Ariceum Therapeutics Doses First Patient in SANTANA-225 Phase 1/2 Clinical Trial of 225Ac-SSO110 in Patients with Extensive-Stage Small Cell Lung Cancer or Merkel Cell Carcinoma




Ariceum Therapeutics Doses First Patient in SANTANA-225 Phase 1/2 Clinical Trial of 225Ac-SSO110 in Patients with Extensive-Stage Small Cell Lung Cancer or Merkel Cell Carcinoma

225Ac-SSO110 has received U.S. FDA Orphan Drug Designation

Initial safety data from SANTANA-225 in ES-SCLC and MCC expected in 2026

Potential to address a broad range of neuroendocrine cancers

BERLIN, Nov. 11, 2025 (GLOBE NEWSWIRE) — Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, today announced that the first patient has been dosed in the SANTANA-225 Phase 1/2 study of 225Ac-SSO110 for the treatment of extensive stage small cell lung cancer (ES-SCLC) and Merkle Cell Carcinoma (MCC). 225Ac-SSO110 is a potentially first- and best-in-class Actinium-225-labelled antagonist of the somatostatin type 2 receptor (SSTR2). SSTR2 is highly overexpressed in neuroendocrine tumors relative to healthy tissue, making it an ideal target for radioligand therapies (RLTs).

The SANTANA-225 clinical trial (NCT06939036) is a global, open-label Phase 1/2 study that will assess the safety, tolerability, preliminary efficacy, and recommended Phase 2 dose of 225Ac-SSO110 in patients with ES-SCLC treated with checkpoint inhibitors (CPI) in first-line maintenance therapy or MCC patients treated with CPI in first-line therapy. The trial is expected to enroll approximately 20 patients in the dose escalation phase of the study, followed by expansion cohorts. In February 2025, 225Ac-SSO110 received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of ES-SCLC.

“RLTs are redefining precision oncology by enabling targeted delivery of radiation directly to tumor cells while minimizing exposure to healthy tissue,” said Germo Gericke, MD, Chief Medical Officer of Ariceum Therapeutics. “225Ac-SSO110 is the first SSTR2 antagonist RLT in clinical development, designed to deliver higher doses of alpha radiation directly to patients’ tumors while maintaining a favorable safety profile for individuals with neuroendocrine cancers, including ES-SCLC and MCC. Dosing the first patient in the SANTANA-225 trial is a significant step for our lead program and an important milestone towards addressing urgent patient needs in these aggressive cancers. We expect to report initial safety data from the SANTANA-225 trial in 2026, which may support expansion into additional neuroendocrine tumor indications and further validate the differentiated mechanism of action of 225Ac-SSO110.”

ES-SCLC is a deadly and aggressive cancer that represents a significant unmet medical need due to the limited number of treatment options available to patients. Two-thirds of SCLC patients are diagnosed at an advanced stage where the disease has already metastasized, resulting in a poor prognosis and a 5-10% five-year survival rate. MCC is a rare and aggressive type of skin cancer with limited treatment options that also has low survival rates in patients who do not respond to first-line CPI therapy. Both ES-SCLC and MCC are neuroendocrine tumors that frequently express SSTR2, making them compelling initial indications for SSTR2-targeted therapy. 225Ac-SSO110 is the first SSTR2-targeting antagonist radiolabeled with Actinium-225 to undergo human trials in combination with CPI for these neuroendocrine tumor indications, addressing areas of high unmet need and laying the foundation for potential expansion to other SSTR2-expressing cancers.

About Ariceum Therapeutics
Ariceum Therapeutics is a clinical-stage oncology company dedicated to redefining the future of care through targeted radiotherapeutics for patients with aggressive and hard-to-treat cancers. The company’s lead program, 225Ac-SSO110, a novel antagonist of the somatostatin type 2 receptor (SSTR2) with best-in-class potential, is currently being investigated in the Phase 1/2 SANTANA-225 study as the first maintenance radiotherapy for extensive stage small cell lung cancer (ES-SCLC) and Merkel Cell Carcinoma (MCC) –two diseases with limited options and poor prognosis. Ariceum is also developing ATT001, a novel radiolabeled I-123 PARP inhibitor designed to deliver subcellular precision radiotherapy to aggressive solid tumors.

Headquartered in Berlin, Ariceum operates across Germany, Switzerland, Australia, the United Kingdom, and the United States. The company is supported by leading global life sciences investors, including EQT Life Sciences, HealthCap, Pureos Bioventures, Andera Partners, and Earlybird Venture Capital.

For further information, please visit www.ariceum-therapeutics.com and follow us on LinkedIn.

Investor Contact
Kevin Lui
Director, Investor Relations
kevin.lui@precisionaq.com

Media Contact
Genevieve Britton
Group Account Director, Public Relations
genevieve.britton@precisionaq.com

Vor Bio Announces Pricing of Public Offering of $100 Million of Common Stock




Vor Bio Announces Pricing of Public Offering of $100 Million of Common Stock

BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) — Vor Biopharma Inc. (Nasdaq: VOR), a clinical-stage biotechnology company dedicated to transforming the treatment of autoimmune diseases, today announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $10.00 per share. The gross proceeds from the offering are expected to be $100 million, before deducting the underwriting discounts and commissions and offering expenses. The offering is expected to close on or about November 12, 2025, subject to customary closing conditions. In addition, Vor Bio has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being sold by Vor Bio.

J.P. Morgan, Jefferies, Citigroup and TD Cowen are acting as joint book-running managers for the offering.

The shares of common stock described above are being offered by Vor Bio pursuant to a shelf registration statement filed by Vor Bio with the Securities and Exchange Commission (SEC) that was declared effective by the SEC on March 31, 2025. The offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to this offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or via telephone: (800) 831-9146; or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Vor Bio

Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide.

Forward Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. These statements may be identified by introductory words such as “anticipate,” “believe,” “expects,” “intends,” “may,” “plan,” “should,” “subject to,” “will,” “would” or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements include statements regarding the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the anticipated gross proceeds from the offering. For such statements, Vor Bio claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Vor Bio’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, and those factors disclosed in Vor Bio’s filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. These forward-looking statements represent Vor Bio’s judgment as of the time of this release. Vor Bio disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com 

Sarah Spencer
investors@vorbio.com 

Canadian Red Cross sending emergency medical clinic to Jamaica




Canadian Red Cross sending emergency medical clinic to Jamaica

Humanitarian experts deploying to help people impacted by Hurricane Melissa

OTTAWA, Ontario, Nov. 10, 2025 (GLOBE NEWSWIRE) — In response to the devastating impact of Hurricane Melissa across the Caribbean region, the Canadian Red Cross, in collaboration with the International Federation of Red Cross and Red Crescent Societies (IFRC) and the Jamaica Red Cross, is deploying an emergency medical clinic to help people impacted by the disaster.

