Tag: Biotech

Zimmer Biomet Acquires Monogram Technologies to Lead in Robotic Orthopedics

Posted on by slightbourne@noblecapitalmarkets.com

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.

Eledon Pharmaceuticals (ELDN) – Meeting Highlights Tegoprubart Data Milestones and New Indications

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 10, 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.

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. 

XOMA Acquires Turnstone in $0.34 Per Share Deal with Future Payouts

Posted on by slightbourne@noblecapitalmarkets.com
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 (OCGN) – Merger Agreement Moves NeoCart Into A New Company

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 24, 2025

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.

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.


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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. 

GeoVax Labs (GOVX) – EMA Allows GEO-MVA To Leapfrog To Phase 3 Trial In EU

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 17, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

GEO-MVA Gets An Accelerated Pathway To European Approval. GeoVax announced that it has received guidance from the EMA (European Medicines Agency) that provides an accelerated path to approval for GEO-MVA, its modified vaccinia ankara (MVA) based vaccine for smallpox/Mpox. It will only be required to conduct immune-bridging and toxicity studies before moving directly to Phase 3. This cuts several years from development time and saves many millions of dollars in clinical expenses.

Only Phase 3 Will Be Needed. The Committee for Medicinal Products for Human Use (CHMP) of the EMA stated that only requirements before beginning a Phase 3 study will be a non-clinical immuno-bridging and toxicity studies. No Phase 1 or Phase 2 studies are required. An MAA regulatory application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine (Imvanex or Jynneos, from Bavarian Nordic). The proposed endpoints of the study would be demonstration of immunogenicity to show non-inferiority.


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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. 

Sanofi Acquires Vigil Neuroscience in $470 Million Deal to Bolster Alzheimer’s Drug Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Sanofi to acquire Vigil Neuroscience for $470 million, expanding its neurology focus.
– Deal includes $8 per share and a $2 contingent value right tied to an Alzheimer’s candidate.
– The acquisition strengthens Sanofi’s long-term R&D pipeline without impacting 2025 guidance.

In a strategic move to deepen its commitment to neuroscience and neurodegenerative disorders, French pharmaceutical giant Sanofi (SASY.PA) announced it will acquire Vigil Neuroscience (VIGL.O), a U.S.-based clinical-stage biotech company, in a deal valued at $470 million. The transaction includes an upfront cash payment of $8 per share, along with a $2 per share contingent value right (CVR) tied to the progress of Vigil’s Alzheimer’s drug candidate, VG-3927.

The acquisition signals Sanofi’s growing ambition in the neurology space, particularly in the high-stakes race to develop effective treatments for Alzheimer’s disease, a market expected to grow dramatically as global populations age. VG-3927, an oral drug currently in clinical development, is the centerpiece of the deal and could offer a differentiated approach to treating Alzheimer’s by targeting the TREM2 receptor, which plays a role in immune responses in the brain.

This deal is part of a broader, aggressive push by Sanofi into neuroscience and U.S.-based innovation. Earlier this month, the company announced it would invest $20 billion in the U.S. through 2030, a capital injection aimed at bolstering research, development, and domestic manufacturing capabilities. The acquisition of Vigil aligns with this strategic direction, expanding Sanofi’s U.S. biotech footprint and pipeline in tandem.

The CVR component of the deal is particularly notable. CVRs are often used in biotech mergers to tie additional shareholder value to the success of specific development milestones. In this case, the extra $2 per share is dependent on the advancement of VG-3927, which could become a valuable addition to Sanofi’s neurology portfolio if it clears clinical and regulatory hurdles.

Sanofi already had a vested interest in Vigil before this announcement. In June 2024, the French firm made a $40 million equity investment in Vigil, securing exclusive negotiation rights to VG-3927. This prior relationship helped pave the way for the full acquisition, giving Sanofi a head start in due diligence and integration planning.

Interestingly, Vigil’s other key asset, VGL101, a monoclonal antibody program, is excluded from the acquisition and will be returned to its original licensor, Amgen (AMGN). This indicates Sanofi’s laser focus on VG-3927 and its potential as an oral therapy—a more scalable and patient-friendly alternative to injectable biologics currently used in Alzheimer’s treatment.

The transaction is expected to close in the third quarter of 2025, pending customary regulatory approvals. Sanofi confirmed that the acquisition would not impact its 2025 financial guidance, suggesting it is being funded through existing capital reserves or allocated R&D spending.

As big pharma continues to chase the next blockbuster treatment in neurology, Sanofi’s acquisition of Vigil could position the company as a stronger contender in the evolving Alzheimer’s market—provided VG-3927 delivers on its clinical promise.

