Health-ISAC 2026 Report Details Rising Cyber Threats Across Health Sector




Health-ISAC 2026 Report Details Rising Cyber Threats Across Health Sector

Report highlights rising ransomware attacks, third-party vulnerabilities, and evolving social engineering tactics shaping health sector security

ORLANDO, Fla., Jan. 26, 2026 (GLOBE NEWSWIRE) — Health-ISAC today released its 2026 Global Health Sector Threat Landscape Report, providing a detailed analysis of the cyber and physical threats affecting health organizations worldwide. The report underscores a continued surge in ransomware activity, growing exploitation of third-party suppliers, and the emergence of sophisticated social engineering tactics designed to bypass traditional security controls – threatening operational continuity and patient care.

The report identifies ransomware as the most persistent and damaging threat to the health sector in 2025. Health-ISAC tracked 455 ransomware incidents globally targeting health organizations, underscoring the ongoing business and clinical impact of profit-driven cybercriminals. Ransomware groups, including Qilin, INC Ransom, and SAFEPAY, were among the most active in targeting health entities.

“The Health sector has become one of the most targeted sectors in the world, not because it’s the easiest, but because the consequences of disruption are so severe,” said Errol Weiss, Chief Security Officer (CSO) at Health-ISAC. “This report is a clear warning: cyber threats are no longer isolated events. They represent life-saving business continuity crises that can impact patient care, staff safety, and public trust.”

Beyond ransomware, the report emphasizes the growing role of supply chain and third-party compromise, as adversaries increasingly target vendors to gain access at scale. The findings reinforce a critical reality: even organizations with strong internal security may remain vulnerable through a partner, platform, managed service provider, or widely used software solution.

The report also highlights the latest tactics in deception-based attacks, including QR code phishing (“quishing”) and new social engineering techniques such as ClickFix and FileFix, which exploit human behavior to deliver malware and reduce the effectiveness of traditional security awareness strategies.

In addition, Health-ISAC included findings from a member survey of nearly 250 health executives and cybersecurity professionals, who ranked ransomware, phishing, third-party compromise, and exploitation of newly discovered software flaws among the top risks facing the sector. Respondents also cited growing concern around AI-enabled tactics heading into 2026.

To read the full report, click here.

About Health-ISAC
Health-ISAC (Health Information Sharing and Analysis Center) is a non-profit, member-driven organization dedicated to protecting the global health sector from cyber and physical threats. Through real-time alerts, collaboration, and usable intelligence, Health-ISAC helps healthcare organizations improve security and resilience.

Media Inquiries: Mary Stratton, AVP of Marketing, contact@health-isac.org +1 321-593-1470

Purely Me Skin Tag Remover Product Information Updated as Consumer Interest in At-Home Skin Tag Solutions Grows in 2026




Purely Me Skin Tag Remover Product Information Updated as Consumer Interest in At-Home Skin Tag Solutions Grows in 2026

An informational overview examining category context, publicly available product disclosures, and what consumers often consider when researching non-prescription skin tag products

New York, NY, Jan. 26, 2026 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only. It is not medical advice. Skin concerns should be evaluated by a qualified healthcare professional. This content does not diagnose, treat, cure, or prevent any disease. If you purchase through links in this article, a commission may be earned at no additional cost to you.

As consumer interest in at-home skin tag solutions continues to grow heading into 2026, updated product disclosures for Purely Me Skin Tag Remover have recently been made publicly available. With more people researching non-prescription options online, detailed product information is now accessible for consumers seeking to make informed decisions about their skincare choices.

This article provides informational context about the skin tag remover category and summarizes what Purely Me has disclosed about its product. Readers can view the current Purely Me Skin Tag Remover offer (official Purely Me page) to access the company’s complete product disclosures directly. Nothing in this content should be interpreted as medical advice, an endorsement, or a product recommendation.

Why Consumers Are Researching Skin Tag Solutions

Skin tags are a common concern for many adults. These small, benign growths often appear on the neck, underarms, eyelids, and other areas where skin experiences friction. While generally harmless, many people explore options for addressing them for cosmetic reasons.

Online searches for skin tag remover and related terms have remained consistent as consumers look for information about what options exist. People often want to understand what products are available, how different approaches are positioned, and what factors might be worth considering before making any decisions.

