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  • Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders

    Jaguar Health Reports Approval of All Proposals at August 2025 Annual Meeting of Stockholders

    Jaguar CEO Lisa Conte presenting August 20 at Emerging Growth Conference to provide updates on near-term catalysts; Click here to register

    As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome (SBS-IF) patient by up to 12.5%; FDA meeting resulted in planned Jaguar regulatory pathway to complete supplemental NDA strategy for crofelemer for patients with metastatic breast cancer, a population meeting orphan definition in US

    Company strategy: Seek business development partnerships for license to develop and commercialize Jaguar’s orphan indication products, resulting in non-dilutive funding for Jaguar

    SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the voting results of the Company’s Annual Meeting of Stockholders held on August 19, 2025 (the “Annual Meeting”).

    Seven proposals were submitted to and approved by the stockholders of the Company at the Annual Meeting. The proposals are described in detail in the Company’s definitive proxy statement on Schedule 14A relating to the Annual Meeting and supplemental information filed with the Securities and Exchange Commission on July 21, 2025 and as amended on August 6, 2025. Stockholders may obtain a free copy of the proxy statement and other documents filed by Jaguar with the SEC at http://www.sec.gov. The proxy statement is also available on the Company’s corporate website.

    About the Jaguar Health Family of Companies

    Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo’s crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar’s Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.

    For more information about:

    Jaguar Health, visit https://jaguar.health

    Napo Pharmaceuticals, visit www.napopharma.com

    Napo Therapeutics, visit napotherapeutics.com

    Magdalena Biosciences, visit magdalenabiosciences.com

    Canalevia-CA1, visit canalevia.com

    Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram

    Forward-Looking Statements

    Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that Jaguar management will present at the August 2025 Emerging Growth Conference, and statements regarding Jaguar’s planned regulatory pathway to complete a supplemental NDA for crofelemer for patients with metastatic breast cancer. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact:

    hello@jaguar.health

    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.

    View the original press release on ACCESS Newswire

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  • Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment

    Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment

    Arrowhead Clinic in Garden City is excited to announce a new resource available on their WordPress site detailing advanced car accident treatment techniques. Known for their expertise in treating auto accident injuries, the clinic has developed this article to help people understand their care options after a car accident.

    In the Garden City Arrowhead Clinic auto accident treatment article, the clinic emphasizes the need for quick medical attention and explains the detailed chiropractic care methods they use. Often, injuries from accidents don’t show immediate symptoms, so the clinic stresses how important it is to seek early treatment to avoid further complications.

    Arrowhead Clinic in Garden City Georgia for auto accident chiropractic treatment

    Dr. NiAmber Harris, a seasoned practitioner at Arrowhead Clinic in Garden City, explained, “Our aim is to provide care that tackles both the obvious and hidden injuries. Using advanced diagnostics and specialized therapies helps people recover not just from immediate pain but toward better overall health.”

    The article highlights the variety of diagnostic and therapeutic technologies available at the clinic. Patients receive a thorough evaluation, which includes advanced imaging, orthopedic testing, and neurological screenings. These methods create a clear picture of the injuries, helping in the development of personalized treatment plans.

    Treatment at the Garden City clinic combines modern chiropractic techniques with rehabilitation practices. Techniques like diversified methods, soft tissue mobilization, and advanced therapies such as cold laser therapy are utilized to speed up recovery and improve patient results. Additionally, electrical stimulation devices and rehabilitation exercise plans are available to help patients regain their strength and functionality.

    A key feature of the clinic’s approach is the use of technology in treatments. Patients benefit from digital X-ray analyses, computerized postural assessments, and other digital tools that assist in tracking progress and planning exercises. This approach allows treatment to be tailored to individual needs and keeps patients informed about their progress.

    For more detailed information about these techniques, visit the Arrowhead Clinic Chiropractor website. This resource is invaluable for understanding the integrated approaches being taken by the clinic.

    Dr. Harris noted, “Technology allows us to continuously monitor each patient’s recovery journey, ensuring the best possible outcomes. The personalized care at our Arrowhead Clinic in Garden City location helps us adjust to each patient’s unique situation, aiding in more effective healing.”

    Beyond treatment, the clinic focuses on education and prevention. Regular educational initiatives offer patients valuable advice on preventing injuries and maintaining wellness after treatment.

