Healthcare Archives - Page 2 of 22

The Oncology Institute, Inc. (TOI) – Strong Results Driven By Covered Population Growth With Improving Margins

Posted on March 13, 2026March 13, 2026 by slightbourne@noblecapitalmarkets.com

Friday, March 13, 2026

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

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.

4Q25 Had Strong Revenue Growth. The Oncology Institute reported a 4Q25 loss of $7.5 million or $(0.06) per share and a FY2026 loss of $60.6 million or $(0.54) per share. Importantly, 4Q25 Revenues of $142.0 million were up 41.6% over 4Q24, close to our estimate of $142.4 million, with a slightly different mix from Patient Services and Dispensary Revenues. EBITDA in 4Q25 was $0.15 million, turning positive for the first time, and compares with $(7.8) million in 4Q24. Cash balance on December 31, 2025 was $33.6 million.

Margins Improved During 4Q and For FY2025. Overall Gross Margin for 4Q2025 improved to 16.0% of revenues compared with 14.6% in 4Q2024. This reflects margins improvements in Patient Services of 11.9% compared with 8.9% in 4Q24, and Dispensary margins of 18.1% compared with 16.9% in 4Q24. FY2025 Overall Gross Margin was 15.2% compared with 13.7% for FY2024.

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

Gyre Therapeutics, Inc (GYRE) – 4Q25 Report Meets Expectations As A Transition Year Begins

Posted on March 13, 2026March 13, 2026 by slightbourne@noblecapitalmarkets.com

Friday, March 13, 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.

4Q25 Revenues Showed Modest Increase. Gyre reported a 4Q loss of $1.7 million or $(0.02) per share and profit of $5.0 million or $0.06 per basic share and $0.02 per fully diluted share. Revenues of $116.6 million increased 10.2% over the $105.8 million in FY2024. These results are consistent with our view that FY2026 is a transition year, as the company focuses on approval and launch of Hydronidone plus the acquisition of Cullgen, Inc, adding its degrading protein technology platform (discussed in our Research Note on March 3).

Product Sales and Financials. FY2025 revenue of $116.6 million was driven by continued sales of Etuary and new product launches. Etuary sales of $106.1 million for FY2026 compare with $105.0 million in 4Q25. During the year, Gyre launched Contiva (avatrombopag maleate tablet) in March 2025 and Etorel (nintedanib ethanesulfonate capsules) in June 2025. Contiva sales were $5.5 million and Etorel sales were $4.6 million for the full year. The company expects the National Drug Procurement Program in China and market conditions to lower sales of $100.5 million to $111.0 million.

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Ocugen (OCGN) – FY2025 Reported With All Three Clinical Trials On Schedule

Posted on March 5, 2026March 5, 2026 by slightbourne@noblecapitalmarkets.com

Thursday, March 05, 2026

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

FY2026 Reported With Important Milestones Ahead. Ocugen reported a loss for 4Q25 of $17.7 million or $(0.06) per share, with a FY2025 loss of $67.8 million or $(0.23) per share. Cash on December 31, 2025, was $18.6 million, not including $22.5 million from a common stock offering in January 2026. Importantly, the company confirmed several clinical trial milestones had been achieved or were on schedule for announcement later in 2026. This maintains the goal of submitting three BLAs for three products during the next three years.

Topline Data From OCU400 Expected In March 2027. The Phase 3 liMeliGhT trial testing OCU400 for retinitis pigmentosa (RP) has completed enrollment. The patients have a 1-year evaluation after treatment, with top-line data expected during March 2027. Ocugen plans to begin a rolling BLA submission with the Manufacturing and Preclinical Data sections later in 2026. The Phase 3 data and clinical sections are expected to be filed shortly after the final analysis. The full filing is expected to be completed in 1Q27. We anticipate 6-month review, with FDA approval received in Fall 2027.

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Greenwich LifeSciences, Inc. (GLSI) – FLAMIMGO-01 Trial Screening Rate Now Higher Than Expected

Posted on March 4, 2026March 4, 2026 by slightbourne@noblecapitalmarkets.com

Wednesday, March 04, 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.

