Latest news with #IgAN
Yahoo
07-07-2025
- Business
- Yahoo
Leerink Partners Reiterates a Bullish Stance on Travere Therapeutics (TVTX)
Travere Therapeutics, Inc. (NASDAQ:TVTX) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On June 16, Leerink Partners analyst Joseph Schwartz reiterated the firm's bullish stance on Travere Therapeutics, Inc. (NASDAQ:TVTX), assigning it a Buy rating and a $42 price target. The analyst supported the positive rating with Travere Therapeutics, Inc.'s (NASDAQ:TVTX) positive trajectory, supported by its product Filspari, which attained complete approval for the treatment of IgA nephropathy (IgAN) in 2023. A laboratory technician working on a solution of rare diseases, housed in a cholic acid capsule. When considered in conjunction with the updated treatment guidelines, this approval has resulted in a notable growth in Filspari's market presence. Although competition is anticipated to rise in the IgAN market, the firm anticipates Filspari to hold a competitive market edge due to its full approval status, as other treatments only have accelerated approval. Schwartz also reasoned that Travere Therapeutics, Inc. (NASDAQ:TVTX) is looking into expansion opportunities in focal segmental glomerulosclerosis (FSGS), and a supplemental New Drug Application is under review by the FDA. While such processes have inherent regulatory risks, the analyst expressed optimism about Travere Therapeutics, Inc.'s (NASDAQ:TVTX) prospects because of its strategic positioning and management's confidence. Guggenheim analyst Vamil Divan also reiterated a Buy rating on Travere Therapeutics, Inc.'s (NASDAQ:TVTX) on July 2 with a price target of $47.00. Travere Therapeutics, Inc. (NASDAQ:TVTX) is a biopharmaceutical company that identifies, develops, and delivers therapies for rare kidney and metabolic diseases. Its product, FILSPARI (sparsentan), reduces proteinuria in individuals with primary IgAN at risk of rapid disease progression. The company's commercial products, Thiola and Thiola EC, treat cystinuria, a rare genetic cystine transport disorder. While we acknowledge the potential of TVTX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data


Int'l Business Times
30-06-2025
- Business
- Int'l Business Times
Travere Therapeutics Draws Institutional Interest from Armistice Capital, Driehaus, and Wellington
Travere Therapeutics stock has climbed roughly 110% from its 52-week low of around $6.80 to $14.30, as hedge funds such as Armistice Capital, Driehaus Capital Management, and Wellington Management have built positions around the company's rare kidney disease therapeutics. The biopharmaceutical company's lead asset, FILSPARI, has achieved full FDA approval for IgA nephropathy (IgAN), or Berger's disease. Fourth quarter 2024 revenue reached $73.5 million, driven by FILSPARI's momentum in kidney disease treatment, while the company maintained a robust $370.7 million cash position. The performance has attracted attention from both specialized healthcare investors and broader institutional managers. FILSPARI and Regulatory Momentum FILSPARI received full FDA approval in the third quarter of 2024 as the only non-immunosuppressive treatment that significantly slows kidney function decline in IgAN. The regulatory achievement transformed the drug from an accelerated approval based on surrogate endpoints to full approval based on clinically meaningful outcomes. It initially received accelerated approval on February 17, 2023, for reducing proteinuria in adults with primary IgAN, with commercial availability beginning the week of February 27, 2023. Converting to full approval within 18 months reflects both the strength of clinical data and the company's regulatory execution capabilities. The FDA recently accepted for review Travere's supplemental New Drug Application requesting modification of liver monitoring for FILSPARI in IgAN, with a target action date of August 28, 2025. Reducing monitoring requirements could expand patient access and physician adoption, factors that institutional investors monitor closely when evaluating commercial potential. Pipeline Expansion Beyond IgAN, Travere is developing sparsentan to treat focal segmental