What “At-Home Skin Tag Solutions” Typically Refers To

The phrase at-home skin tag solutions generally describes consumer products positioned as alternatives to in-office procedures. These products vary widely in their formulations, application methods, and how companies describe their intended use.

Some products in this category use topical serums or liquids. Others use devices, patches, or bands. The category includes both branded products sold directly to consumers and generic options found in retail stores. Non-prescription skin tag products exist across a broad price range, and companies position them differently based on their ingredients and intended application.

It’s worth noting that this category is distinct from medical evaluation and professional dermatological procedures. Consumers researching skin tag removal options often encounter both consumer product information and guidance suggesting consultation with healthcare providers.

Safety and Regulatory Context Consumers Often Encounter

When researching products in this category, consumers frequently encounter varying types of marketing language. Some companies make broad claims, while others focus on ingredient transparency and usage instructions.

Consumers are often advised to consult qualified healthcare professionals for proper diagnosis of any skin concern. Dermatologists and other medical providers can evaluate whether a growth is indeed a skin tag or something that requires different attention.

Marketing language can vary significantly by brand. Some companies provide detailed ingredient lists and usage guidance, while others offer less transparency. Consumers researching this category may find it helpful to note what specific information each company makes publicly available about their products.

What Purely Me Discloses About Its Product

According to its official product page, Purely Me Skin Tag Remover is positioned as a liquid serum designed for at-home use. The company states the product is manufactured in the United States and describes the formula as containing plant-based and mineral-based ingredients.

The company lists two primary ingredients in its product disclosures:

Sanguinaria Canadensis — According to the company, this is a perennial flowering plant native to eastern North America with historical use in traditional remedies.

Zincum Muriaticum — The company describes this as a mineral compound included in its disclosed ingredient list.

The company’s website provides information about the product format and how it is positioned for consumer use within the at-home skincare category. Readers interested in the full product disclosures can review the official page directly for the most current and complete information.

Purely Me states it offers a 60-day refund policy and provides customer service availability Monday through Saturday, 9am to 9pm EST. Readers interested in reviewing these disclosures firsthand can view the current Purely Me Skin Tag Remover offer (official Purely Me page) for complete details.

What Consumers Often Consider When Reviewing Information in This Category

When comparing publicly available information across brands in this space, consumers often look at several factors that have nothing to do with efficacy claims:

Ingredient transparency — Does the company clearly list what’s in the product and provide context about those ingredients?

Company-provided usage guidance — How clearly does the brand explain its intended use and application method?

Return and refund policies — What does the company disclose about its policies if a customer is unsatisfied?

Customer service accessibility — Does the company provide clear contact information and support availability?

Product format and packaging — Does the company explain what the consumer will receive and how the product is designed to be stored or used?

These are informational considerations, not performance evaluations. Each consumer must determine what factors matter most to their own decision-making process.

Where to Find Official Information

Consumers who want to review Purely Me’s complete product disclosures can access the company’s official website, where complete product disclosures and availability details are published.

Readers can view the current Purely Me Skin Tag Remover offer (official Purely Me page) for the latest product disclosures and availability.

About Purely Me

Purely Me is a skincare company that offers a topical serum positioned within the at-home skin tag solution category. According to the company, the product is manufactured in the United States using a formula that includes plant-based and mineral-based ingredients. Additional details about the company and its product line are available on its official website.

Email: care@purelymeskin.com

Customer Service Phone: (877) 762-8258

Disclaimer: This content is for informational purposes only and does not constitute medical advice. Skin concerns should always be evaluated by a qualified healthcare professional. This article does not diagnose, treat, cure, or prevent any disease.

Affiliate Disclosure: This content may contain affiliate links. If you purchase through links in this article, a commission may be earned at no additional cost to you. This does not influence the informational content provided.

Product and Pricing Disclaimer: Product availability, pricing, and promotional offers are determined solely by the manufacturer and may change without notice. Verify all details on the official product page before making any purchase decisions.

Publisher Responsibility Disclaimer: The publisher of this content is not the manufacturer of the product discussed and makes no independent claims about product performance. All product-specific information is attributed to publicly available company disclosures.