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

Regeneron Acquires 23andMe for $256 Million Amid Bankruptcy

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Regeneron to acquire 23andMe’s assets, including its vast genetic data bank, for $256 million.
– The deal raises significant privacy concerns among customers and regulators.
– Despite bankruptcy, 23andMe’s consumer services will continue under Regeneron’s oversight.

In a major move with wide-reaching implications for healthcare, privacy, and small-cap investors, Regeneron Pharmaceuticals has announced its acquisition of embattled DNA-testing company 23andMe for $256 million. The deal comes as 23andMe, once valued at over $6 billion following its 2021 public debut, filed for Chapter 11 bankruptcy earlier this year after prolonged profitability issues.

The acquisition includes 23andMe’s flagship Personal Genome Service, its Total Health and Research Services businesses, and a massive biobank of consumer genetic data collected over the years. While this trove of genetic information presents an invaluable asset for advancing personalized medicine, it also ignites fresh concerns about consumer privacy, data protection, and ethical oversight.

Regeneron, a major player in biotechnology and pharmaceuticals, has committed to maintaining 23andMe’s existing privacy protections and compliance with applicable laws. A court-appointed ombudsman will oversee the company’s plans for handling consumer data, and Regeneron has pledged transparency and high standards in its management of the sensitive dataset.

“We assure 23andMe customers that we are committed to protecting the 23andMe dataset with our high standards of data privacy, security and ethical oversight and will advance its full potential to improve human health,” said Aris Baras, a senior vice president at Regeneron.

The transaction, expected to close in Q3 2025, ensures that 23andMe’s genome services will continue without interruption. However, many former customers remain uneasy. When the company filed for bankruptcy, California Attorney General Rob Bonta advised users to request deletion of their genetic data and destruction of any physical samples stored by the company.

Despite reassurances from both Regeneron and 23andMe that existing privacy policies—designed to prevent data sharing with employers, insurers, law enforcement, and public databases—will remain in effect, skepticism lingers. This is particularly relevant in an age where genetic data is increasingly valuable for drug development, disease prediction, and targeted therapies.

For small-cap investors, this deal is noteworthy for several reasons. First, it reflects a growing trend of larger pharmaceutical firms acquiring innovative—but financially struggling—startups to bolster their pipelines and data assets. Second, it highlights the inherent volatility and risks associated with investing in biotech startups, especially those that go public with limited monetization strategies.

23andMe’s rise and fall underscore the importance of business sustainability in data-centric healthcare models. Meanwhile, Regeneron’s acquisition offers a potential long-term payoff through access to a highly unique, large-scale genomic dataset that could fuel years of research and development.

Investors will be watching closely how Regeneron integrates 23andMe’s assets and navigates the complex ethical landscape surrounding personal genetic data.

Cocrystal Pharma (COCP) – 1Q25 Reported With Clinical Trial Milestone Updates

Posted on by slightbourne@noblecapitalmarkets.com


Monday, May 19, 2025

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.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.

Fourth Quarter Included New Data On Norovirus Variants. Cocrystal reported a 1Q25 loss of $2.3 million or $(0.23) per share. During the quarter the company announced Phase 1 results from its CDI-988 study in norovirus. Importantly, preclinical data showed efficacy against new norovirus variants. We believe this provides additional support to Cocrystal’s method of targeting highly-conserved viral replication enzymes to make effective drugs against both current and future variants. Cash on March 31, 2025 was $6.9 million.

CDI-988 Activity Includes New Variant Strains. CDI-988 is a protease inhibitor in development for norovirus and corona virus. CDI-988 has shown activity against multiple strains, with new preclinical data in April 2025 showing efficacy against the GII.17 and GII.4 strains that have recently been most prevalent. Results from the Phase 1 high-dose cohort in healthy subjects is expected to be announced in 2Q2025. A human challenge trial is planned for later in FY2025 to evaluate CDI-988 for treatment and prophylaxis against norovirus.


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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. 

Novartis to Acquire Regulus Therapeutics in $1.7 Billion Biotech Buyout

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Novartis to acquire Regulus for up to $1.7B, including $7/share upfront and $7/share tied to farabursen approval.
– Farabursen, a potential first-in-class ADPKD treatment, heads into Phase 3 with FDA alignment.
– Boosts Novartis’s kidney disease pipeline and commitment to innovation in rare conditions.

