Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Initiating Coverage of The Oncology Institute With An Outperform Rating. The Oncology Institute of Hope & Innovation (TOI) is a medical practice management company specializing in community-based oncology practices. It manages and operates oncology clinics in five states using its proprietary, value-based methodology. These treatment regimens have improved outcomes for patients while reducing the cost of care.
TOI Uses Capitated Contracts To Control Costs. TOI enters into contracts with third-party payers to treat a specified number of health plan members based on the estimated per-member, per-month cost. This method of providing coverage based on population size is known as capitation. It also offers traditional fee-for-service as well as value-based oncology care. This provides TOI with the flexibility to contract with more insurance plans.
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Key Points: – ARCHIMED to acquire ZimVie Inc. for $19/share, nearly doubling its 90-day average price. – The $730M deal will take ZimVie private, accelerating its dental technology growth. – Positive signal for middle market healthcare investors as valuations rebound.
In a strategic move that underscores growing momentum in middle-market healthcare, ZimVie Inc. (Nasdaq: ZIMV), a leader in dental implant technology, has entered into a definitive agreement to be acquired by healthcare-focused investment firm ARCHIMED. The all-cash transaction values ZimVie at approximately $730 million, or $19.00 per share — nearly double its 90-day volume-weighted average price of $9.57.
For ZimVie shareholders, the nearly 99% premium represents a compelling exit, especially as the company faced headwinds in public markets. The deal will take the Florida-based firm private, offering it the strategic flexibility and financial backing often difficult to realize under the scrutiny of quarterly earnings and shareholder pressure.
The acquisition is expected to close by the end of 2025, pending regulatory and shareholder approvals. Until then, ZimVie will continue to operate independently.
ZimVie has carved out a niche in the global dental implant market, developing and delivering a comprehensive portfolio of restoration products and digital workflow solutions. Its global footprint and innovation in oral health make it a prime example of a middle-market firm with strong fundamentals and potential for accelerated growth under private ownership.
ARCHIMED’s interest aligns with a broader trend: private equity firms are showing renewed appetite for small and mid-cap healthcare players that have proven tech, scalable platforms, and room for international expansion. ARCHIMED, which manages €8 billion across its healthcare-focused funds, has a track record of guiding companies through global scaling, M&A, and innovation cycles.
While this deal removes a promising small-cap from public investor reach, it also sends a positive signal to investors looking to identify the next undervalued gem. ZimVie’s valuation leap shows that quality middle-market healthcare firms can still command significant premiums — and that smart capital is actively hunting in this space.
Notably, ZimVie has entered a 40-day “go-shop” period, during which it can solicit competing bids. Though there’s no guarantee of a superior proposal, this opens the door for additional interest, potentially raising the final sale price — a factor for investors still holding shares.
As healthcare innovation continues to be a resilient sector, especially in medtech and dental care, this deal could be a bellwether. Middle market investors may find increasing value in companies that combine specialized solutions with long-term demand — especially before they’re targeted by institutional buyers.
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 expanded launch of their innovative concierge-like service designed to specifically improve medication adherence for Medicare beneficiaries managing multiple chronic conditions and complex medication regimens. SelectQuote’s SelectRx pharmacy recently trialed a new approach with a regional health plan that demonstrated over 90% adherence, strengthening HEDIS Star ratings across the triple-weighted cholesterol, diabetes and hypertension measures. The Company plans to expand to additional payers this calendar year and will roll out across SelectRx’s pharmacy platform in 2026.
This program further demonstrates SelectQuote’s deep commitment to driving better health outcomes and greater value for both patients and payer partners. This high-touch solution is purpose-built to address the critical challenge of medication non-adherence, which often leads to preventable hospitalizations, adverse drug interactions, and escalating healthcare costs for the Medicare system.
SelectRx designed the program to proactively identify and engage high- and medium-risk patients, prioritizing those with a higher likelihood of adherence gaps. These beneficiaries stand to benefit most from enhanced support in managing their complex medication schedules. SelectQuote aims to help patients overcome adherence barriers through escalations to its clinical pharmacist team, who can provide specialized intervention. The Company also plans to launch a complementary program for lower risk members to support their continued medication adherence.
