Akebia Therapeut Stock Price, News & Analysis

Akebia Therapeutics (Nasdaq: AKBA) announced it will release its third quarter 2024 financial results on Thursday, November 7, 2024, before market open. The company will host a conference call at 8:00 a.m. EST on the same day to discuss financial results and recent business highlights. Investors can access the call through a registration link and are encouraged to dial in 15 minutes before the scheduled start time. A live webcast and archive will be available through the company's investor relations website.

Akebia Therapeutics (Nasdaq: AKBA) has signed a multi-year commercial contract with a leading kidney care provider to expand access to Vafseo® (vadadustat) for patients on dialysis. This agreement allows physicians to prescribe Vafseo to dialysis patients as clinically appropriate, with availability expected in January 2025.

The contract is with a comprehensive kidney care provider serving over 200,000 patients at thousands of U.S. dialysis centers. Vafseo, approved by the FDA in March 2024 for treating anemia due to chronic kidney disease in adults on dialysis for at least three months, received Transitional Drug Add-On Payment Adjustment reimbursement from CMS starting January 1, 2025.

Akebia's Chief Commercial Officer, Nik Grund, emphasized that expanding access to Vafseo is a priority for their commercial launch, aiming to provide a new option in anemia management for dialysis patients.

Akebia Therapeutics (Nasdaq: AKBA) announced seven poster presentations at the American Society of Nephrology Kidney Week 2024 in San Diego, CA from October 24-27. Six posters present clinical data on vadadustat, Akebia's oral HIF-PH inhibitor for anemia due to chronic kidney disease (CKD). Vadadustat was approved by the FDA in March 2024 for adults on dialysis for at least three months, with U.S. market availability expected in January 2025.

The posters cover topics including:

• Real-world evidence from postmarketing surveillance in Japan
• Framework for assessing benefits and risks of CKD anemia treatments
• Cardiovascular safety analyses from Phase 3 trials
• Safety and efficacy in ESA-naïve patients new to dialysis
• Long-term safety data

Akebia Therapeutics (Nasdaq: AKBA) announced that the Center for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) reimbursement for Vafseo® (vadadustat) starting January 1, 2025. This provides two years of additional reimbursement to dialysis organizations beyond the ESRD bundled rate. Vafseo, approved by the FDA in March 2024 for treating anemia in adults with chronic kidney disease on dialysis for at least three months, is expected to be available in January 2025.

CMS has also assigned a Level II Healthcare Common Procedure Coding System (HCPCS) code to Vafseo to facilitate billing. Akebia's Chief Commercial Officer, Nicholas Grund, highlighted the importance of TDAPA in supporting innovation and new treatments in dialysis practices. The company is actively engaging with dialysis organizations for contracting and plans to interact with healthcare providers at the upcoming American Society of Nephrology conference to drive interest in Vafseo.

Akebia Therapeutics (Nasdaq: AKBA) and U.S. Renal Care (USRC) have signed a multi-year commercial supply contract for Vafseo® (vadadustat), a treatment for anemia due to chronic kidney disease in adults on dialysis. The agreement covers all USRC dialysis centers, allowing USRC physicians to prescribe Vafseo when it becomes available in January 2025.

Vafseo was approved by the FDA in March 2024 for patients who have been on dialysis for at least three months. Akebia expects to receive Transitional Drug Add-on Payment Adjustment designation for Vafseo in January 2025. This partnership is expected to provide nearly 2000 nephrologists access to prescribe Vafseo for their patients, as clinically appropriate.

Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has granted stock options to a newly-hired employee as an inducement for employment. The grant, made on September 30, 2024, includes options to purchase 111,600 shares of Akebia's common stock at an exercise price of $1.32 per share, equal to the closing price on the grant date.

The options are structured with a four-year vesting period, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. These options have a 10-year term and are subject to Akebia's inducement award program and a stock option agreement. The grant was made in compliance with Nasdaq Listing Rule 5635(c)(4).

Akebia Therapeutics (Nasdaq: AKBA) and U.S. Renal Care (USRC) have announced the initiation of the VOICE trial for Vafseo® (vadadustat) in dialysis patients. The study aims to assess mortality and hospitalization outcomes compared to standard care. Key points:

- Approximately 2,200 patients will be enrolled
- Randomized to Vafseo 300 mg tablets (3x/week) or standard erythropoiesis-stimulating agents
- Primary endpoint: all-cause mortality (non-inferiority)
- Secondary endpoint: all-cause hospitalization (10% reduction, superiority)
- Trial duration: ~18 months after last patient randomization

The collaboration seeks to build real-world evidence on Vafseo's potential benefits and risks in treating anemia due to chronic kidney disease, with enrollment expected to begin in 2024.

Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has granted stock options to a newly-hired employee. The grant, made on August 30, 2024, includes options to purchase 4,000 shares of Akebia's common stock at an exercise price of $1.55 per share, matching the closing price on the grant date. These options were awarded as an inducement for employment and comply with Nasdaq Listing Rule 5635(c)(4).

The stock options have a four-year vesting schedule, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. The options have a 10-year term and are subject to Akebia's inducement award program and a stock option agreement.

Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has announced its participation in two upcoming investor conferences in September 2024. The company's executives will attend the Wells Fargo Healthcare Conference in Boston from September 4-6 and the H.C. Wainwright 26th Annual Global Investment Conference in New York from September 9-11.

CEO John Butler will present at both events:

• Wells Fargo Healthcare Conference: Friday, September 6 at 9:30 a.m. EST
• H.C. Wainwright Global Investment Conference: Monday, September 9 at 10:30 a.m. EST (fireside chat)

Webcasts of both presentations will be available through Akebia's investor relations website for approximately 90 days following the conferences.