glomerulosclerosis (FSGS), another rare kidney disease that often leads to kidney failure. FSGS damages the tiny filters in the kidneys, causing protein to leak into urine. Following meetings with the FDA, the company plans to submit a supplemental New Drug Application for FSGS treatment around the end of the first quarter of 2025, using data from two major clinical studies called DUPLEX and DUET. If approved, sparsentan would become the first FDA-approved medicine specifically for FSGS patients, giving Travere a significant competitive advantage in treating this rare condition. The company is also developing a drug called pegtibatinase for homocystinuria, a genetic disorder where the body cannot properly break down certain amino acids. This buildup can damage blood vessels and cause developmental delays. International expansion could provide another growth avenue. Travere's partner Renalys Pharma expects results from its Phase 3 clinical trial of sparsentan for IgAN treatment in Japan during the second half of 2025. This partnership allows Travere to enter the Japanese market without direct investment while receiving milestone payments and future royalties if the treatment succeeds. Institutional Investment Travere Therapeutics has 447 institutional owners holding a total of 117,537,916 shares, with the largest shareholders including Armistice Capital, BlackRock Inc., Janus Henderson Group, Vanguard Group Inc., and Driehaus Capital Management. The institutional ownership structure spans both passive index funds and active specialty investors. Armistice Capital owns approximately 8.9 million shares, accounting for 2.38% of the hedge fund's portfolio. Other institutional participants include Wellington Management Group, which acquired a new stake during the fourth quarter, purchasing 33,493 shares valued at approximately $583,000. Emerald Advisers LLC raised its stake by 8.4% during the fourth quarter to 2,125,744 shares worth $37.03 million. Several major institutional investors expanded their Travere positions during the fourth quarter. Rock Springs Capital Management added 289,173 shares, bringing its total to nearly 5 million shares valued at $86.6 million. Renaissance Technologies increased its stake by 28.5% to 2.4 million shares worth $42 million. Driehaus Capital Management made the largest percentage increase, adding over 1.9 million shares for a 608% jump. The firm now holds 2.2 million shares valued at $38.6 million. Jacobs Levy Equity Management grew its position by 37% to 2.2 million shares worth $37.9 million, while Emerald Advisers added 165,085 shares to reach 2.1 million shares valued at $37 million. The combination of new entrants and existing shareholders increasing positions is a sign of continuing investor interest amid the stock's strong performance over the past year. Financial Position and Development Goals Travere ended 2024 with approximately $371 million in cash, cash equivalents, and marketable securities. The financial position supports ongoing commercial activities and clinical development through multiple regulatory catalysts without requiring additional equity financing. As of June 2025, Travere's market capitalization stood at approximately $1.27 billion. Meanwhile, the rare disease therapeutic market presents unique investment characteristics that attract institutional capital. Institutional investors evaluate rare disease companies based on regulatory expertise, commercial execution capabilities, and pipeline diversification. Travere's progression from accelerated to full approval demonstrates regulatory competence, while consistent patient start form growth is a sign of commercial execution. The company's advancement of multiple indications for sparsentan and development of pegtibatinase provide portfolio diversification within the rare disease focus. Investment from hedge funds such as Armistice Capital, Driehaus Capital Management, and Wellington Management reflects institutional positions on Travere's ability to execute on its rare disease focus. The combination of commercial revenue, regulatory momentum, and pipeline expansion opportunities continues to attract institutional capital to the company's equity.