Patient Screening Is Ahead Of Expectations. Greenwich LifeSciences reported a large increase in the rate of patient screening in the FLAMINGO-01 Phase 3 trial. The rate increased to about 200 patients per quarter, reaching an annual rate of over 800 per year, compared with the previous rate of 600 patients per year. The reflects an increased number of patients at existing sites as well as opening of additional sites in Europe. We see this increase in same-site and additional site screening as a positive sign for the trial.

Additional Data Release Coming Soon. In late February, Greenwich announced that two abstracts were accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting to be held April 17-22, 2026. The AACR plans to publish the abstract titles on March 17, followed by the full abstracts on April 17. The full posters will be published on the date of presentation at the conference.

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Gyre Therapeutics, Inc (GYRE) – Cullgen Acquisition Adds New Platform To Build Long-Term Pipeline

Posted on March 3, 2026March 3, 2026 by slightbourne@noblecapitalmarkets.com

Tuesday, March 03, 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.

Gyre To Acquire Cullgen. Gyre Therapeutics announced the acquisiton of Cullgen, a privately-held company developing targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies. The all-stock transaction valued Cullgen at approximately $300 million. We believe this acquisition adds a novel technology platform to the mid-term to long-term product pipeline.

The Cullgen Acquisition Transforms Gyre. Cullgen was private company founded in 2018. It has been developing its proprietary technology platform, uSMITE (ubiquitin-mediated small molecule-induced target elimination), to create targeted protein degrading drugs and antibody conjugates. These drugs are in development to treat pain, cancer, inflammation, autoimmune diseases, and neurodegenerative diseases.

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

RadNet Buys Gleamer, Building a Global Radiology AI Powerhouse

Posted on March 2, 2026March 2, 2026 by slightbourne@noblecapitalmarkets.com

RadNet (NASDAQ: RDNT) is making a decisive move in healthcare AI. The Los Angeles-based outpatient imaging leader announced it has acquired Paris-based Gleamer SAS, integrating the business into its DeepHealth digital subsidiary. The all-cash deal, valued at up to €230 million including a post-closing milestone, positions DeepHealth as what the company describes as the largest provider of radiology clinical AI solutions worldwide.

For investors, the transaction underscores how artificial intelligence is shifting from pilot projects to scaled deployment across diagnostic imaging.

Gleamer brings more than 700 customer contracts across 44 countries and a cloud-first AI portfolio spanning musculoskeletal, breast, lung and neurologic applications. Its solutions include FDA-cleared and CE-marked products designed to support radiologists in screening, detection and workflow prioritization.

DeepHealth, RadNet’s digital health arm, already offers AI-enabled imaging tools across breast, chest, neuro, prostate and thyroid care. Combined, the companies report more than 2,700 customer contracts globally, a portfolio of 26 FDA-cleared and 22 CE-marked devices, and coverage across MR, CT, X-ray, mammography and ultrasound.

That breadth matters in a market where imaging volumes continue to rise while radiologist shortages persist worldwide.

RadNet CEO Dr. Howard Berger framed the deal around workflow automation—particularly in high-volume modalities like X-ray, ultrasound and mammography—where AI-enabled prioritization and draft reporting may help maintain access and efficiency.

Gleamer has operated under a SaaS model, generating annual recurring revenue (ARR) from subscription-based contracts. The company reported a compound annual ARR growth rate exceeding 90% from 2022 through 2025 and expects to reach approximately $30 million in ARR in 2026.

RadNet indicated that, on a combined basis, DeepHealth and Gleamer anticipate ARR approaching or exceeding $140 million by the end of 2026. ARR is a non-GAAP metric representing contracted recurring revenue and excludes one-time implementation and hardware sales.

For public market investors, recurring revenue visibility is increasingly central to valuation in health tech and AI-enabled platforms. The addition of Gleamer enhances DeepHealth’s cloud-native revenue base and expands its European footprint at a time when regulatory-cleared AI tools are gaining broader institutional adoption.

Beyond external sales, RadNet intends to deploy Gleamer’s AI capabilities across its own imaging network, which spans multiple U.S. states and performs millions of exams annually.

