Press Release
Sector Spotlight: Orphan Drug Developers With Significant Upside
–News Direct–
The biotech sector is finally beginning to recover following a two year stretch of underperformance that was largely driven by rising interest rates and other macro factors. Biotech has a track record of strong recoveries, with the sector typically seeing double-digit gains after a downturn. This is something investors shouldnt ignore.
This recent turnaround can be credited to a robust increase in fundraising efforts and an uptick in IPOs, reaching levels not seen since the peak of the mid-pandemic market boom.
According to the Financial Times, drug developers raised $6 billion in equity capital markets in January, the largest total since February 2021 a period when biotech stocks hit their all-time high. Moreover, the SPDR S&P Biotech ETF (XBI) returned 28.7% over the past six months alone, clearly illustrating investors' rising confidence in the biotech rebound.
Identifying biotech stocks with the potential to deliver superior returns is no easy feat. There are specific milestones that companies can achieve to signal positive momentum to investors. For example, smaller biotech companies may have received the nod from regulatory authorities such as the FDA, or new breakthroughs from clinical trials, to offer a compelling investment opportunity.
With that in mind, two stocks that investors should consider looking at are Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) and Kiniksa Pharmaceuticals (NASDAQ:KNSA).
Cardiol Therapeutics lead product is CardiolRx, a small molecule therapy that appears on track to bring major disruption to the pericarditis market.
CardiolRx received a vote of confidence as it was granted Orphan Drug Designation (ODD) by the FDA for the treatment of pericarditis back in February, illustrating the potential of the drug. Apart from providing a seven-year term of market exclusivity upon final FDA approval, the ODD also positions Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees, and certain tax credits.
The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders, defined as one that affects fewer than 200,000 people in the U.S. There are approximately 160,000 cases of recurrent pericarditis in the U.S. annually, which includes 38,000 cases with a recurrence. Having secured FDA approval, Cardiol Therapeutics is an exemplary company likely to attract biotech investors seeking assurance in smaller firms.
While the stock had a significant rally on the backdrop of this news and continues to show strength, we believe that there is still potential for further upside.
Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) is expected to release topline data in June for its Phase 2 MAvERIC-Pilot clinical trial, which if positive, could unlock significant shareholder value. Several analysts have already indicated that they are highly optimistic that the data could be a catalyst, with one analyst noting that CardiolRxs potential to be a safe, new approach to RP (recurrent pericarditis) treatment is underappreciated.
CardiolRx stands out when compared to the only FDA-approved therapy because it is administered orally and expected to be offered as a first-line therapy for pericarditis, opening it up to an even bigger opportunity as it could be prescribed at the first occurrence.
Orphan drugs have become lucrative business opportunities because these drugs command premium drug pricing, with the average price for an orphan drug at $32,000 per year per patient according to a 2021 study published in the journal Rare Diseases & Journal of Orphan Drugs.
That could explain why analysts who have been tracking CRDL are so bullish on the stock. For instance, Joe Gantoss of Chimera Research Group says he wont be surprised to see Cardiols price break past the 3-year high at $4.96, while analyst Vernon Bernardino of H.C. Wainwright & Co. reiterated their Buy rating and issued a $9.00 price target.
That would imply that Cardiol Therapeutics (NASDAQ:CRDL) (TSX:CRDL) has a potential upside of about 300% from its current share price.
Kiniksa Pharmaceuticals (NASDAQ:KNSA) offers some insight into the revenue potential of an orphan drug that treats recurrent pericarditis.
So far, KNSA has had a great run, gaining about 36% over the past year and trading at about $18.00 per share despite challenges in the sector. It is currently valued at $1.3 billion. Kiniksas portfolio of assets includes ARCALYST, the first and only FDA-approved therapy for recurrent pericarditis.
For some context, the FDA granted Breakthrough Therapy designation to ARCALYST for recurrent pericarditis in 2019; the FDA granted Orphan Drug exclusivity to ARCALYST in March 2021 for the treatment of recurrent pericarditis and a reduction in the risk of recurrence in adults and pediatric patients 12 years of age and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021.
