exercised on a cash basis, will be approximately $5.8 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The offering is expected to close on or about July 1, 2026, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

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, those with left ventricular assist devices, and potentially, those with Kawasaki disease (KD), an acute self-limited febrile illness that primarily affects children <5 years old, and the leading cause of acquired heart disease in developed countries.

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 closing of the offering, the satisfaction of customary closing conditions related to the offering, the expected gross proceeds from the offering, the Company seeking stockholder approval, receipt of stockholder approval, the filing of one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering, the intended use of net proceeds from the offering, the potential exercise of the warrants for cash prior to their expiration and the Company’s receipt of potential proceeds therefrom, net proceeds anticipated to extend the Company’s cash runway into first quarter of 2027; and the Company’s cash runway anticipated to be extended into second half of 2027 to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to close the offering, the ability of the Company to obtain stockholder approval, the ability of the Company to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT; the ability to raise sufficient capital to continue progress of its product candidates; the ability to 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]

Unicycive Therapeutics (UNCY) – Delay in Manufacturing Inspection Leads To Complete Response Letter (CRL)


Wednesday, July 01, 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.

We Now Expect Product Approval Around YE2026. Unicycive announced it has received a CRL (Complete Response Letter) stating that the NDA for OLC (oxylanthanum carbonate), its phosphate binder for patients on dialysis, has not been approved. The reason stated is that the FDA has not conducted its required inspection of the third-party manufacturing vendor. This step is expected to be completed during the summer, allowing for an NDA resubmission and approval near YE2026.

All Other Steps In The NDA Review Appear To Be Complete. The FDA inspection appears to have been the only remaining step for OLC approval. After a meeting with the FDA, steps to resolve manufacturing issues with the third-party vendor were identified, addressed, and the plant readied for inspection. The review of clinical efficacy and safety data was completed in 2025, with no new issues raised. Product labeling and packaging discussions have been ongoing, typically the last step before approval.


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Release – Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

Unicycive Therapeutics, Inc

Research News and Market Data on UNCY

June 30, 2026 7:05am EDT Download as PDF

— Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor —

— FDA inspection of third-party facility did not occur during the NDA resubmission review —

— Labeling discussions currently underway; latest communication received by the Company from FDA on June 29 regarding carton and container label —

— FDA did not raise concerns regarding the clinical efficacy or safety data of OLC, and no additional data was requested —

MOUNTAIN VIEW, Calif., June 30, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The FDA has not raised any concerns regarding clinical efficacy or safety data, and no additional data was requested from Unicycive.

The CRL is based on the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025. Unicycive understands that the FDA has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process of the resubmitted NDA. The NDA for OLC had been resubmitted based on Unicycive’s belief of continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the deficiencies identified in the Company’s CRL related to the compliance status of the vendor. The FDA did not express any concerns about the third-party manufacturer’s progress and no additional issues were raised by the FDA at the Type A meeting.

“We remain confident in the efficacy and safety of OLC,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA.”

The OLC NDA is supported by data from three clinical studies: a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in chronic kidney disease (CKD) patients on dialysis, multiple preclinical studies, as well as chemistry, manufacturing and controls (CMC) data.

About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:
Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:
Layne Cosgrove
Real Chemistry
[email protected]

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Source: Unicycive Therapeutics, Inc.

Released June 30, 2026

Release – NeuroSense Achieves Primary Endpoint in Phase 2b ALS Study with Statistically Significant Reduction of TDP-43, the Defining Pathological Hallmark of ALS

Research News and Market Data on NRSN

  • First randomized, double-blind, placebo-controlled trial to demonstrate treatment-associated reduction of TDP-43 in people living with ALS
  • TDP-43 pathology is present in more than 97% of ALS cases and is widely recognized as a central driver of disease progression
  • PrimeC demonstrates target engagement with consistent effects across clinical outcomes, survival, and biomarkers, supporting its potential as a disease-modifying therapy

CAMBRIDGE, Mass., June 29, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that its Phase 2b PARADIGM study of PrimeC in amyotrophic lateral sclerosis (ALS) has successfully met its primary efficacy endpoint, demonstrating a statistically significant reduction in TDP-43 levels compared to placebo. This is the first randomized, double-blind, placebo-controlled clinical study to demonstrate a treatment-associated reduction in TDP-43 in people living with ALS. The analysis was performed using the NeuroDex ExoSORT procedure, an immunoaffinity-based methodology that selectively isolates neuron-derived extracellular vesicles (NDEs). This approach enables measurement of neuron-derived TDP-43, providing a CNS-relevant signal that can be distinguished from TDP-43 released by non-neuronal cells and peripheral tissues.

