Category: Healthcare

Release – The Oncology Institute Reaffirms 2025 Guidance and Provides Preliminary 2026 Outlook

Posted on by [email protected]

Research News and Market Data on TOI

Jan 12, 2026

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CERRITOS, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based oncology groups in the United States, today reaffirmed 2025 guidance and provided its preliminary 2026 outlook.

2026 Outlook

For 2026, TOI anticipates that total revenue will be in the range of $630 million to $650 million, reflecting 28% growth from the midpoint of 2025 and 2026 guidance ranges, and including approximately $150 million of Capitation revenue in 2026. This expected top-line increase reflects continued expansion of delegated contracts in Florida, the annualized impact of strong volumes in the Dispensary segment during the second half of 2025, and broader organic growth and new contract wins across the platform. While these drivers are expected to contribute meaningfully to revenue in 2026, the Company anticipates profitability from newly onboarded delegated contracts to build progressively over the course of the year, with more fully realized economics in 2027.

Based on these factors, and inclusive of targeted investments to support TOI’s ongoing growth, we expect Adjusted EBITDA for 2026 to be in the range of $0 million to $9 million. At the midpoint of this range, 2026 would represent TOI’s first full year of Adjusted EBITDA profitability as a public company.

TOI uses Adjusted EBITDA, a non-GAAP metric, as an additional tool to assess its operational and financial performance. See “Financial Information: Non-GAAP Financial Measures” below. In reliance on the unreasonable efforts exception provided under Regulation S-K, TOI is not reasonably able to provide a quantitative reconciliation for forward-looking information of Adjusted EBITDA to net (loss) income, the most directly comparable GAAP financial measure, without unreasonable efforts due to uncertainties regarding taxes, capital expenditures, operating activities, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized (gains) losses on investments, practice acquisition-related costs, consulting and legal fees, transaction costs and other non-cash items. The variability of these items could have an unpredictable, and potentially significant, impact on TOI’s future GAAP financial results.

Longer-Term Outlook

Looking beyond 2026, we believe the Company is well positioned for continued expansion.

We seek to grow total revenue at an annual rate of approximately 20% through 2028 and believe Capitation and Dispensary revenue could increase to approximately 30% and 50% of total revenue, respectively. This projection reflects the ongoing migration of the business model towards comprehensive oncology care in an increasingly value-based landscape.

As TOI continues to scale, we believe margins have the potential to expand through 2028 to the mid-single-digit range as a percentage of revenue, driven by the expansion of the asset-light delegated capitated model, and continued SG&A leverage.

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. 

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “preliminary,” “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “project,” “predict,” “potential,” “guidance,” “approximately,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding outlook, projections, anticipated financial results, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations. These statements are based on various assumptions and on the current expectations of TOI and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by anyone as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of TOI. These forward-looking statements are subject to a number of risks and uncertainties, with such risks and uncertainties increasing with the passage of time for longer-term outlook, including the accuracy of the assumptions underlying the 2026 full fiscal year outlook and the longer-term outlook with respect to Adjusted EBITDA and margins discussed herein, the outcome of judicial and administrative proceedings to which TOI may become a party or investigations to which TOI may become or is subject that could interrupt or limit TOI’s operations, result in adverse judgments, settlements or fines and create negative publicity; changes in TOI’s patient or payors’ preferences, prospects and the competitive conditions prevailing in the healthcare sector; failure to continue to meet stock exchange listing standards; the impact of a cybersecurity incident affecting a software provider on TOI’s business; those factors discussed in the documents of TOI filed, or to be filed, with the SEC, including the Item 1A. “Risk Factors” section of TOI’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 26, 2025 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that TOI currently is evaluating or does not presently know or that TOI currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect TOI’s plans or forecasts of future events and views as of the date of this press release. TOI anticipates that subsequent events and developments will cause TOI’s assessments to change. TOI does not undertake any obligation to update any of these forward-looking statements. These forward-looking statements should not be relied upon as representing TOI’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Financial Information: Non-GAAP Financial Measures

Some of the financial information and data contained in this press release, such as Adjusted EBITDA, have not been prepared in accordance with United States generally accepted accounting principles (“GAAP”). TOI’s non-GAAP financial measures may be different from non-GAAP financial measures used by other companies. The presentation of non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial measures determined in accordance with GAAP. Because of the limitations of non-GAAP financial measures, you should consider the non-GAAP financial measures presented in this press release in conjunction with TOI’s financial statements and the related notes thereto.

