Category: Healthcare

Sanofi to Acquire Dynavax in $2.2 Billion Deal, Strengthening Its Adult Vaccine Portfolio

Posted on by slightbourne@noblecapitalmarkets.com

Sanofi has agreed to acquire Dynavax Technologies Corporation in an all-cash transaction valued at approximately $2.2 billion, a move that significantly bolsters the French drugmaker’s position in the adult vaccines market. Under the terms of the deal, Dynavax shareholders will receive $15.50 per share in cash, representing a 39% premium to the company’s closing share price on December 23, 2025.

The acquisition brings Sanofi a marketed adult hepatitis B vaccine, HEPLISAV-B®, along with a differentiated shingles vaccine candidate currently in Phase 1/2 development. Together, the assets enhance Sanofi’s immunization portfolio at a time when adult vaccination is increasingly viewed as a major growth opportunity within global healthcare.

HEPLISAV-B is Dynavax’s flagship product and is already approved and marketed in the United States, the European Union, and the United Kingdom. The vaccine stands out due to its two-dose regimen administered over one month, compared with traditional hepatitis B vaccines that require three doses over six months. This shorter schedule enables faster and higher rates of seroprotection, addressing a key barrier to adult vaccination adherence.

Sanofi executives emphasized that the transaction aligns with the company’s long-term vaccines strategy. Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, said the deal adds “differentiated vaccines that complement Sanofi’s expertise” while reinforcing the company’s commitment to vaccine protection across the lifespan. With Sanofi’s global commercial infrastructure, HEPLISAV-B could see expanded adoption beyond its current markets.

In addition to its hepatitis B franchise, Dynavax brings a shingles vaccine candidate, Z-1018, which is currently in early-stage clinical development. Shingles represents a sizable and growing market, with the World Health Organization estimating that one in three adults will develop the condition during their lifetime. While Sanofi already has experience in vaccines, the addition of an early-stage shingles program provides optionality and long-term pipeline upside.

From a public health perspective, the acquisition targets areas of substantial unmet need. In the United States alone, nearly 100 million adults born before 1991 remain unvaccinated against hepatitis B, leaving them vulnerable to chronic infection that can lead to cirrhosis and liver cancer. Adult immunization has historically lagged childhood vaccination rates, creating a meaningful opportunity for growth and impact.

Financially, Sanofi plans to fund the acquisition using existing cash resources. The transaction has been unanimously approved by Dynavax’s board of directors and will proceed via a tender offer for all outstanding shares. Completion is subject to customary closing conditions, including regulatory approvals, and is expected in the first quarter of 2026.

Dynavax CEO Ryan Spencer said joining Sanofi will provide the scale and expertise needed to maximize the impact of the company’s vaccines. He described the transaction as delivering compelling value to shareholders while advancing Dynavax’s mission to protect against infectious diseases.

Overall, the deal underscores continued consolidation in the biotech and pharmaceutical sectors, particularly around vaccines and infectious disease prevention. For Sanofi, the acquisition of Dynavax represents both a near-term revenue opportunity through HEPLISAV-B and a longer-term pipeline investment as it looks to strengthen its leadership in adult immunization.

Fulgent Genetics Expands Pathology Footprint With $55.5 Million Acquisition of Bako Diagnostics and StrataDx

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Fulgent Genetics is accelerating its transformation into a comprehensive precision diagnostics platform with the announced acquisition of selected assets of Bako Diagnostics and the full acquisition of StrataDx in a combined transaction valued at approximately $55.5 million. The deal, which will be funded entirely with cash on hand, is expected to close in the first half of 2026, subject to customary regulatory approvals.

The acquisition marks a strategic expansion of Fulgent’s laboratory services business, adding anatomic pathology services, proprietary PCR-based molecular tests, and a significantly broader national client base. Together, Bako Diagnostics and StrataDx bring deep expertise in specialty pathology and dermatopathology, positioning Fulgent to meaningfully strengthen its diagnostic offerings across multiple clinical touchpoints.

