Category: Health

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

Posted on by [email protected]

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)

Posted on by [email protected]


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)

Posted on by [email protected]
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

Posted on by [email protected]

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

Posted on by [email protected]

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

Posted on by [email protected]
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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

Release – NeuroSense Reports Positive Biomarker Findings from Phase 2 RoAD Proof-of-Concept Study of PrimeC in Alzheimer’s Disease

Posted on by [email protected]

Research News and Market Data on NRSN

PrimeC was associated with changes across multiple biomarkers spanning key neurodegenerative disease pathways, providing early biological evidence consistent with potential target engagement

Findings support continued development of PrimeC’s multi-target approach in Alzheimer’s disease

Continue Reading

CAMBRIDGE, Mass., June 25, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive biomarker findings from its Phase 2, randomized, double-blind, placebo-controlled proof-of-concept RoAD study (NST-AD-001) of PrimeC in Alzheimer’s disease (AD).

The RoAD clinical trial enrolled eight participants, randomized to PrimeC or placebo. Three participants completed a 12-month follow-up period, with both CSF and plasma samples collected at three timepoints.

The plasma biomarker analysis showed multiple, distinctive protein biomarker changes. Most notably, these included changes in the hallmark protein biomarkers of AD – brain-derived tau (total) and phospho-tau(s) as well as the amyloid-beta 42/40 ratio. Distinctive changes were also found in the levels of other major neurodegenerative disease misfolding proteins: alpha-synuclein (total, oligomeric and p129) and TAR DNA-binding protein 43 (“TDP-43,” both total and p409). TDP-43 is the hallmark of ALS while Parkinson’s and dementia with Lewy bodies are characterized by accumulations of alpha-synuclein. These pathological proteins commonly co-occur with Alzheimer’s disease. Either (or both) of these may be present in more than 50% of Alzheimer’s disease cases, and when co-pathology is present, it is associated with faster and/or more severe dementia. Finally, additional changes were observed in key biomarkers of oxidative stress and inflammation affecting proteostasis and neurodegeneration. All of these changes were directionally consistent with PrimeC’s proposed mechanism of action and align with biomarker effects previously observed in the Company’s ALS program, supporting engagement of shared neurodegenerative pathways.

The biomarker findings supporting PrimeC’s target engagement build on its previously reported favorable safety and tolerability profile from RoAD, in which no serious adverse events and no new or unexpected safety signals were identified.

“The initial findings seen from the RoAD study are encouraging, in that they may suggest that the same multi-target mechanism we have been advancing in ALS is engaging biology that is also central to Alzheimer’s,” said Alon Ben-Noon, Co-Founder and Chief Executive Officer of NeuroSense. “This was a small, exploratory proof-of-concept study with a limited number of analyzable patient samples, and so we are appropriately measured about what it can tell us on its own. But seeing biological signals that point in the same direction across two distinct neurodegenerative diseases strengthens our conviction in PrimeC’s underlying approach and helps inform the design of a next, adequately powered study.”

“Alzheimer’s disease is driven by multiple, interacting pathological processes, which is one reason single-target therapies so often fall short. The biomarker findings in this first treated AD patient suggest broad proteostatic effects, consistent with PrimeC’s proposed mechanism of action,” said Prof. Steven E. Arnold, Professor of Neurology at Harvard Medical School and member of NeuroSense’s Scientific Advisory Board. “Of course these are the very first biomarker data of PrimeC treatment in AD and should be interpreted with that in mind. They do, however, support the rationale for evaluating PrimeC in a larger, well-controlled trial designed to test whether these biological effects replicate and more importantly, translate into meaningful clinical benefit.”

Next Steps

NeuroSense intends to use these proof-of-concept findings to help inform the design of a future, adequately powered clinical study of PrimeC in Alzheimer’s disease, and will continue engaging with scientific and regulatory stakeholders as the program advances.

About RoAD

RoAD (NST-AD-001) is a Phase 2, randomized, double-blind, placebo-controlled, exploratory proof-of-concept study evaluating the safety, tolerability, and biomarker effects of PrimeC in eight participants with Alzheimer’s disease. As a proof-of-concept study, clinical outcome measures are descriptive by design.

About Alzheimer’s Disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

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 NeuroSense

NeuroSense Therapeutics, Ltd. is a late-stage clinical biotechnology company focused on discovering and developing treatments for people suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

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.

