How do we know if we are living in a miracle moment. And if we are, what should we do. On July 27th, 2023, I received an email asking me if I wanted to be interviewed by Oprah Winfrey for a special she was doing about obesity.It is an incredible time to be a physician scientist specializing in obesity. After decades of struggling to improve the health of our patients, we finally have effective new medications for this disease. Until 2023, my research focused on the care of obesity was only published in acad ...

Summary of Akebia Therapeutics (AKBA) FY Conference Call Company Overview - Akebia Therapeutics is a fully integrated biotech company founded in February 2007, focused on improving the lives of patients with chronic kidney disease (CKD) [2][3] - The company has two commercial products: Auryxia and Vassio [5][6] Core Products Auryxia - Auryxia is a phosphate binder used for controlling serum phosphorus in dialysis patients and treating iron deficiency anemia in non-dialysis adult patients [5][6] - The product lost exclusivity in March 2025, leading to the launch of an authorized generic [35][36] - Despite the competition, Auryxia has maintained strong clinical demand due to its clinical profile and economic value proposition [36][37] Vassio - Vassio is an oral HIF PH inhibitor launched in January 2025, indicated for treating anemia due to CKD in adult patients on dialysis [6][12] - It stimulates the body's natural production of erythropoietin, offering a novel mechanism of action compared to traditional erythropoiesis-stimulating agents (ESAs) [8][9] - Approximately 25% of patients on ESAs struggle to meet hemoglobin targets, highlighting a significant unmet need in the market [9][10] Market Dynamics - The dialysis market is characterized by a slow adoption process, with small to mid-sized dialysis organizations adopting new therapies before larger organizations [24][26] - The TDAPA (Transitional Drug Add-On Payment Adjustment) mechanism incentivizes dialysis organizations to adopt innovative therapies like Vassio [28][30] - Vassio's pricing post-TDAPA is set at approximately $2,500 per year, which is significantly lower than the initial starting dose price of $15,500, making it a billion-dollar market opportunity [30][31] Launch Progress and Adoption - In the first quarter post-launch, over 640 physicians prescribed Vassio, averaging 12 prescriptions per physician [18][21] - The company anticipates that larger dialysis organizations will begin to adopt Vassio more significantly in the second half of the year [26][34] - A pilot program with a large dialysis organization is expected to start in Q3 2025, testing operational systems for Vassio [31][34] Future Opportunities - The non-dialysis (NDD) market represents a significant opportunity, with a potential market size four to five times greater than dialysis [46][48] - The company plans to initiate a phase three study for NDD in the second half of the year, following FDA feedback on the protocol [48][49] Key Catalysts - Near-term catalysts include successful pilot program execution, full enrollment in the voice study aimed at reducing hospitalization and mortality, and progress on NDD studies [57][61] - The company is focused on Vassio as the primary growth driver, with plans to leverage its clinical differentiation and real-world physician experience to establish it as the standard of care [40][41] Underappreciated Aspects - Akebia has a pipeline of early-stage HIF assets, including studies for acute kidney injury and retinopathy of prematurity, which are significant unmet needs [62][63] - While investor focus is primarily on Vassio, the company aims to highlight its broader pipeline once Vassio demonstrates continued success [63]

Core Viewpoint - ProKidney Corp. has experienced significant stock volatility following positive Phase 2 clinical trial results for its REGEN-007 study, which shows promise for treating chronic kidney disease (CKD) and diabetes [2][5]. Group 1: Clinical Trial Outcomes - The Phase 2 trial results indicated a 78% improvement in the annual decline of estimated glomerular filtration rate (eGFR) for Group 1 participants who received two rilparencel injections [6]. - Group 2 participants, who received a single injection with a conditional second injection, showed a 50% improvement in annual eGFR decline, although this result was not statistically significant [6]. - These findings represent a significant clinical milestone, as CKD affects millions globally and treatment options are limited [2]. Group 2: Market Response and Stock Performance - Following the positive trial results, ProKidney's stock surged over 500% on July 8, although it remains over 70% below its 2023 peak of approximately $13 [2]. - Current analyst consensus price targets are around $4.00, suggesting the stock may be fairly valued at its current levels [3]. Group 3: Financial Position - ProKidney holds a robust cash balance of $358 million, representing 81% of its total assets, and has a minimal debt load of $3.2 million, resulting in a debt-to-equity ratio below 1% [3]. - The company incurred operating expenditures totaling $185 million over the past year and has no commercial products generating revenue, necessitating continuous observation of its cash burn rate [4]. Group 4: Risks and Challenges - The uncertainty surrounding the Phase 3 trial poses a significant risk, as success in Phase 2 does not guarantee success in subsequent phases or regulatory approvals [5]. - ProKidney faces competitive risks from other companies developing therapies for CKD and has a limited pipeline reliant on rilparencel, which adds to its risk profile [5]. - The stock has shown substantial price fluctuations, with a notable decline of 91% from a high of $13.78 on March 13, 2023, to $1.21 on November 17, 2023 [5].