With support from donors and the Government of Canada, a multidisciplinary team of Canadian Red Cross humanitarian experts are leaving for Jamaica, with equipment to follow, to assist with the response. Their efforts complement and strengthen the work of the Jamaica Red Cross, who were already on the ground when Category 5 Hurricane Melissa struck and continue to deliver critical assistance.

Quick Facts: 

• Canadian Red Cross emergency medical clinic deploying to Jamaica, with support from the Government of Canada and Canadian donors.
• Deploying seven humanitarian experts to assist alongside Jamaica Red Cross and the IFRC. The team will provide vital operational leadership and health expertise, including outreach services to communities severely impacted by the hurricane, medical supplies and medication, mental health and psychosocial support materials, and operations management.
• Sent more than 24,000 emergency relief items to help people in Jamaica, such as hygiene kits, shelter toolkits, and mosquito nets, with support from the Government of Canada.
• Supported response efforts in Haiti to help people with shelter, water, sanitation, and hygiene.
• Pharmaceutical kits, including medical supplies and medication, being provided to help people in Cuba.

Quote:
“The Red Cross is working tirelessly to help people affected by the devastation caused by Hurricane Melissa. The Canadian Red Cross is working alongside the Jamaica Red Cross and our international partners to deliver urgent care, comfort, and vital supplies. With support from the Government of Canada and the generosity of donors, we are deploying an emergency medical clinic and a team of humanitarian experts to provide life-saving assistance to those who need it most.”

— Conrad Sauvé, president and CEO, Canadian Red Cross

Those who would like to help people in the Caribbean impacted by Hurricane Melissa are encouraged to donate to the Hurricane Melissa Appeal online at redcross.ca or by calling 1-800-418-1111.

Additional Resources
@redcrosscanada.bsky.social | facebook.com/CanadianRedCross | redcross.ca/blog  
Red Cross donor inquiries: WeCare@redcross.ca or 1-800-418-1111

About the Canadian Red Cross
Here in Canada and overseas, the Red Cross stands ready to help people before, during and after a disaster. As a member of the International Red Cross and Red Crescent Movement – which is made up of the International Federation of Red Cross and Red Crescent Societies, the International Committee of the Red Cross and 191 national Red Cross and Red Crescent societies – the Canadian Red Cross is dedicated to helping people and communities in Canada and around the world in times of need and supporting them in strengthening their resilience.

MEDIA CONTACTS
English Media: 1-877-599-9602 media@redcross.ca  
French Media: 1-888-418-9111 communication@croixrouge.ca

Rezolute Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)




Rezolute Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

REDWOOD CITY, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) — Rezolute, Inc. (NASDAQ: RZLT), (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced that it has granted as of October 31, 2025 equity inducement awards to two new employees. The equity awards were approved by the Compensation Committee of the Company’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) and were made as a material inducement to the employees’ acceptance of employment with Rezolute.

The Company granted options to purchase 245,000 shares, in the aggregate, of Rezolute common stock to the new employees. The options have a 10-year term and an exercise price per share equal to $9.32, which was the closing price of the Company’s common stock on October 31, 2025. The options vest over four years, subject to the employees’ continued service through the applicable vesting dates.

Forward-Looking Statements

This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in the Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the SEC’s website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement.
  
Rezolute Contacts:

Christen Baglaneas
cbaglaneas@rezolutebio.com
508-272-6717

Carrie McKim
cmckim@rezolutebio.com
336-608-9706

MediPharm Labs Sets Date to Report Third Quarter 2025 Financial Results




MediPharm Labs Sets Date to Report Third Quarter 2025 Financial Results

TORONTO, Nov. 10, 2025 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQB: MEDIF) (FSE: MLZ) (“MediPharm”, “MediPharm Labs” or the “Company”) a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it will release its third quarter financial results for the three and nine months ended September 30^th, 2025, before markets open on Thursday, November 13^th, 2025.

MediPharm Labs executive management team will also host a conference call and webcast on Thursday, November 13^th, 2025 at 10:00 a.m. (Eastern time) to discuss the Company’s financial results.

Conference Call Dial in Details:

North America Toll-Free: (888) 330-2454

International Toll: +1 (240) 789-2714

Conference ID: 4921762

Participants are asked to dial in approximately 15 minutes before the start of the call.

Webcast:

A webcast will be available by visiting the following link here.

For those who are unable to participate on the live conference call or webcast, a replay will be available at https://www.medipharmlabs.com/investors approximately one day after completion of the call.

About MediPharm Labs 

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities for delivery of pure, trusted and precision-dosed cannabis products for its customers. MediPharm Labs develops, formulates, processes, packages and distributes cannabis and advanced cannabinoid-based products to domestic and international medical markets.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment License from Health Canada, becoming the only company in North America to hold a commercial-scale domestic Good Manufacturing Practices License for the extraction of multiple natural cannabinoids. This GMP license was the first step in the Company’s current foreign drug manufacturing site registration with the US FDA.

In 2023, MediPharm acquired VIVO Cannabis Inc. which expanded MediPharm’s reach to medical patients in Canada via Canna Farms medical ecommerce platform, and in Australia and Germany through Beacon Medical PTY and Beacon Medical GMBH. This acquisition also included Harvest Medical Clinics in Canada which provides medical cannabis patients with Physician consultations for medical cannabis education and prescriptions.

The Company carries out its operations in compliance with all applicable laws in the countries in which it operates.

Website: www.medipharmlabs.com

Cautionary Note Regarding Forward-Looking Information

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, statements regarding the release of MediPharm’s financial results and the future of MediPharm’s foreign drug manufacturing site registration. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm’s filings, available on the SEDAR+ website at www.sedarplus.ca. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

SOURCE MediPharm Labs Corp.

For further information, please contact: MediPharm Labs Investor Relations,
1 416.913.7425, investors@medipharmlabs.com

Burn Blend 2025 | Effective Weight Loss Supplement Read Benefits, Ingredients Lunch Burn Blend Canada & Australia




Burn Blend 2025 | Effective Weight Loss Supplement Read Benefits, Ingredients Lunch Burn Blend Canada & Australia

Burn Blend is a natural Weight Loss Supplement that combines nature’s most effective ingredients to support focus, endurance, and metabolism. Read BurnBlend consumer reports.

New York City, Nov. 10, 2025 (GLOBE NEWSWIRE) —

Introducing Burn Blend: 

[New York City, Nov. 11, 2025 — Burn Blend is redefining the way people approach energy and wellness. Designed for today’s busy lifestyles, Burn Blend combines nature’s most effective ingredients to support focus, endurance, and metabolism—without the crash or compromise.

