Category: Healthcare

MAIA Biotechnology (MAIA) – First Data From Phase 2 Part C Trial Shows Data Consistent With Earlier Studies

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Thursday, July 09, 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.

Data From Part C Announced. MAIA announced data from Part C (Expansion stage) of its Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC). This open-label stage of the trial tests the combination of ateganosine and cemiplimab (Libtayo, from Regeneron) as a third-line (3L) therapy for patients with advanced disease that no longer respond to other therapies. The data after the first evaluation have a Disease Control Rate (DCR) of 90.5% (19 out of 21 patients), compared with published rates of 25% to 35%. We view this as a good sign that patient responses are consistent with previous data.

Design Of the Phase 2 THIO-101 Trial. The Phase 2 THIO-101 Expansion stage is the third part of the Phase 2 trial. Part A tested safety, while Part B was for dose optimization and selection. Part C is currently testing the combination of the 180 mg dose of ateganosine with cemiplimab. If positive, the data could be used to apply for accelerated approval from the FDA.


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*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. 

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

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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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*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. 

Zymeworks Moves to Acquire Theravance Biopharma in $929 Million Deal

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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.

Boundless Bio Pivots From Cancer to a Rare Genetic Disease in a Reverse Merger With Serapha Bio

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In a transaction that illustrates how struggling clinical-stage biotechs are increasingly being repurposed as vehicles for more promising assets, Boundless Bio (Nasdaq: BOLD) announced Tuesday it has entered into a definitive all-stock merger agreement with privately held Serapha Bio. The deal will see Serapha combine with Boundless Bio and effectively take over the public company, pivoting the combined entity away from Boundless’s cancer research and toward Serapha’s gene editing therapy for a serious inherited disease. Boundless Bio shares surged approximately 75% on the news to around $2.50.

Upon completion, the combined company will operate under the name Serapha Bio and is expected to trade on Nasdaq under the new ticker symbol “AATD” — a direct reference to the disease its lead program targets.

The Structure of the Deal

This is a reverse merger, a structure in which a private company merges into a public one to gain a stock market listing without conducting a traditional IPO. The ownership split makes the dynamic clear: pre-merger Boundless Bio stockholders are expected to own approximately 3.7% of the combined company, while pre-merger Serapha stockholders — including investors participating in the concurrent financing — will own approximately 96.3%.

Two features make this transaction particularly notable for shareholders. First, alongside the merger, Serapha is raising $230 million in a concurrent private placement co-led by RTW Investments and RA Capital Management, with participation from a syndicate of top healthcare investors and mutual funds. That level of institutional backing provides the combined company with substantial capital to advance its lead program through clinical development. Second, prior to closing, Boundless Bio expects to declare a cash dividend to its pre-merger stockholders to distribute excess net cash, currently estimated at approximately $44 million to $48 million. That dividend, combined with the stock’s jump, gives existing Boundless holders both an immediate cash return and continued exposure to the new program.

What Serapha Is Actually Developing

Serapha’s lead program, SERP-01, is an investigational in vivo base editing therapy targeting Alpha-1 Antitrypsin Deficiency, a serious inherited genetic disorder that can cause progressive lung and liver disease. The therapy specifically targets the SERPINA1 E342K mutation — known as the PiZZ genotype — which is the most common cause of severe AATD. The company has reported proof-of-concept data demonstrating restoration of serum AAT to normal levels, an encouraging early signal for a disease that currently has limited treatment options.

The asset has an international development backstory. Serapha licensed SERP-01, developed as YOLT-202 in Greater China, from YolTech Therapeutics in June 2026 in exchange for an upfront cash payment and a minority equity stake. Under the agreement, YolTech is eligible to receive regulatory and commercial milestones totaling over $2 billion plus tiered royalties, while retaining development and commercialization rights for the Greater China territory. YolTech has been enrolling AATD patients in an investigator-initiated trial at Renji Hospital in Shanghai.

The Small Cap Biotech Read

For investors tracking the small and microcap biotech space, this transaction reflects a pattern that has become increasingly common in 2026. Clinical-stage companies whose original programs have stalled or been deprioritized are valuable to private biotechs precisely because of what they already possess: a Nasdaq listing, a cash balance, and an existing shareholder base. Rather than navigate the lengthy and uncertain IPO process, a promising private company like Serapha can access public markets, raise institutional capital, and advance its lead asset all in a single coordinated transaction.

The base editing space in particular has attracted significant investor attention as next-generation gene editing technologies move from theoretical promise toward clinical proof of concept. With $230 million in fresh capital, validated early data, and a clear regulatory target in a serious genetic disease, the newly formed Serapha Bio enters the public market positioned to advance one of the more closely watched programs in the in vivo base editing field. The transaction is expected to close in the fourth quarter of 2026, subject to stockholder approval and customary closing conditions.

