Category: Healthcare

Tonix Pharmaceuticals (TNXP) – TNX-102 SL Receives FDA Approval As Expected

Posted on by slightbourne@noblecapitalmarkets.com


Monday, August 18, 2025

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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

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

Tonix Announced The Approval of TNX-102 SL. As we had anticipated, TNX-102 SL (Tonmya) has received approval for the treatment of fibromyalgia. A conference call is planned for 8:30 am on August 17. Further details on the marketing program and plans for product launch are expect to be discussed. First sales are expected by 4Q25.

TNX-102 SL Addresses Numerous Symptoms of Fibromyalgia. The NDA (New Drug Application) was based on two Phase 3 studies. The primary endpoint was a reduction in pain scores at 14 days compared with placebo. After three months about 30% of the patients had a clinically meaningful reduction in pain compared with placebo. The studies also met all six of the secondary endpoints with high levels of statistically significance.


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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. 

Unicycive Therapeutics (UNCY) – Actions Taken To Address Issues That Caused The CRL

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 15, 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.

Actions Taken To Correct Manufacturing Findings. Unicycive reported a 2Q25 loss of $6.4 million or $(0.52) per share, with cash on June 30, 2025 of $22.3 million. Based on our current estimates, we believe this is sufficient to fund operations through 2H25. On June 30, the company received a CRL (Complete Response Letter) following an FDA inspection that found deficiencies at a contract manufacturer’s facility. The findings stopped the labeling discussions required for completion of the NDA review. The company has shifted to one of its other manufacturers, and filed a request for a meeting with the FDA. 

A Request For A Type A Meeting Was Filed. Following the receipt of the CRL, Unicycive filed a request for a Type A meeting with the FDA. This type of meeting is held to discuss the issues that led to the CRL and how to correct them. These meetings are usually scheduled within 30 days of the request. After meeting is held the company will receive the meeting minutes with requirements for resubmission of the NDA application. Unicycive expects to announce an updated plan for OCL development during 3Q25.


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Cocrystal Pharma (COCP) – 2Q25 Reported With Norovirus and Influenza Product Updates

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 15, 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.

Antivirals Continue To Move Forward. Cocrystal reported 2Q25 loss of $2.1 million or $(0.20) per share. During 2Q, the company presented data from its CDI-988 Phase 1 study in norovirus. Separately, CDI-988 has demonstrated inhibition of multiple strains, including GII.17 and GII.4 that have caused norovirus outbreaks over the past 2 years. The Phase 2a human challenge study testing CC-42344 in influenza has been extended. CC-42344 has shown inhibition of several strains of avian influenza that have caused public health concerns. Cash on June 30, 2025 was $4.8 million.

Phase 1b Is Planned For CDI-988  In Norovirus. Data from a Phase 1 trial showing safety and efficacy of CDI-988 was presented in August. The data show that CDI-988 was safe and effective through a range of doses in a single-ascending (SAD) and multiple-ascending (MAD) dose cohorts. A Phase 1b study testing CDI-988 as both treatment and prophylaxis for norovirus is planned for later 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. 

The Oncology Institute, Inc. (TOI) – Patient Additions And Pharmacy Division Drive 2Q25 Revenues Above Expectations

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, August 14, 2025

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

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.

Revenues Were Driven By New Patients Under Contract. The Oncology Institute reported a loss for 2Q25 of $17.0 million or $(0.15) per share. Revenues of $119.8 million exceeded our estimate of $110.4 million. The company discussed newly active or pending contracts that will add covered lives during 2H25. It reiterated its guidance for Revenues, Gross Profit, Adjusted EBITDA, and Free Cash Flow. Cash on June 30, 2025 was $30.3 million.

Patient Services Were Close To Our Expectations. The Patient Services division reached $55.9 million. New payor contracts added patients during 1H25 that began generating revenues, although they have a period of higher cost during the transition to TOI management. We expect the patient mix to include more continuing patients during 2H25, improving margins while new contracts continue to drive growth.