CONTACT: Email: care@purelymeskin.com
Customer Service Phone: (877) 762-8258

Quantum Brainwave Protocol Product Information Updated as Consumer Interest in Digital Audio Relaxation Programs Grows in 2026




Quantum Brainwave Protocol Product Information Updated as Consumer Interest in Digital Audio Relaxation Programs Grows in 2026

An informational overview examining category context, publicly available product disclosures, and what consumers often consider when researching digital audio relaxation programs

New York, NY, Jan. 26, 2026 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only. It is not medical advice. Wellness and relaxation concerns should be evaluated by a qualified healthcare professional. This content does not diagnose, treat, cure, or prevent any disease. If you purchase through links in this article, a commission may be earned at no additional cost to you.

As consumer interest in digital audio relaxation programs continues to grow heading into 2026, updated product disclosures for Quantum Brainwave Protocol have recently been made publicly available. With more people researching non-prescription relaxation and audio-based wellness programs online, detailed product information is now accessible for consumers seeking to make informed decisions about their wellness choices.

This article provides informational context about the digital audio wellness category and summarizes what Quantum Brainwave Protocol has disclosed about its product. Readers can view the current Quantum Brainwave Protocol offer (official Quantum Brainwave Protocol page) to access the company’s complete product disclosures directly. Nothing in this content should be interpreted as medical advice, an endorsement, or a product recommendation.

Why Consumers Are Researching Audio-Based Relaxation Solutions

Interest in audio-based relaxation and wellness tools has grown as more consumers look for non-pharmaceutical approaches that fit into their daily routines. Many people report feeling overwhelmed by modern stress and are actively researching what products are available that might align with their lifestyle without requiring medication or extensive time commitments.

Consumers searching in this space often want to understand what factors might be worth considering when evaluating different audio programs, including format, accessibility, pricing, and what companies disclose about their products. The variety of options available, from meditation apps to standalone audio downloads, means consumers benefit from understanding what distinguishes one product from another.

What “Digital Audio Relaxation Programs” Typically Refers To

The phrase “digital audio relaxation programs” generally refers to downloadable or streaming audio content designed for personal use. These products vary widely in format, with some offering guided meditations, others featuring ambient soundscapes, and others utilizing specific audio technologies such as binaural beats or isochronic tones.

Non-prescription audio wellness products are distinct from clinical treatments or medical devices. They are typically positioned as lifestyle tools rather than therapeutic interventions. Consumers interested in addressing specific health concerns are often advised to seek consultation with healthcare providers to determine what approaches may be appropriate for their individual circumstances.

The category includes products at various price points, from free apps to premium programs, with differences in production quality, included materials, and company support policies.

Safety and Regulatory Context Consumers Often Encounter

The digital audio wellness space is not regulated in the same manner as pharmaceuticals or medical devices. This means marketing language and product positioning can vary significantly from one company to another. Consumers researching these products often encounter a range of claims and descriptions that may be difficult to evaluate independently.

Consumers are often advised to consult qualified healthcare professionals for proper diagnosis of any wellness concern. Audio programs are generally considered lifestyle products, and companies in this space typically include disclaimers clarifying that their products are not intended to diagnose, treat, cure, or prevent any disease.

When researching any wellness product, consumers may find it helpful to review company disclosures, refund policies, and available customer support information before making a purchase decision.

What Quantum Brainwave Protocol Discloses About Its Product

According to its official product page, Quantum Brainwave Protocol is positioned as a digital audio program designed for daily use. The company describes the product as professionally produced audio content utilizing binaural beats and isochronic tones, which are established audio production techniques used across various relaxation products in the market.

The names of individual audio tracks reflect the company’s internal labeling and marketing terminology and are not intended to imply medical, psychological, or financial outcomes. The company states that the program includes three primary audio tracks:

“Wealth Frequency” (Track 1) — According to the company, this is a 7-minute audio track designed for morning listening.

“Deep Sleep Eraser” (Track 2) — The company describes this as a 20-minute audio track intended for evening use.

“Genius Focus” (Track 3) — The company positions this as a productivity-focused audio track.

The company also discloses that purchases include three digital bonuses: a printable journal workbook, a reference guide, and a quick-start user manual. All materials are delivered digitally with no physical shipping required.

Quantum Brainwave Protocol states it offers a 60-day refund policy and provides customer service via email at support@quantumbrainprotocol.com. Payment processing is handled through ClickBank, a third-party digital retailer. Readers interested in reviewing these disclosures firsthand can view the current Quantum Brainwave Protocol offer (official Quantum Brainwave Protocol page) for complete details.