Born from a simple idea—to create balance between energy and wellbeing—Burn Blend brings together science and sustainability in one powerful mix. Each serving is thoughtfully crafted to help users feel more alert, active, and in control of their day. Whether it’s powering through a workout, managing long hours at work, or finding motivation for everyday tasks, Burn Blend delivers clean, consistent energy that supports both body and mind.

Unlike traditional energy products packed with artificial additives, Burn Blend focuses on real ingredients and honest results. It’s not about quick fixes, but about lasting performance and better living. The brand stands for transparency, integrity, and a genuine passion for helping people feel their best.

Burn Blend invites everyone to experience a new approach to energy—one that fuels ambition while respecting health. With its launch, the company hopes to inspire a movement toward smarter choices and sustainable vitality.

For more information, visit [https:://newburnblend.com/]

What is Burn Blend?

BurnBlend is a carefully formulated dietary supplement designed to support natural energy, metabolism, and healthy weight management. It combines plant-based ingredients, vitamins, and adaptogens to create a balanced formula that works in harmony with the body, helping individuals feel energized, focused, and supported throughout the day.

Unlike quick-fix solutions, Burn Blend focuses on sustainable results. Its ingredients, such as green tea extract, L-carnitine, Garcinia Cambogia, and Rhodiola Rosea, are chosen for their potential to support fat metabolism, appetite control, and mental clarity. The supplement is intended to complement a healthy lifestyle rather than replace exercise or nutritious food.

Burn Blend is suitable for a wide range of users—from busy professionals seeking steady energy and focus, to fitness enthusiasts looking to enhance their performance, to anyone aiming for gradual, healthy weight management. Its formulation avoids harsh stimulants and artificial additives, prioritizing clean, natural support for overall well-being.

By addressing multiple aspects of wellness—including metabolism, energy, focus, and appetite—Burn Blend provides a comprehensive, clinically inspired approach to weight management. It empowers individuals to take control of their health while supporting their body’s natural processes.

Burn Blend is more than a supplement; it is a partner in promoting a balanced, active, and energized lifestyle.

Unlock Your Weight Loss Full Potential – Visit the Official Burn Blend Website

How Burn Blend Works: The Science Behind Natural Energy and Metabolic Balance

Burn Blend is changing the way people think about energy and wellness. Built on a foundation of natural science and smart nutrition, Burn Blend works by supporting the body’s natural metabolism, helping to convert stored fat into usable energy—without relying on harsh stimulants or artificial boosters.

The formula is designed to work in harmony with the body’s rhythm. Key plant-based ingredients help increase thermogenesis, the process through which the body generates heat to burn calories more efficiently. At the same time, adaptogenic herbs and clean antioxidants help reduce fatigue, balance energy levels, and support mental clarity throughout the day.

What makes BurnBlend different is its focus on sustainable energy rather than temporary bursts. By combining targeted nutrients with natural metabolism enhancers, Burn Blend Weight Loss Supplement helps users feel more focused, active, and refreshed from morning to night.

Every component in Burn Blend is carefully sourced, tested for purity, and blended with precision to ensure consistent results. The result is a clean, effective formula that supports a healthy lifestyle—helping users move, think, and feel better every day.

Ingredients in BurnBlend

Burn Blend is created with a thoughtful mix of natural, science-backed ingredients that work together to boost energy, support metabolism, and promote overall wellness. Each ingredient is carefully chosen for purity, balance, and effectiveness.

• Green Tea Extract: A natural source of antioxidants and mild caffeine that helps increase fat oxidation, boost alertness, and support steady energy throughout the day.
• L-Carnitine: An amino acid compound that helps the body convert stored fat into usable energy, supporting endurance and performance.
• Garcinia Cambogia: Known for its natural hydroxycitric acid (HCA) content, this tropical fruit extract helps manage appetite and reduce fat storage.
• Cayenne Pepper Extract: A natural thermogenic that gently raises body temperature, helping the body burn more calories and improve circulation.
• Green Coffee Bean Extract: Contains chlorogenic acids that may support healthy metabolism and help regulate energy release from carbohydrates.
• Chromium Picolinate: A trace mineral that helps maintain balanced blood sugar levels and supports healthy metabolism of fats and carbohydrates.
• Black Pepper Extract (BioPerine®): Enhances nutrient absorption, ensuring the body receives maximum benefit from every ingredient in Burn Blend.
• Rhodiola Rosea: An adaptogenic herb that helps the body adapt to stress, enhance focus, and maintain energy without jittery side effects.
• Vitamin B Complex: Essential for converting food into energy, supporting brain function, and reducing fatigue.

Together, these ingredients create a clean, effective blend that fuels energy naturally while supporting a balanced, healthy lifestyle. Burn Blend stands for transparency, quality, and genuine care for well-being—empowering every individual to feel their best, every day.

Burn Blend: Clinically-Inspired Weight Loss Support

Burn Blend is more than just an energy formula—it’s a carefully developed system designed to support healthy weight management through natural, science-based ingredients. Inspired by clinical research and nutritional science, Burn Blend focuses on the body’s own ability to burn fat, sustain energy, and maintain balance.

Each component in Burn Blend Weight Loss Supplement plays a specific role in helping users achieve their goals safely and effectively. The formula supports thermogenesis, the natural process where the body converts calories into heat, promoting a steady increase in calorie burning without overstimulation. Ingredients such as green tea extract and cayenne pepper help raise metabolic rate, while L-carnitine assists in transforming stored fat into energy the body can use.

Beyond metabolism, Burn Blend also supports appetite control and mental focus—two key areas that influence long-term success. Natural plant extracts like Garcinia Cambogia and Rhodiola Rosea help reduce cravings and improve mood, making it easier to stay on track with a balanced diet and active lifestyle.

Unlike quick-fix solutions, Burn Blend is built around sustainability and wellness. It avoids artificial additives, relying instead on clean, plant-based ingredients that work harmoniously with the body. Every batch is blended with care to deliver consistent quality, purity, and results you can trust.

Burn Blend’s clinically inspired approach isn’t just about weight loss—it’s about empowering individuals to feel stronger, more energized, and more confident in their everyday lives.

Burn Blend Benefits

Burn Blend is designed to support a healthy, active lifestyle by combining nature’s best ingredients with modern nutritional science. Each serving is thoughtfully formulated to help individuals feel more energetic, focused, and confident in their health journey. The benefits of Burn Blend go beyond weight management—it’s about creating lasting wellness and balance from within.