“We are incredibly excited about this initiative and its potential to significantly improve medication management for our most vulnerable Medicare beneficiaries,” said Bob Grant, President of SelectQuote. “Our SelectRx pharmacy offering already dramatically improves medication adherence and other health measures through timely, convenient delivery and easy-to-use packaging. We believe this new concierge-like program underscores that we are much more than a traditional Medicare broker helping beneficiaries find the right health plan. The program now takes our foundational commitment to improving Medicare patient outcomes to the next level. It embodies our mission to provide ongoing, personalized support that directly impacts patient health and well-being, significantly reducing costly acute episodes and improving quality of life.”
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, 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.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Setting up fiscal 2026. We are adjusting our fiscal Q4 estimates to reflect updated expectations for the Medicare Advantage market, with a particular focus on recent regulatory changes affecting Special Needs Plans (SNPs). While these developments introduce near-term challenges, we believe SelectQuote is well-positioned heading into fiscal 2026. We expect the company to rebuild agent capacity ahead of the next Annual Enrollment Period (AEP), to support a trajectory of sustained revenue growth and adj. EBITDA margin expansion.
Special Needs changes. Our revised Q4 outlook is primarily driven by recent changes implemented by CMS that restructure Special Needs Plan switching rights. The policy shift narrows mid-year enrollment flexibility for a significant portion of dual-eligible consumers (those enrolled in non-integrated D-SNPs), leading to the prospect of a smaller pool of shopping beneficiaries during the middle of calendar 2025. In addition, we are accounting for SelectQuote’s reduced year-over-year agent count, which entered fiscal 2025 approximately 22% below the prior-year level due to capital constraints at the time. These factors combined create a more muted backdrop for near-term Medicare Advantage performance.
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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.
In a major milestone for type 1 diabetes treatment, a groundbreaking clinical trial has shown that stem cell-derived islet cell transplantation can effectively eliminate the need for insulin in patients. This advancement marks a turning point in diabetes care and highlights the efforts of leading researchers, including Dr. Piotr Witkowski at the University of Chicago, and the collaborative work of Vertex Pharmaceuticals (VRTX) and Eledon Pharmaceuticals (ELDN).
Historically, islet cell transplantation involved harvesting pancreatic islets from deceased organ donors—a limited and logistically challenging source. Patients often required multiple transplants to see long-term benefits, and donor scarcity severely limited access to the therapy. But now, lab-manufactured islets derived from stem cells are changing the game, offering a consistent, scalable, and potentially off-the-shelf solution to treating the most severe forms of type 1 diabetes.
In the ongoing multicenter clinical trial, presented at the American Diabetes Association’s Scientific Sessions and published in the New England Journal of Medicine, 10 of 12 patients remained insulin-independent for over a year after just a single infusion of stem cell-derived islets. This level of success, particularly from a single dose, is unprecedented in the field and demonstrates the power of scientific innovation to transform chronic disease management.
Dr. Witkowski, a lead investigator and transplant surgeon at the University of Chicago, has been at the forefront of this effort. His involvement traces back to the early development of the clinical protocol in 2019 with Andrea Vergani at Semma Therapeutics. After Vertex Pharmaceuticals acquired Semma, Dr. Witkowski continued his work as a member of the Scientific Advisory Board and as a principal investigator performing transplants. As of last week, his team has successfully infused their 10th patient with Vertex’s stem cell-derived islets.
While these results are promising, patients receiving the treatment still require immunosuppressive therapy to prevent rejection—typically involving drugs like tacrolimus, which can be toxic over time. That’s where Eledon Pharmaceuticals (ELDN) enters the picture. In a parallel pilot study, researchers are evaluating Tegoprubart, Eledon’s novel immunosuppressive agent designed to reduce toxicity while maintaining immune protection. If successful, Tegoprubart could offer a safer path forward and expand access to islet transplantation for a broader population.
The future is bright. Trials are now underway to test the therapy in kidney transplant recipients—patients already on immunosuppressants—providing an ideal setting to further prove the therapy’s safety and effectiveness. With continued success, stem cell-derived islets could soon become a standard-of-care treatment, immediately benefitting the 40,000+ patients in the U.S. suffering from the most unmanageable forms of diabetes.