TOI believes that the use of Adjusted EBITDA provides an additional tool to assess our operations and results of our performance, to plan and forecast future periods, and factors and trends in, and in comparing our financial measures with, other similar companies, many of which present similar non-GAAP financial measures to investors. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recorded in TOI’s financial statements.

TOI defines Adjusted EBITDA as net (loss) income plus depreciation, amortization, interest, taxes, non-cash items, share-based compensation, goodwill impairment charges, change in fair value of liabilities, unrealized gains or losses on investments and other adjustments to add-back the following: consulting and legal fees related to acquisitions, one-time consulting and legal fees related to certain advisory projects, software implementations and debt or equity financings, severance expense and temporary labor and recruiting charges to build out our corporate infrastructure.

Contacts

Media
The Oncology Institute, Inc.
[email protected]

Investors
ICR Healthcare
[email protected]

Release – SelectQuote Secures New $415 Million Credit Facility Comprised of $325 Million Term Loan with Pathlight Capital Alongside $90 Million Revolving Credit Facility with UMB Bank

Posted on by [email protected]

Research News and Market Data on SLQT

01/12/2026

New Agreement Significantly Extends Debt Maturity and Enhances Operational Flexibility

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today announced the successful completion of a new $415 million credit facility comprised of a $325 million term loan facility with Pathlight Capital LP (“Pathlight”) and an enhanced $90 million revolving credit facility with UMB Bank (“UMB”).

The new credit facility immediately strengthens the company’s financial position by extending its term debt maturity to 2031 and providing greater access to liquidity for future operations. This successful transaction is a testament to the confidence placed by Pathlight and UMB Bank in the stability and long-term cash flow potential of the SelectQuote business model, including the Company’s approximately $1 billion in commissions receivable and increasingly cash generative SelectRx pharmacy and healthcare services division.

The new agreement benefits the Company in several ways, including:

  • Extended Maturity: The proceeds from the new term loan facility were used to fully repay all existing term debt, including the outstanding balances previously due in June 2026 and September 2027. The transaction significantly extends the debt maturity by providing a new five-year maturity period to January 2031.
  • Enhanced Liquidity and Flexibility: The UMB revolving credit facility increases the Company’s access to liquidity with up to $90 million available during the peak season compared to the prior facility limit of $72 million. The new term loan provided by Pathlight offers a lower principal amortization and greater investment flexibility compared to the prior facility.
  • Improved Cost of Capital: The new credit facility provides a slightly improved cost of capital, provides for future interest rate step downs totaling up to 100 basis points, and significantly improves the Company’s operating flexibility.

“We are extremely pleased to announce this new financing agreement, which marks a significant milestone in the continued optimization of our capital structure,” said Tim Danker, SelectQuote’s Chief Executive Officer. “As we emerge from another successful Medicare Annual Enrollment Period, this new financing agreement positions us well to continue to invest and grow our industry-leading senior health insurance and healthcare services businesses.”

Tyler Harrington, Managing Director at Pathlight Capital said, “What gave us conviction was the strength and candor of the management team. They’ve built a diversified business and successfully navigated through periods of rapid growth and industry change. Our financing provides flexible capital to support the next phase of the Company’s growth.”

SelectQuote’s Chief Financial Officer, Ryan Clement added, “The Pathlight term loan provides a substantial extension of our debt maturity and a strong foundation for future growth. This successful financing is a clear validation of our business model and the confidence our lending partners have in SelectQuote’s cash flow generation capabilities. Coupled with the enhanced UMB revolver, we have significantly strengthened our liquidity position and overall financial flexibility to execute on our strategic priorities. We are excited to partner with Pathlight and to build upon our long-standing relationship with UMB Bank on this transaction.”

Jefferies served as Exclusive Financial Advisor to SelectQuote in the transaction. Wachtell, Lipton, Rosen & Katz served as legal advisor to SelectQuote.

