Cadrenal Therapeutics (CVKD) – 2Q25 Included Clinical Strategy Change and Manufacturing Progress


Tuesday, August 12, 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.

Cadrenal Reports 2Q With Product News. Cadrenal reported a 2Q25 loss of $3.7 million or $(1.87) per share. During the quarter, the company announced a design modification for the upcoming tecarfarin clinical trial. The company also transferred its manufacturing technology to a CDMO and completed production scale-up in preparation for clinical trials. Cash on June 30, 2025 was $5.6 million.

New Trial Focuses On First Months Of Dialysis. As described in our Research Note on August 7 , the new trial design reflects recent research showing the first four to six months after the start of renal dialysis are an ultra-high-risk period for cardiac events including myocardial infarction, stroke, embolism, and death. The design change will be testing tecarfarin as an anticoagulant to reduce these events. The clinical site activation and trial enrollment are expected to begin around year-end.


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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. 

Eledon Pharmaceuticals (ELDN) – Phase 1b Data Continues To Show Improved Outcomes


Thursday, August 07, 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.

Phase 1b Kidney Transplant Data Presented. Eledon presented data from its Phase 1b trial using tegoprubart as part of an immunosuppressive regimen at The World Transplant Congress. The data from the first 32 patients at two dosage cohorts continues to show meaningful improvement over the standard of care. We believe this supports our expectations for strong data for the Phase 2 BESTOW trial in November.

Study Design. The presentation included data from 32 patients receiving kidney transplants followed by an immunosuppressive regimen tegoprubart instead of tacrolimus, the standard of care. The primary endpoints are safety and pharmacokinetics. Secondary endpoints include patient survival, graft survival, biopsy proven acute rejection, with kidney function measured by eGFR and iBOX score.


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Ocugen (OCGN) – 2Q25 Reported With All Three Trials On Schedule


Monday, August 04, 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.

Product Updates All Three Trials Are On Schedule. Ocugen reported a 2Q25 loss of $14.7 million or $(0.05) per share. During the quarter, the clinical trials made progress to keep the products on schedule for 3 BLA filings beginning in 2026. The quarter also included a licensing agreement covering OCU400 in South Korea and the reverse merger to form OthroCellix, a new company focused on regenerative medicine.

OrthoCellix Has Been Formed To Develop NeoCart. Ocugen and Carisma Therapeutics, Inc. announced a reverse merger that will create a new company developing regenerative cellular therapies.  As discussed in our Research Note on June 24, NeoCart  cellular therapy is outside its main focus. The transaction is expected to close in September-October with the new company valued at $150 million. The Phase 3 pivotal trial is expected to begin in FY2025.


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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) – 2Q25 Reported With MVA and Gedeptin Trial Updates


Tuesday, July 29, 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.

GeoVax Reports 2Q25 Financials With Updates Trials For MVA and Gedeptin. GeoVax reported a 2Q25 loss of $5.4 million or $(0.35) per share. Revenues of $0.9 million were for work performed under the BARDA contract prior to its cancellation in April 2025. During the quarter, the EMEA communicated that the GEO-MVA vaccine in development for smallpox/Mpox could skip Phase 1 and 2, then receive approval based on Phase 3 immune markers. The company also amended its trial plans for Gedeptin in HNSCC.

GEO-MVA Phase 3 Is Expected To Begin In 2H26. As discussed in our Research Note on June 17,GeoVax received Scientific Advice (SA) from the EMA for GEO-MVA smallpox/Mpox vaccine stating the Phase 1 and 2 studies would not been needed. An MAA will only require a single Phase 3 immuno-bridging trial comparing the immune response in healthy volunteers receiving GEO-MVA against the approved vaccine. The study is expected to begin in 2H26.


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Zimmer Biomet Acquires Monogram Technologies to Lead in Robotic Orthopedics

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


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

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


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


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

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

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


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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Novartis to Acquire Regulus Therapeutics in $1.7 Billion Biotech Buyout

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.