Novartis AG announced plans to acquire Regulus Therapeutics Inc. in a transaction valued at up to $1.7 billion, reinforcing the Swiss pharmaceutical giant’s strategy to deepen its portfolio in renal and genetic disease treatments. The deal includes an upfront cash payment of $7.00 per share, representing approximately $800 million in equity value, and an additional $7.00 per share tied to a regulatory milestone via a contingent value right (CVR), pending approval of Regulus’s lead drug candidate, farabursen.

Farabursen is being developed as a novel treatment for autosomal dominant polycystic kidney disease (ADPKD), a condition with limited current options and significant unmet clinical need. If approved, farabursen could become the first systemic therapy of its kind in this indication, offering a potentially superior safety and efficacy profile compared to existing treatments.

The acquisition reflects a growing trend in the biopharma sector where large-cap pharmaceutical companies pursue innovative pipelines through targeted M&A. In recent quarters, the industry has seen an uptick in transactions focused on small to mid-sized biotech firms that specialize in high-impact therapies for rare or underserved diseases. Regulus’s focus on microRNA-based therapies, a field once viewed as experimental, is now receiving renewed attention as advances in RNA technology improve target precision and therapeutic delivery.

For Novartis, the move expands its nephrology franchise and bolsters its pipeline in genetic disorders, aligning with the company’s long-term innovation strategy. Financially, the deal signals confidence in both Regulus’s platform and farabursen’s development prospects. The 274% premium to Regulus’s 60-day volume-weighted average price underscores the strategic value Novartis sees in the program.

The transaction is expected to close in the second half of 2025, subject to regulatory approval and the successful tender of a majority of Regulus’s outstanding shares. Once finalized, Regulus will become a wholly owned subsidiary of Novartis, with its operations and development programs integrated into Novartis’s global R&D structure.

The deal may also serve as a bellwether for continued consolidation in biotech, particularly among companies advancing oligonucleotide or RNA-based therapeutics. Investors are likely to see the acquisition as further validation of microRNA platforms, potentially reinvigorating interest in similar early-stage biotech firms.

At a time when cost pressures and generic competition are accelerating across the pharmaceutical landscape, acquiring promising assets with a clear regulatory path remains a preferred strategy for growth. For Regulus, integration with Novartis offers the financial and operational muscle needed to take farabursen through the final stages of development and, if approved, to global markets.

As the biotech sector continues to recalibrate from recent valuation contractions, strategic acquisitions like this illustrate the enduring value of focused innovation, especially in areas with limited treatment alternatives and high unmet demand.

Release – Ocugen to Present on Modifier Gene Therapy Platform at Association for Research in Vision and Ophthalmology 2025 Annual Meeting and Retina World Congress

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on Ocugen

April 29, 2025

MALVERN, Pa., April 29, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410ST for the treatment of Stargardt disease (Phase 2/3 pivotal confirmatory clinical trial), and OCU410 for the treatment of geographic atrophy (Phase 2 ArMaDa clinical trial), at The Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting at the Calvin L. Rampton Salt Palace Convention Center in Salt Lake City, Utah from May 4-8, 2025, and Retina World Congress at the Marriott Harbor Beach Resort in Ft. Lauderdale, Florida from May 8-11, 2025.

“We look forward to sharing more about the potential of our modifier gene therapy platform and the meaningful results we are seeing in the clinic during these two important meetings for the retina community,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Ocugen remains on track to deliver on our commitment to file three Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs) in the next three years—potentially addressing significant unmet medical need for large patient populations through our gene-agnostic approach.”

The ARVO Annual Meeting is a premiere gathering for eye and vision scientists from across the globe, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions. Retina World Congress brings together leading retina specialists from every continent to achieve a global scientific and clinical exchange in retinal health.

Ocugen’s presence in Utah kicks off with the Company Showcase at Eyecelerator, presented by Dr. Huma Qamar, Chief Medical Officer at Ocugen, and continues through presentations and thought leadership engagement at ARVO.

Eyecelerator @ Park City 2025

Session: Retina—Gene Therapy and Novel Mechanisms of Action Showcase
Location: Grand Hyatt Deer Valley, Strawberry Ballroom, Park City, UT
Date: Friday, May 2, 2025
Time: 2:06 p.m. MDT
Presenter: Dr. Huma Qamar

ARVO

Exhibitor Education Forum
Two-Year Follow-Up of a Phase 1/2 Clinical Trial for the Safety and Efficacy of OCU400 Novel Modifier Gene Therapy for Retinitis Pigmentosa
Location: Exhibitor Floor, Section 1037
Date: Monday, May 5, 2025
Time: 2 p.m. MDT 
Presenter: Benjamin Bakall, MD, Ph.D., Assistant Clinical Professor, University of Arizona, College of Medicine–Phoenix, and Director for Clinical Research, Director for The Inherited Retinal Disease and Visual Function Clinic, Associated Retina Consultants