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, including, without limitation, statements regarding the interpretation, significance and potential implications of the exploratory biomarker observations from the RoAD study, the potential of PrimeC to affect disease related biology or engage mechanisms relevant to Alzheimer’s disease and the potential for these preliminary observations to inform the design of future studies. 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 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, without limitation, the very limited sample size and exploratory nature of the biomarker analyses reported in this press release; the risk that preliminary observations from three analyzed patients may not be predictive, may not be statistically meaningful, may not be replicated in this study or future studies and may not correlate with or translate into clinical outcomes or benefit or disease modification; risks related to the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; the risk that additional data from the RoAD study may differ from the observations reported in this press release; 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 April 7, 2025 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.

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SOURCE NeuroSense

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

Release – MAIA Biotechnology Completes International Enrollment in Part C of Phase 2 THIO-101 Expansion Trial in Third-Line Non-Small Cell Lung Cancer

Posted on by [email protected]
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Research News and Market Data on MAIA

June 25, 2026 8:08am EDTDownload as PDF

Part C domestic enrollment is underway at three clinical sites in the U.S.

CHICAGO, June 25, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has completed international enrollment in Part C of its Phase 2 THIO-101 expansion trial evaluating its lead candidate, ateganosine, in advanced non-small cell lung cancer (NSCLC) patients receiving third line (3L) therapy. Ateganosine is an investigational dual-mechanism therapy targeting telomeres and immune activation in difficult-to-treat cancers.

THIO-101 Part C patients, who are resistant to prior checkpoint inhibitor (CPI) therapy and chemotherapy, are randomized between MAIA’s proposed combination regimen of ateganosine followed by cemiplimab (Libtayo®) and treatment with ateganosine alone for two cycles. International screening was conducted in Taiwan, Turkey, Poland, Hungary, Romania and Georgia, with 41 patients enrolled and receiving treatment. The Part C study is currently screening patients at multiple clinical sites in the United States.

“We greatly appreciate the dedication and contributions of the investigators supporting our THIO-101 trial,” said Vlad Vitoc, Founder and Chief Executive Officer of MAIA Biotechnology. “With enrollment now complete at the international Part C clinical sites, we are closely monitoring patient outcomes as the data continues to mature, including key efficacy measures such as disease control rate and overall survival, which have remained central endpoints throughout the Phase 2 THIO-101 trial. Meanwhile, patient screening is ongoing at three activated clinical sites in the United States.”

In Parts A and B of THIO-101, MAIA reported data showing median survival of 17.8 months. Overall survival (OS) beyond two years was observed for eight patients in Parts A and B of THIO-101; the patients did not receive subsequent lines of therapy. One patient in this cohort receiving 3L therapy has survived for over 33 months. Expected survival in this heavily pre-treated population is 5.8 months.1

The FDA has granted Fast Track designation for ateganosine in NSCLC treatment, potentially expediting the regulatory process to a potential Accelerated Approval and Priority Review.

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 Girard N, et al. J Thorac Onc 2009;12:1544-1549

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Source: MAIA Biotechnology, Inc.

Released June 25, 2026

NeuroSense Therapeutics Ltd. (NRSN) – Phase 2 RoAD Trial Findings In Alzheimer’s Disease Reported

Posted on by [email protected]


Thursday, June 25, 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 Data Supports Mechanism of Action. NeuroSense reported data from its Phase 2 RoAD trial testing PrimeC in Alzheimer’s Disease (AD). The study was designed to evaluate safety, efficacy, and disease-associated biomarkers. The results showed changes consistent with the prevention of degeneration and neuronal cell death. We believe these data support PrimeC’s mechanism and its benefits, providing proof of concept for further studies.

Study Design. The Phase 2 RoAD trial was a placebo-controlled study testing PrimeC in Alzheimer’s disease. The trial enrolled eight patients who were randomized to receive PrimeC or placebo for 52 weeks. Three participants completed a 12-month follow-up period, with CSF and plasma samples evaluated at three timepoints.