Sales of ARCALYST were $38.5 million in 2021; $122.5 million in 2022; $233.2 million in 2023 further reaffirming the massive revenue potential for treating recurrent pericarditis. For the first quarter of 2024, ARCALYST sales were $78.9 million representing 85% year-over-year growth.
Furthermore, since its launch in April 2021, approximately 2,000 prescribers have written ARCALYST prescriptions for recurrent pericarditis, illustrating the massive demand for effective recurrent pericarditis therapies.
Going forward, Kiniksa anticipates that it will bring in between $370 million and $390 million in 2024, up from the earlier guidance of $360 million to $380 million. The revised outlook represents roughly 63% year-over-year growth at the midpoint.
Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by Cardiol Therapeutics to assist in the production and distribution of content related to CRDL. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content.
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View source version on newsdirect.com: https://newsdirect.com/news/sector-spotlight-orphan-drug-developers-with-significant-upside-473277125
RazorPitch CRDL, KNSA
COMTEX_453280304/2655/2024-06-03T07:03:00
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Press Release
Superior Roofing & Siding Long Island Launches to Serve Long Island Homeowners and Businesses
Superior Roofing & Siding Long Island has officially opened its doors, offering expert roofing and siding solutions for residential and commercial properties across Long Island. The company combines decades of industry experience to provide high-quality services, including roof installation, repair, siding installation, maintenance, and comprehensive commercial roofing solutions. With a focus on superior craftsmanship, exceptional customer care, and a customer-first philosophy, Superior Roofing & Siding Long Island is poised to become a trusted name in the Long Island community. Backed by a workmanship guarantee and licensed and insured professionals, the company delivers durable, aesthetically pleasing results that stand the test of time.
Long Island, NY, United States, 6th Jan 2025 – Superior Roofing & Siding Long Island is proud to announce its official opening, bringing expert roofing and siding services to homeowners and businesses throughout Long Island. This new venture combines decades of industry expertise to deliver reliable, high-quality roofing and siding solutions for both residential and commercial properties.
Specializing in comprehensive exterior services, Superior Roofing & Siding Long Island offers roof installation, repair, maintenance, siding installation, and more. With a commitment to superior craftsmanship and exceptional customer care, the company is poised to become Long Island’s go-to solution for protecting and enhancing properties.
“We look forward to bringing an even greater depth of expertise and resources to the Long Island community,” said Julian Hooks, CMO of Contractor Lead Partners. “Together, we aim to provide dependable, long-lasting solutions that improve both functionality and aesthetic appeal.”
Services Offered
- Roof Installation & Repair: High-quality materials and skilled craftsmanship to address all roofing needs.
- Siding Installation & Repair: Durable, weather-resistant siding to protect and beautify homes and businesses.
- Roof Inspections & Maintenance: Preventative services to extend the life of roofs and catch issues early.
- Commercial Roofing Solutions: Expertise in flat, metal, and other commercial roofing systems.
- General Contracting Services: Seamless collaboration with General Contractors for larger projects.
Why Choose Superior Roofing & Siding Long Island?
- Partnership Expertise: Leveraging the resources and experience of expert roofing contractors for unbeatable results.
- Customer-First Philosophy: Transparent communication and tailored solutions for every client.
- Licensed & Insured: Ensuring safety and professionalism on every project.
- Workmanship Guarantee: Backed by a commitment to excellence and client satisfaction.
To mark its grand opening, Superior Roofing & Siding Long Island is offering free roof inspections for a limited time.
Residents and business owners can learn more or schedule a free consultation by visiting https://superiorroofinglongisland.com/ or calling 631-817-4907.
About Superior Roofing & Siding Long Island
Superior Roofing & Siding Long Island is a trusted provider of roofing and siding solutions for Long Island residents and businesses. The company combines unmatched craftsmanship, local expertise, and exceptional service to deliver superior results that stand the test of time.