Thanks to the visionary work of scientists, clinicians, and companies like Vertex and Eledon, what was once a highly experimental and limited therapy is on track to become a scalable medical solution. As Dr. Piotr Witkowski and his team continue their work, the path to a functional cure for type 1 diabetes is finally within reach.
Zimmer Biomet (NYSE: ZBH), one of the world’s leading medical technology companies, announced a definitive agreement to acquire Monogram Technologies (NASDAQ: MGRM), a fast-growing robotics innovator, in a strategic move that could redefine the future of orthopedic surgery. The $177 million all-cash deal includes an upfront payment of $4.04 per share and a potential additional $12.37 per share via a non-tradeable contingent value right (CVR), contingent on milestones through 2030.
The acquisition marks a major milestone in Zimmer Biomet’s mission to deliver a next-generation surgical robotics platform. Monogram brings proprietary semi- and fully autonomous robotic systems designed for total knee arthroplasty (TKA), bolstered by FDA clearance in early 2025. The deal also positions Zimmer Biomet to be the first company in orthopedics to offer a fully autonomous surgical robot—a potential game-changer in an increasingly tech-driven sector.
Zimmer Biomet’s existing ROSA® Robotics platform already leads in imageless robotics and is nearing 2,000 global installations. By integrating Monogram’s AI-driven, CT-based surgical systems, the company expands its portfolio to address varying surgeon preferences—manual, semi-autonomous, or fully autonomous—and across different anatomical procedures.
This acquisition gives Zimmer Biomet a first-mover advantage in the race for orthopedic robotics innovation. With Monogram’s platform, the company aims to deliver safer, more efficient surgeries and drive adoption across hospitals and ambulatory surgery centers (ASCs) seeking digital and robotic enhancements.
Monogram’s technology complements Zimmer Biomet’s current development pipeline, including ROSA Knee with OptimiZe, ROSA Posterior Hip, and ROSA Shoulder—key components of its multi-year plan to remain the global leader in orthopedic robotics.
Financially, the acquisition is expected to be neutral to Zimmer Biomet’s adjusted earnings per share through 2027 and accretive thereafter. Management projects high-single-digit returns on invested capital by year five, fueled by accelerated robotic knee adoption, greater share of wallet, and broader customer reach in the U.S. and internationally.
Tariffs and broader market volatility have weighed on the healthcare sector in 2025, but Zimmer Biomet’s move signals a long-term, innovation-led growth strategy. By enhancing its robotics suite, the company is positioning itself to capture demand in one of the fastest-growing medtech segments.
With regulatory approval and Monogram shareholder consent still pending, the merger is expected to close later this year. Once complete, Zimmer Biomet will be uniquely positioned with the industry’s most flexible and comprehensive orthopedic robotics ecosystem.
This acquisition isn’t just a strategic bolt-on; it’s a forward-looking bet on where surgery is headed—autonomous, data-driven, and personalized. For investors seeking exposure to the convergence of AI, robotics, and healthcare, Zimmer Biomet’s expanding portfolio offers a compelling case for long-term value creation.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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R&D Day Highlighted Science, Current Trials, Future Indications. We attended the Eledon R&D Day on July 9 to hear and evaluate the progress in tegoprubart development. The presentations focused on the current clinical indications in renal transplantation, islet cell transplantation, xenotransplants, and plans for liver and other solid organ transplants. Conference presentation dates for upcoming data announcements were also announced.
Phase 1b Data Update Is Planned For August. The Phase 1b open-label trial has been expanded to enroll up to 36 patients, an increase from the original 9 patients. Data is scheduled for presentation at the World Transplant Congress on August 9, 2025. Previous data presentations have included 13 patients. We expect to see follow-up data from more patients treated longer, with data from additional patients beyond the initial 12-month trial duration.
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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.
President Donald Trump announced on Tuesday his intention to impose tariffs of up to 200% on imported pharmaceutical products, a move that could dramatically reshape the pharmaceutical landscape. While the tariffs would not go into effect immediately, the president indicated they could be implemented “very soon,” with a grace period of roughly a year to a year and a half for companies to adapt.