    Reviews from former patients often highlight the welcoming and professional atmosphere of the clinic. With an impressive 4.8-star rating, many patients have praised the effectiveness of the treatment protocols and the supportive environment. Such positive feedback demonstrates the lasting impact the clinic aims to achieve in its community.

    For those impacted by auto accidents, quickly connecting with knowledgeable healthcare providers is very important. Garden City Arrowhead Clinic auto accident treatment services prioritize rapid and thorough care after such incidents. This newly released article aims to offer guidance and assistance to those seeking recovery options.

    Anyone interested in learning more about the advanced treatment methods used by the clinic can read the full article on the Arrowhead Clinic website or connect with our Arrowhead Clinic Garden City location directly. The staff is ready to answer questions and help individuals seeking advice on their health and wellness after an accident.

    Arrowhead Clinic is committed to enhancing patient outcomes through advanced chiropractic care, ensuring that individuals involved in auto accidents receive the comprehensive treatment necessary for a speedy and effective recovery.

    The post Discover Advanced Car Accident Care at Arrowhead Clinic in Garden City, GA: New Resource Unveiled for Auto Injury Treatment appeared first on DA80 Hub.

  • Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business

    Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business

    Trusted firearms retailer and training center offers entrepreneurs a rare chance to own a piece of its legacy.

    ORLANDO, FL / ACCESS Newswire / August 19, 2025 / Rieg’s Gun Shop & Shooting Range, a family-founded business serving firearm owners since 1968, has announced the launch of its first-ever franchise program.

    Known for its strong brand recognition, comprehensive training, and proven business model, Rieg’s is opening franchise opportunities to qualified entrepreneurs with a passion for firearms and a commitment to responsible ownership.

    Franchisees will benefit from:

    • A 2-week hands-on training program

    • Established supply chain and exclusive territories

    • Multiple revenue streams including retail, range fees, classes, and rentals

    • Ongoing support from industry veterans

    “The firearm industry is booming, and our franchise partners will enter the market backed by a respected name and over five decades of experience,” said Justin Hilton

    According to the NSSF, over 26 million new gun owners have entered the U.S. market since 2020, fueling growth in an industry that generated $91.65 billion in 2024.

    Contact:

    Justin Hilton
    Email: Franchise@TheRiegs.com
    Office: 407.473.0869

    SOURCE: Rieg’s Gun Shop & Range

    View the original press release on ACCESS Newswire

    The post Rieg’s Gun Shop & Shooting Range Launches Franchise Program After 55 Years in Business appeared first on DA80 Hub.

  • ClaimNotify.org Launches to Help Californians Reclaim Millions in Unclaimed Assets

    ClaimNotify.org Launches to Help Californians Reclaim Millions in Unclaimed Assets

    LOS ANGELES, CA / ACCESS Newswire / August 19, 2025 / ClaimNotify.org, a new online tool and educational hub for all things unclaimed assets, launched today to help Californians easily navigate the complex world of abandoned assets. With a mission to become the trusted national resource, the platform empowers residents to recover funds and assets that rightfully belong to them.

    Unclaimed assets- ranging from forgotten bank accounts and uncashed checks to insurance benefits and safe deposit box contents- are currently valued at over $2.5 billion in Los Angeles County and $600 million in San Diego County, according to recent public notices. Until now, finding and reclaiming these funds has been a confusing and time-consuming process.

    The launch comes at a pivotal moment: on September 4, 2025, new California code changes- driven by the passage of SB 822, which expands the state’s Unclaimed Property Law to include digital financial assets- will make it easier for residents to submit claims online. ClaimNotify.org will offer up-to-the-minute guidance on these changes, ensuring no eligible Californian misses their opportunity to reclaim what’s theirs.

    ClaimNotify.org streamlines the journey, offering:

    • A Centralized Resource for Californians: One place to access news, updates, and verified links for unclaimed asset searches, starting with California and expanding to other states.

    • Educational Tools: Easy-to-follow guides explaining what unclaimed assets are, how they get lost, and how residents can submit claims.

    • Breaking Updates: Timely alerts on new policies, large asset disclosures, and deadlines for filing claims.

    • Step-by-Step Support: Clear instructions to help users submit claims directly, without costly third-party services.