Forward Looking Statements

This release contains forward-looking statements. These forward-looking statements reflect our current views with respect to, among other things, future events and our financial performance. These statements are often, but not always, made through the use of words or phrases such as “may,” “should,” “could,” “predict,” “potential,” “believe,” “will likely result,” “expect,” “continue,” “will,” “anticipate,” “seek,” “estimate,” “intend,” “plan,” “projection,” “would” and “outlook,” or the negative version of those words or other comparable words or phrases of a future or forward-looking nature. These forward-looking statements are not historical facts, and are based on current expectations, estimates and projections about our industry, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, we caution you that any such forward-looking statements are not guarantees of future performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. There are or will be important factors that could cause our actual results to differ materially from those indicated in these forward-looking statements, including, but not limited to, the following: our reliance on a limited number of insurance carrier partners and any potential termination of those relationships or failure to develop new relationships; existing and future laws and regulations affecting the health insurance market; changes in health insurance products offered by our insurance carrier partners and the health insurance market generally; insurance carriers offering products and services directly to consumers; changes to commissions paid by insurance carriers and underwriting practices; competition with brokers, exclusively online brokers and carriers who opt to sell policies directly to consumers; competition from government-run health insurance exchanges; developments in the U.S. health insurance system; our dependence on revenue from carriers in our senior segment and downturns in the senior health as well as life, automotive and home insurance industries; our ability to develop new offerings and penetrate new vertical markets; risks from third-party products; failure to enroll individuals during the Medicare annual enrollment period; our ability to attract, integrate and retain qualified personnel; our dependence on lead providers and ability to compete for leads; failure to obtain and/or convert sales leads to actual sales of insurance policies; access to data from consumers and insurance carriers; accuracy of information provided from and to consumers during the insurance shopping process; cost-effective advertisement through internet search engines; ability to contact consumers and market products by telephone; global economic conditions, including inflation; disruption to operations as a result of future acquisitions; significant estimates and assumptions in the preparation of our financial statements; impairment of goodwill; potential litigation and other legal proceedings or inquiries; our existing and future indebtedness; our ability to maintain compliance with our debt covenants; access to additional capital; failure to protect our intellectual property and our brand; fluctuations in our financial results caused by seasonality; accuracy and timeliness of commissions reports from insurance carriers; timing of insurance carriers’ approval and payment practices; factors that impact our estimate of the constrained lifetime value of commissions per policyholder; changes in accounting rules, tax legislation and other legislation; disruptions or failures of our technological infrastructure and platform; failure to maintain relationships with third-party service providers; cybersecurity breaches or other attacks involving our systems or those of our insurance carrier partners or third-party service providers; our ability to protect consumer information and other data; failure to market and sell Medicare plans effectively or in compliance with laws; and other factors related to our pharmacy business, including manufacturing or supply chain disruptions, access to and demand for prescription drugs, changes in reimbursement rates under our contracts with pharmacy benefit managers, and regulatory changes or other industry developments that may affect our pharmacy operations. For a further discussion of these and other risk factors that could impact our future results and performance, see the section entitled “Risk Factors” in the most recent Annual Report on Form 10-K (the “Annual Report”) and subsequent periodic reports filed by us with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on any such forward-looking statements. Any forward-looking statement speaks only as of the date on which it is made, and, except as otherwise required by law, we do not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

About Pathlight Capital:

Pathlight Capital is a private credit investment manager dedicated to meeting the needs of companies that operate across a broad range of industries by providing asset-based loans secured on a first or second lien basis against tangible and intangible assets. Pathlight aims to provide creative financing solutions to allow management teams to access incremental liquidity for the purposes of funding working capital, debt refinancings, growth, acquisitions, dividends and turnaround strategies. For more information, please visit www.pathlightcapital.com.

About UMB:

UMB Financial Corporation (Nasdaq: UMBF) is a financial services company headquartered in Kansas City, Mo. UMB offers commercial banking, which includes comprehensive deposit, lending, investment and retirement plan services; personal banking, which includes comprehensive deposit, lending, wealth management and financial planning services; and institutional banking, which includes asset servicing, corporate trust solutions, investment banking and healthcare services. UMB operates branches throughout Missouri, Arizona, California, Colorado, Iowa, Kansas, Illinois, Minnesota, Nebraska, New Mexico, Oklahoma, Texas, Utah, and Wisconsin. As the company’s reach continues to grow, it also serves business clients nationwide and institutional clients in several countries. For more information, visit UMB.com, UMB Blog, UMB Facebook and UMB LinkedIn.

Investor Relations:
Sloan Bohlen
877-678-4083
[email protected]

Media:
Matt Gunter
913-286-4931
[email protected]

Source: SelectQuote, Inc.

Release – The Oncology Institute Announces Leadership Promotions

Posted on by [email protected]

Research News and Market Data on TOI

Jan 09, 2026

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Rakesh Panda appointed Chief Information Officer

Nolan Mariano appointed Chief People Officer

CERRITOS, Calif., Jan. 09, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (NASDAQ: TOI) announced today the promotions of Rakesh Panda to Chief Information Officer and Nolan Mariano to Chief People Officer. These promotions reinforce TOI’s continued focus on leading the way in value-based cancer care through further development of our technology-enabled care delivery platform as well as strengthening our mission-oriented culture supported by strong leadership.

