CAMBRIDGE, Mass., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that members of its executive team will participate in a Fireside Chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12 at 9:30 AM EST. A webcast of the presentation can be accessed through the “Investors” section of Akebia’s website at https://ir.akebia.com followi ...

Company Overview - Akebia Therapeutics, Inc. (AKBA) primarily generates revenue through the commercialization of Vafseo, an oral therapy approved for treating anemia due to chronic kidney disease (CKD) in adults [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience as a lab technician in drug discovery, providing a strong foundation in the challenges of drug development [1] - The analyst has been active in the investment space for five years, focusing on biotechnology companies that innovate through unique mechanisms, first-in-class therapies, or platform technologies [1] Investment Focus - The analyst aims to identify promising biotechnology companies and evaluates the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals and valuation [1] - The goal is to provide insights that help investors understand both opportunities and risks in the biotech sector, which can yield significant returns through breakthrough science [1]

分组1 - Akebia Therapeutics, Inc. (AKBA) primarily generates revenue through the commercialization of Vafseo, an oral therapy approved for treating anemia due to chronic kidney disease (CKD) in adults [1] - The company focuses on identifying promising biotechnology innovations, including novel mechanisms of action and first-in-class therapies, to reshape treatment paradigms [1] - The analysis emphasizes the importance of evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]

Product Development and Clinical Trials - The first patient was dosed in the Phase 2 clinical trial for Praliciguat, targeting focal segmental glomerulosclerosis (FSGS), with initial data expected in 2027[6] - Akebia plans to initiate an open-label Phase 2 rare kidney disease basket study for AKB-097 in the second half of 2026, with initial data generation expected in 2027[12] - The company enrolled approximately 350 patients in the VOCAL Phase IV trial, which is expected to report data in Q4 2026[7] - VOICE trial topline results are expected in early 2027, which may help establish Vafseo as a standard of care for treating anemia due to chronic kidney disease in dialysis[4] Revenue and Market Access - Akebia Therapeutics has secured broad prescribing access for Vafseo, covering approximately 275,000 patients on dialysis, which is expected to drive additional demand in 2026[3] - The company anticipates revenue growth to resume in Q1 2026 due to increased patient access and expected improvements in adherence and compliance[7] - Vafseo's underlying patient dosing demand in Q4 2025 was estimated to be between $10.5 million and $11.5 million, with net product revenue expected to be in the range of $5 million to $6 million[7] - The total number of prescribers for Vafseo increased by 8% in Q4 2025 compared to Q3 2025, reaching approximately 785[7] - At least 25% of new patients in Q4 2025 came from dialysis organizations other than U.S. Renal Care, up from less than 10% in Q3 2025[7] - Akebia's future market opportunities for Vafseo are being evaluated, including potential demand and reimbursement scenarios[25] Strategic Focus and Competitive Landscape - Akebia is leveraging its scientific leadership in nephrology to progress its mid-stage rare kidney disease pipeline, aiming to provide new therapies for patients[2] - Akebia is focused on the potential therapeutic benefits and market acceptance of its products, particularly Vafseo and Auryxia[25] - The company is currently assessing the competitive landscape for Auryxia and Vafseo, including the impact of generic entrants[25] Operational Management and Risks - Akebia is working to maintain profitability while managing operating expenses in line with its operational plan[25] - The company faces risks related to regulatory decisions by health authorities, including the FDA, which could impact its clinical trials and product approvals[25] - Akebia is addressing manufacturing, supply chain, and quality matters, which could affect its product availability and financial performance[25] - The company is aware of geopolitical risks and uncertainties surrounding U.S. trade policy that may influence its operations[25] - Akebia has not committed to updating forward-looking statements unless required by law, indicating a cautious approach to future projections[26] - The company emphasizes the importance of attracting and retaining qualified personnel to support its growth and operational needs[25] - The company has outlined various risks in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025[26]

 Positioned to increase depth of Vafseo prescribing entering 2026 with access to approximately 275,000 patients First patient dosed in Praliciguat Phase 2 clinical trial studying focal segmental glomerulosclerosis (FSGS) AKB-097 Phase 2 rare kidney disease basket trial scheduled to begin in 2H 2026 with initial data expected in 2027 CAMBRIDGE, Mass., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impac ...

Core Insights - Akebia Therapeutics has initiated a Phase 2 clinical trial for praliciguat, targeting biopsy-confirmed FSGS, a rare kidney disease affecting approximately 40,000 patients in the U.S. [2] - The trial aims to evaluate the efficacy and safety of praliciguat, with a primary endpoint of change in urine protein-to-creatinine ratio (UPCR) at Week 24 [2][3]. Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4]. - The company has a mid-stage pipeline for rare kidney diseases, with praliciguat being a key component [2]. Clinical Trial Details - The Phase 2 trial is randomized, double-blind, placebo-controlled, and multicenter, involving approximately 60 patients already on maximally tolerated doses of ACE inhibitors or ARBs [2]. - Participants will be randomized 1:1 to receive either praliciguat or placebo for an initial 24-week period, followed by an open-label phase for an additional 24 weeks [2]. Safety and Efficacy - No significant safety issues were reported for praliciguat in previous Phase 1 and Phase 2 studies, indicating a favorable safety profile [3]. - Adverse events were infrequent and consistent with the known blood pressure-lowering effects of praliciguat [3].