• Supports Natural Fat Burning: Burn Blend helps stimulate the body’s thermogenic process, encouraging the conversion of stored fat into usable energy. This promotes a gradual, sustainable approach to weight management without harsh stimulants.
• Boosts Energy and Endurance: With natural caffeine from green tea and plant-based extracts, Burn Blend delivers steady, clean energy that keeps you active and alert throughout the day—without crashes or jitters.
• Enhances Focus and Mental Clarity: Adaptogenic herbs like Rhodiola Rosea support cognitive function and stress resistance, helping you stay calm, focused, and motivated.
• Reduces Cravings and Supports Appetite Control: Ingredients such as Garcinia Cambogia and chromium picolinate help reduce hunger and maintain balanced blood sugar levels, making it easier to follow healthy eating habits.
• Improves Metabolic Efficiency: The carefully balanced formula helps optimize metabolism, ensuring that the body uses nutrients more effectively for fuel and recovery.
• Promotes Overall Well-Being: Packed with antioxidants and essential vitamins, Burn Blend supports cellular health, immune strength, and natural vitality.

Burn Blend isn’t a shortcut—it’s a smart, sustainable companion for anyone striving for better health, improved energy, and a more balanced lifestyle.

How to Use Burn Blend?

Using Burn Blend is simple, effective, and designed to fit easily into your daily routine. To get the best results, consistency and balance are key.

• Recommended Use: Take one serving of Burn Blend each day, preferably in the morning or before physical activity. This timing helps support your body’s natural energy cycle and promotes optimal fat-burning throughout the day.
• With Water or Smoothies: Mix Burn Blend with a full glass of water for a refreshing start to your morning. It can also be added to a smoothie or protein shake for extra flavor and nourishment.
• Stay Hydrated: Because Burn Blend supports metabolism and energy levels, it’s important to drink plenty of water during the day to stay hydrated and help your body perform at its best.
• Pair with a Healthy Lifestyle: For the most effective results, combine Burn Blend with regular exercise, balanced nutrition, and adequate rest. The formula is designed to complement—not replace—healthy habits.
• Consistency Matters: Daily use helps your body adjust to the blend’s natural ingredients, allowing the benefits to build gradually and sustainably.

Burn Blend is about creating small, steady changes that lead to long-term results. When used mindfully, it becomes more than a supplement—it becomes part of a healthier, more energized way of living.

Who Needs the Burn Blend Weight Loss Supplement?

Burn Blend is created for individuals who want to take a balanced, sustainable approach to managing their weight and improving their overall well-being. It’s not just for athletes or fitness enthusiasts—it’s for anyone who wants to feel more energized, focused, and confident in their daily life.

Burn Blend is ideal for:

• Busy Professionals: Those who struggle with low energy, irregular meals, or long working hours can benefit from Burn Blend’s steady energy support and metabolism-boosting properties.
• Fitness Lovers: Whether you’re starting a fitness journey or maintaining a regular routine, Burn Blend helps enhance endurance and supports recovery, making every workout more effective.
• Individuals Seeking Healthy Weight Management: If you’re looking to manage weight naturally without relying on harsh stimulants or crash diets, Burn Blend provides a cleaner, more balanced alternative.
• Anyone Facing Energy Slumps: Its blend of natural ingredients promotes consistent energy and focus throughout the day—helping to avoid mid-afternoon fatigue and sugar cravings.
• People Focused on Long-Term Wellness: Burn Blend supports not just physical goals, but mental clarity and emotional balance as well.

In short, Burn Blend Weight Loss Supplement is for anyone ready to take control of their health with a gentle, natural, and clinically inspired approach to energy and weight management.

Pricing, Packages & Official Website – Where to Buy Burn Blend Safely Online

Burn Blend is available exclusively through its official website, ensuring that every customer receives a genuine product backed by quality assurance and customer support. Purchasing directly from the official source guarantees that you are getting the authentic formula, safely stored, and delivered with care.

The company offers several package options to suit different needs and goals:

• Single Bottle Package: Ideal for first-time users who want to experience Burn Blend’s benefits before committing to a larger supply.
• Three-Bottle Package: A popular choice for consistent users looking to maintain steady results over a longer period.
• Six-Bottle Package: The best value option, recommended for those focused on achieving sustainable results and long-term wellness goals.

Each purchase is protected by a satisfaction guarantee and includes access to helpful usage guidance, nutritional tips, and customer care support.

To ensure safety and authenticity, customers are strongly advised not to purchase Burn Blend from third-party websites, marketplaces, or unverified sellers, as these may offer counterfeit or expired products.

For the latest pricing, special discounts, or bundle offers, visit the official Burn Blend website. directly from the source ensures quality, freshness, and reliable service—giving you confidence in every order.

Tips for Best Results with Burn Blend

To experience the full benefits of Burn Blend, consistency and balance are key. This supplement is designed to work alongside your lifestyle—not replace healthy habits. Here are a few simple tips to help you get the best results:

• Take It Consistently: Use Burn Blend daily as recommended. Regular use helps your body adjust to its natural ingredients, allowing the effects to build gradually for sustainable results.
• Pair with a Balanced Diet: Focus on whole foods, lean proteins, fruits, vegetables, and plenty of water. A nutrient-rich diet enhances the way Burn Blend supports metabolism and energy.
• Stay Active: Combine Burn Blend with light to moderate physical activity. Even small daily movements—like walking, stretching, or short workouts—help boost the body’s fat-burning potential.
• Stay Hydrated: Proper hydration supports digestion, energy, and the thermogenic effects of Burn Blend. Aim for at least 6–8 glasses of water daily.
• Get Enough Rest: Quality sleep helps balance hormones and supports recovery, ensuring your body performs at its best.
• Be Patient and Consistent: Burn Blend is designed for gradual, healthy progress. Small, steady improvements lead to lasting change.

By combining Burn Blend with mindful habits, you’ll build a foundation for long-term energy, balance, and confidence—helping you look and feel your best every day.

Visit The Official Burn Blend Website To Read Customer Reviews About Burn Blend!

Why Burn Blend Weight Loss Is an Emerging Trend in 2025

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Final Verdict: Burn Blend Weight Loss Supplement

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For more information, visit the official website

Company: Burn Blend

1201 N Orange Street, Suite #7223, Wilmington,

 DE, 19801, USA Wilmington

• Email: support@newburnblend.com
• Phone: +1 (727) 761-8803
• Advertise with us: Info@allprsolution.com

TOMI Environmental Solutions, Inc. to Hold Conference Call to Discuss Third Quarter 2025 Financial Results on November 14, 2025




TOMI Environmental Solutions, Inc. to Hold Conference Call to Discuss Third Quarter 2025 Financial Results on November 14, 2025

FREDERICK, Md., Nov. 10, 2025 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced it will report results for the third quarter ended September 30, 2025, after the close of the financial markets on Friday, November 14, 2025, and will hold a conference call at 4:30 p.m. ET that day.