The proposed tariffs come as part of a broader economic strategy aimed at bolstering domestic manufacturing and reducing U.S. reliance on foreign pharmaceutical production. Trump has long criticized the pharmaceutical industry for outsourcing production, and this latest proposal aligns with his “America First” trade agenda. The administration believes steep tariffs would incentivize companies to bring more manufacturing operations back to the United States.
Commerce Secretary Howard Lutnick confirmed that the final details of the pharmaceutical tariffs will be revealed by the end of July, following the conclusion of studies on pharmaceuticals and semiconductors currently under Section 232 of the Trade Expansion Act. This legal framework allows the administration to impose trade barriers on national security grounds—one of the same avenues used for previous tariffs on steel and aluminum.
Pharmaceutical companies and industry groups reacted swiftly to the announcement. Major firms, including Eli Lilly, Johnson & Johnson, and AbbVie, have warned that such a move could lead to unintended consequences. Critics argue the tariffs would raise the cost of essential medicines, disrupt global supply chains, and potentially limit access to critical drugs for patients.
Industry leaders have also expressed concern that the new tariffs could stifle innovation by diverting funds away from research and development. The pharmaceutical sector is already under pressure from other regulatory changes related to drug pricing and reimbursement models. Adding steep tariffs into the mix, they argue, could further destabilize long-term investment in life-saving therapies.
Despite these concerns, Trump maintains that the threat of tariffs is a powerful lever to revive American manufacturing. While some large pharmaceutical companies have increased domestic investment in recent years, U.S.-based drug production still represents only a fraction of global output. Trump’s administration believes that tough economic measures are necessary to reverse decades of offshoring.
Notably, pharmaceutical stocks remained relatively stable in the immediate aftermath of the announcement, reflecting skepticism among investors about whether the tariffs will ultimately materialize or reach the proposed 200% threshold. Trump has previously floated similar trade measures that were later scaled back or delayed.
Still, the mere possibility of such tariffs signals a growing willingness to use aggressive trade policy in sectors traditionally considered too sensitive or complex for broad economic intervention. The coming weeks will likely bring more clarity as the administration finalizes its review and industry stakeholders prepare for what could be a major policy shift.
If enacted, these tariffs would mark one of the most consequential moves in U.S. healthcare trade policy in decades—potentially reshaping supply chains, pricing, and the geopolitical landscape of pharmaceutical production.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
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Amended credit agreement. On June 30, the company announced an amendment to its credit agreement, extending the maturity of the company’s Class A Revolving Commitments from Q2 end to Q3 end. Moreover, any interest due on the revolver and refinanced term loans through that date will be paid in-kind. The amendment also waived financial covenant testing for Q2 and Q3, offering the company a temporary liquidity reprieve.
Cost of amendment. As part of the amendment, GoHealth will pay a 1.00% amendment fee to consenting lenders, which, along with all interest through September 30, will be paid in-kind and added to the principal balance of its loans. As a result, we estimate these provisions will increase the company’s outstanding debt by approximately $6 million.
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Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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Approval Delay Is Not A Surprise. Unicycive announced that it has received a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC). This was expected following the announcement earlier this month stating that the FDA manufacturing inspection had found deficiencies with one of the OLC contract manufacturers. The company has switched to one of its other manufacturers, which we believe can resolve the issues quickly. We see approval possible around 4Q25 to 1Q26.
Plans To Address The Issues. Unicycive plans to hold a Type A meeting with the FDA to determine its requirements for resolution of the issues cited in the CRL. The company’s second manufacturer already produces OLC and has been generating data for FDA certification. This should allow Unicycive to submit any additional data requested quickly to resolve the issue.
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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.
Key Points: – XOMA will acquire Turnstone for $0.34 per share plus a CVR. – 25.2% of shareholders have agreed to the deal. – The acquisition expands XOMA’s biotech royalty portfolio.
In a notable development in the biotech investment landscape, XOMA Royalty Corporation has entered into a definitive agreement to acquire Turnstone Biologics Corp. in a cash and contingent value right (CVR) transaction. The acquisition underscores XOMA’s continued push to expand its royalty and milestone-driven portfolio by targeting biotech firms with high-risk, high-reward therapeutic assets.