Yahoo
26-06-2025
- Health
- Yahoo
BioCity's SC0062 gains NMPA breakthrough therapy designation
The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted BioCity's endothelin receptor type A (ETA) antagonist, SC0062, a second breakthrough therapy designation (BTD). This new designation is intended to treat diabetic kidney disease (DKD) with albuminuria and highlights the therapy's potential for chronic kidney disease indications. The BTD was supported by data from the DKD cohort of the Phase II 2-SUCCEED trial, and SC0062 showed major reductions in albuminuria at the 20mg dose against placebo. The safety profile was favourable both as monotherapy and when combined with treatments such as SGLT2 inhibitors, GLP-1 receptor agonists, RAAS inhibitors, insulin and Finerenone. BioCity co-founder and executive president Dr Ivy Wang stated: 'With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges. 'This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide.' The completed 2-SUCCEED programme achieved all efficacy and safety endpoints at 12 and 24-week timepoints for both Immunoglobulin A nephropathy (IgAN) and DKD cohorts. SC0062 may slow CKD progression compared to non-selective treatments while minimising side effects. Preclinical studies have shown that it significantly improved pathological scores in acute and CKD models. The therapy has completed Phase I trials, demonstrating good tolerability, safety and pharmacokinetics without signs of fluid retention. It has now concluded enrolment for both IgAN and DKD cohorts in the Phase II 2-SUCCEED study and the cohorts have met their primary endpoints. With these developments underway, BioCity is initiating two Phase III clinical trials that include SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). "BioCity's SC0062 gains NMPA breakthrough therapy designation" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 登入存取你的投資組合
Yahoo
24-06-2025
- Business
- Yahoo
BAFF- and APRIL-targeted Therapies Market Sees Surge in Activity Amid Rising Autoimmune Disease Burden
The BAFF- and APRIL-targeted therapies market is experiencing steady growth driven by the rising prevalence of autoimmune diseases such as systemic lupus erythematosus (SLE), IgA nephropathy, and Sjögren's syndrome. Advancements in biologics and the entry of pipeline agents with improved efficacy profiles are further fueling market expansion. LAS VEGAS, June 24, 2025 /PRNewswire/ -- DelveInsight's BAFF- and APRIL-targeted Therapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging BAFF- and APRIL-targeted therapies, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the BAFF- and APRIL-targeted Therapies Market Report As per DelveInsight's analysis, the total market size of BAFF- and APRIL-targeted therapies in the 7MM is expected to surge significantly by 2034. BAFF and APRIL-targeted therapies are actively being developed to address a broad spectrum of autoimmune diseases, including IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions, offering promising new options to modulate pathogenic B-cell activity and improve patient outcomes. Leading BAFF- and APRIL-targeted therapies companies, such as Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others, are developing novel BAFF- and APRIL-targeted therapies that can be available in the BAFF- and APRIL-targeted therapies market in the coming years. Some of the key BAFF- and APRIL-targeted therapies in the pipeline include Atacicept, Telitacicept, AUR200, and others. In May 2025, Vera Therapeutics announced that primary endpoint results from the pivotal Phase III ORIGIN 3 trial of atacicept in Immunoglobulin A Nephropathy (IgAN) are expected in Q2 2025, with plans to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in Q4 2025 for accelerated approval, targeting a potential PDUFA date and commercial launch in 2026. In November 2024, the European Medicines Agency (EMA) granted orphan medicine designation to Atacicept for the treatment of IgAN. In May 2024, Vera Therapeutics announced that the US FDA had granted Breakthrough Therapy Designation (BTD) to atacicept for the treatment of IgAN. The designation reflects the FDA's determination that, based on an assessment of data from the Phase IIb ORIGIN clinical trial of atacicept for IgAN, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Discover which indication is expected to grab the major BAFF- and APRIL-targeted therapies market share @ BAFF- and APRIL-targeted Therapies Market Report BAFF- and APRIL-targeted Therapies Market Dynamics The BAFF- and APRIL-targeted therapies market is evolving rapidly, driven by a growing understanding of B-cell biology and its role in autoimmune diseases. BAFF and APRIL are crucial for B-cell survival, maturation, and function. Overexpression of these cytokines has been implicated in diseases such as IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions. Therapies targeting these pathways