Media Contact
Organization: Superior Roofing & Siding Long Island
Contact Person: Julian Hooks
Website: https://superiorroofinglongisland.com/
Email: julian@contractorleadpartner.scom
City: Long Island
State: NY
Country: United States
Release Id: 06012522313
The post Superior Roofing & Siding Long Island Launches to Serve Long Island Homeowners and Businesses appeared on King Newswire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.
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Press Release
Car Garage Expert Launches Comprehensive Automotive Services in Dubai
Dubai, United Arab Emirates, 6th Jan 2025 – Car Garage Expert, a leading name in automotive services, has announced the launch of its fully integrated car repair and roadside assistance solutions in Dubai. With a mission to redefine convenience and reliability for motorists, the company is set to become a trusted partner for vehicle maintenance and emergency support.
The newly launched services include a state-of-the-art car garage near me offering expert diagnostics, repairs, and routine maintenance for all vehicle types. Complementing this is their 24/7 roadside assistance service, designed to provide immediate help for breakdowns, flat tires, and battery failures across Dubai.
“Drivers in Dubai deserve fast, reliable, and professional automotive services,” said Muhammad Fahad Malik, CEO of Car Garage Expert. “Our integrated approach ensures that whether it’s a routine service or an unexpected roadside emergency, help is always just a call away.”
Car Garage Expert aims to address the challenges of Dubai’s fast-paced lifestyle by offering seamless solutions tailored to the needs of modern motorists. With a focus on quality and customer satisfaction, the company has positioned itself as a one-stop destination for automotive care.
About Car Garage Expert
Car Garage Expert is a premier automotive service provider in Dubai, known for its commitment to excellence and customer-first approach. From cutting-edge car garage facilities to dependable 24/7 roadside assistanceDubai, the company delivers unparalleled convenience and peace of mind to drivers across the city.
Media Contact
Organization: Car Garage Expert
Contact Person: Mian Muhammad Fahad
Website: https://CarGarageExpert.com
Email: info@cargarageexpert.com
Contact Number: +971555797960
Country: United Arab Emirates
Release Id: 06012522292
The post Car Garage Expert Launches Comprehensive Automotive Services in Dubai appeared on King Newswire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.
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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.
Press Release
DCpay Launches Revolutionary Cross-Border Payment Solution
Singapore – DCpay, founded by renowned blockchain expert Dr. Wei Junhua, has launched a high-performance cross-border payment platform based on blockchain technology, which aims to replace the traditional SWIFT system and provide low-cost and efficient payment services to global users. This innovative solution has brought disruptive changes to global capital flows and cross-border remittances.
Technological innovation drives payment revolution
DCpay relies on leading blockchain technology to support 100,000 transactions per second and has the ability to expand to 1 million transactions per second. This makes it one of the most efficient payment systems currently. The platform’s native token DCP is similar to Ethereum’s ETH, which is not only used to pay handling fees, but also plays an important role in the entire ecosystem, such as transaction settlement and smart contract execution.
Global legal and compliance layout
DCpay has obtained a cryptocurrency license from the Czech Republic and a Canadian MSB (Money Services Business) license, providing a solid legal basis for its global operations. These qualifications ensure that the platform meets international regulatory requirements and enhances users’ trust in its services.
Wide application scenarios and advantages
DCpay provides legal currency payment and cross-border remittance functions, allowing users to easily transfer funds to any country in the world. Compared with traditional payment methods, its low cost, instant arrival and high transparency are particularly suitable for individual users, small and medium-sized enterprises and cross-border e-commerce.
Future development and market potential
DCpay is committed to continuously optimizing blockchain performance, expanding the scale of the ecosystem, and promoting the popularization of global payments. Dr. Wei Junhua said: “DCpay is not only a payment tool, but also an important bridge connecting the global economy.”
About DCpay
DCpay focuses on using blockchain technology to solve the problem of cross-border payments and provide global users with fast and reliable capital flow solutions. For more information, please visit https://dcpay.io
Or send an email to: admin@dcpay.io
Media Contact:
Full name: WEI JUNHUA
Website: https://dcpay.io
Email: admin@dcpay.io
Address: Singapore
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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.
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