Eledon Pharmaceuticals (ELDN) – Eledon Presents Data Update From Phase 2 Trial With Clinical Trial Plans

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Tuesday, June 23, 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.

Long-Term Outcomes Favor Tegoprubart. Eledon presented long-term data from its Phase 2 BESTOW trial at the American Transplantation Congress (ATC). The BESTOW trial tested tegoprubart as part of the immunosuppressive regimen for patients receiving kidney transplants. Data from the Open Label Extension study showed consistent improvements in kidney function and a reduction in rejection episodes. Importantly, the side effect profile continues to show significant  improvements over tacrolimus, the standard of care.

Trial Background. The Phase 2 BESTOW trial was a double-blind study testing tegoprubart as an immunosuppressive after kidney transplantation. An active comparator arm included tacrolimus as an immunosuppressive. The primary endpoint of the trial was eGFR (estimated Glomerular Filtration Rate) and BPAR (Biopsy Proven Acute Rejection) episodes. Following the completion of the 12-month course of treatment, patients were given the option to continue in an Open Label Extension (OLE) study.


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MAIA Biotechnology (MAIA) – Stream Of Clinical Milestones Reported In June Shows Ateganosine Progress

Posted on by [email protected]


Monday, June 22, 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.

Strong Progress Reported In Both Clinical Trials. MAIA currently has two clinical trials in progress. Both trials are testing the combination of ateganosine (aka THIO) and the checkpoint inhibitor cemiplimab (Libtayo, from Regeneron) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). During June, MAIA opened two additional clinical sites for Phase 2 and reported strong enrollment progress in Phase 3.

Initial Phase 3 Enrollment Rate Has Been Strong. The Phase 3 THIO-104 trial began treating patients in early December. Within six months, the company opened 34 clinical sites and began treating 29 patients across 6 countries (select European countries, Turkey, Taiwan, and Georgia). THIO-104 has a target enrollment of 300 patients that will be randomized 1:1 to receive either the combination regimen or “investigator’s choice” of standard chemotherapies.


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*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. 

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

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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.


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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

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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 – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on by [email protected]

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

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 researched as a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. 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. 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 and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on by [email protected]

June 03, 2026 9:45am EDT

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 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 U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, 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 third-line NSCLC patients.

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.

MAIA Biotechnology (MAIA) – Phase 3 THIO-104 Trial Design Presented At ASCO

Posted on by [email protected]


Tuesday, June 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.

Phase 3 THIO-104 Design Is Consistent With Expectations. MAIA presented a poster on May 31, 2026, at the Annual ASCO (American Society of Clinical Oncology) Meeting. The poster detailed the design of its ongoing Phase 3 THIO-104 trial that tests ateganosine (aka THIO) in combination with the checkpoint inhibitor cemiplimab as a third-line treatment for patients with non-small cell lung cancer (NSCLC) who have become resistant to CPI treatment and chemotherapy.

Trial Design Is Consistent With Results From Phase 2 THIO-101 Trial. The patient population, selected dose, and combination regimen with Ateganosine 180mg and cemiplimab (Libtayo, from Regeneron) are the same as those in the Phase 2 THIO-101 study. At last analysis as of June 30, 2025, this regimen showed a median observed Overall Survival (OS) of 17.8 months, compared with published studies reporting an OS of 5.8 months.


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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.

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*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. 

Greenwich LifeSciences, Inc. (GLSI) – Additional Phase 3 FLAMINGO-01 Data Presented At ASCO Meeting

Posted on by [email protected]


Tuesday, June 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.

Additional Data Presented At ASCO. Greenwich LifeSciences presented an abstract and poster at the ASCO Annual Meeting.  The data assessed non-HLA-A*02 patients in the open-label arm after six monthly doses of GLA-100. The data show statistically significant injection site reaction (ISR) and immune response at baseline, with increases over time.

Patients Were Evaluated After Initial Immune Stimulation. Patients received the Primary Immunization Series (PIS), consisting of six vaccinations over the first six months of the trial. The fourth, fifth, and sixth vaccinations showed a significant increase in the percentage of patients showing an ISR compared to baseline. Of the 247 patients enrolled, 208 had both baseline vaccination and assessments at 4, 5, or 6 months.


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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. 

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

Posted on by [email protected]
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May 27, 2026 7:00am EDT

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results show that these design objectives were achieved in TNX-1500.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety, tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile, suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose.

TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of 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, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts

Jessica Morris
Tonix Pharmaceuticals
(862) 799-8599
[email protected]

Brian Korb
astr partners
(917) 653-5122
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Media Contacts

Deborah Elson
Tonix Pharmaceuticals
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Ray Jordan
Putnam Insights
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Source: Tonix Pharmaceuticals Holding Corp.