X-ray accounts for nearly 25% of RadNet’s imaging volume. The company expects AI-enabled triage and draft reporting tools to support productivity gains and workflow standardization, with deployment targeted by the third quarter of 2026.

Management has emphasized that benefits could include improved resource utilization and cost efficiencies. As with all integration efforts, realization of these outcomes depends on execution and adoption across clinical teams.

The acquisition arrives amid accelerating consolidation in healthcare AI, as imaging platforms seek both modality breadth and geographic reach. Hospitals and outpatient providers are increasingly evaluating enterprise-wide AI solutions rather than single-use tools.

By combining Gleamer’s automated reporting capabilities—already deployed in Europe—with DeepHealth’s imaging informatics platform, RadNet is aiming to deliver an integrated operating system approach across the radiology workflow.

Investors should view the transaction as part of a broader capital allocation strategy: pairing RadNet’s stable outpatient imaging cash flows with scalable digital health assets that carry higher growth profiles.

As AI moves from experimental deployments to embedded clinical infrastructure, scale, regulatory clearance and recurring revenue models are becoming competitive differentiators. RadNet’s latest acquisition suggests the next phase of radiology AI will be defined less by innovation alone—and more by integration at enterprise scale.

MAIA Biotechnology (MAIA) – Ateganosine Moves Forward With A Pivotal Year Ahead

Posted on March 2, 2026March 2, 2026 by slightbourne@noblecapitalmarkets.com

Monday, March 02, 2026

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.

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

Building On Success In 2025, Ateganosine Continues Moving Forward. MAIA has been conducting the Phase 2 THIO-101 trial, testing ateganosine (also known as THIO) in combination with cemiplimab, a checkpoint inhibitor. The trial is now in its third stage after the data showed meaningful improvements in median survival, overall response rates, and disease control rate. Separately, a Phase 3 trial has begun. Based on the reported results, we believe both trials have a high probability of success and could lead to FDA approvals.

Phase 2 THIO-101 Could Support Early Approval. The THIO-101 trial was designed with three stages. Part A confirmed safety and tolerabity, while Part B tested three doses to determine the optimal dosing regimen. In December 2025, the Part C Expansion/Registration stage began. This is an open-label arm designed to determine the Overall Response Rate (ORR). Positive data could lead to an application for Early Approval from the FDA.

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Release – The Oncology Institute Announces Fourth Quarter and Full Year 2025 Earnings Release Date and Conference Call

Posted on February 26, 2026February 26, 2026 by aweinsoff@channelchek.com

Research News and Market Data on TOI

Feb 26, 2026

PDF Version

CERRITOS, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI) a pioneer in value-based community oncology care, today announced that the company will release its fourth quarter and full year 2025 financial results on Thursday, March 12, 2026, to be followed by a conference call the same day at 5:00 p.m. (Eastern Time).

The conference call can be accessed live over the phone by dialing 1-877-407-0789 or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13758646. The replay will be available until Thursday March 19, 2026.

Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of the Company’s website at https://investors.theoncologyinstitute.com/.

About The Oncology Institute

Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.

Contacts

Media

The Oncology Institute, Inc.
marketing@theoncologyinstitute.com

Investors

ICR Healthcare
TOI@icrhealthcare.com

Cardiff Oncology (CRDF) – FY2025 Reported With Onvansertib Phase 2b Data Review

Posted on February 26, 2026February 26, 2026 by slightbourne@noblecapitalmarkets.com

Thursday, February 26, 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.

FY2026 Reported With Onvansertib Review. Cardiff reported a FY2025 loss of $45.8 million or $(0.69) per share and reviewed the clinical data for onvansertib, its drug for RAS-mutated metastatic colorectal cancer (mCRC). Updated plans for Phase 3 are expected after discussions with the FDA during 1H26. On December 31, 2025, Cardiff ended the year with $58.3 million in cash and equivalents, which it believes can fund operations through 1Q27.

Phase 2 CRDF-004 Trial Design. The CDRF-004 Phase 2 trial was designed to test two doses of onvansertib in combination with two standard-of-care (SOC) regimens against each standard of care regimen alone. It enrolled 110 patients with RAS-mutated mCRC. The primary endpoint was objective response rate (ORR).