An Evaluation of the Safety and Efficacy of Novel Modifier Gene Therapy OCU410 for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Location: Exhibitor Floor, Section 1037
Date: Tuesday, May 6, 2025
Time: 2 p.m. MDT
Presenter: Syed M. Shah, MD, FACS, Vice Chair for Research and Digital Medicine, Director of Retina Service at Gundersen Health System, La Crosse, Wisconsin

Safety and Efficacy of OCU410ST: A Phase 1/2 Trial of a Novel Modifier Gene Therapy for Stargardt Disease (GARDian)
Location: Exhibitor Floor, Section 1037
Date: Wednesday, May 7, 2025
Time: 2 p.m. MDT
Presenter: Neena Haider, Ph.D., Faculty Harvard Medical School and Founder, CEO, Shifa Precision

Paper Session
Preliminary Safety and Efficacy of OCU410 for Treatment of Geographic Atrophy: Phase 1/2 OCU410: The Age-related Macular Degeneration (ArMaDa) Study Update
Presentation Number: 3675 
Session Number and Title: 358/AMD Clinical research II 
Location: Ballroom J 
Date: Tuesday, May 6, 2025
Time: 4:15 p.m. MDT
Presenter: Syed M. Shah, MD, FACS, Vice Chair for Research and Digital Medicine, Director of Retina Service at Gundersen Health System, La Crosse, Wisconsin

Poster Session
A0513: Safety and Efficacy of OCU410ST for the Treatment of Stargardt Disease: Phase 1/2 Study Update
Location: Hall A-E
Date: Thursday, May 8, 2025
Time: 2 p.m. MDT
Presenter: Ramiro Maldonado, MD, Duke Center for Ophthalmic Genetics, Duke Pediatric Retina, Adult vitreo-Retinal diseases

Dr. Qamar will represent Ocugen at Retina World Congress to share the Company presentation and serve alongside notable retinal surgeons and industry peers during a panel discussion.

Retina World Congress

Retina Unplugged
Inherited and Rare Retinal Diseases Session
Moderators: Rishi P. Singh, MD, FASRS and Kourous A. Rezaei, MD
Location: Grand Ballroom
Date: Thursday, May 8, 2025
Time: 10:35 am – 11:12 a.m. EDT

Ocugen is committed to bringing game-changing therapies to treat inherited retinal diseases as well as blindness diseases affecting millions to market and working even harder to provide access to patients globally.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com

Longevity Health Merges with 20/20 BioLabs in Bid to Redefine Healthy Aging

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Longevity Health and 20/20 BioLabs to merge, forming a $99M company focused on diagnostics and healthy aging.
– 2025 revenue expected to double post-merger, driven by cross-sell opportunities and product synergies.
– Combined firm targets expanding into MedSpas, retail, and clinical settings, reflecting a hybrid approach to wellness and diagnostics.

Longevity Health Holdings (Nasdaq: XAGE) is doubling down on its ambition to lead the healthy aging and diagnostics market with the announcement of a strategic all-stock merger with 20/20 BioLabs, a provider of cutting-edge diagnostic tests for early cancer detection and chronic disease risk management. The deal, which is expected to close in Q3 2025, marks another step in Longevity’s pivot toward becoming a vertically integrated longevity-focused healthcare platform.

The merger comes just months after Longevity’s acquisition of Elevai Skincare and follows the company’s March 2025 announcement outlining a broader strategy to combine diagnostics, bio-aesthetics, and nutrition under the unifying theme “Healthy Aging, Inside and Out™.” With 20/20’s technology and distribution capabilities, Longevity is adding a diagnostics engine to its growing wellness infrastructure and positioning itself as a unique player at the intersection of science, skincare, and preventative healthcare.

Under the terms of the agreement, 20/20 shareholders will own approximately 50.1% of the combined company, with Longevity shareholders retaining 49.9%—a sign of parity and the significance of what 20/20 brings to the table. The merged company will continue to trade under the ticker “XAGE” on the Nasdaq.

Founded in Gaithersburg, Maryland, 20/20 operates a CLIA-licensed and CAP-accredited laboratory and has developed OneTest™, a multi-cancer early detection (MCED) blood test capable of identifying over a dozen tumor types for under $200. The company has already integrated its tests into wellness protocols for firefighters and military veterans and is preparing to launch a new “longevity test” this spring that evaluates inflammatory markers tied to aging and disease risk.

