Category: Healthcare

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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*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. 

Supernus Pharmaceuticals Acquires Sage Therapeutics in $795M Deal, Boosting Neuropsychiatric Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs.
– Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio.
– Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.

Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.

The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.

This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”

ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.

From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.

Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.

In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.

While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.

This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.

Unicycive Therapeutics (UNCY) – FDA Finds Deficiencies At Third-Party Manufacturing Subcontractor – Approval Could Be Delayed

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, June 11, 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.

Approval May Come After The PDUFA Date Of June 28. Unicycive announced that an FDA inspection has found deficiencies with the cGMP (certified Good Manufacturing Practice) compliance at a third-party manufacturing subcontractor. The company’s product, OLC, is manufactured by a contract manufacturer with other subcontractors. The deficiency does not involve the active pharmaceutical compound (APC) and may be related to final finishing and packaging operations.

Good News and Bad News. The FDA stated that the manufacturing deficiencies must be resolved before product label discussions can proceed. We interpret this to mean that the FDA review of the clinical data has been completed, the manufacturing inspection was conducted, and product labeling remains as the final step before approval. Although the manufacturing deficiencies have stopped the labeling discussion, we expect NDA approval when corrected.


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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. 

Concentra Biosciences to Acquire Elevation Oncology in Strategic Biotech Merger

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Concentra Biosciences is acquiring Elevation Oncology for $0.36 per share in cash plus a CVR tied to future financial milestones.
– Elevation’s board supports the deal; insiders holding 5.1% have committed to tender their shares.
– Shareholders could earn additional payouts based on net cash reserves and proceeds from potential asset sales.

In a strategic move within the biotech sector, Concentra Biosciences has announced plans to acquire Elevation Oncology, a clinical-stage oncology firm known for its targeted cancer therapies. The transaction, which was unveiled Monday, values Elevation at $0.36 per share in cash. In addition to the upfront payment, shareholders will receive a contingent value right (CVR) tied to future financial outcomes.

This acquisition marks a significant shift for Elevation Oncology, which has focused its efforts on developing precision treatments for solid tumors with limited current treatment options. The deal aligns with Concentra’s expansion strategy in oncology innovation, particularly in addressing high-need patient populations.

Under the terms of the agreement, Elevation stockholders will receive a cash payout of $0.36 per share, with an additional CVR providing potential future compensation. The CVR includes two main components: shareholders could benefit from any closing cash above $26.4 million and from a share of future net proceeds related to the disposition of EO-1022, a clinical asset, if sold within a year of closing. The CVR will remain active for up to five years following the merger.

Elevation’s board of directors has unanimously backed the agreement, emphasizing that the proposed terms serve the best interest of shareholders. A wholly owned subsidiary of Concentra is expected to begin a formal tender offer by June 23, 2025. For the acquisition to proceed, a majority of Elevation’s outstanding shares must be tendered, and at least $26.4 million in net cash must remain on hand after deducting liabilities, transaction costs, and specific payments.

Support for the deal is already emerging. Elevation’s leadership and certain insiders, who collectively own about 5.1% of the company’s shares, have signed agreements to support and tender their holdings. If all conditions are met, the merger is expected to finalize by July 2025.

The acquisition arrives at a pivotal moment for Elevation Oncology. The company has faced challenges navigating the complex landscape of cancer drug development and commercialization. Partnering with Concentra provides a pathway to both secure value for current shareholders and potentially advance EO-1022 and other clinical assets under stronger financial and operational support.

Legal counsel for Elevation Oncology is being provided by Fenwick & West LLP, while Gibson, Dunn & Crutcher LLP is advising Concentra.

This merger is part of a broader trend in the biotech sector, where companies with innovative pipelines seek strategic partnerships or acquisitions to accelerate growth and mitigate risk. For Concentra, the deal expands its reach into solid tumor therapeutics—a market with both high clinical need and strong commercial potential.

As the healthcare sector continues to evolve, this acquisition underscores the importance of collaboration in bringing forward novel cancer treatments and delivering shareholder value in a highly competitive and capital-intensive industry.

Take a moment to take a look at Noble Capital Markets’ Biotechnology and Life Sciences Research Analyst Robert Leboyer’s coverage list.

MAIA Biotechnology (MAIA) – THIO Update Shows Another Increase In Overall Survival

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 06, 2025

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

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

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

New THIO-101 Update Presented AT ASCO. MAIA presented updated data from its THIO-101 trial showing median overall survival increased as more patients advanced through treatment. Data presented showed a median overall survival of 17.8 months for patients receiving the combination of THIO and the PD-1 inhibitor, Libtayo (cemiplimab, a checkpoint inhibitor from Regeneron), an increase from 16.9 months reported in January 2025.

Survival Improved As More Patients Completed The Study. Updated data was presented at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting, with more patients treated for longer periods. The median overall survival reported was 17.8 months compared with the expected survival of 5.8 months for standard of care therapy. This was an improvement from 16.9 months (n=22 patients) reported in January 2025 and 10.6 months (n=19 patients) reported in August 2024.