aim to modulate abnormal B-cell activity, offering more precise immunomodulatory approaches compared to broad immunosuppressants. Market interest in this space has intensified with the development of biologics like atacicept and, more recently, telitacicept. These agents work by neutralizing excess BAFF and/or APRIL, reducing pathogenic autoantibody production. The differentiated mechanism of dual targeting is believed to offer superior efficacy in certain patient subtypes, fueling competitive development programs. The market dynamics are shaped by both unmet clinical needs and strategic commercial considerations. Autoimmune diseases, particularly lupus and IgAN, have long suffered from limited treatment options with poor tolerability or efficacy. As a result, payers and clinicians are keen on alternatives that offer disease modification and long-term remission. However, safety remains a concern, especially the risk of hypogammaglobulinemia and infections due to B-cell suppression. This risk-benefit balance is a key differentiator in positioning products within the competitive landscape. Overall, the BAFF/APRIL-targeted therapy market is transitioning from experimental to established, with first-in-class and best-in-class competition intensifying. Pipeline diversity, biomarker-driven patient selection, and combinatorial strategies with other immunotherapies will be central to shaping the future landscape. As real-world evidence accumulates and regulatory agencies refine guidance, these therapies may move from niche indications to broader frontline use in autoimmune care. BAFF- and APRIL-targeted Therapies Treatment Market The landscape for BAFF- and APRIL-targeted therapies is undergoing rapid transformation, fueled by the pressing need for more precise B cell modulation in autoimmune disorders. As of 2025, no fusion proteins targeting these pathways have received FDA approval, but several promising candidates are advancing through late-stage clinical trials. This progress reflects a positive shift in the field, pointing toward more effective dual-pathway immunotherapies that could address the shortcomings of existing treatments and provide renewed hope for patients with challenging autoimmune conditions. Learn more about the BAFF- and APRIL-targeted therapies @ BAFF- and APRIL-targeted Therapies Analysis Key Emerging BAFF- and APRIL-targeted Therapies and Companies Some of the BAFF- and APRIL-targeted therapies in the pipeline include Atacicept (Vera Therapeutics), Telitacicept (RemeGen), AUR200 (Aurinia Pharmaceuticals), and others. Atacicept is an investigational fusion protein composed of the soluble form of the TACI receptor, which binds to the cytokines BAFF and APRIL—members of the TNF family involved in supporting B-cell survival and promoting the production of autoantibodies linked to autoimmune conditions such as IgAN and lupus nephritis. Vera Therapeutics views atacicept as a strong contender for best-in-class status due to its dual targeting of B cells and plasma cells to lower autoantibody levels. The drug has already been tested in over 1,500 patients across multiple indications in clinical trials. Atacicept is currently undergoing Phase III trials for the treatment of IgAN. Telitacicept, developed by RemeGen, is another fusion protein that also targets BAFF and APRIL, aiming to treat autoimmune diseases driven by B cells. It is being studied globally, including in the U.S., for conditions such as myasthenia gravis, systemic lupus erythematosus (SLE), and Sjögren's syndrome. The U.S. FDA has granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for telitacicept in myasthenia gravis. A notable advancement in its development came in August 2024, when the first U.S. patient was enrolled in a global Phase III trial for generalized myasthenia gravis. The anticipated launch of these emerging therapies are poised to transform the BAFF- and APRIL-targeted therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the BAFF- and APRIL-targeted therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about BAFF- and APRIL-targeted therapies clinical trials, visit @ BAFF- and APRIL-targeted Therapies Treatment BAFF- and APRIL-targeted Therapies Overview BAFF and APRIL, both part of the TNF family, are key regulators of B cell survival, development, and antibody class switching through their interactions with the receptors BAFF-R, TACI, and BCMA. When the BAFF/APRIL pathway becomes dysregulated, often due to ligand overexpression, it can trigger abnormal B cell activation and drive the development of autoimmune diseases. BAFF mainly signals through BAFF-R, activating both the classical and alternative NF-κB pathways, while APRIL binds to TACI and BCMA and also interacts with heparan sulfate proteoglycans to amplify B cell responses. Given their pivotal role in immune system regulation, BAFF and APRIL have emerged as promising therapeutic