To participate in the call by phone, dial (888) 506-0062 approximately five minutes prior to the scheduled start time and provide participant access code 690402, or request the “TOMI Environmental Solutions third quarter earnings call.” International callers please dial (973) 528-0011. To access the live webcast or view the press release, please visit the Investor Relations section of the TOMI website or register at the following link: https://www.webcaster5.com/Webcast/Page/2262/53230.

A replay of the teleconference will be available until Friday, November 28, 2025, and may be accessed by dialing (877) 481-4010. International callers may dial (919) 882-2331. Callers should use replay access code: 53230. A replay of the webcast will be available for at least 90 days on the company’s website, starting approximately one hour after the completion of the call.

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®  
TOMI™ Environmental Solutions, Inc. (NASDAQ: TOMZ ) is a global decontamination and infection prevention company, providing environmental solutions for disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology ® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI products are designed to service a broad spectrum of use sites, including, but not limited to, hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments.

For additional information, please visit www.steramist.com or contact us at info@tomimist.com

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements involve a number of risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control. As such, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors. Important factors that could affect our performance and cause results to differ materially from management’s expectations are described in the section entitled “Risk Factors,” in our Annual Report on Form 10-K and other SEC filings. These factors include: our history of losses that may prevent us from achieving profitability in the future; our lack of long-term customer contracts and our inability to rely on our sales history or backlog as an indicator of our future sales; that we are subject to a variety or risks associated with doing business internationally; our success in business depends on our ability to adequately protect our intellectual property; and that our stock price is volatile and there is a limited market for our shares. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:  
John Nesbett/Rosalyn Christian  
IMS Investor Relations  
tomi@imsinvestorrelations.com  

TG Therapeutics to Participate in the TD Cowen Immunology & Inflammation Summit




TG Therapeutics to Participate in the TD Cowen Immunology & Inflammation Summit

Fireside chat scheduled for Wednesday November 12, 2025 at 10:00 AM ET

NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the TD Cowen Immunology & Inflammation Summit, which is taking place virtually from November 12 – 13, 2025. The fireside chat is scheduled to take place on Wednesday, November 12, 2025, at 10:00 AM ET.

A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI^® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.

BRIUMVI^® is a registered trademark of TG Therapeutics, Inc.

CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations 
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6

Intellia Therapeutics Presents Positive Longer-Term Phase 1 Data of Nexiguran Ziclumeran (nex-z) in Patients with Transthyretin (ATTR) Amyloidosis with Cardiomyopathy




Intellia Therapeutics Presents Positive Longer-Term Phase 1 Data of Nexiguran Ziclumeran (nex-z) in Patients with Transthyretin (ATTR) Amyloidosis with Cardiomyopathy

• One-time treatment of nex-z led to consistently rapid, deep and durable reduction in serum TTR through three years of follow-up
• Consistent trend in disease stability or improvement in multiple measures of cardiomyopathy, regardless of NYHA Class, at 24 months compared to baseline
• Longer-term safety data consistent with previously reported Phase 1 data

CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced positive follow-up data from the ongoing Phase 1 clinical trial of its investigational product nexiguran ziclumeran (nex-z) in patients with transthyretin (ATTR) amyloidosis with cardiomyopathy. Results were shared today in a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans, Louisiana.

“These longer-term data showed a consistent and durable reduction in TTR and stability or improvement in multiple markers of cardiomyopathy following a single dose of nex-z,” said Intellia President and Chief Executive Officer John Leonard, M.D. “It’s remarkable that even in patients with advanced heart failure, a population that declines rapidly, disease stabilization or improvement was observed out to 24 months in a majority of participants. We look forward to seeing how these data mature in longer-term follow up. In addition, we are working diligently to address the ongoing clinical hold the FDA placed on our MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials.”

“ATTR amyloidosis is a progressive and fatal disease, often leaving patients with shortened lifespans and poor quality of life,” said Julian Gillmore, M.D., Ph.D., Professor of Medicine, National Amyloidosis Center, UCL Division of Medicine, Royal Free Hospital, U.K. “Today’s data support the potential benefit of nex-z and how persistently low levels of serum TTR may translate to improved outcomes and lowered rates of mortality.”

The Phase 1 clinical trial is an open-label, two-part trial evaluating the safety and efficacy of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). The trial enrolled 36 patients, a high proportion of whom had advanced disease at baseline (50% classified as New York Heart Association (NYHA) Class III and 31% with variant ATTR-CM). Data presented today were as of an August 23, 2025, data cut-off date.

Continuation of Deep and Durable Serum TTR Reduction in Phase 1
Across all patients, a one-time treatment of nex-z led to consistently rapid, deep and sustained serum TTR reduction, regardless of baseline levels, through the latest follow-up. All patients continued to show a sustained response with no evidence of a waning effect over time. Among the nine patients who reached 36 months of follow-up, the mean serum TTR reduction was 87% (mean absolute serum TTR level of 22.9 µg/mL [mean 95% CI, 16.0 to 29.8]), consistent with the overall cohort at month 24. Based on multiple studies in ATTR amyloidosis, low levels of serum TTR have been shown to lead to a meaningful clinical benefit.

Evidence of Stability or Improvement on Clinical and Biomarker Measures in Phase 1
Patients dosed with nex-z continued to show evidence of disease stabilization or improvement at month 24 compared to baseline. Evaluation was based on multiple markers of cardiomyopathy, including N-terminal pro-B-type natriuretic peptide (NT-proBNP), high sensitivity Troponin T (hs-Troponin T), 6-minute walk test (6MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ) and echocardiographic measures.

At 24 months, NT-proBNP and hs-Troponin T, which are markers known to be associated with disease progression, showed stability or improvement in 70% and 85% of patients, respectively. Preservation of functional status, as measured by 6MWT, was observed with 69% of patients either showing stability or improvement. Notably, 81% of patients were stable or improved in their NYHA classification at 24 months, including improvement in 83% of patients with NYHA Class III. There also was evidence of benefit in quality of life, regardless of NYHA Class at baseline as assessed by KCCQ. Assessment of cardiac structure with echocardiography showed a similar pattern of stability with limited progression of cardiac remodeling at 24 months.

Post-Hoc Mortality Assessment of Phase 1 Data
Additionally, findings from a mortality assessment were presented. This post-hoc analysis was conducted on a cohort of 1,792 ATTR-CM patients from the National Amyloidosis Center (NAC) whose baseline characteristics were matched to those of the Phase 1 nex-z population. The analysis showed patients receiving a one-time treatment with nex-z had an all-cause mortality rate of 3.9 per 100 patient-years, while the matched cohort had an all-cause mortality rate of 12.7 per 100 patient-years (HR 0.27, p=0.009).