Bako Diagnostics, headquartered in Alpharetta, Georgia, is a premier national provider of specialty laboratory testing with a comprehensive menu that includes anatomic pathology, molecular genetic testing, and peripheral neuropathy immunohistochemical analysis. StrataDx, based in Lexington, Massachusetts, is a leading dermatopathology laboratory serving providers nationwide with advanced diagnostics for skin diseases, including melanocytic lesions, lymphomas, and complex dermatoses. Both laboratories are CLIA-certified, CAP-accredited, and licensed in their respective states.

Strategically, the transaction aligns closely with Fulgent’s long-term vision of becoming a one-stop diagnostic partner across the healthcare continuum. One of the most compelling aspects of the deal is the opportunity to apply Fulgent’s existing investments in digital pathology and artificial intelligence to Bako’s and StrataDx’s operations. Fulgent has already developed proprietary tools such as Eziopath, an image management system designed to enhance workflow efficiency, turnaround time, and diagnostic quality. Integrating these technologies is expected to increase capacity while maintaining high clinical standards.

The acquisition also significantly expands Fulgent’s test menu. Bako’s proprietary PCR assays offer faster turnaround times and cost efficiencies, strengthening Fulgent’s competitive position in molecular diagnostics. Combined with StrataDx’s dermatopathology expertise, the expanded portfolio allows Fulgent to serve a wider range of clinicians and patients with more comprehensive diagnostic solutions.

Commercial synergies represent another major driver of the transaction. Bako’s nationwide sales organization will nearly double the size of Fulgent’s pathology-focused sales team, immediately extending its commercial reach. The expanded client base creates additional opportunities to cross-sell existing Fulgent services, deepen payer relationships, and increase access to covered lives through managed care contracts.

Geographically, the acquisition enhances Fulgent’s laboratory footprint with additional certified facilities in Georgia and Massachusetts, including New York State–approved labs. This broader presence improves logistical efficiency and positions the company for future growth in regulated markets.

Ming Hsieh, Chairman and CEO of Fulgent Genetics, emphasized the strategic fit of the deal, highlighting the company’s ability to layer new pathology services onto a rapidly growing laboratory platform while leveraging AI to drive efficiency and quality. Bako and StrataDx leadership echoed that sentiment, pointing to the benefits of combining specialized diagnostic expertise with Fulgent’s technology-driven infrastructure.

As healthcare increasingly shifts toward precision medicine, Fulgent’s acquisition of Bako Diagnostics and StrataDx represents a calculated step toward scale, integration, and long-term growth in advanced diagnostics.

Release – NeuroSense Confirms Favorable Safety and Tolerability of PrimeC in an Alzheimer’s Phase 2 Study

Posted on by slightbourne@noblecapitalmarkets.com

CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer’s disease.

The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified.

As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results expected in the first quarter of 2026.

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 clinical-stage biotechnology company focused on discovering and developing treatments for patients 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. 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 timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer’s disease, 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; 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.

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

SOURCE NeuroSense

Greenwich LifeSciences, Inc. (GLSI) – FLAMINGO-01 Open-Label Arm Reports Preliminary Results and Reaches An Important Milestone

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Friday, December 19, 2025

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 Reported From the Open-Label Arm Of The FLAMINGO Trial Greenwich LifeSciences announced preliminary Phase 3 results from the open-label, non-HLA-A*02 arm of its FLAMINGO-01 trial. The data showed a reduction in breast cancer recurrence rates of about 80% for patients that completed the primary vaccination series (PIS) ofGLSI-100. In addition, the first patient has completed the full 3-year treatment.

FLAMINGO0-01 Divides Patients By Immune Classification. The FLAMINGO-01 trial divides patients by their HLA types, a system of classifying a patient’s immune response. Patients with the most common HLA type, HLA-A*02, have enter one of the double-blind placebo-controlled arms of the trial. About 250 patients with other HLA types have been entered into an open-label portion, referred to as non-HLA-A*02.


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Tonix Pharmaceuticals (TNXP) – Tonix Acquires Another Pipeline Product For Neuropathic Pain

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Wednesday, December 17, 2025

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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Tonix Announced Acquisition of A Non-Opioid Pain Reliever. Tonix continues to build its neurological pain pipeline with the licensing of a Sigma-1 receptor antagonist for development in neuropathic pain relief. Published studies on the Sigma-1 receptor’s mechanism of action have shown activity in pain and several neurological diseases. We see this as an extension of the company’s product line in neurology, including products for fibromyalgia/pain, acute stress disorder, major depressive disorder, and migraine headache.