    “Unclaimed assets can be life-changing, but most people don’t even realize they exist- let alone how to recover them,” said a ClaimNotify.org spokesperson. “Our goal is to be the go-to source for accurate, accessible, and timely information, so Californians can claim what’s theirs without unnecessary stress or confusion.”

    Claim Notify plans to expand its coverage to include news and resources from multiple states, helping Americans nationwide access the billions in unclaimed property sitting in government coffers.

    To view the resources and learn more, visit: Claimnotify.org

    About ClaimNotify.org
    ClaimNotify.org is a public information portal dedicated to helping individuals navigate the often-confusing process of recovering unclaimed property. By consolidating updates, official resources, and step-by-step guides, ClaimNotify.org empowers people to reclaim their money and property with confidence. For more information, visit: ClaimNotify.org

    Contact:
    info@claimnotify.org

    SOURCE: govrecover

    View the original press release on ACCESS Newswire

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  • Sunseeker Launches Robotic Mowers on Lowe’s Online Platform

    Sunseeker Launches Robotic Mowers on Lowe’s Online Platform

    CHARLOTTE, NC / ACCESS Newswire / August 19, 2025 / Most Sunseeker Tech products, including the X7 Series of state-of-the-art robotic mowers, can now be purchased online as a part of the new partnership between Sunseeker Tech and Lowe’s. This partnership marks a significant step in expanding Sunseeker’s reach to more homeowners in the United States. It offers innovative solutions with its advanced lawn care machines.

    “At Sunseeker, robotic lawn care is the norm, not the exception. The collaboration with Lowe’s will enable us to target more homeowners than ever before, giving them the ease, accuracy, and sustainability,” said the CEO.

    Putting Smart Lawn Care in More Lawns

    With the collaboration between Lowe’s and Sunseeker, the company would turn a new leaf in its quest to popularize robotic mowing as an option among housekeepers. Lowe’s is the most recognized online shopping platform in home improvement in America.

    It offers the best medium to reach the tech-savvy segment of consumers eager to find sustainable and efficient form of maintaining their property. This will allow customers in Charlotte and beyond to buy robotic mowers. This ensure professional-quality results with minimum human interaction.

    Features of Sunseeker X7 Series

    Among the product line, X7 Series is a fully autonomous robot lawn mower designed to provide unique lawn care experience, with highly advanced AI technology, RTK (Real-Time Kinematic) navigation and high-grade engineering.

    It is unique due to the following features:

    • Adaptive AI Mowing Patterns: The mower learns and can adapt to growth of the grass, weather and obstacles providing smooth and consistent cutting

    • RTK-level Accuracy: Operates at sub-centimeter campus-wide accuracy without the use of perimeter wires. It can reduce cost on an installation and enhance dependability

    • Smart Collision Sensing: Automatically senses pets, children, and garden decor and goes around them unhindered

    • All-Weather Performance: The construction is designed to work in any kind of weather with rain sensors and IPX durability rating

    The electric, less noisy motor of the X7 does not only limit environmental interference but also promotes silent work. It is a vehicle-friendly in the neighborhoods. With a companion mobile app, homeowners can view, schedule, and control their mower remotely from anyplace, welcoming it to their smart home system.

    High-End, Low Pressure

    The mission of Sunseeker is not just a grass cutting machine but about giving back time to people. The CEO said that the target was to assist homeowners in reclaiming their weekends. You will never have to worry about your lawn with Sunseeker. You can rest in knowing that you have one less thing to worry about because your lawn is well taken care of.

    Whether on tightly trimmed urban gardens or expansive suburban gardens, the X7 is able to adjust to all set-ups. It can move over hills, rugged land, and different types of grasses easily. That is why it is good both in residential areas, Charlotte neighborhood, and golf resort spaces.

    Making Lawn Care Futuristic

    Robotic mowing has a positive impact on the world. Not only does it make life easier, but also helps create a healthier planet. When homeowners upgrade their gas mowers to battery-operated ones such as the X7, they reduce noise pollution caused by emissions.

    Its smart scheduling of the mower also ensures that whether it cuts the lawn more often or less, it is healthy without any extra energy. This increased enthusiasm among consumers on eco-friendly technology that can sustain the lifestyle without sacrificing performance.