Phase 1 Safety
Nex-z was generally well tolerated across all patients in the Phase 1 clinical trial. The most commonly reported treatment-related adverse events were infusion-related reactions (IRRs) and transaminase elevations. In this Phase 1 population, liver enzyme elevations did not exceed Grade 2. Through the long-term follow-up evaluation, including patients who reached 44 months, any event leading to death (n=4) was related to the progression of the patients’ underlying cardiovascular disease, consistent with what is expected for this patient population.

The AHA data presentation will be available on the Scientific Publications & Presentations section of intelliatx.com.

About nex-z
Based on Nobel Prize-winning CRISPR/Cas9 gene editing technology, nex-z has the potential to become the first one-time treatment for transthyretin (ATTR) amyloidosis with cardiomyopathy (ATTR-CM) and/or polyneuropathy (ATTRv-PN). Nex-z is designed to inactivate the TTR gene that encodes for the transthyretin (TTR) protein. Interim Phase 1 clinical data showed the administration of nex-z led to consistent, deep and long-lasting TTR reduction. This investigational product is being investigated in the ongoing MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials in ATTR-CM and ATTRv-PN, respectively, which are currently on clinical hold by the U.S. Food and Drug Administration (FDA). Further information about the clinical hold can be found here. Nex-z has received Orphan Drug and RMAT Designations from the FDA and an Orphan Drug Designation (ODD) from the European Commission. Intellia leads development and commercialization of nex-z as part of a multi-target discovery, development and commercialization collaboration with Regeneron Pharmaceuticals, Inc. 

About Transthyretin (ATTR) Amyloidosis
Transthyretin amyloidosis, or ATTR amyloidosis, is a rare, progressive and fatal disease. Hereditary ATTR (ATTRv) amyloidosis occurs when a person is born with mutations in the TTR gene, which causes the liver to produce structurally abnormal transthyretin (TTR) protein with a propensity to misfold. These damaged proteins build up as amyloid in the body, causing serious complications in multiple tissues, including the heart, nerves and digestive system. ATTRv amyloidosis predominantly manifests as polyneuropathy (ATTRv-PN), which can lead to nerve damage, or cardiomyopathy (ATTRv-CM), which can lead to heart failure. Some individuals without the genetic mutation produce non-mutated, or wild-type TTR proteins that become unstable over time, misfolding and aggregating in disease-causing amyloid deposits. This condition, called wild-type ATTR (ATTRwt) amyloidosis, primarily affects the heart. There are an estimated 50,000 people worldwide living with ATTRv amyloidosis and between 200,000 and 500,000 people with ATTRwt amyloidosis. There is no known cure for ATTR amyloidosis and currently available medications are limited to slowing accumulation of misfolded TTR protein.

About Intellia Therapeutics
Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. The company’s in vivo programs use CRISPR to enable precise editing of disease-causing genes directly inside the human body. Intellia’s ex vivo programs use CRISPR to engineer human cells outside the body for the treatment of cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at intelliatx.com and follow us @intelliatx.

Forward-Looking Statements
This press release contains “forward-looking statements” of Intellia Therapeutics, Inc. (“Intellia” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the safety, efficacy, success and advancement of its clinical programs for nexiguran ziclumeran or “nex-z” (f/k/a NTLA-2001), for transthyretin (“ATTR”) amyloidosis, including the ability to address the clinical hold that the United States Food and Drug Administration (“FDA”) placed on the investigational new drug (“IND”) applications for our global Phase 3 MAGNITUDE study for ATTR amyloidosis with cardiomyopathy (“ATTR-CM”) and our global Phase 3 MAGNITUDE-2 study for hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”), and to resume those clinical trials; and its belief that greater TTR reduction may lead to greater clinical benefit.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including nex-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including risks related to our ability to address the clinical hold that the FDA placed on the IND applications for the MAGNITUDE Phase 3 study for ATTR-CM and the MAGNITUDE-2 Phase 3 study for ATTRv-PN and to resume those clinical trials; the risk that any one or more of Intellia’s product candidates, including nex-z, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates; and risks related to Intellia’s reliance on collaborations, including that its collaboration with Regeneron will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Intellia’s most recent annual report on Form 10-K and quarterly form on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law.

Intellia Contacts:

Investors:
Jason Fredette
Vice President, Investor Relations and Corporate Communications
Intellia Therapeutics, Inc.
jason.fredette@intelliatx.com

Media:
Matt Crenson
Ten Bridge Communications
media@intelliatx.com
mcrenson@tenbridgecommunications.com

Idorsia’s aprocitentan improved key prognostic indicators in patients with difficult-to-control hypertension




Idorsia’s aprocitentan improved key prognostic indicators in patients with difficult-to-control hypertension

• New analysis from landmark Phase 3 PRECISION trial published in the Journal of Hypertension highlights aprocitentan led to improvements in dipping pattern and BP load

• Findings reinforce the role of aprocitentan’s novel endothelin pathway mechanism in addressing significant medical need in difficult-to-control hypertension

Allschwil, Switzerland – November 10, 2025
Idorsia Ltd (SIX: IDIA) announced the publication of a new analysis from the landmark Phase 3 PRECISION study in the Journal of Hypertension titled “Effects of aprocitentan on prognostically relevant ambulatory blood pressure-derived variables in resistant hypertension”¹. The analysis examined the changes in variables derived from ambulatory BP monitoring that are shown to drive better outcomes for patients at high risk of cardiovascular events.

Aprocitentan (TRYVIO™/JERAYGO™), the first approved antihypertensive targeting the endothelin pathway, substantially lowered 24-hour blood pressure (BP) in patients with confirmed resistant hypertension, with particularly pronounced effects at night. Night-time BP is a strong indicator of poor long-term outcome. The new analysis shows that aprocitentan on top of at least triple anti-hypertensive therapy improved multiple characteristics of resistant hypertension that are linked to poor clinical outcomes, including reducing blood pressure load and normalizing night-time “dipping” patterns, and is efficacious in patients with increased arterial stiffness and salt sensitivity.

Markus Schlaich, MD, FAHA, FESC, ISHF, The University of Western Australia / Royal Perth Hospital and an investigator in the PRECISION study commented:
“Aprocitentan resulted in substantial and sustained improvements in ambulatory BP parameters which are predictive of cardiovascular risk. As a result, aprocitentan is positioned as a promising option that could reduce cardiovascular events and improve long-term outcomes in patients with resistant hypertension.”

Michael A. Weber, MD, preventative cardiologist and hypertension specialist at Downstate College of Medicine of the State University of New York, commented:
“The availability of aprocitentan in routine clinical practice is a welcome and much needed addition to our armamentarium to effectively treat a broad range of patients with difficult-to-control hypertension. It has the added benefit of targeting the otherwise unopposed yet highly relevant endothelin mechanism in the pathogenesis of hypertension, potentially yielding therapeutic effects beyond BP lowering per se.”

