Akebia Therapeut Stock Price, News & Analysis

Akebia Therapeutics (Nasdaq: AKBA) announced a meeting with the FDA regarding a Formal Dispute Resolution related to a Complete Response Letter received for its drug vadadustat in March 2022. The meeting involved discussions with Dr. Peter Stein, who is overseeing the appeal process. Akebia anticipates a response from the FDA within thirty days after Dr. Stein's internal consultations conclude, likely in the second quarter of 2023. Vadadustat is aimed at treating anemia associated with chronic kidney disease but is still pending FDA approval.

Akebia Therapeutics (NASDAQ: AKBA) announced a revised definitive proxy statement for a special meeting on April 11, 2023. The main agenda is to seek shareholder approval for a reverse stock split aimed at regaining compliance with Nasdaq's minimum bid price rule, thus avoiding delisting. The proposal also includes a proportional decrease in authorized shares and a potential increase in authorized shares. The company's board strongly recommends approval, citing the critical nature of maintaining a Nasdaq listing for liquidity and shareholder value. The revised proxy card must be used for voting.

Akebia Therapeutics (Nasdaq: AKBA) reported a net product revenue of $177.1 million for 2022, a 24.5% increase from 2021. The company anticipates potential Marketing Authorization for its drug Vafseo™ (vadadustat) in Europe by May 2023 after receiving a positive opinion from the CHMP. For 2023, Akebia set a revenue guidance of $175-$180 million for Auryxia, although it remains cautious regarding the phosphate binder market recovery due to ongoing COVID-19 impacts. Significant operational improvements were made, including a restructuring of the supply chain which reduced costs.

Akebia Therapeutics (NASDAQ: AKBA) will release its financial results for the fourth quarter and full-year ended December 30, 2022, on March 9, 2023, before market opening. The company aims to improve the lives of those affected by kidney disease and plans to host a conference call at 8:30 a.m. ET on the same day to discuss its results and business updates. Interested parties can access the call via a registration link or through a live webcast on Akebia's website. The company emphasizes its commitment to innovation in kidney disease therapeutics.

Akebia Therapeutics (NASDAQ: AKBA) announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding the approval of Vafseo™ (vadadustat) for treating symptomatic anemia in adults with CKD on chronic dialysis. The decision from the European Commission (EC) is expected within two months and is applicable in all EU member states plus Iceland, Norway, and Liechtenstein.

The CHMP's recommendation is based on comprehensive data from over 7,500 patients, demonstrating the drug's efficacy and safety in clinical trials. The positive opinion is crucial for Akebia's goal to partner in Europe for Vafseo's commercialization.

Akebia Therapeutics (NASDAQ: AKBA) announced an update regarding its drug vadadustat aimed at treating anemia due to chronic kidney disease. The FDA provided a second interim response to Akebia's Formal Dispute Resolution Request linked to the Complete Response Letter previously received in March 2022. Due to staffing constraints, the appeal's oversight has shifted to Dr. Peter Stein, Director at the Office of New Drugs. Akebia anticipates a decision within thirty days post Dr. Stein’s consultations with nephrology and cardiology experts.

On February 1, 2023, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to three newly-hired employees. A total of 18,000 shares were awarded as inducements for joining the company, in compliance with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.63 per share, matching Akebia's closing stock price on the grant date. The options will vest over four years, with 25% vesting on the first anniversary and the rest vesting quarterly, contingent upon continued employment. These options have a 10-year term, governed by Akebia's inducement award program and related agreements.

Akebia Therapeutics (Nasdaq: AKBA) announced an interim response from the FDA regarding its Formal Dispute Resolution Request about vadadustat, aimed at treating anemia in chronic kidney disease. Following a meeting in November, Akebia will provide additional information to the FDA by January 2023, anticipating a response within 30 days post-submission. Vadadustat remains under review in Europe, while it is already approved in Japan for similar indications.

On December 2, 2022, Akebia Therapeutics (Nasdaq: AKBA) announced the granting of stock options to a newly-hired employee, totaling 3,000 shares. These options have an exercise price of $0.27 per share, matching the closing stock price on the grant date of November 30, 2022. The options vest over four years, with 25% vesting after one year, while the remaining 75% vest quarterly, contingent on the employee's continued service. This action complies with Nasdaq Listing Rule 5635(c)(4), indicating Akebia’s commitment to attract talent.