    More Smarter Lawn Care

    Sunseeker expects to be an entirely incorporated player in the smart home ecosystem. The company’s vision is that its mowers will interact with other smart devices and adapt intelligently to the shifts in the environment. It is also to present hyper-personalized mowing formats to the yard. As the company continues to innovate, it will continue to add more products to its line. It seeks to address the requirements of all kinds of homeowners, whether of a small city plot or large estate.

    Availability

    TheLowe’s online store now offers the Sunseeker robotic mowers, such as the X7 Series which is the more advanced version of their product line. Customers will have access to product specifications, models to compare, and convenience of shipping and customer services offered by Lowe’s.

    To know more about the products of Sunseeker, you can visit the site www.sunseekertech.com Follow the brand on social media to get acquainted with the latest news, user experience, and views:

    About Sunseeker Robotic Technology

    Sunseeker Robotic Technology will ensure it is a pioneer in smart yard technology recreating the outdoor living experience with the ideal totality of current robotics, AI navigation engineering, and green engineering. Its premium X7 Series robotic mower is the benchmark of accuracy, adaptability, and convenience in a robot mower. This makes it more versatile to the homeowner that cares about performance and sustainability.

    Coupled with the drive to undeniably innovate and make its customers happy, Sunseeker is constantly exploring ways to automate exterior maintenance. So, people spend less time maintaining their lawns and more time enjoying them.

    Media Details:
    Website URL: sunseekertech.com
    Company Name: Sunseeker North America
    Email address: marketing.global@sunseekertech.com
    Address: 4330 Matthews Indian Trail Rd STE A
    Indian Trail, NC, USA 28079

    SOURCE: Sunseeker North America

    View the original press release on ACCESS Newswire

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  • Commonwealth M&A Welcomes Industry Veteran Joe DiGiacomo As Senior Advisor & Managing Director

    Commonwealth M&A Welcomes Industry Veteran Joe DiGiacomo As Senior Advisor & Managing Director

    The new relationship brings extensive experience to elevate client offerings and support future growth

    PHILADELPHIA, PA / ACCESS Newswire / August 19, 2025 / Commonwealth M&A, LLC, a premier full-service Merger & Acquisition advisory firm providing transactional and valuation services to small and medium sized businesses, today announced that Joe DiGiacomo has joined the team as a Senior Advisor and Managing Director. DiGiacomo will play a key role in company operations managing specific transactions, and will also offer counsel on other transactions, utilizing his 40+ years of experience to ensure deals close smoothly, companies get the valuation they deserve, and sellers are optimized to secure the best transition for their business.

    A seasoned professional who is well-established in the lower middle market, DiGiacomo has a diverse background in investment banking, business valuation, accounting, and mergers and acquisitions. Most recently as the Founder and President of D5 Capital Advisors, a boutique lower middle market M&A advisory firm headquartered in the Lehigh Valley, as well as previous positions as the President and CFO of a $135 million multimodal transportation and logistics business, and Partner of a regional CPA firm.

    “Our goals for Commonwealth M&A have been big from the start and bringing Joe on our team is going to supercharge our capabilities,” said Rick Calabrese, co-founder of Commonwealth M&A. “Having previously worked with Joe in my capacity as a transactional attorney, I know first hand the wealth of knowledge and experience he brings to the table. We are excited to add his expertise to our team to continue to bring our clients exceptional results, which is always our top priority.”

    “When I was considering combining my practice with another firm, I knew I wanted to join a team that was talented and motivated. I had worked with Rick in the past and when I found out he had started his own firm, I immediately wanted to learn more. I met with him and Joe [Bergin] and the pieces just fell into place, their mindset and business approach is exactly what I was looking for,” commented Joe DiGiacomo. “This team knows what they’re doing and I really think that their energy and technical experience paired with my background is going to be a dynamic offering. I’m very excited about this new chapter and know there’s an extremely bright future ahead for Commonwealth M&A.”

    In the last calendar year alone, Commonwealth M&A has closed more than $50M in transaction value for clients. Founders Rick Calabrese and Joe Bergin both offer unique expertise, Calabrese as a transactional attorney and CPA, and Bergin with a decade of corporate M&A experience at Johnson & Johnson. The team believes they can leverage DiGiacomo’s broad expertise to help lower middle market businesses find a deal that fits all of their needs.

