Fintech
Quoin Pharmaceuticals Targeting Regulatory Approvals for Lead Candidate for Netherton Syndrome in 2024
As company (QNRX) gains strength, Chief Operating Officer, Denise Carter, talks about what’s next for Quoin
New York, New York–(Newsfile Corp. – March 24, 2022) – PCG Digital — Netherton Syndrome (NS) is a rare and devastating skin disease that is estimated to affect between 2,000 and 4,000 people in the United States, and a similar number in Europe. It has no cure, and current treatment primarily involves the use of over-the-counter moisturizers which provide only minor symptomatic relief.
Quoin Pharmaceuticals’ (NASDAQ: QNRX) investigational product for NS, QRX003, may become the first approved treatment available to patients. It acts on skin to reduce the excessive shedding characteristic of NS and which results in patients’ skin being highly porous and therefore not functioning as the effective barrier it was designed to be. QRX003 is a topical lotion which, if approved, will be used on the entire body surface every day to enable the skin architecture to recover while providing an effective barrier over the skin to limit penetration by unwanted environmental agents.
The company’s share price has seen an increase of 52% in the past month, and as Quoin sees continued positive momentum this week, Chief Operating Officer and company co-founder, Ms. Denise Carter, joins us to answer some questions about what’s next for the company as it marches toward commercialization of QRX003.
Q: Quoin has received constructive feedback from the FDA for the development of QRX003. Can you tell us more about what the clinical requirements are?
A: Last week, we submitted our Investigational New Drug (IND) filing with the FDA, an important milestone as we work to bring QRX003 to an underserved patient population. Previously, the FDA provided Quoin with constructive guidance based on our pre-IND submission, indicating that a total patient population of approximately 20 subjects, at the commercial dose, may be sufficient for approval.
Q: You are targeting seeking regulatory approvals for QRX003 in both the US and EU in 2024. What are the next steps on the regulatory pathway?
A: We’ve already received guidance from the US FDA and so the next step was to seek guidance from the regulators in Europe. Earlier this month we submitted a Scientific Advice Briefing Document to the European Medicines Agency (EMA), which is the first step in the formal development process of QRX003 as a potential treatment for Netherton Syndrome in the EU. Based on this submission, the EMA will provide guidance on the clinical and regulatory requirements to advance the development of the product.
Q: When will clinical trials for QRX003 begin?
A: In the US, we are preparing to start our clinical trial in the first half of 2022. Netherton Syndrome is a very rare condition, so we have been working closely with supporting foundations and leading dermatology experts who treat these patients, to ensure that trial enrollment is a smooth and efficient process.
Q: How will you go about commercializing QRX003 once you have obtained regulatory approvals?
A: Our goal is to launch immediately upon receiving approvals in our two key markets, to get our products to patients as quickly as possible. We will be using our own commercial infrastructure and we anticipate that fewer than 30 people will be sufficient to support both US and European markets. In addition, we have secured exclusive distribution and revenue-sharing agreements covering nearly 60 countries, which brings us closer to our goal of getting our product to every patient, everywhere who needs it.
Q: Quoin has demonstrated its strategic approach to developing and commercializing its products. What would you say to new investors asking about the company’s value drivers?
A: Quoin is potentially positioned to deliver the first FDA-approved treatment for Netherton Syndrome. We believe our product works and our clinical trials will provide the data we need to take it to patients around the world. As a rare disease, Netherton Syndrome has a smaller addressable market, but that market is defined and concentrated, and with no approved treatment or cure, so there is little competition in the space. Rare and orphan drugs also have higher pricing power and can be highly profitable. QRX003 is a once-daily topical treatment that patients will use for life, making it a long-term marketing opportunity for Quoin. Finally, we have a strong balance sheet and a robust pipeline of different products that will potentially address a range of rare skin diseases for which there are no approved treatments or cures.
Disclaimer
This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client’s securities. See www.pcgadvisory.com/disclosures.
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As we close out 2024, the fintech industry continues to deliver headlines that underscore its dynamism and innovation. From IPO aspirations to groundbreaking regulatory milestones, today’s updates highlight the transformative power of fintech partnerships, regulatory evolution, and disruptive technologies. Here’s what you need to know.
Chime’s Quiet Step Toward Public Markets
Chime, the U.S.-based financial technology startup best known for its digital banking services, has taken a significant step by filing confidential paperwork for an initial public offering (IPO). As one of the most valuable private fintechs in the U.S., Chime’s move could potentially signal a renewed appetite for fintech IPOs in a market that has been cautious following fluctuating valuations across the tech sector.
With a valuation that reportedly exceeded $25 billion in its last funding round, Chime’s IPO could set a new benchmark for the industry. Observers note that its strong customer base and revenue growth may make it an appealing choice for investors seeking to capitalize on the digital banking boom. However, the timing and success of the IPO will depend on broader market conditions and the regulatory landscape.
Source: Bloomberg
ZBD’s Pioneering Achievement: EU MiCA License Approval
ZBD, a fintech company specializing in Bitcoin Lightning network solutions, has made history by becoming the first to secure an EU MiCA (Markets in Crypto-Assets Regulation) license. This landmark approval by the Dutch regulator positions ZBD at the forefront of compliant crypto-fintech operations in Europe.
MiCA, which aims to harmonize the regulatory framework for crypto-assets across the EU, has been a focal point for industry players aiming to establish legitimacy and expand their offerings. ZBD’s achievement not only validates its operational rigor but also sets a precedent for other fintech firms navigating the evolving regulatory landscape.
Industry insiders view this as a strategic advantage for ZBD as it broadens its footprint in Europe. By leveraging its regulatory approval, the company can accelerate its product deployment and establish trust with institutional and retail users alike.