John M. Flack, MD, MPH, Director, Hypertension Center, Southern Illinois University School of Medicine, commented: 
“This is an important analysis as it provides insight into the benefit of targeting the endothelin system with aprocitentan to address the needs of the many patients with difficult-to-control hypertension, without risks of hyperkalemia, known drug interactions or worsening renal function. This makes aprocitentan a unique and important treatment option for physicians who are struggling to maintain 24-hour blood pressure control in their patients, particularly at night.”

There are 1.4 billion people worldwide living with hypertension.² Hypertension remains a leading global health challenge and the number one modifiable risk factor for early morbidity and mortality. Despite advances in treatment, many patients still struggle with uncontrolled blood pressure, leaving them at significantly higher risk of heart attack, stroke, kidney failure, and premature death.³ In the US, approximately 50% of patients living with hypertension on multiple treatments do not have their blood pressure under control.⁴ Consistent 24-hour blood pressure control is an important clinical outcome in patients with difficult-to-control hypertension.^5-7 Multiple studies have demonstrated that 24-hour blood pressure is a more powerful predictor of cardiovascular events than a clinic-based measurement.^8-10 

Endothelin-1 (ET-1) is a potent vasoconstrictor that also induces neurohormonal activation, vascular hypertrophy and remodeling, cardiac hypertrophy and fibrosis, and endothelial dysfunction. In hypertension, both ET_A and ET_B receptors mediate harmful effects of ET-1.¹¹ As a vasoconstrictor, co-mitogenic agent, linking pulse pressure and vascular remodeling, and mediator of aldosterone and catecholamine release, endothelin is a key player in hypertension and end-organ damage.^12,13

About the analysis¹
The Phase 3 PRECISION study demonstrated both the safety and the efficacy of aprocitentan to lower office BP in patients with resistant hypertension. The post-hoc analysis evaluated the BP-lowering effects of aprocitentan on derivatives of ambulatory BP measurements (ABPM) – dipping pattern, BP load, heart rate, arterial stiffness, and salt sensitivity.

The analysis revealed that in addition to significant and sustained daytime and nighttime ambulatory BP reduction, aprocitentan was associated with:

• In patients classified as non-dippers – those who do not have the normal nighttime BP drop – aprocitentan treatment resulted in a higher proportion achieving normalization of their dipping pattern compared to placebo. This normalization of the nocturnal BP fall is a positive prognostic indicator with a lower risk of cardiovascular disease.
• Aprocitentan significantly reduced the BP load – the proportion of time BP exceeds threshold values – by about 20% during both daytime and nighttime, potentially lowering the risk of hypertension-mediated organ damage.
• Despite the BP lowering effect of aprocitentan, heart rate remained unchanged at Week 36.
• The blood pressure lowering effect of aprocitentan was consistently observed regardless of the patients’ baseline arterial stiffness or salt sensitivity, indicating aprocitentan’s effectiveness even in patients with clinical features traditionally associated with poor BP control.

About aprocitentan
Aprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO^® in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). TRYVIO is now included in the American College of Cardiology’s (ACC) and the American Heart Association’s (AHA) new comprehensive clinical practice guidelines for the management of high blood pressure. Aprocitentan is approved as JERAYGO^® for the treatment of resistant hypertension in combination with other antihypertensives in the European Union, the UK, and Switzerland, and a marketing authorization application is under review in Canada.

About PRECISION^14,15 (NCT03541174)
PRECISION was a multicenter, blinded, randomized, parallel-group, Phase 3 study, which was performed in hospitals or research centers in Europe, North America, Asia, and Australia. Patients were eligible for randomization if their sitting systolic blood pressure was 140 mm Hg or higher despite taking standardized background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: Part 1 was the 4-week double-blind, randomized, and placebo-controlled part, in which 730 patients were randomized to aprocitentan 12.5 mg (n=243), aprocitentan 25 mg (n=243), or placebo (n=244) in a 1:1:1 ratio; Part 2 was a 32-week single (patient)-blind part, in which all patients received aprocitentan 25 mg (n=704); and Part 3 was a 12-week double-blind, randomized, and placebo-controlled withdrawal part, in which patients were re-randomized to aprocitentan 25 mg (n=307) or placebo (n=307) in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes.

At baseline, 69.2% of patients were obese or severely obese, 54.1% had diabetes, 22.2% had stage 3-4 chronic kidney disease and 19.6% had congestive heart failure. 63% of randomized patients were receiving at least 4 anti-hypertensive therapies at screening.

Key PRECISION findings¹⁵
The least square mean change in office SBP at 4 weeks was –15.3 mmHg for aprocitentan 12.5 mg, –15.2 mmHg for 25 mg, and –11.5 mmHg for placebo, for a difference versus placebo of –3.8 mmHg (p=0.0042) and –3.7 mmHg (p=0.0046), respectively. Office diastolic blood pressure (DBP) also decreased with both aprocitentan doses compared to placebo (–3.9 mmHg for the 12.5 mg dose and –4.5 mmHg for the 25 mg dose). Office SBP and DBP were maintained during Part 2 in patients previously receiving aprocitentan and decreased within the first 2 weeks of Part 2 before stabilizing in those previously receiving placebo. In Part 3, office SBP after 4 weeks of withdrawal (the key secondary endpoint) increased significantly with placebo compared to aprocitentan (5.8 mmHg; p<0.0001). Office DBP also increased with placebo compared to aprocitentan (5.2 mmHg; p<0.001). The difference between the two groups remained up to week 48.

The results from ambulatory BP monitoring, a strong predictor of cardiovascular mortality,^1,2 confirmed those derived from office measurements. At the end of Part 1, aprocitentan, after placebo correction, decreased both the 24-hour ambulatory SBP (–4.2 mmHg for the 12.5 mg dose and –5.9 mmHg for the 25 mg dose) and DBP (–4.3 mmHg for the 12.5 mg dose and –5.8 mmHg for the 25 mg dose). The placebo-corrected SBP lowering effect was –5.1 mmHg and –7.4 mmHg during the nighttime and –3.8 mmHg and –5.3 mmHg during the daytime, for the 12.5 mg and 25 mg doses, respectively. In Part 3, after 4 weeks of withdrawal (week 40), both the 24-hour ambulatory SBP and DBP increased with placebo compared with aprocitentan (6·5 mm Hg and 6·8 mm Hg respectively).

