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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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.
PU Prime is excited to introduce its VPS Promotion, designed to help traders achieve seamless, uninterrupted trading. By meeting the deposit and trading volume requirements, eligible clients can get their VPS costs refunded, ensuring a stable and high-speed trading environment.
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For media inquiries, please contact the PU Prime PR team via media@puprime.com.
About PU Prime
Founded in 2015, PU Prime is a leading global fintech company providing innovative online trading solutions. Today, we offer regulated financial products across various asset classes, including forex, commodities, indices, and shares. Committed to providing advanced technology and educational resources, PU Prime supports traders and investors at every stage, from beginner to professional. With a presence in over 200 countries and exceeding 40 million app downloads, PU Prime is dedicated to enabling financial success and fostering a global community of empowered traders. Discover PU Prime’s latest promotions and join us for a fruitful trading journey today.
Company Information
Organization:PU Prime
Contact Person Name:Qianyi Hong
Website:https://www.puprime.com/
Email:media@puprime.com
About Author
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.
PU Prime, a globally acclaimed online trading platform, has secured the coveted title of Best Partnership Program Brokerage Firm Global 2025, awarded by the prestigious Global Business & Finance Magazine. This recognition shines a spotlight on PU Prime’s unwavering dedication to excellence, groundbreaking innovation, and top-tier partnership offerings that set it apart in the financial world.
The Global Business & Finance Magazine stands as a trusted authority, delivering sharp, unbiased insights into the international business and finance scene. With a team of veteran journalists and industry experts, the magazine keeps its audience ahead of the curve on global markets, investment tactics, corporate finance, and economic policies. Through its renowned awards, it celebrates trailblazers—individuals, companies, and organizations—that push the boundaries of achievement in the business and finance sectors.
A Nod to PU Prime’s Stellar Standards
The Best Partnership Program Brokerage Firm Global award highlights firms excelling in service, transparency, and partner value. PU Prime’s partnership program has been a game-changer, building strong, win-win relationships with affiliates, introducing brokers (IBs), and institutional partners across the globe. Armed with cutting-edge trading tech, lucrative commission setups, and hands-on support, PU Prime is redefining what’s possible in financial services.
This global accolade cements PU Prime’s status as a frontrunner in the financial markets, driven by its relentless push to refine its partnership model with fresh strategies, sharper tools, and flawless user experiences.
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PU Prime’s award-winning program packs a punch with perks like:
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By pouring resources into its partners and delivering elite tools, PU Prime locks in growth and success amid a fast-changing financial landscape.
Eyes on the Future
As PU Prime basks in this milestone, the firm is already gearing up to broaden its global footprint and supercharge its partnership network. Built on trust, dependability, and bold innovation, PU Prime is poised to keep empowering partners and traders while raising the bar for the industry.
For press inquiries, reach out to our PR crew at media@puprime.com.
About PU Prime
Founded in 2015, PU Prime is a leading global fintech company providing innovative online trading solutions. Today, we offer regulated financial products across various asset classes, including forex, commodities, indices, and shares. Committed to providing advanced technology and educational resources, PU Prime supports traders and investors at every stage, from beginner to professional. With a presence in over 200 countries and exceeding 40 million app downloads, PU Prime is dedicated to enabling financial success and fostering a global community of empowered traders. Discover PU Prime’s latest promotions and join us for a fruitful trading journey today.
Company Information
Organization:PU Prime
Contact Person Name:Qianyi Hong
Website:https://www.puprime.com/
Email:media@puprime.com
About Author
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.
PU Prime, a globally recognized online trading platform, is proud to announce its partnership with the Argentine Football Association (AFA) as an Official Regional Sponsor. The partnership, commencing on March 17, 2025, underscores PU Prime’s commitment to excellence and innovation, aligning with one of the most iconic institutions in world football.
This collaboration reflects the shared values between football and trading—discipline, strategy, and execution—all of which are key to achieving success both on and off the field. PU Prime will leverage this partnership to strengthen its regional presence while engaging with football fans through exclusive experiences and unique promotional activities.
As part of the agreement, PU Prime will gain access to a wide range of marketing assets, including exclusive VIP experiences, match tickets, and signed jerseys from AFA icons. These exclusive opportunities will enhance PU Prime’s brand presence and engagement within the football community.
“We are delighted to welcome PU Prime as an official sponsor of the Argentine Football Association. At AFA, we continue to collaborate with strategic partners that share our vision and values, both on and off the pitch. PU Prime’s leadership in its sector aligns with our commitment to excellence, and we look forward to a strong and successful partnership,” said Claudio Fabián Tapia, President of AFA.
“We are honored to partner with such a legendary institution. Just as the Argentina National Team has cemented its place as a powerhouse in world football, PU Prime is on a similar trajectory—continuously evolving, innovating, and striving for excellence. This collaboration embodies the spirit of teamwork and perseverance, values that define both great football teams and great trading platforms,” added Daniel Bruce, Managing Director of PU Prime.
More than just a sponsorship, this partnership is a tribute to passion, performance, and the relentless pursuit of excellence. Whether in trading or football, success is driven by precision, strategy, and commitment. PU Prime is excited to bring exclusive experiences to its clients, reinforcing its dedication to innovation and excellence in every aspect of its business.
For more information about the partnership, please visit https://www.puprime.com/pu-prime-becomes-the-official-regional-sponsor-of-the-argentine-football-association/ .
About AFA
Founded in 1893, the Argentine Football Association (AFA) is the governing body of football in Argentina and one of the oldest football federations in the world. Headquartered in Buenos Aires, AFA oversees all aspects of the sport, including the organization of domestic leagues such as the Primera División, Primera Nacional, and lower divisions, as well as national cup competitions like the Copa Argentina and Supercopa Argentina.
For more information, kindly refer to afa.com.ar.
Company Information
Organization:PU Prime
Contact Person Name:Qianyi Hong
Website:https://www.puprime.com/
Email:media@puprime.com
About Author
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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