targets. Clinical studies have shown that inhibiting BAFF can significantly reduce disease activity in various autoimmune conditions by curbing harmful B-cell activity and helping to restore immune homeostasis. BAFF- and APRIL-targeted Therapies Epidemiology Segmentation The BAFF- and APRIL-targeted therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases in Selected Indications for BAFF- and APRIL-targeted Therapies Total Eligible Patient Pool in Selected Indications for BAFF- and APRIL-targeted Therapies Total Treated Cases in Selected Indications for BAFF- and APRIL-targeted Therapies BAFF- and APRIL-targeted Therapies Report Metrics Details Study Period 2020–2034 BAFF- and APRIL-targeted Therapies Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report IgA nephropathy (IgAN), lupus nephritis, myasthenia gravis, systemic lupus erythematosus (SLE), Sjögren's syndrome, and other B-cell-mediated autoimmune conditions Key BAFF- and APRIL-targeted Therapies Companies Vera Therapeutics, RemeGen, Aurinia Pharmaceuticals, and others Key BAFF- and APRIL-targeted Therapies Atacicept, Telitacicept, AUR200, and others Scope of the BAFF- and APRIL-targeted Therapies Market Report BAFF- and APRIL-targeted Therapies Therapeutic Assessment: BAFF- and APRIL-targeted Therapies current marketed and emerging therapies BAFF- and APRIL-targeted Therapies Market Dynamics: Conjoint Analysis of Emerging BAFF- and APRIL-targeted Therapies Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, BAFF- and APRIL-targeted Therapies Market Access and Reimbursement Discover more about BAFF- and APRIL-targeted therapies in development @ BAFF- and APRIL-targeted Therapies Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary 4. Key Events 5. Epidemiology and Market Forecast Methodology 6. BAFF- and APRIL-targeted Therapies Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2025 6.2. Market Share (%) Distribution by Therapies in 2034 6.3. Market Share (%) Distribution by Indications in 2025 6.4. Market Share (%) Distribution by Indications in 2034 7. BAFF- and APRIL-targeted Therapies: Background and Overview 7.1. Introduction 7.2. Potential of BAFF- and APRIL-targeted Therapies in Different Indications 7.3. Clinical Applications of BAFF- and APRIL-targeted Therapies 8. Target Patient Pool of BAFF- and APRIL-targeted Therapies 8.1. Assumptions and Rationale 8.2. Key Findings 8.3. Total Cases of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 8.4. Total Eligible Patient Pool of Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 8.5. Total Treatable Cases in Selected Indication for BAFF- and APRIL-targeted Therapies in the 7MM 9. Emerging Therapies 9.1. Key Competitors 9.2. Atacicept: Vera Therapeutics 9.2.1. Product Description 9.2.2. Other developmental activities 9.2.3. Clinical development 9.2.4. Safety and efficacy 9.3. Telitacicept: RemeGen 9.3.1. Product Description 9.3.2. Other developmental activities 9.3.3. Clinical development 9.3.4. Safety and efficacy List to be continued in the report 10. BAFF- and APRIL-targeted Therapies: Seven Major Market Analysis 10.1. Key Findings 10.2. Market Outlook 10.3. Conjoint Analysis 10.4. Key Market Forecast Assumptions 10.4.1. Cost Assumptions and Rebates 10.4.2. Pricing Trends 10.4.3. Analogue Assessment 10.4.4. Launch Year and Therapy Uptakes 10.5. Total Market Sizes of BAFF- and APRIL-targeted Therapies by Indications in the 7MM 10.6. The United States Market Size 10.6.1. Total Market Size of BAFF- and APRIL-targeted Therapies in the United States 10.6.2. Market Size of BAFF- and APRIL-targeted Therapies by Indication in the United States 10.6.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in the United States 10.7. EU4 and the UK 10.7.1. Total Market Size of BAFF- and APRIL-targeted Therapies in EU4 and the UK 10.7.2. Market Size of BAFF- and APRIL-targeted Therapies by Indications in EU4 and the UK 10.7.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in EU4 and the UK 10.8. Japan 10.8.1. Total Market Size of BAFF- and APRIL-targeted Therapies Inhibitors in Japan 10.8.2. Market Size of BAFF- and APRIL-targeted Therapies by Indications in Japan 10.8.3. Market Size of BAFF- and APRIL-targeted Therapies by Therapies in Japan 11. SWOT Analysis 12. KOL Views 13. Unmet Needs 14. Market Access and Reimbursement 15. Appendix 15.1. Bibliography 15.2. Report Methodology 16. DelveInsight Capabilities 17. Disclaimer 18. 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IgA Nephropathy Market IgA Nephropathy Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IgAN companies, including Novartis, F. Hoffmann-La Roche, Ionis Pharmaceuticals, AstraZeneca (Alexion Pharmaceuticals), Vertex Pharmaceuticals, Otsuka Pharmaceutical, Biogen, Arrowhead Pharmaceuticals, NovelMed, Q32 Bio, Walden Biosciences, Takeda Pharmaceutical, Vera Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-06-2025
- Business
- Yahoo