Treatment-emergent adverse events (TEAEs) during the 4-week double-blind study period (Part 1) were reported in 27.6% and 36.7% of the patients treated with 12.5 and 25 mg aprocitentan, respectively, versus 19.4% in the placebo group. The most frequent adverse event was fluid retention which was reported more frequently with aprocitentan than with placebo in a dose-dependent fashion (9.1%, 18.4%, and 2.1% for patients receiving aprocitentan 12.5 mg, 25 mg and placebo, during Part 1, respectively; 18.2% for patients receiving aprocitentan 25 mg during Part 2; and 2.6% and 1.3% for patients on aprocitentan 25 mg and placebo, during Part 3, respectively). Fluid retention was generally mild-to-moderate, was primarily peripheral edema and was manageable by current clinical practice including use of diuretics. Discontinuation due to edema/fluid retention was reported for seven patients.

Notes to the editor

About Dr. Markus Schlaich, MD
Markus Schlaich is a nephrologist and a European Society of Hypertension (ESH) accredited hypertension specialist. He is a Fellow of the American Heart Association (FAHA), the European Society of Cardiology (FESC), and the International Society of Hypertension (ISHF). He served as an Executive Committee of the ISH from 2018-2020 and is currently on the Management Board of the global ISH May Measurement Month campaign. Markus is President of the High Blood Pressure Research Council of Australia and a Trustee of the Foundation for High Blood Pressure Research.

Markus has a strong background in clinical research with a focus on the pathophysiology of hypertension, involvement of the kidneys, and hypertension mediated organ damage. He has a specific interest in treatment modalities targeting the sympathetic nervous system and other relevant pathways such as the endothelin system to improve BP control and thereby outcomes for patients with difficult to control hypertension. For his work he received the Björn Folkow Award from the European Society of Hypertension (ESH) and the Arthur C. Corcoran Award from the AHA Hypertension Council, both in 2021. He has authored more than 530 articles in peer-reviewed journals and serves on the Editorial Board of Hypertension and Journal of Hypertension. Prof. Schlaich serves as a consultant to Idorsia.

About Dr Michael A. Weber, MD
Dr. Weber is Professor of Medicine at the SUNY Downstate College of Medicine in Brooklyn, New York. He received his medical degree from Sydney University in Australia.

His career has been focused primarily on hypertension and preventive cardiology. He has published numerous research articles in the medical literature and has authored or edited several books.

Dr. Weber was the Editor-in-Chief of The Journal of Clinical Hypertension for over 10 years. Dr. Weber was one of the founders of The American Society of Hypertension and has served as its President. He also served as Chair of the ASH Hypertension Specialists Program. He is a Fellow of The American College of Physicians, The American College of Cardiology and The American Heart Association. He has served on the Cardiovascular and Renal Drugs Advisory Board of the Food and Drug Administration. He has also served for ten years as Chairman of the Formulary Committee of a major pharmacy benefits provider serving many of the leading health plans in the United States.

His main current research interests are in clinical trials of patients at high risk of cardiovascular events or strokes. He is also participating actively in trials in patients with metabolic disorders such as diabetes and kidney disease. Dr. Weber currently serves on the Steering Committees of several national and international clinical trials. Dr. Weber serves as a consultant to Idorsia.

About Dr John M. Flack, MD
Dr. Flack, an Alpha Omega Alpha (AOA) graduate of the University of Oklahoma School of Medicine, is the Sergio Rabinovich Endowed Chair of Internal Medicine and the Professor and Chair of the Departments of Medicine and Population Science at Southern Illinois University School of Medicine. He is also Director of the Hypertension Clinic.

He is a board-certified Internal Medicine specialist and an internationally renowned hypertension specialist/cardiovascular epidemiologist with widely recognized clinical/research expertise in hypertension in African Americans, resistant/refractory hypertension, device-based therapies for hypertension and racial cardiovascular health disparities. Dr. Flack is the current President of the American Hypertension Specialist Certification Program. He has published over 250 peer-reviewed manuscripts and book chapters and is an Associate Editor for the journal Hypertension. He maintains an active clinical practice in complex hypertension at SIU where he teaches and mentors medical students and residents and undertakes innovative, cutting-edge research.

Dr. Flack has received numerous awards including the Distinguished Research Award (1993) from the International Society on Hypertension in Blacks (ISHIB), the Daniel D. Savage Memorial Scientific Award (1998) from the Association of Black Cardiologist (ABC), the F. Dewey Dodrill Award for Excellence (2007) from the American Heart Association (AHA), the Detroit News Michiganian of the Year (2009), and the University of Oklahoma Academic Physician of the Year (2012). Also, he has been repeatedly named to Top Doctor, Best Doctor, and Super Doctor lists. Previously, he served as a voting member of the FDA Cardio-Renal Advisory Board. Dr. Flack was recently conferred the status of Master by the American College of Physicians (ACP); he also previously served as a member of the ACP Board of Regents. Dr. Flack serves as a consultant to Idorsia.

References

1. Schlaich, MP; et al. Effects of aprocitentan on prognostically relevant ambulatory blood pressure-derived variables in resistant hypertension. Journal of Hypertension, 2025 Oct 2, online.
2. World Health Organization. Global report on hypertension 2025: high stakes: turning evidence into action. 2025.
3. Murray, Christopher J L. Findings from the Global Burden of Disease Study 2021. The Lancet. 2024; 403 (10440): 2259 – 2262
4. Carey RM, et al. Prevalence of Apparent Treatment-Resistant Hypertension in the United States. Hypertension. 2019;73(2):424-431
5. Narita K, et al. Nighttime Home Blood Pressure Is Associated With the Cardiovascular Disease Events Risk in Treatment-Resistant Hypertension. Hypertension. 2022;79(2):e18-e20
6. Kario K, et al. Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis. Circulation. 2020;142(19):1810-1820
7. Williams B, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European Heart Journal. 2018;39(33):3021-3104.
8. Staplin N, et al. Relationship between clinic and ambulatory blood pressure and mortality: an observational cohort study in 59 124 patients. Lancet. 2023;401(10393):2041-2050.
9. Dolan E, et al. Superiority of ambulatory over clinic blood pressure measurement in predicting mortality: the Dublin outcome study. Hypertension 2005; 46:156–61.
10. Niiranen TJ, Mäki J, Puukka P, Karanko H, Jula AM. Office, home, and ambulatory blood pressures as predictors of cardiovascular risk. Hypertension. 2014 Aug;64(2):281-6.
11. Kedzierski RM, et al. Endothelin system: the double-edged sword in health and disease. Annu Rev Pharmacol Toxicol. 2001; 41:851-76.
12. Iglarz M, et al. At the heart of tissue: endothelin system and end-organ damage. Clin Sci 2010; 119:453-63.
13. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398:957-80.
14. Danaietash P et al. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertension 2022 Jul;24(7):804-813.
15. Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937.

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact:
Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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