What Consumers Often Consider When Reviewing Information in This Category

When comparing publicly available information across brands in this space, consumers often look at several factors that have nothing to do with efficacy claims:

Ingredient transparency — Does the company clearly list what’s in the product and provide context about those ingredients?

Company-provided usage guidance — How clearly does the brand explain its intended use and application method?

Return and refund policies — What does the company disclose about its policies if a customer is unsatisfied?

Customer service accessibility — Does the company provide clear contact information and support availability?

Product format and packaging — Does the company explain what the consumer will receive and how the product is designed to be stored or used?

These are informational considerations, not performance evaluations. Each consumer must determine what factors matter most to their own decision-making process.

Where to Find Official Information

Consumers who want to review Quantum Brainwave Protocol’s complete product disclosures can access the company’s official website, where complete product disclosures and availability details are published.

Readers can view the current Quantum Brainwave Protocol offer (official Quantum Brainwave Protocol page) for the latest product disclosures and availability.

About Quantum Brainwave Protocol

Quantum Brainwave Protocol is a digital wellness company that offers audio downloads positioned within the digital audio relaxation programs category. According to the company, the product is produced using binaural beats and isochronic tones and is delivered entirely in digital format. The current retail price is $37, with payment processing handled through ClickBank. Additional details about the company and its product are available on its official website.

Product Support: support@quantumbrainprotocol.com

Order Support (via ClickBank): https://www.clkbank.com/#!/

Phone: (US) +1 800-390-6035 | (International) +1 208-345-4245

Disclaimer: This content is for informational purposes only and does not constitute medical advice. Wellness and relaxation concerns should always be evaluated by a qualified healthcare professional. This article does not diagnose, treat, cure, or prevent any disease.

Affiliate Disclosure: This content may contain affiliate links. If you purchase through links in this article, a commission may be earned at no additional cost to you. This does not influence the informational content provided.

Product and Pricing Disclaimer: Product availability, pricing, and promotional offers are determined solely by the manufacturer and may change without notice. Verify all details on the official product page before making any purchase decisions.

Publisher Responsibility Disclaimer: The publisher of this content is not the manufacturer of the product discussed and makes no independent claims about product performance. All product-specific information is attributed to publicly available company disclosures.

CONTACT: Product Support: support@quantumbrainprotocol.com
Order Support (via ClickBank): https://www.clkbank.com/#!/
Phone: (US) +1 800-390-6035 | (International) +1 208-345-4245

DoseSpot’s pVerify Achieves Multiple 2025 Recognitions from Gartner Digital Markets’ Capterra, Software Advice and GetApp




DoseSpot’s pVerify Achieves Multiple 2025 Recognitions from Gartner Digital Markets’ Capterra, Software Advice and GetApp

BOSTON, Jan. 26, 2026 (GLOBE NEWSWIRE) — DoseSpot, which delivers best-in-class e-prescribing, insurance verification and revenue cycle management solutions for healthcare providers, announced today that its pVerify solution has received multiple 2025 recognitions from Capterra, Software Advice and GetApp – all part of Gartner Digital Markets.

pVerify, a DoseSpot solution, is a leading SaaS platform specializing in patient healthcare insurance eligibility and benefits verification. With flexible API access, SFTP batch processing, and a secure cloud portal, pVerify streamlines both front-end insurance verification and back-end claims and billing workflows.

By offering additional revenue cycle management (RCM) tools, such as Patient Estimator and Insurance Discovery, pVerify helps healthcare organizations increase efficiency, reduce denials, and optimize revenue, making insurance verification and RCM faster, easier, and more accurate.

pVerify received the following honors in 2025:

• Capterra Shortlist for Medical Billing
• Software Advice Frontrunner: Top Medical Billing Software, March 2025
• GetApp’s Category Leaders in Medical Billing

“These are powerful testaments to the consistent value and quality pVerify delivers to our users every single day,” said Josh Weiner, CEO at DoseSpot. “2025 has been remarkable, but we’re just getting started. Looking ahead, DoseSpot is dedicated to evolving and enhancing pVerify to meet customers’ changing needs. We’re thrilled about the opportunities on the horizon and look forward to continuing our journey of growth with our customers.”

Learn more about pVerify at https://pverify.com/.

About Gartner Digital Markets:

Gartner Digital Markets is the world’s largest platform for finding software and services. More than 100 million people visit Capterra, GetApp, Software Advice, and UpCity across over 70 localized sites every year to read objective research and verified customer reviews that help them confidently choose the right software and services. Thousands of B2B companies work with Gartner Digital Markets to build their brand, capture buyer demand, and grow their business.