TNX-4900 Is Highly Selective For The Sigma-1 Receptor.  The new molecule, known as TNX-4900, is a small molecule developed to be highly selective for the Sigma-1 receptor, avoiding the Sigma-2 and other Sigma receptor-family members. It  has been tested in multiple models of pain and selected for its efficacy and safety profile. TNX-4900 has also shown ability to cross the blood-brain barrier, with favorable adsorption, distribution, metabolism and elimination (ADME) properties.


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Biotech M&A Activity Signals a Potential Turnaround for the Sector

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After several challenging years marked by higher interest rates, tighter capital markets, and depressed valuations, signs are emerging that the biotech sector may be on the cusp of a meaningful turnaround. One of the clearest indicators is the renewed pickup in mergers and acquisitions activity across biotech and pharmaceutical companies. Historically, periods of rising M&A have often preceded broader recoveries in biotech equities, particularly among small- and mid-cap names that have been trading at discounted valuations.

Large pharmaceutical companies are once again stepping up as active acquirers. Many face looming patent expirations that threaten billions of dollars in revenue over the next several years, creating urgency to replenish drug pipelines. Rather than relying solely on in-house research and development, big pharma is increasingly turning to acquisitions and strategic partnerships with innovative biotech firms that already have promising assets in development. This dynamic disproportionately benefits smaller biotech companies, which often lack the capital to fully commercialize therapies on their own but possess highly valuable intellectual property.

The macroeconomic backdrop is also becoming more supportive. Expectations around interest rate cuts play a critical role in driving this renewed activity. Biotech companies are capital-intensive by nature, frequently operating for years without meaningful revenue while funding clinical trials and regulatory processes. When interest rates are high, the cost of capital rises, making financing more difficult and suppressing valuations. As rates begin to fall—or even as markets anticipate easing—capital becomes cheaper and more accessible, enabling both buyers and sellers to transact more confidently.

Lower interest rates also have a powerful effect on biotech valuations. Because many biotech companies derive much of their value from future potential cash flows rather than current earnings, they are particularly sensitive to discount rates used in valuation models. When rates decline, the present value of future earnings increases, supporting higher valuations across the sector. This dynamic can help reverse the multiple compression biotech stocks experienced during the tightening cycle.

In addition, rate cuts tend to shift investor behavior toward a more “risk-on” environment. As yields on safer assets like bonds decline, investors are more inclined to seek growth opportunities in sectors such as biotech, where innovation and breakthrough therapies can drive outsized returns. Rising equity prices and improved sentiment, in turn, make biotech companies more attractive acquisition targets, reinforcing the M&A cycle.

For small-cap biotech investors, this combination of increased deal activity and improving macro conditions is particularly significant. M&A announcements often come with substantial acquisition premiums, providing immediate upside for shareholders and helping reprice comparable companies across the sector. Even firms that are not direct acquisition targets can benefit as investors reassess the strategic value of underappreciated pipelines and platforms.

While risks remain and selectivity is still critical, the resurgence of biotech M&A alongside a more favorable interest rate environment suggests that the sector’s prolonged downturn may be nearing its end. If rate cuts materialize and deal momentum continues, biotech—especially at the small-cap level—could be positioned for a sustained recovery rather than just a short-term bounce.

Take a moment to take a look at some emerging growth biotech companies by taking a look at Noble Capital Markets’ Research Analyst Robert LeBoyer’s coverage list.

MAIA Biotechnology (MAIA) – Phase 3 THIO-104 Begins, Capping Off A Significant Year

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Tuesday, December 16, 2025

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 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.

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

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Phase 3 Trial Has Treated Its First Patient. MAIA has begun its pivotal Phase 3 trial for THIO in NSCLC (non-small cell Lung Cancer), meeting our expected timeframe. In October, the Phase 2 THIO-101 trial began its Part C and will continue as  the Phase 3 is running. These trials are the latest in a series of positive announcements for THIO (ateganosine) clinical development, keeping it on schedule for additional milestones in 2026.