Akebia Therapeutics Inc. (NASDAQ:AKBA) is one of the cheap penny stocks to invest in. On December 1, Akebia Therapeutics announced the official establishment of its rare kidney disease pipeline. This expansion is centered on two primary product candidates: AKB-097, a next-generation complement inhibitor, and praliciguat, a soluble guanylate cyclase/sGC stimulator. The development aligns with Akebia’s two-pronged corporate strategy: establishing Vafseo (vadadustat) as the standard of care for anemia in dial ...

Market Trends - Capital is shifting from high-multiple mega-cap stocks to small caps, cyclical sectors, and international markets, driven by easy monetary policy and anticipated fiscal policy impacts on the US economy [1] - The S&P SmallCap 600 is highlighted as a preferred investment vehicle for small caps due to its concentration in industrials and financials [1] - Small caps are considered undervalued and historically outperform during rate-cutting cycles [1] Small Cap Performance - The Russell 2000 index reached new all-time highs in September, while the S&P 600 struggled initially, indicating a prior reliance on lower-quality stocks [2] - Recently, the S&P 600 has joined the upward trend of the Russell 2000, nearing its own all-time highs [2] - Small caps are currently at levels similar to those four years ago, suggesting potential for significant upside if the breakout holds [2] Company Insights: Ambev (NYSE:ABEV) - Ambev has a forward P/E ratio of 13.30 and a share price of $2.30, with 20 hedge fund holders [8] - The company reported a normalized net income of BRL 3.8 billion, a 7% increase, and a stated net income of BRL 4.9 billion, a 36% surge year-over-year [11] - Ambev's premiumization strategy led to over 9% growth in volumes for premium brands, capturing nearly 50% market share in Brazil [10] Company Insights: Akebia Therapeutics Inc. (NASDAQ:AKBA) - Akebia has a forward P/E ratio of 8.73 and a share price of $1.66, with 21 hedge fund holders [13] - The company is expanding its pipeline for rare kidney diseases, focusing on two product candidates: AKB-097 and praliciguat [13] - Akebia's Vafseo is an oral treatment for anemia in dialysis patients, approved in 37 countries, with a Boxed Warning for increased risks of serious health issues [14]

Core Insights - Q32 Bio's shares more than doubled following a strategic deal with Akebia Therapeutics, indicating strong market interest and validation of its complement inhibitor platform [1][3] - The deal involves an upfront payment of $12 million for the Phase complement inhibitor ADX-097, with potential total transaction value reaching $592 million through various milestones [1][3] - The transaction allows Q32 Bio to monetize a key asset while retaining rights to its broader tissue-targeted complement inhibitor platform, which includes ADX-096 for ophthalmologic indications [3] Financial Implications - The divestment of ADX-097 provides immediate cash flow and long-term revenue potential through tiered royalties ranging from low single-digit to mid-teen percentages on future sales [4] - The company plans to refocus on advancing Bempikibart, a treatment for alopecia areata, which represents a strategic pivot that may enhance stock value in 2026 [4] Market Reaction - At its peak, Q32 Bio stock traded nearly 350% above its year-to-date low, but closed the session at $3.82, reflecting a 75% increase on the day [2] - Despite the positive outlook from the Akebia deal, there are concerns regarding the sustainability of the stock's rapid price increase and inherent execution risks associated with biotech investments [5][6]

Core Insights - Q32 Bio Inc. has sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics, leading to a significant increase in its stock price by 115.07% to $4.71 [1][6] Group 1: ADX-097 Overview - ADX-097 is a humanized anti-C3d Factor H monoclonal antibody fusion protein designed to inhibit complement activation, which is crucial for the innate immune system [2][3] - The drug has potential applications in various conditions related to C3d deposition, including kidney, autoimmune, vascular, and skin diseases [2] Group 2: Financial Terms of the Sale - Q32 Bio will receive $12 million in upfront payments from Akebia, with a structured payment plan including $7 million at signing, $3 million after six months, and $2 million upon achieving a milestone or by the end of 2026 [5] - The total potential payments from Akebia could reach up to $592 million, including development, regulatory, and commercial milestones [5] Group 3: Future Prospects - Q32 Bio retains rights to its tissue-targeted complement inhibitor platform, including other early-stage assets like ADX-096, and is exploring strategic options for these programs [4] - The company expects its cash reserves, combined with the upfront payments and near-term milestones from the ADX-097 sale, to sustain operations into the second half of 2027 [6]