TDP-43 is the defining pathological hallmark of ALS, present in more than 97% of cases, and is widely recognized as a central driver of disease progression. The observed reduction in TDP-43 provides biological evidence that PrimeC is engaging a core disease mechanism.

Primary Efficacy Endpoint Achieved with Statistical Significance

The randomized, double-blind, placebo-controlled Phase 2b PARADIGM study evaluated the safety, tolerability, biomarkers and efficacy of PrimeC in people with ALS. At Day 180, the pre-specified primary endpoint timepoint, PrimeC produced a statistically significant reduction in TDP-43 versus placebo (p=0.0421). The effect was sustained and deepened over the full 18 months of the study, with continuously treated PrimeC participants maintaining lower TDP-43 levels than the placebo arm at Day 540 (p<0.001).

These findings build upon previously reported clinical outcomes from the PARADIGM study, including:

  • Statistically significant slowing of ALSFRS-R decline at 12 and 18 months (36.5%, p=0.008; 32.8%, p=0.007)
  • Statistically significant ~15-month median survival benefit (HR 0.35, p=0.004)
  • Consistent modulation of TDP-43, iron-regulatory and ALS-associated microRNA, supporting multi-target engagement
  • Favorable safety and tolerability profile with no new safety signals observed over up to 18 months of treatment

“Achieving the primary endpoint of PARADIGM with a statistically significant reduction in TDP-43 marks a defining moment for NeuroSense and for ALS research,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “For decades, TDP-43 has been recognized as the pathological signature of ALS, yet demonstrating a treatment-associated reduction in people with ALS has remained elusive. Combined with the clinically meaningful slowing of disease progression, significant survival benefit, and consistent biomarker findings previously reported from PARADIGM, these results provide a compelling and highly differentiated body of evidence supporting PrimeC’s potential as a disease-modifying therapy. We believe this growing dataset further validates our scientific approach and positions PrimeC as one of the most comprehensively supported therapeutic candidates in ALS today.”

“One of the central questions in ALS drug development is whether a therapy is truly affecting the underlying biology of the disease,” said Prof. Merit Cudkowicz, MD, MSc, Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and Professor of Neurology at Harvard Medical School. “The TDP-43 findings reported in PARADIGM are particularly important because they suggest target engagement of a pathological process present in the majority of people with ALS. When viewed together with the previously reported safety, biomarker and clinical outcome data, and the high unmet need, these results provide compelling data supporting advancement into a confirmatory Phase 3 clinical trial.”

“It is remarkable to see that the increase in NDE-associated TDP-43 observed in the placebo group follows the same trajectory as that identified in our longitudinal studies. This effect, together with the positive outcome of PARADIGM, highlights the promise of TDP-43 as a biomarker for monitoring treatment response,” said Dr. Erez Eitan, CEO of NeuroDex.

Having secured FDA clearance to initiate its global Phase 3 (PARAGON) study, NeuroSense is advancing trial preparations while progressing regulatory interactions across multiple jurisdictions, including Canada.

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.

About ExoSORT and Neuron-derived EV

ExoSORT™ is NeuroDex’s proprietary automated platform for the enrichment of neuron-derived extracellular vesicles (NDEs) from blood samples. Utilizing a combination of highly specific neuronal antibodies and a scalable 96-well workflow, ExoSORT™ selectively isolates extracellular vesicles originating from the brain, increasing the neuronal signal by more than 50-fold compared to conventional plasma analyses.