Rakesh Panda has more than 25 years of experience across IT, digital transformation, cybersecurity, and enterprise software development, including leadership roles at Cisco and Infosys. Mr. Panda will continue to guide TOI’s technology strategy, including AI-enablement efforts and enterprise-level data privacy and security practices. Nolan Mariano has 18 years of experience in People Operations and organizational leadership across several industries. Mr. Mariano joined TOI in 2022 and, as Chief People Officer, will oversee HR Operations, Total Rewards, Learning and Development, and Talent Acquisition functions.

Dr. Daniel Virnich, Chief Executive Officer at TOI, commented, “I’m extremely pleased to promote two strong internal leaders into key roles at TOI as we continue to experience rapid growth and new ways of driving world-class community-based cancer care for our patients and payor partners.”

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.
[email protected]

Investors

ICR Healthcare
[email protected]

Gyre Therapeutics, Inc (GYRE) – Hydronidone NDA Planned For 1H26, Meeting Expected Milestone

Posted on by [email protected]


Tuesday, January 06, 2026

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

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

Positive Guidance Received From CDE. Gyre announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Ltd, has completed pre-NDA discussions with the Chinese Center for Drug Evaluation (CDE). The CDE indicated that the Phase 3 data meets the requirements for approval in chronic hepatitis B-associated liver fibrosis, as expected. An NDA submission is planned for 1H26, meeting our expected milestones for the product and the company.

Approval Would Allow Full Commercialization. Under the CDE regulations, the Phase 3 supports Conditional Approval for Hydronidone, allowing full commercialization. As part of the approval, company agrees to conduct a Phase 3c study after commercialization to confirm the effects seen in Phase 3. This is similar to a Phase 4 study in the US. The study design has not be finalized, although we expect similar endpoints for confirmation of the Phase 3 data.


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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).

*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. 

Release – The Oncology Institute Announces Addition of Board Member Mark Stolper

Posted on by [email protected]

Research News and Market Data on TOI

Jan 05, 2026

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CERRITOS, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, today announced that Mark Stolper has joined the Board of Directors, effective January 2, 2026. Mr. Stolper brings significant public markets, financial and operational leadership experience to The Oncology Institute’s board. Mr. Stolper serves as Executive Vice President and Chief Financial Officer of RadNet, Inc. (NASDAQ: RDNT), a position he has held since 2004. Mr. Stolper has also been a member of the Board of Directors of various publicly traded and privately held healthcare companies, including 21st Century Oncology Holdings, Inc., which at the time was one of the nation’s leading radiation and medical oncology companies.

“We are very pleased to have a seasoned public company CFO like Mark join our board,” said Anne McGeorge, Chairman of the Board of The Oncology Institute. “Mark brings tremendous experience in capital markets, fundraising strategies, strategic financial planning and payor strategy that will be invaluable to TOI in our next phase of growth.”

“I am very excited to join The Oncology Institute’s Board of Directors,” commented Mr. Stolper. “The Company’s mission to provide leading-edge, cost-effective cancer care to improve outcomes and streamline the patient journey is critically important at this time in healthcare. I truly believe that TOI is poised for continued growth and profitability in the coming years.”

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. For more information, visit www.theoncologyinstitute.com

Contacts

Media

The Oncology Institute, Inc.
[email protected]

Investors

ICR Healthcare
[email protected]

Cardiff Oncology (CRDF) – Onvansertib Could Treat Colorectal Cancers That Escape Other Treatments

Posted on by [email protected]


Monday, January 05, 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.

Initiating Coverage With A $12 Price Target. Cardiff Oncology is developing onvansertib for the treatment of multiple cancer indications. Its lead program is in metastatic colorectal cancer for patients with a mutation that makes the cancer more aggressive and difficult to treat. This mutation, KRAS, is found in about 45% of the colorectal cancer patients. As a result of the mutation, several standard therapies are ineffective. We believe onvansertib’s unique mechanisms of action could be a breakthrough in cancer treatment.

Onvansertib Has Two Main Mechanisms of Action. Onvansertib inhibits PLK1, an intracellular protein needed for regulatory  functions that control cell growth and division. This protein can be overexpressed in many cancers, including colorectal cancer, overriding the normal controls. A second mechanism stops a pathway that allows tumors to survive in low oxygen environments and resist treatment with bevacizumab (Avastin).


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

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

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

Posted on by [email protected]

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

Posted on by [email protected]

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 [email protected]

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

Posted on by [email protected]


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

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

Posted on by [email protected]


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.

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

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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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

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

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

Posted on by [email protected]

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

Posted on by [email protected]


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.

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

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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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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

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