Source: Coindesk, PR Newswire
The Fintech-Credit Union Synergy: A Blueprint for Innovation
The convergence of fintechs and credit unions continues to reshape the financial services ecosystem. Collaborative initiatives, such as the one highlighted in the recent partnership between fintech innovators and credit unions, are proving to be a potent force in delivering tailored financial solutions.
This “dream team” approach allows credit unions to leverage fintech’s technological expertise while maintaining their community-focused ethos. Key areas of collaboration include digital payments, personalized financial management tools, and enhanced loan processing capabilities. These partnerships not only enhance member engagement but also enable credit unions to remain competitive in an increasingly digital-first financial environment.
Industry analysts emphasize that such collaborations underscore a broader trend of traditional financial institutions embracing fintech-driven solutions to bridge service gaps and foster innovation.
Source: PYMNTS
Tackling Student Loan Debt: A Fintech’s Mission
Student loan debt remains a pressing issue for millions of Americans, and a Rochester-based fintech aims to offer relief through its cloud-based platform. This innovative solution is designed to simplify loan management and provide borrowers with actionable insights to reduce their debt burden.
The platform’s features include repayment optimization tools, personalized financial education, and seamless integration with loan servicers. By addressing the complexities of student loan management, this fintech is empowering borrowers to make informed decisions and achieve financial stability.
As the student loan crisis continues to evolve, solutions like this highlight the critical role fintech can play in addressing systemic financial challenges while fostering financial literacy and inclusion.
Source: RBJ
Industry Implications and Takeaways
Today’s updates underscore several key themes shaping the fintech landscape:
- Regulatory Milestones: ZBD’s MiCA license approval exemplifies the importance of regulatory compliance in unlocking growth opportunities.
- Strategic Partnerships: The collaboration between fintechs and credit unions demonstrates the value of combining technological innovation with traditional financial models to drive customer-centric solutions.
- Market Opportunities: Chime’s IPO move reflects a potential revival in fintech public offerings, signaling confidence in the sector’s long-term prospects.
- Social Impact: Fintech’s ability to tackle systemic issues, such as student loan debt, showcases its role as a force for positive change.
The post Fintech Pulse: Your Daily Industry Brief (Chime, ZBD, MiCA) appeared first on News, Events, Advertising Options.
Leading global payments platform SPAYZ.io has confirmed it will be attending iFX EXPO Dubai 2025 on 14 to 16 January. Exhibiting at Stand 64 at Trade Centre Dubai, SPAYZ.io’s team of professionals will be on hand providing live demonstrations of its renowned payment services for payment providers. Attendees will also receive exclusive insight into SPAYZ.io’s plans for 2025 alongside early early access to its upcoming plans for the new year.
SPAYZ.io delivers a host of payment solutions that leverage the latest technological innovations and open access to the fastest growing emerging markets across Africa, Europe and Asia. Over the past year, there has been huge demand for its Open Banking and local payment method services, alongside bank transfers, mass payouts, online banking and e-wallets.
Yana Thakurta, Head of Business Development at SPAYZ.io commented: “We look forward to once again participating at iFX Dubai to expand our network of partners and clients. It’s a fantastic way to kick off the year, connecting with thousands of industry leaders from FOREX platforms to trading companies, and everything in between.
“Our key goal for iFX Dubai EXPO 2025 is to expand our portfolio of solutions and geographies. We’re using this as an opportunity to partner with like-minded entities who share our ambition to provide payment solutions that are truly global.”
Come meet SPAYZ.io’s team at the Trade Centre Dubai at Stand 64. You can also book a meeting slot with a member of a team.
The post SPAYZ.io prepares for iFX EXPO Dubai 2025 appeared first on News, Events, Advertising Options.
Airtm, the most connected digital dollar account in the world, is proud to announce the addition of two distinguished industry leaders to its Board of Directors: Rafael de la Vega, Global SVP of Partnerships at Auctane, and Shivani Siroya, CEO & Founder of Tala. These appointments reflect Airtm’s commitment to innovation and financial inclusion as the company enters its next phase of growth.
“We are thrilled to welcome Rafael and Shivani to Airtm’s Board of Directors,” said Ruben Galindo Steckel, Co-founder and CEO of Airtm. “Their unique perspectives and proven track records will be invaluable as we continue scaling our platform to empower individuals and businesses in emerging markets. Together, we’ll push the boundaries of financial inclusion and innovation to create a more connected and equitable global economy. Rafael and Shivani bring a wealth of experience and strategic insight that will strengthen Airtm’s mission to connect emerging economies with the global market.”
Rafael de la Vega, a seasoned leader in fintech global partnerships and technology innovation, is currently the Global SVP of Partnerships at Auctane. With a proven track record of delivering scalable, impactful solutions at the intersection of fintech, innovation, and commerce, Rafael’s expertise will be pivotal as Airtm continues to grow. “Airtm has built a platform that breaks down barriers and opens up opportunities for people in emerging economies to connect to global markets. I am excited to contribute to its growth and help further its mission of fostering financial inclusion on a global scale,” said Rafael.
Shivani Siroya, CEO and Founder of Tala, is a pioneer in financial technology, renowned for empowering underserved communities through access to credit and essential financial tools. Her leadership in leveraging data-driven innovation aligns seamlessly with Airtm’s vision of creating more equitable financial opportunities. “Empowering underserved communities has always been at the core of my work, and Airtm’s mission resonates deeply with me. I’m thrilled to join the Board and work alongside such a dynamic team to expand access to financial tools that truly make a difference in people’s lives,” said Shivani.
The post Airtm Enhances Its Board of Directors with Two Strategic Appointments appeared first on News, Events, Advertising Options.
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