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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. 

Release – MAIA Biotechnology Announces New Responder in Non-Small Cell Lung Cancer Phase 2 Clinical Trial

Posted on by slightbourne@noblecapitalmarkets.com

June 05, 2025 11:10am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced a new partial response (PR) was identified in a patient after 20 months of treatment in its Phase 2 THIO-101 clinical trial evaluating ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy. A partial response is defined as a decrease in tumor size of at least 30%.

“The patient remained on treatment and we observed stable disease for more than twenty months before the partial response was identified, highlighting the efficacy, safety and low toxicity of the treatment. Extended-term responses like this are not often seen in heavily pretreated patients in hard-to-treat diseases such as NSCLC, where the prognosis for the advanced-stage of the disease is typically poor,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We confirmed this response with a second scan, and we are highly confident that ateganosine could become an outstanding therapeutic alternative for third-line NSCLC patients.”

THIO-101 third line (3L) data cutoff from May 15, 2025, showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine in parts A and B of the trial. At the data cutoff, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.1

MAIA has announced the trial design for an expansion of its THIO-101 pivotal Phase 2 trial in NSCLC to assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous CPI treatment and chemotherapy.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

1 Girard N, et al. J Thorac Onc 2009;12:1544-1549.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology

Released June 5, 2025

Release – MAIA Biotechnology Announces Positive Efficacy Update for Phase 2 THIO-101 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by slightbourne@noblecapitalmarkets.com

June 05, 2025 8:04am EDT

Median overall survival (OS) from ateganosine (THIO) treatment extends to 17.8 months in latest data

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.

As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population.1 Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.2-3

“It is gratifying to see that our treatment further extends lives for these hard-to-treat patient populations, especially in third-line NSCLC treatment where patients are most resistant to therapy,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “This new benchmark of 17.8 months median OS is nearly triple the recognized SOC data for third-line NSCLC found in medical literature. We believe this is a substantial indicator of the potential ateganosine has to shift the NSCLC treatment landscape.”

MAIA’s multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

1Details on safety can be found on the previously announced ASCO 2025 poster available on MAIA’s website.
2Girard N, et al. J Thorac Onc 2009;12:1544-1549.
3A.T. Freeman et al. Curr Oncol. 2020 May 1;27(2):76–82

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released June 5, 2025

Release – Ocugen, Inc. Announces Signing of Binding Term Sheet for the License of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

Posted on by slightbourne@noblecapitalmarkets.com

June 5, 2025

PDF Version

  • Upfront fees and near-term development milestone payments totaling up to $11 million
  • Sales milestones of $150 million or more in first 10 years of commercialization
  • Royalties equaling 25% of net sales
  • Ocugen to manufacture and supply OCU400

MALVERN, Pa., June 05, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a licensing agreement with a well-established leader in the pharmaceutical and healthcare sector in Korea, for exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).

Pursuant to the term sheet, under the license agreement Ocugen will receive upfront license fees and near-term development milestones equaling up to $11 million. The Company will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea in addition to a royalty of 25% on net sales of OCU400 generated by Ocugen’s partner. Additionally, Ocugen will manufacture commercial supply of OCU400 under terms of a supply agreement.

There are an estimated 15,000 individuals in the Republic of Korea with RP. OCU400 provides the opportunity for our partner to help thousands of patients and become a leader in gene therapy in Korea.

“This regional licensing agreement is aligned with our business development strategy to partner with well-established companies in their respective countries and regions—leveraging their networks and know-how to treat as many RP patients as possible,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating return for our shareholders.”

Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 60 days.

Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target Biologics License Application filing of mid-2026.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases 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 address significant unmet medical need for large patient populations through our gene-agnostic approach. 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 the terms of the definitive license and timing of a definitive agreement or if a definitive agreement will be executed at all or the anticipated benefits to Ocugen of the definitive license agreement, 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 a definitive agreement for the license will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that contemplated license agreement, if executed, will not lead to the current anticipated benefits to Ocugen, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study 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

Nutriband (NTRB) – 1Q26 Results Within Expectations

Posted on by slightbourne@noblecapitalmarkets.com


Monday, June 02, 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.

Net Loss of $1.4 Million Was Less Than We Expected. 1Q25 Nutriband reported a loss for 1Q26, ended April 30, 2025, of $1.4 million or $(0.12) per share. Product Sales were $0.67 million, slightly below the $0.7 million we had estimated. Importantly, the company made progress advancing its abuse-resistant AVERSA Fentanyl patch toward clinical testing. We expect future revenues to be driven by AVERSA Fentanyl and see the current product sales as a means to offset the cost of product development. Cash at the end of the quarter was $3.0 million.

