Welcome to our dedicated page for Akebia Therapeut news (Ticker: AKBA), a resource for investors and traders seeking the latest updates and insights on Akebia Therapeut stock.
Akebia Therapeutics, Inc. develops and commercializes therapeutics for people impacted by kidney disease. Company news commonly covers Vafseo® (vadadustat), an oral HIF-PH inhibitor indicated for anemia due to chronic kidney disease in adults receiving dialysis, and Auryxia® (ferric citrate), a U.S.-marketed therapy for chronic kidney disease-related conditions.
Recurring updates also address product revenue, dialysis-market access, clinical data publications, and kidney disease pipeline programs, including praliciguat in focal segmental glomerulosclerosis, AKB-097 in rare kidney diseases, and AKB-9090 for cardiac surgery-associated acute kidney injury. Akebia also reports Nasdaq inducement grants, board changes, investor presentations, and quarterly financial results.
On April 6, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced its participation in the National Kidney Foundation Spring Clinical Meetings 2022 in Boston, scheduled for April 6-10, 2022. The company will present three significant posters focusing on real-world healthcare costs, adherence to phosphate binders, and thrombotic events in dialysis-dependent patients. Notably, Vadadustat, an investigational drug for chronic kidney disease anemia, received a complete response letter from the FDA on March 29, 2022, while still under review by the European Medicines Agency.
On April 4, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to nine newly-hired employees, totaling 53,000 shares. Each option has an exercise price of $0.72, matching the closing stock price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder quarterly, contingent on continued employment. The grant complies with Nasdaq Listing Rule 5635(c)(4) and aims to strengthen employee retention and incentivize performance.
Akebia Therapeutics (Nasdaq: AKBA) announced that the FDA has issued a complete response letter (CRL) for its New Drug Application (NDA) for vadadustat, aimed at treating anemia due to chronic kidney disease (CKD). The FDA cited safety concerns, including a failure to demonstrate non-inferiority in major adverse cardiovascular events in non-dialysis patients, and risks of thromboembolic events and liver injury. Akebia plans to discuss next steps with partners and the FDA. Vadadustat remains under review in Europe and is approved in Japan for CKD-related anemia.
Akebia Therapeutics (Nasdaq: AKBA) granted stock options for 97,000 shares to 12 newly-hired employees on February 28, 2022. The exercise price is set at $2.16 per share, matching the stock's closing price on the grant date. These options vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly, contingent on the employees' continued service. This grant adheres to Nasdaq Listing Rule 5635(c)(4) and aims to incentivize new talent joining the company focused on kidney disease therapeutics.
Akebia Therapeutics (Nasdaq: AKBA) reported its financial results for Q4 and FY 2021, highlighting a total revenue of $59.6 million for Q4, up from $56.7 million in Q4 2020, and $213.6 million for 2021, down from $295.3 million in 2020. The net product revenue for Auryxia was $142.2 million, a 10% increase year-over-year. Akebia aims for a significant catalyst with the upcoming PDUFA date of March 29, 2022, for its drug vadadustat, which may transform treatment options for anemia due to CKD if approved.
On February 22, 2022, Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced an amended license agreement with Vifor Pharma to enable the sale of vadadustat, an investigational treatment for anemia due to chronic kidney disease (CKD). This amendment expands Vifor's access to U.S. dialysis patients, anticipated to support a U.S. launch following vadadustat's FDA PDUFA date of March 29, 2022. Vifor will invest $20 million equity and provide $40 million for working capital. Akebia will retain 66% of the profits from sales, sharing others with Otsuka in the non-dialysis market.
Akebia Therapeutics (Nasdaq: AKBA) announced plans to release its financial results for Q4 and full-year 2021 on March 1, 2022. The company will not host a conference call prior to the March 29, 2022 PDUFA date for vadadustat, an investigational drug under FDA review for treating anemia due to chronic kidney disease. Vadadustat is already approved in Japan for similar indications. The company aims to improve the lives of those affected by kidney disease.
On February 1, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to 17 new employees, totaling 129,000 shares. The exercise price of these options is $1.99 per share, which corresponds with the closing stock price on the grant date, January 31, 2022. Options will vest over four years, beginning with 25% after one year. This move aims to incentivize the new hires as part of Akebia's ongoing strategy to enhance its workforce and improve outcomes in kidney disease treatment.
Akebia Therapeutics (Nasdaq: AKBA), a biopharmaceutical company focused on improving the lives of those affected by kidney disease, will have its Chief Financial Officer, David Spellman, participate in a virtual fireside chat at the H.C. Wainwright Bioconnect Conference from January 10-13, 2022. An audio replay of the conversation will be available on the Investors section of Akebia's website for 90 days post-conference. Founded in 2007 and headquartered in Cambridge, MA, Akebia is dedicated to developing therapeutics for kidney patients.
On January 4, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to eight newly-hired employees, totaling 49,000 shares. The options have an exercise price of $2.26 per share, in line with the stock's closing price on the grant date, December 31, 2021. The vesting period spans four years, with 25% vesting after the first anniversary and the remainder quarterly, contingent upon continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4), aimed at incentivizing new talent in the biopharmaceutical sector focused on kidney disease.