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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. 

Tonix Pharmaceuticals (TNXP) – 2Q25 Reported As We Await The TNX-102 SL PDUFA Date Of August 15

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, August 13, 2025

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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

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

We Are On The Edge Of Our Seats Waiting For TNX-102 SL. Tonix reported a 2Q25 loss of $28.3 million or $(3.86) per share. Importantly, the PDUFA date for TNX-102 SL is August 15. This is the date when the FDA is required to answer the application for approval. We continue to expect TNX-102 SL to be approved this week. Cash on hand at the end of the quarter was $125.3 million.

TNX-102 SL Launch Is Planned For 4Q25. The company expects to have TNX-102 SL available during 4Q25, as we expected. It will be the first drug developed and approved for fibromyalgia, compared with the current therapies that were approved for other conditions then expanded into fibromyalgia. Importantly, TNX-102 SL met its primary endpoint of pain relief and all six secondary endpoints for relief of symptoms.


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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. 

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

Posted on by slightbourne@noblecapitalmarkets.com


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. 

DLH Holdings (DLHC) – Post Call Commentary

Posted on by slightbourne@noblecapitalmarkets.com


Monday, August 11, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

When, Not If. We continue to believe it is a matter of when, not if, DLH begins to capitalize on the large opportunity set for its mission critical skill set. Current disruptions in Federal government contracting will pass, and DLH’s capabilities, in areas such as digital transformation, cybersecurity, and addressing critical public health issues, align well with the government’s goals.

Still Accumulating. Mink Brook Asset Management continues to accumulate DLHC shares, including 5,900 shares at the end of last week. Mink Brook now owns 2,389,350 DLHC shares, representing 16.6% of the outstanding common, up from 2,164,058 shares at the end of May.


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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. 

GoHealth (GOCO) – Forecast Trimmed, Flexibility Restored

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 08, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

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

Hits headwinds in Q2. GoHealth reported Q2 revenue of $94.0 million, below our $110.0 million forecast, as Medicare Advantage softness and CMS policy shifts weighed on volumes. Revenue declined 11% year-over-year. Despite the top-line miss, adj. EBITDA loss of $11.3 million beat our expected loss of $13.2 million, reflecting ongoing cost discipline and benefits from automation initiatives underway in agent workflows.

Recapitalization improves liquidity, alleviates covenant concerns. The company secured $80 million in new term loans and amended its credit agreement to eliminate principal payments through 2026. Liquidity covenants were reduced to a single minimum cash test. While the 4.77 million Class A shares issued represent roughly 20% dilution, we believe the transaction aligns lender and shareholder incentives and resolves the going concern issue.


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

Release – SelectQuote to Release Fiscal Fourth Quarter and Full Year 2025 Earnings on August 21

Posted on by aweinsoff@channelchek.com

Research News and Market Data on SLQT

08/07/202

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its fourth quarter and full year 2025 financial results before market open on Thursday, August 21, 2025. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (August 21, 2025) at 8:30 am ET to discuss the results.

To register for this conference call, please use this link: https://registrations.events/direct/Q4I547808.

After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.

About SelectQuote:

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

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

Investor Relations:
Sloan Bohlen
877-678-4083
investorrelations@selectquote.com

Media:
Matt Gunter
913-286-4931
matt.gunter@selectquote.com

Source: SelectQuote, Inc.

DLH Holdings (DLHC) – First Look – 3Q25 Results

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, August 07, 2025

DLH delivers improved health and readiness solutions for federal programs through research, development, and innovative care processes. The Company’s experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,300 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to public health to improve the lives of millions. For more information, visit www.DLHcorp.com.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

Making Progress. In the third quarter, DLH effectively navigated changes in the competitive landscape and transition in the industry overall, preserving margin delivery and strong operating cash flow. Headwinds such as the transition of CMOP locations, unbundling of DOD contracts, and scope reductions as a result of government efficiency efforts all impacted the quarter.