For more information, visit https://www.gartner.com/en/digital-markets.

About DoseSpot

DoseSpot delivers best-in-class e-prescribing, insurance verification and revenue cycle management solutions for healthcare providers, improving price transparency and outcomes for patients and reducing clinician and staff burnout. The company’s comprehensive solutions strengthen connections among patients, prescribers, payers, pharmacies and health technology vendors – whether it’s getting prescriptions into the hands of patients at a price they can afford or providing visibility into a patient’s benefit plan. Hundreds of thousands of providers, health plans, pharmacies and health technology partners rely on DoseSpot and its subsidiary pVerify to facilitate tens of millions of healthcare transactions each year. Visit http://dosespot.com and https://www.pverify.com.

Disclaimer:

The Gartner Digital Markets badges from Capterra, GetApp, and Software Advice are trademarks and service marks of Gartner, Inc. and/or its affiliates are used herein with permission. All rights reserved. Gartner Digital Markets badges constitute the subjective opinions of individual end-user reviews, ratings, and data applied against a documented methodology; they neither represent the views of, nor constitute an endorsement by, Gartner, Inc. or its affiliates.

Media contact:
Michelle Faulkner
Big Swing PR
617-510-6998
michelle@big-swing.com

Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)




Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)

• ELPIS II top-line trial results are anticipated in the third quarter of 2026
• Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated if ELPIS II results are positive
• U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation
• Laromestrocel HLHS program has the potential to address an unmet medical need with significant U.S. market opportunities
• Even with current standard of care surgeries, only 50% of infants survive to adolescence due to right ventricular failure

MIAMI, Jan. 26, 2026 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout of ELPIS II, the pivotal Phase 2 clinical trial evaluating the Company’s proprietary stem cell therapy, laromestrocel (LOMECEL-B®), as a potential treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints and statistical analysis plan (SAP) to support a Biologics Licensing Application (BLA).

The Company expects to provide a regulatory update after the receipt of the official meeting minutes.

ELPIS II is a Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy for HLHS. The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).

About Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, infants born with this condition have severely diminished systemic blood flow, which requires them to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. Although surgical advances have enabled survival into adulthood for some patients, early mortality remains substantial in this population, due to right ventricular failure. As such, there remains an important unmet medical need to improve right ventricular function in these patients in order to support both short-term and long-term outcomes.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program – Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program – Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com

LB Pharmaceuticals Initiates Phase 2 ILLUMINATE-1 Trial in Bipolar Depression, Expanding LB-102 Development Program




LB Pharmaceuticals Initiates Phase 2 ILLUMINATE-1 Trial in Bipolar Depression, Expanding LB-102 Development Program

Topline data expected in 1Q 2028

Phase 2 bipolar depression trial initiation follows positive Phase 2 results in acute schizophrenia

NEW YORK, Jan. 26, 2026 (GLOBE NEWSWIRE) — LB Pharmaceuticals Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases, today announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. LB-102, a novel, once-daily, oral investigational small molecule, is a potent and selective antagonist of D2, D3, and 5HT7 receptors that is being advanced as a potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders.

“Our year is off to a strong start and the initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders,” said Heather Turner, Chief Executive Officer of LB Pharmaceuticals. “We believe the compelling results from our Phase 2 trial in acute schizophrenia, the heritage of clinical and real-word experience with amisulpride in the treatment of mood disorders, and our innovative fixed-flexible dose trial design can significantly derisk this program. We look forward to a number of late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, as well as from our planned Phase 3 trial in schizophrenia which remains on track to initiate this quarter with results expected in the second half of 2027.”

Anna Eramo, Chief Medical Officer of LB Pharmaceuticals added, “We believe LB-102’s pharmacologic profile, including selective D2, D3, and 5HT7 receptor antagonism and favorable tolerability observed in prior clinical trials, aligns well with the critical unmet needs in bipolar depression. Significant opportunity exists for new therapies that can offer early onset of effect, reduced side effects such as sedation and EPS (including akathisia), and improvement in anhedonia and cognitive deficits, all of which can impact a patient’s ability to function.”

