SAN FRANCISCO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Company will be attending and presenting at the Oppenheimer Movers in Rare Disease Summit being held on December 11, 2025, in New York, NY. Thane Wettig, Chief Executive Officer of FibroGen, will participate in a panel titled Elevator Pitches from Rare Disease Companies with Key Near-Term, Potentially Stock-Moving Catalysts on Thursday, December 11 at 12:15 PM ET at the Sofitel New York. FibroGen’s manage ...

Core Insights - Akebia Therapeutics reported a significant increase in net product revenues for Vafseo, reaching $14.3 million in Q3 2025, contributing to total net product revenues of $56.8 million for the quarter [1][12] - The company aims to make Vafseo the standard of care for treating anemia in dialysis patients, with expectations to quadruple prescribing access by year-end [2][4] - A recent post-hoc analysis presented at ASN Kidney Week indicated that patients receiving vadadustat had statistically more favorable outcomes in terms of all-cause mortality and hospitalization compared to those receiving erythropoiesis-stimulating agents (ESAs) [1][6] Financial Results - Total revenues increased to $58.8 million in Q3 2025 from $37.4 million in Q3 2024, driven by Vafseo and Auryxia sales [12] - Auryxia net product revenues were $42.5 million in Q3 2025, up from $35.6 million in Q3 2024, despite the loss of exclusivity in March 2025 [12] - The company reported a net income of $0.5 million in Q3 2025, a significant improvement from a net loss of $20.0 million in Q3 2024 [12][32] Operational Highlights - An operational pilot of Vafseo at DaVita is expected to complete in Q4 2025, with access anticipated for 275,000 patients by year-end [1][6] - The number of prescribers for Vafseo reached approximately 725 in Q3 2025, with an average of 12.7 prescriptions written per prescriber [6] - The average dose of refills for Vafseo increased by 5% over Q2 2025, indicating growing acceptance among healthcare providers [6] Regulatory Update - Akebia did not achieve alignment with the FDA on its proposed path for a Phase 3 clinical trial in non-dialysis patients and does not plan to initiate the VALOR clinical trial [4][29]

Summary of Akebia Therapeutics Conference Call Company Overview - **Company**: Akebia Therapeutics - **Key Product**: Vafsio, an oral HIF for treating anemia due to chronic kidney disease (CKD) in dialysis patients Core Points and Arguments 1. **Launch Performance**: - Vafsio generated $12 million in revenue in Q1 and $13.3 million in Q2, reflecting a 55% growth quarter-over-quarter [6][9] - Initial access to approximately 40,000 out of 550,000 dialysis patients in the U.S. [7] 2. **Market Expansion Plans**: - Anticipation of expanding prescribing access to additional dialysis providers, potentially increasing access to 275,000 patients by November [8][9] - Focus on making Vafsio the standard of care for anemia management in dialysis patients [12][48] 3. **Market Opportunity**: - The anemia of CKD market is primarily in the dialysis population, with 500,000 out of 550,000 patients on ESA treatments [11] - Non-dialysis market presents a significant opportunity, with a potential market size comparable to dialysis, but with a higher average price per patient post-TDAPA [38] 4. **Clinical Differentiation**: - Vafsio shows a favorable safety profile with no increased risk of major adverse cardiovascular events (MACE) compared to ESAs [20][21] - Fewer hemoglobin excursions and reduced dose titrations required with Vafsio, enhancing convenience for physicians [22][24] 5. **Patient Compliance**: - Oral administration of Vafsio improves patient compliance compared to injectable ESAs, particularly in home dialysis patients [25][26] 6. **Regulatory and Reimbursement Landscape**: - TDAPA (Transitional Drug Add-on Payment Adjustment) allows for reimbursement outside the bundled payment for dialysis for two years, facilitating the adoption of Vafsio [41][42] - Post-TDAPA, Vafsio will become part of the bundled payment, necessitating a strategic pricing approach to maintain market share [44][46] 7. **Future Studies and Trials**: - Plans to initiate a new study in the non-dialysis population, with a target enrollment of 1,500 patients [40][56] - Ongoing studies (VOICE and VOCAL) to explore alternative dosing regimens [27][60] 8. **Auryxia Update**: - Auryxia, a phosphate binder, lost exclusivity in March but continues to generate revenue without significant marketing efforts [49][50] Additional Important Insights - The dialysis market is valued at approximately $1 billion in the U.S., with significant potential for Vafsio to capture market share [38][45] - The company is focused on aligning with the FDA for future studies to ensure a clear path for product development and market entry [57][60] - The ongoing lack of generic approvals for Auryxia is viewed positively for cash flow, contributing to the company's financial stability [51][52]

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]