Under the terms of the deal announced June 27, XOMA Royalty will pay $0.34 per share in cash to Turnstone shareholders, along with a non-transferable CVR tied to future clinical or commercial milestones. The transaction was unanimously approved by Turnstone’s board following a comprehensive strategic review, indicating strong alignment between both companies on the benefits of the proposed merger.
The transaction will be executed through a tender offer, which XOMA is expected to launch by July 11, 2025. To move forward, the offer requires acceptance by holders representing at least a majority of Turnstone’s outstanding shares, along with other standard closing conditions including a minimum cash balance at the time of closing.
Significantly, shareholders representing roughly 25.2% of Turnstone’s stock have already agreed to support the deal and tender their shares, increasing the likelihood of a successful outcome. If the tender offer is completed as planned, remaining shares not tendered—excluding any subject to appraisal rights—will be converted into the same cash and CVR terms. The full acquisition is anticipated to close by August 2025.
The CVR element of the deal provides Turnstone shareholders with potential upside depending on the progress of its pipeline, which historically has focused on Selected Tumor-Infiltrating Lymphocyte (Selected TIL) therapy for the treatment of solid tumors. While the company has faced challenges in recent quarters, its research has positioned it within a promising niche of the immuno-oncology space.
Turnstone has partnered with Leerink Partners as financial advisor and Cooley LLP for legal counsel during the transaction process. On the acquiring side, XOMA is represented by legal firm Gibson, Dunn & Crutcher LLP.
This acquisition adds another layer to XOMA’s unique business model, which focuses on purchasing future economic rights—royalties and milestone payments—from pre-commercial and commercial biotech programs. These rights are typically tied to therapies developed and licensed out by smaller biotech companies to larger pharmaceutical firms. In return, the selling firms receive non-dilutive capital they can reinvest into pipeline development or general operations.
By bringing Turnstone into its fold, XOMA potentially gains exposure to novel cancer therapies while giving Turnstone a viable financial exit at a time when biotech funding remains tight. The CVR component allows existing shareholders to benefit from any future success tied to Turnstone’s core scientific work, creating a hybrid payout structure aligned with both short-term liquidity and long-term optionality.
The transaction reflects a growing trend in biotech M&A, where royalty aggregators like XOMA leverage strategic acquisitions to build long-term value while offering capital relief to development-stage firms.
As of now, both companies remain focused on a smooth closing process, with investors watching closely to see how Turnstone’s science and XOMA’s model will align in the quarters ahead.
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.
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NeoCart Transferred To Form New Regenerative Medicine Company. Ocugen has announced that it has entered into a merger agreement with Carisma Therapeutics to form a new company. Ocugen will transfer its wholly-owned regenerative medicine division, OrthoCellix, including NeoCart, an autologous cartilage implant technology that uses a patient’s cells to repair articular cartilage defects in the knee. The all-stock transaction is valued at $150 million, with Ocugen shareholders owning 90% of the new company.
We Expect The New Company To Accelerate NeoCart Development. Ocugen has been refining the Phase 3 trial design and has planned to start Phase 3 trials during FY2025. NeoCart has received Regenerative Medicine Advanced Therapy (RMAT) designation, which accelerates BLA review and could lead to faster approval. While the NeoCart data has been strong, NeoCart was a legacy product that was acquired by Ocugen as part of its 2019 reverse merger with Histogenics. Regenerative medicine is outside Ocugen’s main focus, and we believe it can be developed more rapidly by a company focused on regenerative medicine.
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.
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.
Preparing For AVERSA Fentanyl Clinical Testing. Nutriband and its partner Kindeva announced that it has completed commercial manufacturing processes and scale-up for AVERSA Fentanyl, its abuse-deterrent fentanyl patch. This allows the company begin manufacturing clinical supplies and filing the IND (Investigational New Drug application) for the Phase 1 clinical study within the timeframe we anticipated. Only a single Phase 1 study is needed to file the application for marketing approval.
Manufacturing Completion Is A Significant Milestone. This scale-up is a significant step that demonstrates the ability to apply Kindeva’s transdermal patch technology for commercial scale production of AVERSA Fentanyl patches. We expect the IND filing to be completed shortly, with clinical testing to follow as expected.
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.