Core Insights - Vivoryon Therapeutics N.V. reported its Q1 2025 financial results and operational progress, focusing on the development of varoglutamstat for kidney diseases, particularly diabetic kidney disease (DKD) [2][3] Financial Performance - Revenues for Q1 2025 were zero, consistent with Q1 2024 [14] - Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in Q1 2025 from EUR 7.4 million in Q1 2024, primarily due to lower third-party expenses [14][16] - General and administrative expenses were EUR 1.3 million in Q1 2025, down from EUR 2.1 million in Q1 2024 [16] - Net loss for Q1 2025 was EUR 2.5 million, compared to EUR 9.3 million in Q1 2024 [17] - Cash and cash equivalents as of March 31, 2025, were EUR 7.0 million, down from EUR 9.4 million as of December 31, 2024 [17] Clinical Development - The company is advancing varoglutamstat in kidney disease, with a planned Phase 2b study in DKD as a priority for 2025 [9] - A meta-analysis confirmed that varoglutamstat at 600mg twice daily significantly improved eGFR kidney function, with effects sustained until week 96 [7] - Preclinical data showed a synergistic effect of varoglutamstat in combination with SGLT-2 inhibitors, indicating potential for enhanced treatment regimens [5][6] Intellectual Property - A new composition of matter patent for varoglutamstat was granted in the U.S., providing exclusivity through 2044, with potential extensions [10] - The company is actively pursuing additional patents related to varoglutamstat and its applications in kidney disease [10] Corporate Developments - Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors for up to EUR 15 million in ordinary shares over the next 36 months, enhancing financial flexibility [12] - Julia Neugebauer was appointed as Chief Operating Officer, effective May 1, 2025, to oversee investor relations and corporate functions [13] Pipeline Updates - The company has nominated a new candidate, VY2149, a next-generation QPCT/L inhibitor, expected to enter late-stage preclinical development [11]

Issues nationwide nephrologist solicitation for patients for a 100-patient study involving kidney disease JACKSON CENTER, Pa., May 28, 2025 (GLOBE NEWSWIRE) -- Halberd Corporation (OTC: HALB) in cooperation with Athena Telemedicine Partners, LLC, announces astounding clinical efficacy for our patent- pending LDX compound for dialysis-borne neuropathy and pruritis in yet another case report and issues nationwide nephrologist solicitation for patients for a 100-patient study involving kidney disease. We previ ...

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Core Insights - Mineralys Therapeutics announced positive topline results from pivotal trials Launch-HTN and Advance-HTN, demonstrating the efficacy and safety of lorundrostat for treating uncontrolled or resistant hypertension [2][3] - The company anticipates topline data from the Explore-CKD Phase 2 trial in Q2 2025 and has initiated the Explore-OSA Phase 2 trial in Q1 2025 [1][12] - The company reported a net loss of $42.2 million for Q1 2025, an increase from $31.5 million in Q1 2024, primarily due to rising research and development expenses [8][22] Clinical Trials and Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 9.1 mmHg, and sustained benefits through week 12 [3] - The Advance-HTN trial reported a 15.4 mmHg absolute reduction in systolic blood pressure at the 50 mg dose, with a placebo-adjusted reduction of 7.9 mmHg [3] - Both trials demonstrated a favorable safety profile, with low incidences of hyperkalemia at 1.1% and 1.5% for the 50 mg and 50 to 100 mg arms in the Launch-HTN trial, respectively [3] Financial Performance - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $343.0 million, up from $198.2 million at the end of 2024 [5][24] - Research and development expenses for Q1 2025 were $37.9 million, compared to $30.8 million in Q1 2024, driven by increased clinical costs and compensation expenses [6][22] - General and administrative expenses rose to $6.6 million in Q1 2025 from $4.6 million in Q1 2024, attributed to higher compensation and professional fees [7][22] Corporate Developments - Eric Warren has been appointed as Chief Commercial Officer, bringing extensive experience in cardiovascular disease to support the company's commercial strategy [2][12] - The company completed a public equity financing on March 18, 2025, raising approximately $201.2 million to strengthen its balance sheet [12] Upcoming Milestones - The Explore-CKD Phase 2 trial is expected to deliver topline data in Q2 2025, focusing on the safety and efficacy of lorundrostat in patients with chronic kidney disease [1][12] - The Explore-OSA Phase 2 trial has been initiated to evaluate lorundrostat in overweight and obese subjects with moderate-to-severe obstructive sleep apnea and hypertension [1][12]

Company Overview - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing medicines targeting hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone [3] - The company's initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions affected by dysregulated aldosterone [3] Financial Results Announcement - Mineralys Therapeutics will report its financial results for the first quarter ended March 31, 2025, after the financial markets close on May 12, 2025 [1] - A live conference call will take place on May 12 at 4:30 p.m. ET, with details provided for both domestic and international participants [2]

Vivoryon Therapeutics N.V. Reports Full Year 2024 Financial Results and Provides Business Update Successful strategic shift towards a focus on inflammatory and fibrotic diseases, in particular on kidney diseaseVaroglutamstat Phase 2 program shows highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studiesStatistical evidence from meta-analysis of VIVIAD and VIVA-MIND enables ...