Total Expenses Were Below Expectations. During the quarter, COGS were $0.4 million or 62% of sales, lower than the 70% we had expected and the 65% seen for FY2024. SG&A and R&D were both close to our estimates, with Total Expenses of $2.1 million lower than our estimate of $2.5 million. We had initially allowed for a stock offering during the quarter that would have increased the Weighted Average Shares Outstanding to 13.2 million, compared with the reported 11.1 million.


Get the Full Report

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

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

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

Superior Group of Companies (SGC) – An Investment Opportunity In Keeping With Its Name

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, May 29, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Initiating Coverage with Outperform rating and $16 price target. Our favorable rating is based on a company in sectors that should grow faster than the US economy, a seasoned, successful management team, a capable balance sheet positioned to support acquisition fueled growth, a history of return of capital to shareholders and a compelling stock valuation. 

Favorable industry trends. The company operates in three distinct sectors, healthcare apparel, branded products and call centers. Each segment has favorable, above-average organic growth characteristics, is profitable, and has compelling acquisition target opportunities for enhanced long-term revenue and cash flow growth.


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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. 

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.

Release – Zomedica Unveils Exclusive Fourth Friday at Four Webinar Series to Explore Cutting-Edge Veterinary Innovations

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZOMDF

Engaging Sessions to Highlight Game-Changing Technologies, Expert Insights, and Growth Opportunities in Animal Health Featuring Zomedica Products

ANN ARBOR, MI / ACCESS Newswire / May 19, 2025 / Zomedica Corp. (OTCQB:ZOMDF) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, today announced the launch of a new monthly webinar series designed to highlight its innovative product portfolio, introduce key personnel, showcase manufacturing capabilities, and educate investors and strategic partners on the company’s long-term growth strategy.

This exclusive webinar series scheduled for the fourth Friday of every month beginning May 23rd, offers a front-row seat to Zomedica’s game-changing technologies and strategic vision, providing veterinarians, investors, and industry leaders with an unparalleled opportunity to stay ahead of the curve in animal healthcare. Attendees will gain first-hand insights into cutting-edge advancements that are shaping the future of veterinary medicine while discovering how Zomedica is driving innovation, expanding its market presence, and delivering solutions that improve patient outcomes.

Each engaging session will dive deep into Zomedica’s groundbreaking technologies, including the:

  • PulseVet® Shock Wave system – A revolutionary, non-invasive therapy accelerating healing in musculoskeletal conditions, setting new standards in veterinary therapeutics.
  • Assisi Loop® and Calmer Canine products – Advanced tPEMF™ (Targeted Pulsed Electromagnetic Field) therapy devices that provide drug-free, highly effective pain and inflammation management, as well as the Calmer Canine therapy for behavioral separation anxiety.
  • TRUFORMA® Diagnostic Platform – A next-generation in-clinic system offering unique, precise, rapid diagnostic testing to support complex veterinary cases with unparalleled accuracy at the point of care.
  • TRUVIEW® Digital Cytology System: Best-in-class imaging and the only fully automated slide prep solution-ensuring consistent quality, telepathology-backed confidence, and a streamlined workflow for faster, more accurate diagnoses in veterinary medicine.
  • VETGuardian® No-Touch Monitoring System – A state-of-the-art, contact-free monitoring solution ensuring continuous remote tracking of vital signs for enhanced patient care.
  • VETIGEL® – An innovative, plant-based hemostatic gel designed for rapid and effective bleeding control, revolutionizing wound management in veterinary medicine.

“Zomedica’s monthly webinar series isn’t just about showcasing our products-it’s about building a community of forward-thinking professionals and investors dedicated to advancing animal healthcare,” said Larry Heaton, CEO of Zomedica. “Through these interactive sessions, we are offering an exclusive look at our industry-leading technologies, expert-driven discussions, and our commitment to driving growth and innovation in veterinary medicine.”

Designed to be interactive and insightful, each webinar will feature product demonstrations, in-depth discussions with industry experts, and Q&A opportunities with Zomedica’s leadership team. Investors and strategic partners will gain a deeper understanding of the company’s expanding market influence, robust R&D pipeline, and vision for sustainable revenue growth and shareholder value.

Webinar Registration & Details

Don’t miss this opportunity to connect with industry experts, discover groundbreaking technologies, and explore new possibilities in veterinary healthcare. The series is open to veterinary professionals, industry partners, investors, and all who are interested in improving the lives of our family pets.

To secure your spot in the upcoming sessions, click on the link below https://us02web.zoom.us/webinar/register/WN_lUpmJTicRliHUCVyz6JEbg or visit www.investors.zomedica.com.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW® digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. Zomedica grew revenue 8% in 2024 to $27 million and maintains a strong balance sheet with approximately $65 million in liquidity as of March 31, 2025. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements and our ability to realize upon our business plans and cost control efforts.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, including international efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to realize the anticipated growth opportunities from our acquisitions; uncertainty as to our ability to supply products in response to customer demand; supply chain risks associated with tariff changes;; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products and purchase of consumables following adoption of our capital equipment; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:

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

SOURCE: Zomedica Corp.

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.