Phase 2 Bipolar Depression ILLUMINATE-1 Trial Design

The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled trial with fixed- and flexible-doses and is designed to evaluate the efficacy and safety of two doses (25 mg and 50 mg given once daily) of LB-102 for the treatment of bipolar depression. The two-arm, six-week, outpatient trial is expected to enroll approximately 320 patients with bipolar 1 depression at approximately 30 sites in the U.S. Patients will be randomized 1:1 to receive either LB-102 or placebo. The primary endpoint is the Montgomery–Åsberg Depression Rating Scale (MADRS)-10 at week six. The primary statistical analysis will compare results from all patients receiving LB-102, regardless of dose, with placebo. Secondary endpoints include MADRS-6, and CGI-BP, cognition, and anhedonia, as well as safety and tolerability. Topline results from the trial are anticipated in the first quarter of 2028.

About LB-102

LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the U.S. for the treatment of neuropsychiatric disorders. A methylated derivative of amisulpride, a widely used antipsychotics outside the U.S., LB-102 was developed to retain amisulpride’s benefits while addressing its limitations. LB-102 is a potent and selective antagonist of D2, D3, and 5HT7 receptors with few off-target effects and broad therapeutic potential across psychosis and mood disorders. In early 2025, LB Pharmaceuticals announced positive data from a four-week placebo-controlled, double-blinded, Phase 2 trial in patients with acute schizophrenia. In this trial, LB-102 demonstrated statistically significant benefit versus placebo at all doses studied, including rapid and sustained benefit, a potentially class-leading safety profile with low rates of EPS (including akathisia), minimal sedation and few GI side effects, alongside robust effects on cognition and negative symptoms. These data underscore LB‑102’s potential to address multiple dimensions of neuropsychiatric illness. LB-102 is advancing into a Phase 3 clinical trial for schizophrenia and a Phase 2 clinical trial for bipolar depression has been initiated. Additional expansion opportunities for LB-102 include major depressive disorder, predominantly negative symptoms of schizophrenia, Alzheimer’s disease psychosis and agitation, as well as other neuropsychiatric diseases.

About Bipolar Depression

Bipolar disorder is a chronic, debilitating mood disorder in which patients alternate between manic and depressive states. There are approximately 7 million patients in the U.S. and 40 million patients worldwide suffering from bipolar disorder. Antipsychotic medications, with or without mood stabilizers, are a mainstay of therapy for bipolar depression due to their ability to control depressive symptoms while preventing the emergence of mania. Despite the availability of several branded and generic therapeutics, significant unmet needs remain including faster onset without dose titration, lower rates of adverse events (including extrapyramidal symptoms, sedation, and GI side effects), efficacy against residual symptoms (including anhedonia and cognitive deficits), as well as improved medication adherence. Approximately 60% of patients with bipolar depression experience cognitive impairment and loss of interest/enjoyment (anhedonia) despite treatment, as well as high rates of adverse events, which together contribute to high rates of medication discontinuation and increased risk of relapse.

About LB Pharmaceuticals

LB Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. The Company is building a pipeline that leverages the broad therapeutic potential of its lead product candidate, LB-102, which the Company believes has the potential to be the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States. LB-102, if approved, has the potential to become a mainstay of psychiatric practice by offering a balanced clinical activity and tolerability profile that provides a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” or similar expressions are intended to identify forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the expected timing of clinical data readouts for the Company’s Phase 2 ILLUMINATE-1 trial in bipolar depression and Phase 3 trial in acute schizophrenia, planned trial design of the Phase 2 ILLUMINATE-1 trial, clinical development and regulatory pathway and therapeutic benefits of LB-102 and continuing advancement of LB-102 and the Company’s portfolio. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the Company’s limited operating history and historical losses; the Company’s ability to raise additional funding to complete the development and any commercialization of LB-102; the Company’s dependence on the success of its lead product candidate, LB-102; the Company’s ability to obtain regulatory approval of and successfully commercialize its product candidate; the early stages of clinical development of the Company’s lead product candidate, LB-102; any undesirable side effects or other properties of the Company’s product candidate; that the Company may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; the Company’s ability to obtain, maintain and protect its intellectual property; and the Company’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies.

These and other risks are described more fully in the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and its other documents to be subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media and Investor Contact: 
Ellen Rose
erose@lbpharma.us

Arcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa




Arcutis Biotherapeutics, Inc. Announces Termination of Promotion Agreement with Kowa

WESTLAKE VILLAGE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that on January 23, 2026, the Company and Kowa Pharmaceuticals America, Inc. mutually agreed to terminate their promotion agreement. The agreement covered sales and promotion of ZORYVE^® (roflumilast) by Kowa to primary care physicians and pediatricians in the United States.