2 Small-Cap Stocks Under $10 to Buy With Big Potential
The biotechnology industry is rapidly changing, thanks to artificial intelligence (AI). In the fast-paced world of biotech investing, small-cap stocks often get overlooked. However, some have the potential to yield significant long-term gains. These emerging biotech companies, each priced under $10, have groundbreaking pipelines. The Next Trillion-Dollar Boom? 3 Stocks to Buy with 300 Million Humanoid Robots on the Horizon. Meta's Mark Zuckerberg Says the Technology They're Developing Will 'See What You See and Hear What You Hear' Warren Buffett's Berkshire Hathaway Now Pays 5% of All Corporate Income Taxes in America Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. For investors willing to embrace some risk for the possibility of outsized returns, these two small-cap biotech stocks could offer significant upside as they race to develop next-generation therapies. Jade Biosciences (JBIO) is a clinical-stage biotechnology company focused on developing innovative therapies for autoimmune diseases with significant unmet needs. Jade (formerly a private biotech) recently completed a merger with Aerovate Therapeutics and will now operate under the name Jade Bioscience. The stock began trading on the Nasdaq Exchange under the symbol JBIO on April 29, 2025. The company's lead candidate is JADE-101, an anti-APRIL monoclonal antibody being developed to treat Immunoglobulin A nephropathy (IgAN), a chronic autoimmune kidney disease that is underdiagnosed but has a high unmet need. The company intends to begin the first-in-human clinical trial in the second half of 2025. It expects interim data in the first half of 2026. The company has also advanced JADE 201 (from the JADE 002 program) and is working on another antibody program, JADE 003. Both are currently in the preclinical development phase. In addition to the merger, Jade secured $300 million in a private placement and converted $95 million in convertible notes to fund its pipeline until at least 2027. At the end of the first quarter, its balance sheet showed cash and cash equivalents totaling $49.9 million. The merger brought in an additional $205 million in proceeds, providing runway through 2027. In Q1, the company spent $20 million on R&D, maintaining its aggressive approach. Jade has a strong capital position right now. Furthermore, if JADE 101 is successful, Jade may have a first-mover advantage in the IgAN treatment market. However, as a clinical-stage biotech company, success may be years away. Thus, Jade is a high-risk, high-reward investment opportunity for those who are willing to take the risk. Overall, Wall Street says JBIO is a 'Strong Buy' with all four analysts in coverage optimistic about the stock. Analysts have set a mean target price of $16.67 for the stock, which implies upside potential of 74% from current levels. Its high price estimate is set at $19, which suggests the stock can go as high as 98% over the next 12 months. With a market cap of $81.5 million, TScan Therapeutics (TCRX) is a clinical-stage biotech company focused on T-cell receptor-engineered T-cell therapies (TCR-T) to treat cancer. TScan stock has dipped 50% year-to-date, compared to the overall market gain of 1.8%. The Phase I ALLOHA trial is evaluating TScan's lead programs, TSC 100 and TSC 101, with the goal of preventing relapse following allogeneic hematopoietic cell transplantation (HCT). The company is planning a registration trial for TSC-101 in the second half of 2025 after receiving feedback from regulators. Additionally, TScan intends to file an investigational new drug (IND) application for TSC-102-A0301. While TScan continues to generate no revenue, its collaboration with Amgen (AMGN) resulted in $2.2 million in net revenue in the first quarter. TScan continues to spend heavily on R&D, which totaled $29.8 million in the quarter. Being in the clinical stage, it reported a net loss of $34.1 million, compared to $30.1 million in the prior-year quarter. On its balance sheet, TScan had $251.7 million in cash, cash equivalents, and marketable securities. The company expects to use this cash balance to fund its operations until the first quarter of 2027. With a strong balance sheet, validated platform, promising dual pipelines, and data releases expected in late 2025, the company has significant potential. It is still a high-risk, high-reward small-cap biotech. For long-term investors, this biotech stock is the one to watch. Overall, Wall Street analysts rate Tscan stock a 'Strong Buy.' Of the eight analysts covering the stock, seven rate it a 'Strong Buy,' while one suggests it is a 'Moderate Buy.' The stock's average analyst target price of $9 suggests upside potential of 525% over the next 12 months. The high price target estimate stands at $12, which suggests the stock can climb as much as 733% from current levels. On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data