3Q25 Results. Revenue was $83.3 million, compared to $100.7 million in the year ago quarter. We had forecasted $83 million. DLH reported adjusted EBITDA of $8.1 million, down from $10 million in 3Q24 and our $8.5 million estimate. Net income was $0.3 million, or $0.02/sh, versus $1.1 million, or $0.08/sh last year. We had projected $0.35 million, or $0.02/sh.


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

Posted on by slightbourne@noblecapitalmarkets.com


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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*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. 

Cadrenal Therapeutics (CVKD) – Tecarfarin Clinical Trial To Begin With Modified Design

Posted on by slightbourne@noblecapitalmarkets.com


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.

Cadrenal Announces New Trial Design. Cadrenal announced that it plans to begin a trial testing tecarfarin in patients who are starting renal dialysis, both with and without atrial fibrillation (ESKD-Afib). This design reflects recent studies showing that the first several months after starting dialysis are an ultra-high risk period for mortality and cardiac events. The trial will test tecarfarin efficacy in reducing these events and could begin in late 2025 to early 2026.

Modified Study Design Focuses On Highest Risk Period. The initiation of renal dialysis impacts several important cardiovascular and renal functions. New studies show that the first six months after starting dialysis have a 20-fold increase in cardiovascular events and mortality. This has not previously been recognized due to pathologies of the underlying conditions that lead to CKD and dialysis. 


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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. 

Alcon to Acquire STAAR Surgical in $1.5 Billion Deal to Expand Vision Correction Portfolio

Posted on by slightbourne@noblecapitalmarkets.com

Alcon (NYSE: ALC), a global leader in eye care, has signed a definitive agreement to acquire STAAR Surgical Company (NASDAQ: STAA) in a cash transaction valued at approximately $1.5 billion. The acquisition is aimed at bolstering Alcon’s position in the surgical vision correction market, particularly in addressing the growing global demand for alternatives to LASIK.

The deal will see Alcon purchasing all outstanding shares of STAAR common stock at $28 per share, representing a 59% premium to STAAR’s 90-day volume-weighted average price and a 51% premium over its August 4 closing price.

STAAR Surgical is best known for its EVO family of Implantable Collamer Lenses (ICLs), which offer minimally invasive, reversible vision correction for patients with moderate to high myopia, including those with astigmatism. These lenses are implanted behind the iris and in front of the eye’s natural lens, offering a surgical option that avoids corneal tissue removal.

For Alcon, the acquisition is a strategic complement to its existing laser vision correction business. By incorporating STAAR’s EVO ICL technology, the company aims to provide a broader spectrum of refractive solutions for patients, especially those who are not ideal candidates for LASIK or other laser procedures.

The need for such alternatives is expanding rapidly. Global studies suggest that by 2050, half of the world’s population will be myopic, with approximately 500 million people falling into the high myopia category—a group that often requires advanced vision correction techniques.

Alcon expects the acquisition to be accretive to earnings by the second year post-closing. The company plans to finance the purchase through short- and long-term credit facilities and noted that the transaction is not subject to a financing condition.

STAAR has faced recent market challenges, including fluctuating demand in key international markets such as China. By joining Alcon, STAAR is expected to benefit from increased operational scale and broader global distribution, which could accelerate the adoption of its EVO ICLs.

The transaction has received unanimous approval from both companies’ boards of directors. It is expected to close within six to twelve months, pending customary closing conditions, including regulatory clearances and approval by STAAR shareholders.

Financial advisors on the deal include Morgan Stanley for Alcon and Citi for STAAR, while legal counsel was provided by Gibson, Dunn & Crutcher LLP and Wachtell, Lipton, Rosen & Katz, respectively.

As part of ongoing developments, STAAR is scheduled to release its Q2 2025 earnings on August 6, though it will not hold an investor conference call due to the pending acquisition.