Following the termination, Arcutis plans to assume responsibility for sales and promotion of ZORYVE in the pediatric and primary care settings. The Company is finalizing its plans for promotion to these clinicians and will provide further updates during the Q4 earnings call on February 25, 2026. This initiative is distinct from and in addition to the targeted expansion of the Company’s dermatology salesforce, which will remain focused on serving dermatology clinicians and growing prescriptions of ZORYVE in dermatology practices.

“Our promotion agreement with Kowa has laid important groundwork for the promotion of ZORYVE in the primary care and pediatric markets,” said Frank Watanabe, president and CEO of Arcutis. “As a once-daily topical that can be used anywhere on the body and for any duration, ZORYVE has the potential to simplify disease management across three major inflammatory skin diseases. In 2026, we are well-positioned to drive adoption and growth of ZORYVE in the primary care market through incremental investments that we will scale over time, while maximizing the growth of ZORYVE in dermatology.”

Under the terms of the Termination Agreement, Kowa will cease all sales and promotions of ZORYVE and Arcutis will not be required to make any further payments. The Company expects to remain cash flow break even and does not expect this change to negatively affect 2026 net product sales guidance.

INDICATIONS
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

ZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal use.

Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam.

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding Arcutis’ plans to promote ZORYVE and further penetrate the primary care and pediatric segments, as well as expectations regarding the adoption, growth, and commercial success of ZORYVE. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

Leios Therapeutics and BNC Korea Announce Strategic Collaboration to Accelerate Development of 10XB-101 in South Korea




Leios Therapeutics and BNC Korea Announce Strategic Collaboration to Accelerate Development of 10XB-101 in South Korea

10XB-101 Being Developed for Focal Fat Reduction and Body Contouring

LA JOLLA, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) — Leios Therapeutics, a clinical-stage biotechnology company focused on innovative aesthetic therapies, today announced the execution of a licensing agreement for 10XB-101, its investigational product for focal fat reduction and body contouring, along with a strategic equity investment by BNC Korea (KOSDAQ:256840), a leading healthcare and aesthetics-focused company in South Korea.

“We are delighted to enter this strategic partnership with BNC Korea for 10XB-101, marking a significant milestone for Leios Therapeutics,” said Ted White, Chief Executive Officer of Leios Therapeutics. “BNC Korea’s leadership in the aesthetics market, deep regional expertise, and outstanding commercialization capabilities make them an ideal partner to help bring 10XB-101 to market. The strategic investment further validates the potential of our pipeline, strengthens our balance sheet and supports the advancement of our clinical development program and long-term growth strategy.”

Choi Wan-gyo, CEO of BNC Korea added, “We are pleased to partner with Leios Therapeutics on 10XB-101, a promising candidate in the rapidly expanding body contouring market, which demonstrated compelling results in the Phase 2b study, with 64% and 70%% of completers in higher dose groups (3.0% and 4.5%) achieving grade 2 or greater improvement in both clinician and patient submental fat scales (CSFS and PSFS) compared to 0% on placebo, as part of the patient reported outcome assessment. Importantly, a pristine safety profile of 10XB-101 was observed. We believe this product has the potential to address unmet needs in focal fat treatment, and we look forward to working closely with the Leios team to advance development and commercialization in our region.”

Under the terms of the agreement, Leios Therapeutics has granted BNC Korea the rights to develop and commercialize 10XB-101 in the following territories; South Korea, Taiwan, Singapore, Indonesia, Thailand, Vietnam, Russia, Belarus, and Kazakhstan.

Vault Advisors acted as the exclusive financial advisor to Leios Therapeutics in the transaction.

About 10XB-101

10XB-101 is being developed as a best-in-class minimally invasive injectable treatment designed to reduce focal fat deposits and enhance body contouring outcomes. Leios has completed Phase 2 trials in submental fat reduction indication.

About Leios Therapeutics

Leios Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative therapies for aesthetic indications. The company’s mission is to deliver scientifically differentiated products that offer meaningful benefits to patients, healthcare providers and partners.

For more information, please visit www.leiostherapeutics.com.