Trial Design Can Lead To First Approval. The Phase 3 THIO-104 is an open-label trial is testing ateganosine in combination with an CPI (immune checkpoint inhibitor) as a third-line treatment in patients who are resistant to CPIs and chemotherapy. Patients who have failed two courses of chemotherapy including CPIs will be randomized into two groups to receive either the ateganosine/CPI combination or standard of care chemotherapy. The primary endpoint is Overall Survival (OS).


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DLH Holdings (DLHC) – Looking Toward a Brighter Future

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Monday, December 15, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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Overview. Fiscal 2025, and the start of fiscal 2026, continued the loss of contracts to small business set asides. While the loss of the Head Start contract and the expected eventual loss of all of the CMOP locations is impacting operating results today, we believe the resolution of these set aside contracts removes a big overhang from the business and enables the Company to grow from a solid base of higher value-added technology-powered applications business.

4Q25. Revenue fell 15.8% y-o-y to $81.2 million, driven by the loss of CMOP locations, as well as other set aside contracts. Gross margin fell to 17.1% from 19.9% a year ago. DLH reported a net loss of $920,000, or a loss of $0.06/sh., compared with net income of $2.3 million, or EPS of $0.16, in 4Q24. Adjusted EBITDA fell to $6.6 million from $10.7 million. We were at $83.5 million, $250,000, $0.02/sh., and $8.15 million, respectively.


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Superior Group of Companies (SGC) – Highlights From NobleCon21

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Friday, December 12, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

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NobleCon21. On December 3rd, management presented at NobleCon20 at Florida Atlantic University (FAU) in Boca Raton, Florida. The presentation was conducted by Michael Benstock, Chairman & CEO, and Mike Koempel, CFO. The executives highlighted the company’s century-old operating history, its three diversified and profitable segments, branded products, healthcare apparel, nearshore contact centers, and a capital allocation strategy focused on shareholder returns. A replay of the presentation can be viewed here.

Healthcare. The healthcare apparel segment boasts multi-channel reach across retailers, e-commerce platforms, uniform stores, hospital systems, and specialty distributors. More than two million professionals wear the company’s brands, which includes Wink, Carhartt-branded scrubs, and Fashion Seal Healthcare. Notably, the company is well positioned for expansion supported by demographic aging and persistent healthcare labor shortages.


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Cadrenal Therapeutics (CVKD) – New Anticoagulant Acquired For Heparin-Induced Thrombocytopenia.

Posted on by slightbourne@noblecapitalmarkets.com


Friday, December 12, 2025

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

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Cadrenal Continues Build Its Anticoagulation Pipeline. Cadrenal has acquired VLX-1005, a platelet inhibitor from Veralox Therapeutics, adding another novel small-molecule anti-coagulant to its pipeline. VLX-1005 is a selective inhibitor of 12-LOX, an enzyme that initiates a signaling pathway for platelet-mediated inflammation and leads to heparin induced thrombocytopenia (HIT). VLX-1005 has Orphan Drug Designation from the FDA and EMA.

VLX-1005 Has Completed A Phase 2 Clinical Trial. Two Phase 1 studies showed safety and tolerability, followed by a Phase 2 trial in patients with suspected heparin induced thrombocytopenia (HIT). Interim results to date showed reductions in thromboembolic events.


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Greenwich LifeSciences, Inc. (GLSI) – Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestones

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Wednesday, December 10, 2025

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

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Phase 3 FLAMINGO-01 Trial Reaches Enrollment Milestone. Greenwich Pharmaceuticals has completed enrollment in the open-label arm (non HLA-A*2 patients) in the Phase 3 FLAMINGO-01 trial, its trial testing GLSI-100 for prevention of breast cancer recurrence in high-risk patients. The patients are stratified according to their HLA (human leukocyte antigen) types, immune system characteristics that classify an individual’s potential response to antigens. Over 1,000 patients have been screened for the trial at over 140 clinical sites in the US and Europe.

Greenwich Pharmaceuticals Presented At the NobleCon21 Conference. CEO Snehal Patel spoke at the annual NobleCon21 conference. He presented a brief summary of GLSI-100 and the clinical trial, followed by a fireside chat discussion, and questions from the audience. To listen to the presentation, click here.