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Biotech’s 2026 Capital Window: Why Clinical-Stage Companies Are Preparing Now

Posted on February 26, 2026February 26, 2026 by slightbourne@noblecapitalmarkets.com

Clinical development is inherently capital intensive. As programs move from early-stage studies into Phase 2 and Phase 3 trials, costs typically rise due to expanded enrollment, multi-site coordination, manufacturing scale-up, and regulatory preparation.

Companies such as Eledon Pharmaceuticals, which is advancing immune-modulating therapies, and Cardiff Oncology, focused on targeted oncology treatments including onvansertib, illustrate the type of clinical-stage businesses navigating these funding dynamics. As programs mature, capital planning becomes increasingly tied to milestone timing.

Similarly, Ocugen, with gene therapy and ophthalmology-focused programs, and Cocrystal Pharma, which develops antiviral therapeutics, operate in segments where development timelines and regulatory pathways can require sustained financial flexibility.

Even companies earlier in commercialization strategy development, such as Nutriband, which is advancing transdermal pharmaceutical technologies, must balance product advancement with capital market realities.

These examples reflect a broader sector pattern: advancing innovation requires consistent access to funding.

The Importance of the Catalyst Calendar

Biotech financing windows often open around meaningful clinical or regulatory catalysts. Positive data can strengthen negotiating leverage. But waiting until after results are announced can introduce risk — particularly if broader market conditions shift.

With 2026 shaping up to include a number of anticipated data readouts across the industry, companies are evaluating whether to raise capital ahead of milestones, opportunistically during periods of sector strength, or in response to results.

Preparation matters.

Management teams that establish investor visibility and maintain consistent communication before catalysts emerge may find themselves better positioned if and when market windows open.

M&A Activity Is a Tailwind — Not a Strategy

Large pharmaceutical companies continue to evaluate external pipelines to supplement internal research efforts. Periodic acquisition activity can improve sentiment across small-cap biotech and help reset valuation benchmarks.

However, M&A remains selective and unpredictable. Most clinical-stage companies must plan under the assumption that equity or structured financing will remain the primary funding path.

For investors, that distinction is important.

Why Capital Strategy Matters for Shareholders

In small-cap biotech, capital access influences more than just cash runway. It can affect development pace, trial continuity, partnership leverage, and dilution levels.

A company that secures funding under stable market conditions may retain greater operational flexibility. One that is forced to raise under pressure may encounter less favorable terms.

As 2026 approaches, the differentiator may not simply be who generates data — but who manages capital strategy effectively alongside clinical execution.

Biotech remains data-driven and inherently volatile. Yet improving sector sentiment and a growing milestone calendar suggest that capital formation decisions could play a defining role in shaping outcomes over the next 12–18 months.

For small-cap investors, understanding both the science and the financing strategy may be equally important in the year ahead.

Release – Zomedica Expands Distribution of TRUVIEW(R) Digital Microscopy Platform Through National Agreement with Moichor, a Leader in Veterinary Pathology

Posted on February 25, 2026February 25, 2026 by slightbourne@noblecapitalmarkets.com

Partnership Expected to Accelerate System Placements and Support Recurring Consumables Revenue Growth

ANN ARBOR, MI / ACCESS Newswire / February 25, 2026 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), an animal health company offering innovative diagnostic and therapeutic products for equine and companion animals, today announced a commercial distribution agreement with Moichor, a recognized leader in veterinary reference and point-of-care laboratory services across the United States.

Under the agreement, in addition to Zomedica’s own direct placements of TRUVIEW systems in the United States, it will also supply its TRUVIEW digital microscopy systems and associated testing supplies for Moichor’s sale to its point-of-care veterinary customers nationwide. The systems will be co-branded and integrated with Moichor’s proprietary AI engine and board-certified pathology services to support rapid, accurate clinical decision-making in veterinary practices.

Moichor is widely regarded for its expertise in both canine and feline diagnostic services and has established leadership in the exotic animal segment, with placements in numerous exotic veterinary practices throughout the United States. This agreement expands the TRUVIEW platform’s reach into both traditional companion animal practices and specialized exotic animal hospitals.