About BNC Korea

BNC Korea (KOSDAQ: 256840), founded in 2007 and based in Daegu, South Korea, is a manufacturer of dermal fillers, specializing in wrinkle improvement fillers and adhesion prevention products. The company researches and develops strategic application products that will lead the next-generation bio markets for medical devices, pharmaceuticals and cosmeceutical products containing physiologically active substances by processing biomaterials such as hyaluronic acid and collagen. 

For more information, visit www.bnckorea.co.kr.

Media Contact:
Kevin Gardner
kgardner@lifesciadvisors.com

CONTACT: 617-283- 2856

Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)




Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST)

–   Cogent will submit the PEAK New Drug Application (NDA) under previously announced RTOR designation; on track to complete NDA submission in April 2026

WALTHAM, Mass. and BOULDER, Colo., Jan. 26, 2026 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. 

“We are excited to announce this Breakthrough Therapy Designation which recognizes the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We look forward to the continued collaboration with the FDA as we work to bring the first new treatment option in over twenty years to this patient population.”

This Breakthrough Therapy Designation is based on results from the PEAK trial which demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. The combination was well tolerated, and no new safety risks were observed when compared to the known safety profile of sunitinib. Breakthrough Therapy Designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown clinical evidence indicating the potential for substantial improvement over available therapies.

Earlier this month, the FDA agreed to accept Cogent’s NDA under the FDA’s Real-Time Oncology Review (RTOR) program which allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, in mid-2026 Cogent expects to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2/3, ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

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 company’s plans to submit its PEAK NDA under RTOR and to complete the NDA submission in April 2026; the potential for the bezuclastinib combination to substantially improve upon the currently available treatment options for patients with imatinib-resistant GIST; the anticipated benefits of FDA’s RTOR and Breakthrough Therapy Designation; plans to present the full results from the PEAK trial at a major medical meeting during the first half of 2026 and the expectation to initiate in mid-2026 a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Contact:

Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653

Primmune Therapeutics Announces Additional Close of Series B Financing




Primmune Therapeutics Announces Additional Close of Series B Financing

SAN DIEGO, Jan. 26, 2026 (GLOBE NEWSWIRE) — Today, Primmune Therapeutics, a biotech company harnessing the power of the innate immune system, announced an additional close of its Series B financing round for a total of $8.6 million with participation from Bioqube Ventures, Oberland Capital and Samsara Biocapital. This close brings the total Series B raise to $23.3 million. These funds will be used to support the further clinical development of PRTX007, a novel orally administered, systemically acting, small molecule toll-like receptor 7 (TLR7) agonist as an immunotherapy for solid tumors.

With the latest close of the Series B financing, Primmune Therapeutics will initiate Study PRTX007-003, a Phase 2 neoadjuvant efficacy study using PRTX007 in combination with standard-of-care anti-PD-1 therapy in patients with Stage III resectable melanoma.

“This financing enables us to rapidly advance PRTX007 into a clearly defined proof-of-principle study with validated efficacy and safety endpoints, with the goal of establishing PRTX007 as a class-leading immunotherapy option for patients with solid tumors,” said Charlie McDermott, Chief Executive Officer and Director of Primmune Therapeutics. The study will be conducted entirely in Australia by Primmune Therapeutics Pty Ltd. in conjunction with Novotech acting as the in country clinical research organization.

About PRTX007 
PRTX007 is a novel orally administered, systemically acting, toll-like receptor 7 (TLR7) agonist designed in house at Primmune to functionally tune immune signaling toward an IRF7-driven poly-interferon response and away from the NF-KB-mediated pro-inflammatory cytokine signaling that has limited the utility of systemically acting TLR7, TLR7/8, and TLR8 agonists. PRTX007 has been administered to over 100 healthy human volunteers in two separate phase 1 clinical studies (Study PRTX007-001 and Study PRTX007-002). In these studies, PRTX007 drove the desired systemic IRF7 poly-IFN response without the undesired NF-KB pro-inflammatory response. PRTX007 was generally well-tolerated with no serious adverse events (SAEs).

About Primmune Therapeutics 
Primmune Therapeutics is a clinical-stage therapeutics company dedicated to the design and development of systemically acting, orally administered, novel small molecule, toll-like receptor 7 (TLR7) agonists as immunotherapies for the treatment of cancer and other diseases responsive to immunotherapy. For more information, please visit: www.primmunerx.com

Media Contact:
Cammy Duong
LifeSci Communications
cduong@lifescicomms.com