    About Commonwealth M&A, LLC
    Commonwealth M&A, LLC is a full-service Merger & Acquisition advisory firm providing transactional and valuation services to small and medium-sized businesses. Commonwealth M&A offers a differentiated approach derived from the team’s diverse set of experiences. Our mission is to deliver personalized, high-quality service that exceeds expectations. Visit us at https://commonwealthmna.com/

    Media Contact
    Martina Corona
    Martina@notablypr.com

    SOURCE: Commonwealth M&A

    View the original press release on ACCESS Newswire

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  • Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)

    Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID)

    As announced, initial proof-of-concept results from the ongoing investigator-initiated trial in Abu Dhabi show crofelemer reduced the required total parenteral nutrition in the first participating MVID patient by up to 27%; abstract describing results accepted for presentation at upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2025 Annual Meeting in Chicago

    SAN FRANCISCO, CA / ACCESS Newswire / August 19, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that it plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the company’s ongoing clinical development program for crofelemerfor the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo’s Scientific Advisory Board will join Napo and Jaguar representatives at the meeting.

    “We’re very pleased that Napo has been granted a meeting with the FDA to discuss Napo’s development plans for crofelemer for MVID – a devastating pediatric disease characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there no approved drug treatments,” said Pravin Chaturvedi, PhD, Napo’s and Jaguar’s Chief Scientific Officer and Chair of the Scientific Advisory Board. “A core Napo goal for this meeting is to obtain input from the FDA on the clinical program and potential expedited regulatory pathways for this rare orphan indication.”

    As announced, and as presented April 26, 2025 at the Annual ELITE PED-GI Congress, the initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) of a novel crofelemer powder formulation for oral solution in Abu Dhabi in the United Arab Emirates show that crofelemer reduced the required total parenteral nutrition (TPN) and supplementary intravenous fluids in the first participating MVID patient by up to 27%. An abstract describing the initial results of this trial has been accepted for presentation at the upcoming North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting taking place November 5-8, 2025 in Chicago.

    Jaguar, through Napo, is supporting the independent proof-of-concept IIT in pediatric intestinal failure (IF) patients at Sheikh Khalifa Medical City in Abu Dhabi, and is conducting the placebo-controlled Phase 2 study of crofelemer in pediatric MVID patients with IF at sites in the U.S., European Union, and Middle East/North Africa regions under appropriate regulatory approvals in each of these geographies.

    “Given the ultrarare nature of MVID, and the groundbreaking initial proof-of-concept results from the IIT in Abu Dhabi, even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval,” said Lisa Conte, Jaguar’s Founder and CEO.

    Based on the initial findings from the IIT in Abu Dhabi, crofelemer’s paradigm-shifting mechanism of action has the potential to provide a novel therapeutic option to reduce parenteral support and associated complications in MVID patients.

    About the Jaguar Health Family of Companies

    Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including MVID and short bowel syndrome.

    For more information about:

    Jaguar Health, visit https://jaguar.health

    Napo Pharmaceuticals, visit www.napopharma.com

    Napo Therapeutics, visit napotherapeutics.com

    Forward-Looking Statements

    Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that Napo personnel will meet with the FDA to discuss Napo’s development plans for crofelemer for MVID, statements regarding Jaguar’s expectation that an abstract describing the results of the investigator-initiated trial in Abu Dhabi will be presented at NASPGHAN 2025, Jaguar’s expectation that even a small number of MVID patients showing benefit with crofelemer may allow Napo to explore pathways for expedited regulatory approval, and Jaguar’s expectation that crofelemer’s paradigm-shifting mechanism of action has the potential to provide a novel therapeutic option to reduce parenteral support and associated complications in MVID patients. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact:

    hello@jaguar.health
    Jaguar-JAGX

    SOURCE: Jaguar Health, Inc.

    View the original press release on ACCESS Newswire

    The post Jaguar Health Family Company Napo Pharmaceuticals to Meet with FDA to Discuss Potential Regulatory Pathways for Crofelemer for Treatment of Ultrarare Pediatric Indication Microvillus Inclusion Disease (MVID) appeared first on DA80 Hub.

  • MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

    MIRA Pharmaceuticals Announces Completion of Phase 1 Single Ascending Dose for Oral Ketamir-2 with No Safety Concerns, Advances to Multiple Ascending Dose Stage

    Following FDA IND clearance for neuropathic pain, the Company is preparing to initiate its U.S. Phase 2a trial in Q4 2025

    MIAMI, FL / ACCESS Newswire / August 19, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the successful completion of the Single Ascending Dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2. The study, conducted at the Hadassah Clinical Research Center in Israel under the direction of Principal Investigator Prof. Yoseph Caraco, demonstrated a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed to date.

    “Completion of the SAD portion with a favorable safety and tolerability profile is an important milestone in the clinical development of Ketamir-2,” said Prof. Yoseph Caraco, Principal Investigator of the Phase 1 study. “Importantly, no severe or clinically significant adverse effects have been observed to date, which supports continued progression into the Multiple Ascending Dose stage of the trial.”

    Phase 1 Study Overview

    The study-A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Centre Study of Single and Repeated Dosing of Ascending Doses, to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects-is designed to establish the safety, tolerability, and pharmacokinetics of Ketamir-2 in healthy adult volunteers.

    • Design: Single-center, randomized, double-blind, placebo-controlled SAD/MAD with sentinel dosing and Safety Steering Committee (SSC) reviews between cohorts.

    • SAD completed: Four cohorts (single doses 50 mg to 600 mg); 32 participants treated (male and female).

    • Safety monitoring: Extensive central nervous system (CNS) safety assessments were performed using well-validated clinical research tools:

      • Columbia-Suicide Severity Rating Scale (C-SSRS) – screens for suicidal ideation or behavior, supporting early detection of potential mood or psychiatric changes.

      • Bowdle Visual Analogue Scale (VAS) – measures possible psychedelic or dissociative effects sometimes seen with ketamine and related compounds.

      • Ketamine Side Effect Tool (KSET) – tracks a broad range of known ketamine-related side effects over time, including sensory, cognitive, and mood changes.
        These tools provided multiple, complementary layers of safety evaluation to help detect even subtle CNS effects throughout the trial.

    • Status: To date, no severe or clinically significant adverse effects have been observed at any dose level in the SAD portion of the study.

    While the study remains ongoing and blinded, it is worth noting that, across the pharmaceutical industry as a whole, approximately one-third of investigational drugs fail during Phase 1 due to safety concerns (Tufts Center for the Study of Drug Development). These interim observations provide encouraging context as MIRA advances Ketamir-2 through the next stage of clinical evaluation, consistent with the Company’s mission to prioritize safety in every step of development.

    The Company is advancing to the Multiple Ascending Dose (MAD) portion, which will evaluate three cohorts receiving daily oral doses of 150 mg, 300 mg, or 600 mg for five consecutive days in up to 24 participants.

    “The emerging human safety profile complements the preclinical data we’ve generated, which show Ketamir-2’s superior efficacy in multiple neuropathic pain models without triggering the hallmark CNS side effects of ketamine,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA. “This combination of efficacy, safety, and oral delivery positions Ketamir-2 as a promising next-generation treatment for neuropathic pain and potentially other CNS disorders.

    Strategic & Commercial Potential

    Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and shows no significant off-target activity across a broad receptor panel. Preclinical studies have demonstrated superior performance versus ketamine, pregabalin, or gabapentin (depending on comparator and model) in gold-standard neuropathic pain models-without the dissociative effects associated with ketamine.

    Neuropathic pain affects an estimated 36-51 million people in North America and represents a multi-billion-dollar market today, with long-term growth driven by diabetes prevalence, cancer survivorship, and aging-related nerve damage. MIRA intends to submit a Phase 2a clinical protocol in neuropathic pain by year-end 2025 and continue evaluating potential applications in depression, anxiety, PTSD, and localized pain, subject to ongoing results and regulatory feedback.

    “We are pleased to see our Phase 1 program progress as planned,” said Erez Aminov, CEO of MIRA. “Advancing into the MAD stage is an important operational step as we continue to build a rigorous safety and PK foundation for Ketamir-2 and work to deliver a differentiated, non-opioid option for patients with neuropathic pain.

    About MIRA Pharmaceuticals, Inc.

    MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company’s pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

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

    Cautionary Note Regarding Forward-Looking Statements

    This press release and the statements of MIRA’s management related thereto contain “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA’s current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA’s potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA’s programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

    Contact:
    Helga Moya
    info@mirapharma.com
    (786) 432-9792

    SOURCE: MIRA Pharmaceuticals

    View the original press release on ACCESS Newswire

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  • essoc Voted Best No Show Socks for Its Stay-Put Comfort and Design

    essoc Voted Best No Show Socks for Its Stay-Put Comfort and Design

    NEW YORK, NYessoc, a company renowned for its innovative approach to solving the universal and persistent problem of slipping no-show socks, has been officially voted the provider of the best no show socks in a comprehensive consumer poll and industry analysis. This significant accolade reflects the brand’s unwavering commitment to superior comfort, breakthrough innovation, and genuine inclusivity, setting a new and formidable standard in the everyday essentials market. The recognition validates essoc’s success in creating a product that consumers don’t just wear, but genuinely rely on.

    The inspiration behind essoc is drawn directly from the dynamic, stylish, and demanding lifestyle of its New York City home. The founder observed a fundamental disconnect: people invested in high-quality footwear for their fast-paced lives, only to be undermined by the constant distraction and discomfort of socks slipping down inside their shoes. This insight sparked a mission to engineer a solution. essoc designed socks that not only stay perfectly in place from the morning commute to a late-night social engagement but also feel like a seamless second skin. This unique and powerful combination of absolute functionality and sublime comfort has resonated deeply with consumers globally, leading directly to the brand earning this prestigious recognition.

    “Being recognized as the maker of the best no show socks is a profound testament to our team’s relentless dedication to quality and our core principle of listening intently to our customers’ needs,” said Stella Liu, founder of essoc. “Our mission was never just about making another sock. It was about meticulously re-engineering a fundamental wardrobe item to enhance everyday life, removing a small but significant friction point. This award is incredible validation that our efforts have made a real difference in the daily experience of our customers.”

    What truly distinguishes essoc in a crowded marketplace is its holistic approach to design. essoc has a design patent, which mainly protects their cutting technology and overall design.The company invested heavily in research and development, focusing on three key areas: a proprietary, skin-friendly silicone grip technology that provides a secure hold without irritation; an ergonomic, contoured fit that respects the natural shape of the human foot; and the use of premium, breathable fabric blends that ensure all-day freshness and prevent overheating. This trifecta of innovation directly addresses the primary complaints associated with conventional no-show socks—slipping, discomfort, and lack of durability.

    “Our socks are more than just a fashion accessory; they are a daily essential engineered to support and empower an active, modern lifestyle,” added Liu. “Whether you’re an executive running between meetings, a creative professional on your feet all day, or a parent navigating the city, your focus should be on your life, not on your socks. We are thrilled to be acknowledged for our commitment to this level of excellence and innovation, proving that even the most basic items can be perfected.”

    essoc’s success is deeply rooted in its ability to masterfully blend high-fashion sensibility with uncompromising practicality. The brand offers a product that flawlessly meets the sophisticated demands of modern living, ensuring that individuals never have to sacrifice style for comfort, or function for form. This unwavering focus on creating socks that provide uninterrupted, all-day comfort has allowed essoc to carve out a leadership position. The brand has demonstrated that consumers are eager to invest in high-quality essentials when they deliver tangible benefits and superior performance.

    As essoc continues to grow and innovate, this recognition as the best no show socks provider serves as a pivotal milestone. It marks a key moment in its journey to redefine what consumers can and should expect from their everyday apparel. Looking ahead, the brand remains passionately committed to pushing the boundaries of design and functionality, with plans to expand its range of materials and styles. essoc is dedicated to ensuring that its products not only remain at the forefront of the industry but continue to offer the perfect foundation for a confident and comfortable day.

    About essoc: essoc was created to solve a small but universal problem—no-show socks that slip off. Inspired by the active, stylish lifestyle of New York City, they designed socks that stay put, feel like a second skin, and keep feet comfortable all day. With a focus on comfort, innovation, and inclusivity, essoc is more than just a sock—it’s a daily essential made for real life. Stay focused. Stay comfortable. Stay put.