Each TRUVIEW system placement drives demand for proprietary testing materials and consumables supplied by Zomedica. As systems are adopted across Moichor’s customer base, the Company expects to generate recurring revenue tied to diagnostic utilization.

“Partnering with Moichor represents a meaningful step forward in expanding the commercial footprint of the TRUVIEW microscope,” said Bill Campbell, Zomedica’s Vice President, Imaging. “Moichor’s reputation for pathology excellence and its growing presence in both companion and exotic animal medicine align perfectly with our mission to deliver accessible, high-quality diagnostic solutions at the point of care. By combining digital slide preparation, high-resolution imaging, and integrated pathology support, we are helping practices modernize cytology workflows while maintaining diagnostic confidence.”

Expanding Access to AI-Enhanced Digital Cytology

The TRUVIEW^® platform is designed to modernize in-clinic cytology by enabling automated slide preparation and high-resolution digital imaging that can be reviewed locally or shared remotely. Consistent, standardized slide preparation is a critical component of accurate cytologic interpretation. By automating this process, the TRUVIEW system helps reduce variability between samples, minimize the occurrence of unreadable or suboptimal slides, and improve overall diagnostic confidence.

Through this agreement, veterinary customers will utilize Moichor’s proprietary AI engine in combination with its pathology services to help ensure rapid and accurate diagnoses.

By combining TRUVIEW digital microscopy capabilities with Moichor’s AI-enabled workflow and pathology expertise, practices can:

Improve diagnostic turnaround times
Increase confidence in cytology interpretation
Leverage the TRUVIEW microscope’s automated slide preparation to reduce unreadable slides and improve consistency of pathology interpretation
Enhance collaboration between in-clinic teams and pathology specialists
Deliver improved patient care across canine, feline, and exotic species

“We are excited to partner with Zomedica to expand access to advanced digital cytology solutions,” said Joe Faiella, CEO of at Moichor. “The integration of the TRUVIEW platform with our proprietary AI engine and pathology services allows us to provide veterinarians with a seamless, technology-enabled diagnostic experience. Together, we are strengthening point-of-care capabilities while maintaining the high standards of accuracy and service our customers expect.”

The co-branded systems will support Moichor’s expanding point-of-care strategy, allowing practices to integrate advanced digital cytology into their existing workflows while maintaining access to expert pathology oversight.

Strengthening Zomedica’s Recurring Revenue Model

From a strategic perspective, this commercial agreement is expected to contribute to both capital equipment sales and ongoing consumables revenue. As TRUVIEW systems are deployed through Moichor’s customer network, Zomedica will supply the associated consumables, supporting a scalable, recurring revenue stream tied to diagnostic utilization.

“This agreement reflects our disciplined approach to expanding distribution through partners who bring strong clinical credibility and national reach,” said Larry Heaton, Chief Executive Officer of Zomedica. “By integrating Zomedica’s TRUVIEW platform with Moichor’s AI engine and pathology services, we are enhancing the value proposition for veterinarians while strengthening our long-term growth trajectory. We believe that partnerships like this allow us to accelerate adoption, increase recurring revenue, and deliver sustainable value for our shareholders.”

Supporting Innovation in Veterinary Diagnostics

The veterinary diagnostics market continues to evolve as practices seek faster, technology-enabled tools that improve clinical efficiency and elevate standards of care. Digital imaging, artificial intelligence, and remote pathology integration are increasingly shaping the future of in-clinic laboratory services.

Through this agreement, Zomedica and Moichor aim to deliver a comprehensive, technology-driven cytology solution that empowers veterinarians to make informed decisions with speed and confidence-ultimately benefiting both patients and pet owners.

About Zomedica

Zomedica is a leading equine and companion animal health company dedicated to improving animal health by providing veterinarians with innovative therapeutic and diagnostic solutions. Our gold standard PulseVet^® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi^® line of therapeutic devices, the TRUFORMA^® diagnostic platform, the TRUVIEW^® digital cytology system, the VETGuardian^® PLUS^™Zero Touch^™ monitoring system, and Vetigel^® hemostatic gel, a revolutionary hemostatic agent that rapidly stops bleeding, each designed to empower veterinarians to deliver top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $54.4 million in liquidity as of September 30, 2025. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Investor Relations Contact:

Zomedica Investor Relations
Investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

Cadrenal Therapeutics (CVKD) – CAD-1005 Phase 2 Results Announced, With FDA Guidance Meeting Scheduled

Posted on February 25, 2026February 25, 2026 by slightbourne@noblecapitalmarkets.com

Wednesday, February 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.

