Fintech
The R&D Sweet Spot: Quoin Pharmaceuticals Delivering Value-Based Drug Development Through Rare and Orphan Disease Therapeutics
New York, New York–(Newsfile Corp. – December 14, 2021) – PCG Digital — Drug development is complex, lengthy and expensive, and not without its risks. Bringing a drug to market takes years, with costs quickly running into hundreds of millions of dollars, and no promise of success at the end of it all.
Rare and orphan indications provide an R&D ‘sweet spot’ for biopharmaceutical companies pursuing drug development. Drugs for rare diseases have a high rate of success in obtaining regulatory approval, with around 26% being approved, versus 11% for all other drugs.
Rare diseases affect fewer than 200,000 individuals and of the more than 7,000 rare or orphan diseases, 90% are without any FDA-approved treatment. Drugs that make it to market have defined, concentrated patient populations, and limited or no competition from established therapeutics. Orphan drug development represents a lucrative opportunity for drug developers and can often be more profitable than non-orphan therapeutics.
On the FDA Fast Track
The market for rare diseases is robust. In 2019, nearly half of all FDA approvals (44%) were for orphan drugs. Early, and sometimes more frequent, discussions with the FDA can help reduce the uncertainty of how applications will be received, helping with planning and managing expectations both in and out of the clinic.
Quoin Pharmaceuticals (NASDAQ: QNRX), a specialty pharmaceutical company developing therapeutics for rare skin disorders, is an excellent example of a company that has found that R&D sweet spot. Quoin’s management team has received very constructive feedback from the FDA regarding its lead candidate, QRX003, for Netherton Syndrome, and now has a clear pathway to approval. The FDA’s supportive position has resulted in the potential for a lower criteria for a successful clinical outcome. In addition, QRX003 potentially qualifies for Rare Pediatric Disease Designation and a freely tradable Priority Review Voucher on approval, which could result in a net cash influx of approximately $100 million. The product also qualifies for a number of expedited approval pathways.
Pricing Power
Although patient populations for rare and orphan diseases are smaller in scale, they can be well-defined and are often geographically concentrated. Due to the rarity of these conditions, a small number of specialist physicians often treat entire patient groups, and these can be more easily identified and targeted for marketing. As the only available, approved treatment for a specific condition, orphan drugs have higher pricing power and can be highly profitable in spite of smaller addressable market sizes. The mean orphan drug cost per patient of the top 100 US orphan drugs is almost 4.5 times greater than the non-orphan drug cost, and orphan drug sales are forecast to reach $217 billion in 2024.
Quoin Pharmaceuticals is positioning QRX003 as a ‘whole body, whole life’ therapeutic, meaning that patients will apply the once-daily topical lotion to their entire skin surface, for the rest of their lives, providing a long-term market opportunity for the company. Quoin also intends to pursue the development of QRX003 for related rare skin disorders for which there are currently no approved treatments or therapies, such as SAM Syndrome and Peeling Skin Syndrome.
Delivering Value
For investors and shareholders, growth, progress and value are key. Strong FDA engagement, incentivized drug development programs and low market competition are an attractive value proposition for investors. With a $25 million cash runway, Quoin has been adding value beyond drug development, by entering into licensing and distribution partnerships to ensure a wider commercialization of its products beyond the company’s core US and EU markets.
Quoin recently entered into an exclusive license and distribution agreement with AFT Pharmaceuticals for the commercialization of QRX003 in Australia and New Zealand. It has also inked an exclusive agreement with rare disease and specialty pharmaceutical company, GenPharm, for the MENA region. Additional out-licensing opportunities are being actively pursued by the company.
Quoin is targeting regulatory approvals for its pipeline of therapeutics in the US and Europe in 2024, 2025 and 2026 and plans to establish its own commercial infrastructure for sales and distribution in both geographies.
Finally, Quoin has demonstrated its commitment to longer term R&D opportunities by in-licensing a novel protein from the Queensland University of Technology in Australia.
Market-Creating Impact
Since 1983, when the Orphan Drug Act changed the face of drug development, rare and orphan drugs have had market-creating impact. Beyond the life-altering, and often life-saving, attributes of these treatments, orphan drug designation has a positive financial impact on smaller drug developers. Tax credits for R&D costs, grants and market exclusivity all make for an attractive commercial opportunity for drug developers and value creation for investors.
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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