By enriching for brain-derived vesicles, ExoSORT™ enables detection of disease-associated proteins present in multiple tissues, like TDP-43.

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 and include statements regarding the potential of PrimeC. Further, certain forward-looking statements, including statements regarding future development 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 outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development, 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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

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

Zymeworks Moves to Acquire Theravance Biopharma in $929 Million Deal

Vancouver-based Zymeworks (Nasdaq: ZYME) announced this morning it has signed a definitive agreement to acquire Theravance Biopharma (Nasdaq: TBPH) for $17.00 per share in cash, a deal valued at roughly $929 million. The transaction adds YUPELRI® (revefenacin), the only nebulized once-daily LAMA approved for COPD maintenance therapy, to Zymeworks’ growing portfolio of partnered commercial assets.

The move is consistent with the strategy Zymeworks outlined earlier this year: pair royalty-generating assets with its internal R&D pipeline to create a more durable, self-funded business. The company has been building toward this kind of deal since pivoting away from a pure drug development model, and today’s announcement is the clearest sign yet that the strategy is gaining traction.

YUPELRI® has been on the U.S. market since 2019, co-promoted by Viatris and Theravance Biopharma. Full-year 2025 net sales came in at $266.6 million, up 12% over the prior year, with Q1 2026 sales of $62.4 million representing 7% growth year-over-year. Zymeworks will receive a 35% U.S. net profit share, which at current run-rates translates to roughly $60 million in annualized cash flow. Generic entry has been pushed to April 2039 following settlements with all filers, giving the asset a clear commercial runway.

Financing the deal involved some creativity. Zymeworks secured a $350 million non-recourse note from OMERS Life Sciences, structured so that 75% of the YUPELRI® profit-share cash flows service the debt. Critically, the note has no recourse to the rest of Zymeworks’ balance sheet. The company will contribute $219 million in existing cash, with Theravance Biopharma’s expected net cash balance of approximately $360 million at closing covering most of the remainder. A $100 million milestone payment from Royalty Pharma related to TRELEGY ELLIPTA® sales is expected in Q1 2027, which effectively cuts Zymeworks’ net cash outlay roughly in half.

Beyond YUPELRI®, the deal brings additional upside. Theravance Biopharma holds royalty interests on VIBATIV® through Cumberland, is eligible for up to $125 million in future YUPELRI® commercial milestones from Viatris, and carries approximately $2.5 billion in Irish tax attributes that Zymeworks intends to preserve for future use. A preclinical inflammation and immunology portfolio also transfers, though Zymeworks has signaled it will evaluate those assets against its broader pipeline priorities.

CEO Kenneth Galbraith framed the deal as core to the company’s longer-term vision of blending commercial cash flows with internal innovation, describing it as a way to fund next-generation therapies while supporting patients who need access today. The boards of both companies have unanimously approved the transaction.

Closing is expected in the second half of 2026, subject to Theravance Biopharma shareholder approval and regulatory clearance. Kirkland & Ellis is serving as legal counsel to Zymeworks, with TD Cowen advising on the OMERS note. Lazard and Evercore are advising Theravance Biopharma.

Release – MariMed Submits DEA Registration Applications For State-Licensed Medical Cannabis Businesses

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Research News and Market Data on MRMD

June 25, 2026 2:50pm EDTDownload as PDF

Registration Aligns With The Federal Rescheduling of Cannabis to Schedule III, Which Grants Federal Safe Harbor To Licensed Operators And Removes IRS Section 280E Restrictions

NORWOOD, Mass., June 25, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQB: MRMD), a leading multi-state cannabis operator, today announced the Company has submitted applications with the U.S. Drug Enforcement Agency (“DEA”) to register certain state-licensed medical cannabis operations. Registering the Company’s medical cannabis licenses with the DEA is a requirement to qualify for protections provided by the federal rescheduling of medical marijuana to Schedule III of the Controlled Substances Act.

“DEA registration of certain of our medical businesses marks an important step forward for MariMed as we move the Company toward becoming a federally legal business,” said MariMed CEO Jon Levine.

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

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Source: MariMed Inc.

Released June 25, 2026