Cadrenal Announced Phase 2 Data With End-of-Phase-2 Meeting Scheduled. Cadrenal announced data from the Phase 2 trial of its anti-thrombotic CAD-1005 (formerly known as VLX-1005) for HIT, or heparin-induced thrombocytopenia. Cadrenal has also been granted an End-of-Phase 2 meeting with the FDA to discuss the trial results and design of a Phase 3 trial. These are important milestones in the development of CAD-1005.

Phase 2 Produced Unexpected Findings. The Phase 2 trial tested safety and efficacy of CAD-1005 in patients receiving standard anticoagulant therapy. Its Primary Endpoint was designed to show CAD-1005 improved platelet recovery, testing platelet count recovery as a biomarker for thrombosis and outcome. This Primary Endpoint did not meet statistical significance, and did not find a correlation between platelet count normalization and thrombotic events.

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Gilead to Acquire Arcellx in $7.8B Bet on Next-Gen CAR-T Leadership

Posted on February 24, 2026February 24, 2026 by slightbourne@noblecapitalmarkets.com

Gilead Sciences (Nasdaq: GILD) is doubling down on cell therapy. The Foster City–based biopharma announced it will acquire Arcellx (Nasdaq: ACLX) in a transaction valued at approximately $7.8 billion in equity value, giving Gilead full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.

Kite, a Gilead company, has partnered with Arcellx since 2022 to co-develop and co-commercialize anito-cel. Under the new agreement, Gilead will acquire all outstanding shares of Arcellx it does not already own for $115 per share in cash, plus one non-transferable contingent value right (CVR) worth $5 per share if cumulative global net sales of anito-cel reach $6.0 billion from launch through year-end 2029.

The $115 cash component represents a 68% premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026. Gilead already owns approximately 11.5% of Arcellx’s outstanding common stock. The transaction, approved by both companies’ boards, is expected to close in the second quarter of 2026, subject to customary conditions including the tender of a majority of outstanding shares, regulatory approvals and other standard closing requirements.

If completed, the acquisition would eliminate profit-sharing, milestone payments and royalty obligations tied to the existing collaboration, streamlining economics as Gilead prepares for potential commercialization.

The timing is notable. The U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) for anito-cel as a fourth-line treatment for adult patients with relapsed or refractory multiple myeloma. The application is supported by results from a Phase 1 study and the pivotal Phase 2 iMMagine1 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 23, 2026.

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, according to company disclosures. Multiple myeloma remains an area of high unmet need, particularly among heavily pretreated patients who often face diminishing responses, increasing toxicity and fewer therapeutic options over time.

Full ownership provides Gilead with greater flexibility to align development strategy, scale manufacturing through Kite, and potentially explore expansion into earlier lines of therapy, subject to clinical outcomes and regulatory review.

Beyond anito-cel, Gilead is also acquiring Arcellx’s D-Domain CAR platform, which has generated proprietary target-binding domains designed to improve specificity and binding affinity. The platform may support future CAR T-cell programs, bispecific constructs and in vivo cell therapy approaches, further strengthening Gilead’s oncology pipeline.

Management indicated that, upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.

For investors, the acquisition highlights a broader trend in large-cap biotech capital deployment. Established companies are increasingly seeking full ownership of late-stage oncology assets to simplify economics, reduce long-term partnership obligations and consolidate strategic control ahead of potential commercialization milestones.

Cell therapy remains one of the most capital-intensive areas of oncology, requiring specialized manufacturing, logistics and commercial infrastructure. Gilead’s move signals confidence in both the asset and its ability to integrate development and commercialization within its existing cell therapy platform.

The next key inflection point will be the FDA’s review decision later this year, which will shape the commercial trajectory of anito-cel and the long-term impact of the acquisition.