    Media Contact:
    hello@essoc.shop

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  • Harmony & Healing Launches Private Benefit Concert Program, Turning Backyards Into Unforgettable Fundraisers

    Harmony & Healing Launches Private Benefit Concert Program, Turning Backyards Into Unforgettable Fundraisers

    Harmony & Healing has announced the launch of its new Private Benefit Concert program, bringing the energy and connection of live music directly into backyards, wineries, corporate spaces, and private event venues. These intimate, high-energy concert/dance parties not only create unforgettable evenings for hosts and their guests, they also raise vital funds to provide free live musical visits to patients in hospitals, hospices, rehab facilities, and memory care centers.

    The Private Benefit Concert program offers hosts a turnkey way to throw an extraordinary party with a purpose. Harmony & Healing founder David Victor, a former member of the multi-platinum band BOSTON, performs alongside drummer Michael Brandon and bassist Russell Vazquez in their powerhouse trio, “Therapy Dawgs”. The band delivers multiple sets of crowd-pleasing, danceable hits, transforming private venues into unforgettable live music experiences.

    Harmony & Healing Private Benefit Concerts for Fundraising

    Unlike large, formal benefit concerts that require complex logistics, these events are designed to be simpler for the host. Harmony & Healing handles the performance, lighting, sound, and crew, while the host focuses on food and beverages and inviting friends, family, and colleagues to enjoy the show. These events also feature a lively live auction, with prizes such as autographed guitars, exclusive wine tastings, vacation getaways, and VIP tickets to major sporting events or concerts.

    Early hosts are already sharing glowing reviews. Joe Schembri, who hosted a Private Benefit Concert in Danville in June 2025, said, “The energy was absolutely incredible. David and his band brought such professionalism and heart to our backyard. Our guests are still talking about it months later.” In August 2025, Pleasanton host Geoff Rodgers added, “I was worried about logistics, but the team made it so easy. We raised significant funds while creating memories that will last a lifetime.”

    The concept works because it creates an exclusive, intimate atmosphere that cannot be replicated in larger venues. Guests enjoy the rare experience of a private concert by professional musicians in a relaxed, familiar setting, while knowing that their participation is helping to fund a meaningful cause. Every dollar raised supports Harmony & Healing’s mission to provide no-cost, live musical visits both in-person and via Zoom to patients of all ages and their loved ones.

    Founded by David Victor in the San Francisco Bay Area, Harmony & Healing has become known for its compassionate approach to using music as a tool for emotional connection, stress reduction, and joy. These musical visits are not formal music therapy, but rather carefully curated performances that tap into patients’ most cherished memories and associations. The organization’s professional musicians are selected not only for their talent but for their ability to connect on a personal level with patients, families, and caregivers.

    Private Benefit Concerts are an extension of that mission, allowing supporters to bring the same level of artistry and connection into their own communities while raising the funds that make the free patient visits possible. The money generated from each concert directly supports the organization’s roster of artists, ensuring that patients and their families never pay for the performances they receive.

    The need for this work is ongoing. Patients in hospitals, hospices, and long-term care facilities often face long days filled with medical procedures and uncertainty. For many, a live musical visit is a welcome break that lifts spirits, rekindles happy memories, and provides moments of genuine human connection. These visits also reach veterans living with PTSD, children in pediatric care, and individuals in memory care, where music can stimulate recognition and response even when other forms of communication have faded.

    Victor sees the Private Benefit Concert program as a way to deepen community engagement while sustaining the charity’s impact year-round. “A Private Benefit Concert is more than just a party,” he explained. “It’s a way to connect with your friends and neighbors through great music, while knowing that the joy you experience that night is directly bringing comfort and healing to patients in hospice, rehab and hospitals who truly need it.”

    Harmony & Healing encourages interested hosts to think creatively about their venues. While many concerts take place in spacious backyards, others are held in wineries, community centers, or corporate settings. The key is creating a welcoming space where guests can relax, enjoy the music, and participate in the fundraising activities.

    The organization provides guidance on event flow, auction timing, and promotion to make each concert as successful as possible. From the moment the band arrives for setup to the final encore, hosts can relax knowing the details are handled. The result is an evening that strengthens community bonds, celebrates live music, and funds a mission that touches lives across the country.

    To learn more about hosting a Private Benefit Concert and becoming part of this growing movement, visit the Harmony & Healing website.

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