Financially, the merger is set to double Longevity’s expected revenue for fiscal year 2025 from $3–4 million to $7–8 million and deliver at least $1 million in operational synergies. The combined company’s equity valuation is pegged at $99 million, offering a promising growth profile in a market that increasingly values integrated health solutions.

For small-cap investors, the deal highlights an emerging investment theme: convergence in wellness, biotech, and diagnostics. Longevity is carving out a niche in a crowded but high-potential market by integrating scientific, consumer-facing products with medical-grade diagnostics. This cross-disciplinary approach could make it more resilient than standalone players focused solely on aesthetics or lab testing.

Beyond the numbers, Longevity plans to offer 20/20’s tests through its network of physicians to inform more personalized bio-aesthetic treatment plans. Conversely, 20/20 will gain access to Longevity’s customer base—including thousands of firefighters—to introduce its diagnostics in new environments, including MedSpas and retail.

Leadership will be shared post-merger. Longevity’s Rajiv Shukla will remain Chairman, while 20/20’s Jonathan Cohen will step in as CEO, underscoring a collaborative transition.

As Longevity eyes further acquisitions, this deal positions it as a unique micro-cap consolidator in the rapidly evolving healthy aging space. Investors should watch closely as the company scales up from niche science to potentially mass-market longevity solutions.

Release – Gyre Therapeutics Announces Publication of Protocol for Phase 3 Trial Evaluating F351 for CHB-Associated Liver Fibrosis in Journal of Clinical and Translational Hepatology

Posted on by slightbourne@noblecapitalmarkets.com

Research News and Market Data on Gyre Therapeutics

March 27, 2025

PDF Version

SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan.

The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline.

The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025.

About Hydronidone (F351)

F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351’s dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:
Stephen Jasper
stephen@gilmartinir.com

FOXO Technologies Signs Non-Binding Agreement to Acquire Vector Biosource

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– FOXO Technologies has signed a non-binding agreement to acquire Vector Biosource, a biospecimen sourcing provider.
– Vector is expected to generate $800,000 in revenue in 2025 without additional capital.
– The acquisition involves Series D Preferred Stock and milestone-based earnout payments.

FOXO Technologies Inc. (NYSE American: FOXO) has announced the execution of a non-binding agreement to acquire Vector Biosource Inc., a provider of information and biospecimen sourcing services for the biotechnology, clinical research, and pharmaceutical industries. The acquisition aligns with FOXO’s strategy of expanding its footprint in healthcare and biotechnology sectors.

The proposed transaction includes an initial payment of $750,000 in Series D Cumulative Redeemable Preferred Stock, with an additional $750,000 in Series D Preferred Stock contingent on Vector meeting specific revenue and cash collection milestones in 2025. Further earnout payments in Series D Preferred Stock are structured based on Vector’s performance in 2026 and 2027. The deal remains subject to definitive agreements, due diligence, and the provision of $1 million in working capital.

Seamus Lagan, CEO of FOXO Technologies, emphasized the strategic benefits of the deal, stating, “We are excited to have reached agreement with Vector to move forward with this strategic acquisition. We were attracted to Vector’s unique position in this healthcare sector and its growth profile, and we are focused on working closely with Vector senior leadership to aggressively expand the Vector platform.”

Vector’s CEO, Frank Dias, Jr., highlighted the advantages of the partnership, noting, “We believe the partnership with FOXO will allow Vector to achieve its near and long-term growth plans by providing growth capital, corporate infrastructure, and potential synergies with other FOXO subsidiaries. We anticipate a significant increase in expected revenues with the provision of growth capital and corporate infrastructure by FOXO.”

FOXO Technologies operates through three subsidiaries:

  • Rennova Community Health, Inc.: Owner and operator of Scott County Community Hospital (Big South Fork Medical), a critical access hospital in East Tennessee.
  • Myrtle Recovery Centers, Inc.: A 30-bed behavioral health facility offering inpatient detox, residential treatment, and outpatient services.
  • Foxo Labs, Inc.: A biotechnology company dedicated to advancing health and lifespan through innovative technology and product solutions.

The acquisition of Vector Biosource marks another step in FOXO’s broader growth strategy as it continues to integrate specialized healthcare and biotechnology services under its corporate umbrella. The deal is expected to close within the next 45 days, subject to regulatory approvals and standard closing conditions.

Take a moment to take a look at Noble Capital Markets’ biotechnology and life sciences research analyst Robert Leboyer’s coverage list.