Clinical trial evaluating changes in urine protein-to-creatinine ratio, a widely-accepted endpoint measuring risk reduction of kidney failureCAMBRIDGE, Mass., Jan. 06, 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 the first patient has been dosed in a Phase 2 clinical trial of praliciguat, an oral, once-daily soluble guanylate cyclase (sGC) stimulator being evalua ...

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 ...

On December 17, Lale Akoner, Global Market Analyst at eToro, appeared on CNBC to suggest that she is observing capital moving away from high-multiple mega-cap stocks and toward small caps, cyclical sectors, and international markets. This shift is supported by an easy monetary policy, including the end of quantitative tightening and Fed rate cuts, as well as a fiscal policy that is expected to impact the US economy more significantly over the next few quarters. She specifically highlighted the S&P SmallCap ...

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]

Core Insights - Akebia Therapeutics has established a rare kidney disease pipeline, focusing on two main product candidates: AKB-097, a complement inhibitor, and praliciguat, an sGC stimulator [2][3] - The company plans to initiate Phase 2 clinical trials for both AKB-097 and praliciguat in 2026, targeting multiple rare kidney disease indications [1][3] Group 1: Product Candidates - AKB-097 is a tissue-targeted C3d-Factor H fusion protein complement inhibitor acquired from Q32 Bio, expected to address a range of complement-mediated rare kidney diseases [2][5] - Praliciguat is an oral sGC stimulator, with initial clinical trials focusing on focal segmental glomerulosclerosis (FSGS), a rare kidney disease [2][8] Group 2: Clinical Trials - The Phase 2 basket trial for AKB-097 is set to begin in the second half of 2026, with initial data expected in 2027 [6][3] - The Phase 2 trial for praliciguat will enroll up to 60 patients in the U.S., with the primary efficacy endpoint being the change in urine protein-to-creatinine ratio over 24 weeks [10][11] Group 3: Financial Aspects - Akebia paid an upfront fee of $7 million to Q32 Bio for the acquisition of AKB-097, with additional payments tied to development milestones and royalties on net sales [7]

Core Insights - Q32 Bio has sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics, which allows the company to focus on advancing bempikibart for alopecia areata [1][2][3] - The transaction is expected to provide $12 million in upfront payments and potential total payments of up to $592 million based on future milestones [3][4] - Q32 Bio retains its tissue-targeted complement inhibitor platform, including ADX-096 and other early-stage assets, and is evaluating strategic options for these programs [1][2] Financial Implications - The sale of ADX-097 is projected to extend Q32 Bio's cash runway into the second half of 2027, supporting ongoing clinical trials [2][4] - The upfront payment structure includes $7 million at signing, $3 million at the 6-month anniversary, and $2 million upon achieving a milestone or by the end of 2026 [3] Product Development Focus - Q32 Bio is concentrating on bempikibart (ADX-914), a fully human anti-IL-7R antibody, for the treatment of alopecia areata, with topline data from the SIGNAL-AA Phase 2a trial expected in mid-2026 [2][6] - The company’s tissue-targeted complement platform aims to inhibit complement activation while minimizing systemic effects, differentiating it from current therapies [2][3]

Core Viewpoint - Akebia Therapeutics, Inc. will participate in the Piper Sandler 37th Annual Healthcare Conference, highlighting its commitment to addressing kidney disease [1][2]. Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [3]. - The company is fully integrated, indicating a comprehensive approach to its biopharmaceutical endeavors [3]. Event Details - The Fireside Chat featuring Akebia's executive team is scheduled for December 2, 2025, at 4:30 PM EST [1]. - The Piper Sandler Healthcare Conference will occur from December 2-4, 2025, in New York City [2]. - A webcast of the presentation will be available on Akebia's website under the "Investors" section [2].

Summary of Akebia Therapeutics Conference Call Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Product**: Vafseo (vadadustat), a HIF PHI for treating anemia in dialysis patients Key Points Launch Progress of Vafseo - Vafseo was launched in January 2025, with a strong start primarily in U.S. Renal Care, the third-largest dialysis provider [4][5] - Access to dialysis patients increased from approximately 40,000 at the beginning of the year to 260,000, with expectations to reach 275,000 by year-end [6] - The launch is progressing well, but the adoption rate is slower than desired due to operational complexities within dialysis providers [5][8] Market Dynamics - The two largest dialysis providers, Fresenius and DaVita, are critical for Vafseo's adoption. DaVita has opened the product to all its centers as of November 10, 2025, after a successful pilot [5][6] - U.S. Renal Care has been the primary contributor to current patient numbers, with plans to offer treatment on a TIW (three times a week) basis starting January 2026 [13][14] Prescription and Adherence Challenges - The prescriber base remains stable, with 85% of U.S. Renal doctors having written a prescription for Vafseo [17] - Challenges in refill adherence are noted, with a goal to improve rates to 70-80% through education and operational adjustments [16][19] - The transition to TIW dosing is expected to enhance adherence and patient management [20][21] Clinical Data and Efficacy - Recent data presented at ASN supports the efficacy of TIW dosing, showing a statistically significant lower risk of mortality and hospitalization compared to darbepoetin [25][29] - Ongoing studies (VOICE and vocal) aim to confirm the benefits of TIW dosing and the physiological advantages of Vafseo over traditional treatments [26][29] Economic Considerations - The economic implications of hospitalization rates are significant, as dialysis providers share in costs when patients are hospitalized [30] - The TDAPA (Transitional Drug Add-on Payment Adjustment) period is crucial for revenue generation, with expectations of growth in Medicare Advantage prescriptions [39][40] Financial Position - Akebia has a strong balance sheet with $166 million in cash as of the end of Q3 2025, indicating that the company is financed to profitability [48] Future Pipeline - Akebia is exploring additional opportunities in the NDD (non-dialysis dependent) patient population and has a pipeline of HIF-based compounds, including AKB 9090 for acute kidney injury [46][47] Conclusion - Akebia is optimistic about the long-term adoption of Vafseo as the standard of care in anemia treatment for dialysis patients, supported by clinical data and a strong financial position [44][48]

Core Viewpoint - Akebia Therapeutics (AKBA) is experiencing significant selling pressure, having declined 39.9% over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2]. - AKBA's current RSI reading is 24.46, suggesting that the heavy selling may be exhausting, indicating a potential bounce back towards equilibrium in supply and demand [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that earnings estimates for AKBA have increased by 100% over the last 30 days, which usually correlates with price appreciation in the near term [7]. - AKBA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [8].