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NeuroSense Therapeutics Ltd. (NRSN) – Webinar Highlight Regulatory and Clinical Trial Progress

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Tuesday, December 09, 2025

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.

Discussions Of Clinical Trials, Regulatory Developments, Partnerships. NeuroSense held a webinar to review recent regulatory developments related to its Phase 3 PARAGON trial, early approval for ALS in Canada, the Phase 2 study in Alzheimer’s Disease, and product partnerships. There was also a detailed discussion of the Phase 3 PARAGON trial design and milestones for the coming year.

Phase 3 PARAGON Trial Is Expected To Begin In Mid-2026. NeuroSense has received clearance from the FDA to begin the Phase 3 trial testing PrimeC in ALS (Amyotrophic Lateral Sclerosis). The trial design is based on the data from the Phase 2b PARDIGM trial that showed improved survival with biomarkers correlating with slowing disease progression and reduction in markers of the disease process.


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Mirum Pharmaceuticals’ Acquisition of Bluejay Therapeutics Strengthens Its Global Rare Disease Leadership

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Mirum Pharmaceuticals (NASDAQ: MIRM) has announced a definitive agreement to acquire privately held Bluejay Therapeutics in a transformative deal that expands Mirum’s leadership in rare liver diseases and adds a high-potential late-stage asset to its growing pipeline. The acquisition, valued at $620 million upfront in cash and stock — plus up to $200 million in milestone payments — brings worldwide rights to brelovitug, a fully human monoclonal antibody currently in Phase 3 development for chronic hepatitis delta virus (HDV).

For Mirum, a company already recognized for developing and commercializing rare disease therapies—including LIVMARLI, CHOLBAM and CTEXLI—the deal aligns directly with its strategic focus: advancing life-changing medicines for overlooked patient populations. HDV, the most severe form of viral hepatitis, represents a large, high unmet-need market with no FDA-approved treatments, affecting more than 230,000 people across the U.S. and Europe.

Brelovitug has already gained international attention. The therapy holds FDA Breakthrough Therapy designation and the European Medicines Agency’s PRIME and Orphan designations. In Phase 2 trials, it demonstrated strong antiviral activity and a 100% HDV RNA response rate, along with improvements in liver enzyme levels. Its safety profile has been favorable, with the most notable adverse event being injection-site reactions.

The drug is currently being evaluated in the global, registrational AZURE Phase 3 program, which is enrolling patients worldwide. Top-line results are expected in the second half of 2026, with a potential BLA submission and commercial launch in 2027. If approved, brelovitug could become the first widely available treatment for chronic HDV.

Mirum CEO Chris Peetz emphasized that the acquisition fits squarely within Mirum’s mission and capabilities. “Brelovitug in HDV leverages our deep expertise in rare liver disease and builds on the relationships we’ve established with key providers through the volixibat and LIVMARLI programs,” he said. Bluejay’s founder and CEO, Keting Chu, echoed that sentiment, noting that Mirum’s rare disease specialization makes it “the right company to carry this program forward globally.”

The acquisition will be funded through a combination of cash, Mirum common stock, and a concurrent $200 million private placement with healthcare investors. Proceeds from the placement will support both clinical development and future commercial activities. The deal not only adds a late-stage asset to Mirum’s portfolio but also positions the company for four potential registrational readouts within the next 18 months—an unusually rich pipeline for a rare-disease-focused biotech.

Implications for the Biotech Landscape

The acquisition underscores a broader trend in the biotechnology sector: rare disease companies with commercial infrastructure are increasingly seeking late-stage assets to accelerate revenue growth and expand global presence. For small and mid-cap biopharma firms, especially those with single or early-stage assets, partnerships or acquisitions by specialized players like Mirum remain attractive pathways to scale.

Bluejay itself represents a textbook example of a high-quality private biotech that rapidly advanced a novel therapy—from development candidate to global Phase 3 program in four years—making it an appealing target in a competitive rare-disease market.

Pending regulatory approvals, the transaction is expected to close in the first quarter of 2026. If successful, brelovitug could mark one of the most important therapeutic advancements in liver disease in decades—and a major milestone in Mirum’s evolution into a global leader in rare hepatology.