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Release – Cadrenal Therapeutics Announces Selection of CAD-1005 Phase 2 Study for Late-Breaking Oral Presentation at ISTH 2026 Congress

Posted on by [email protected]

Research News and Market Data on CVKD

Selection highlights the clinical value potential of Cadrenal’s first-in-class 12-lipoxygenase inhibitor for Heparin-Induced Thrombocytopenia (HIT)

First-ever randomized, blinded, placebo-controlled trial in HIT, a life-threatening blood-clotting disorder triggered by an immune reaction to heparin, the most widely used blood thinner in hospitals

Phase-3 ready and addresses a peak $2 billion annual revenue potential in the HIT market

PONTE VEDRA, Fla., June 24, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that late-breaking clinical data on its first-in-class 12-lipoxygenase (12-LOX) inhibitor, CAD-1005 (formerly VLX-1005), have been accepted for a prestigious oral presentation at the 34th Congress of the International Society on Thrombosis and Haemostasis (ISTH). The congress will be held live and onsite from July 11-15, 2026, at the Palais des Congrès de Paris in Paris, France.

The abstract, titled “12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia,” was selected by expert peer reviewers for inclusion in the high-profile session on clinical trials and breakthrough innovations.

“The selection of our Phase 2 CAD-1005 study for a late-breakthrough oral presentation at ISTH is another milestone underscoring the scientific integrity and commercial importance of our pipeline,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “Heparin-Induced Thrombocytopenia represents a high-value therapeutic market with significant unmet needs and no approved therapies that target the specific underlying immune mechanisms of HIT. This presentation offers an elite global platform to showcase the clinical potential of CAD-1005.”

“Targeting 12-lipoxygenase is a novel, highly selective therapeutic approach that addresses the root cause of immune-mediated platelet activation in HIT,” added Dr. Steve McKenzie, Professor of Medicine at Thomas Jefferson University, the principal investigator and presenter. “The data we are presenting live in Paris – the first-ever randomized, blinded, placebo-controlled trial in HIT – illustrate how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care and may, if approved, offer a highly differentiated option for these high-risk patients.”

Presentation Details:

  • Session Title: Late-Breakthrough Abstracts I: Clinical Trials and Innovation in Thrombosis
  • Abstract Title: 12-lipoxygenase inhibition with VLX-1005 in heparin-induced thrombocytopenia
  • Date: July 12, 2026
  • Session Time: 11:15 AM – 12:00 PM CEST

For additional details regarding the scientific program, please visit the ISTH Congress Official Website.

About Heparin-Induced Thrombocytopenia (HIT)

HIT is an immune-mediated, prothrombotic adverse drug reaction in which antibodies against platelet factor 4-heparin complexes activate platelets via FcγRIIA receptors, triggering a cascade that can lead to life-threatening thrombosis. Current management relies on non-heparin anticoagulants, which reduce thrombin generation but do not directly address the underlying antibody-mediated platelet activation; new thrombosis remains a major clinical concern even with appropriate anticoagulant therapy.

About CAD-1005

CAD-1005 is a novel investigational therapeutic under development for the treatment of heparin-induced thrombocytopenia (HIT). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling associated with HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that contribute to disease progression.

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. 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 late-breakthrough oral presentation at ISTH being a significant milestone that supports the scientific integrity and commercial importance of the Company’s pipeline and the data being presented illustrating how CAD-1005 could fundamentally shift the treatment paradigm for acute thrombotic care, and may, if approved, offer a highly differentiated option for these high-risk patient patients and CAD-1005 being intended to be used in conjunction with existing standards of care and is being developed to address the underlying biological mechanisms contributing to disease progression.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to Phase 3 study evaluating CAD-1005 in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission; and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

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

For more information, please contact:

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

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

Posted on by [email protected]

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

Posted on by [email protected]


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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Release – EverythingALS to Host NeuroSense in a Community Event Named: PrimeC – Connecting the Dots

Posted on by [email protected]

Research News and Market Data on NRSN

CAMBRIDGE, Mass., June 22, 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 EverythingALS will host a conversation built around a look at emerging data on PrimeC and what it may mean for the science of ALS and the people living with it.

Event details:

Date: June 24, 2026
Time: 7 pm ET
Link for registration: Click Here

The session will be presented by Prof. Jeffrey Rosenfeld, MD, PhD, FAAN, Professor of Neurology and Director of the Neuromuscular ALS/MND Program at Loma Linda University School of Medicine. With more than 30 years caring for people with ALS and leading some of the most extensive multidisciplinary ALS programs in the country, Prof. Rosenfeld brings both the clinical depth and the bedside perspective to walk through what the latest findings show.

He’ll be joined by Alon Ben-Noon, Co-Founder and CEO of NeuroSense Therapeutics, for the conversation that follows.

This is a conversation for people living with ALS, families, caregivers, clinicians, and anyone who wants to understand the latest developments in ALS research.

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.

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SOURCE NeuroSense

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