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Akebia Therapeutics, Inc. (NASDAQ: AKBA) is a fully integrated biopharmaceutical company headquartered in Cambridge, Massachusetts. Focused on delivering innovative therapies for patients with kidney disease, Akebia leverages hypoxia-inducible factor (HIF) biology in its product development. The company's lead product candidate, vadadustat, is an investigational oral therapy aimed at treating anemia related to chronic kidney disease (CKD) in both non-dialysis and dialysis patients. Akebia's global phase 3 program for vadadustat includes the PRO2TECT studies for non-dialysis patients and the INNO2VATE studies for dialysis-dependent patients. Vadadustat has received approval for the treatment of anemia due to CKD in multiple countries including Japan, Europe, and Australia, and is awaiting U.S. FDA approval with a PDUFA date set for March 27, 2024.
In addition to vadadustat, Akebia's portfolio includes Auryxia (ferric citrate), a medicine approved in the U.S. for the control of serum phosphorus levels in adult patients with dialysis-dependent CKD and the treatment of iron deficiency anemia in adult patients with non-dialysis-dependent CKD. Auryxia continues to show robust performance, with 2023 net product revenues totaling $170.3 million.
Akebia recently strengthened its financial position by securing a loan facility from BlackRock, providing up to $55 million in borrowing capacity. This move is geared towards supporting the potential U.S. launch of vadadustat, which Akebia anticipates will transform the company and provide a new oral treatment option for anemia in dialysis patients.
Current projects include exploring new pipeline programs targeted at acute care settings, such as acute kidney injury and acute respiratory distress syndrome, as well as retinopathy of prematurity in neonates.
With significant partnerships, a strong pipeline, and strategic financial maneuvers, Akebia Therapeutics continues to be a key player in the biopharmaceutical space, dedicated to bettering the lives of individuals affected by kidney disease.
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.
Akebia Therapeutics reported its Q2 2024 financial results, revealing a net loss of $8.6M, an improvement from $11.2M in the same quarter last year. Total revenues dropped to $43.6M from $56.4M, mainly due to a decrease in license, collaboration, and other revenues. Net product revenues stood at $41.2M, a slight decline from $42.2M in Q2 2023. Research & Development expenses significantly decreased to $7.6M from $20.2M due to the completion of certain clinical trials. The company set the WAC for its recently FDA-approved Vafseo® at $1,278 for a 30-day supply, with sales expected to begin in January 2025. Akebia expects its existing cash resources and operations to fund its activities for at least two years.
Akebia Therapeutics (Nasdaq: AKBA) has announced plans to release its financial results for the second quarter of 2024 on Thursday, August 8, 2024, before the financial markets open. The company will host a conference call at 8:00 a.m. ET on the same day to discuss the results and recent business highlights.
Investors and interested parties can access the call by dialing (800) 715-9871 (USA & Canada - Toll-Free) and entering Conference ID: 4155557. Additionally, a live webcast of the conference call will be available through the Investors section of Akebia's website at https://ir.akebia.com/. An online archive of the webcast will also be accessible via the same section of the company's website.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has granted stock options to three newly-hired employees as part of their employment inducement. The grants, made on July 31, 2024, include options to purchase a total of 47,000 shares of Akebia's common stock at an exercise price of $1.38 per share, which matches the closing price on the grant date.
These options vest over a four-year period, with 25% vesting after the first year and the remaining 75% vesting quarterly thereafter, contingent on continued employment. Each option has a 10-year term and is subject to Akebia's inducement award program and specific stock option agreements.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on kidney disease, has announced its participation in two upcoming investor conferences in August 2024. The company will be present at the BTIG virtual Biotechnology Conference from August 5-6 and the Canaccord Genuity 44th Annual Growth Conference in Boston from August 13-14.
CEO John Butler will participate in a fireside chat at the BTIG conference on August 6 at 8:00 am EST. At the Canaccord Genuity conference, Mr. Butler will deliver a presentation on August 14 at 8:30 a.m. EST. Investors can access a webcast of the Canaccord Genuity presentation through Akebia's website after the conference.
Akebia Therapeutics has announced significant updates for the commercial launch of Vafseo® (vadadustat) Tablets. Following a termination agreement with CSL Vifor, Akebia now holds full rights to sell Vafseo in the U.S. The Wholesale Acquisition Cost (WAC) has been set at $1,278 for a 30-day supply. Akebia has submitted a TDAPA application for Vafseo, anticipating designation by January 1, 2025. The company aims to finalize contracts with dialysis providers covering the majority of eligible patients by the end of 2024. Additionally, Akebia will host a conference call on July 11, 2024, at 8:00 a.m. ET to discuss these updates.
Akebia Therapeutics (Nasdaq: AKBA) announced inducement grants under Nasdaq Listing Rule 5635(c)(4) for five newly-hired employees. The grants include options to purchase a total of 517,000 shares of common stock, with 500,000 shares allocated to Erik Ostrowski, the new CFO and Chief Business Officer. The exercise price for these options is $1.02 per share, matching the closing price on the grant date, June 28, 2024. These options have a 10-year term and vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly. The grants are part of Akebia’s inducement award program.
Akebia Therapeutics, a biopharmaceutical company focused on improving the lives of people with kidney disease, announced that its CEO, John Butler, will participate in the H.C. Wainwright 3rd Annual Kidney Virtual Conference.
The event is set for Monday, July 15, 2024, at 9:30 a.m. ET. During the conference, Butler will provide updates on the commercial launch activities for Vafseo (vadadustat) Tablets.
Interested parties can access a webcast of the presentation through the Investors section of Akebia's website for 30 days following the event. This conference is an important platform for Akebia to showcase its advancements and strategies in the kidney disease sector.
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