Akebia Therapeutics, Inc. - AKBA STOCK NEWS

Akebia Therapeutics (Nasdaq: AKBA) announced top-line results from the PRO₂TECT Phase 3 study, which evaluated the efficacy and safety of vadadustat for treating anemia due to chronic kidney disease (CKD) in non-dialysis patients. While vadadustat demonstrated non-inferiority in hemoglobin levels compared to darbepoetin alfa, it did not meet the primary safety endpoint concerning major adverse cardiovascular events (MACE), raising concerns about its approval path. The company plans to submit a New Drug Application to the FDA in 2021 and continue collaboration with Otsuka for European approval.

On September 2, 2020, Akebia Therapeutics (Nasdaq: AKBA) announced the grant of stock options to 10 new employees. The options, totaling 54,000 shares, were granted as inducements for employment and have an exercise price of $10.41 per share, equal to the stock's closing price on the grant date. The stock options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting quarterly. This action complies with Nasdaq Listing Rule 5635(c)(4).

Akebia Therapeutics (Nasdaq: AKBA) announces the commercial availability of VAFSEO (vadadustat) in Japan for treating anemia due to chronic kidney disease (CKD). Approved by the Ministry of Health, Labour and Welfare in June 2020, VAFSEO is now listed in the Japan National Health Insurance drug price listing. With an estimated 13 million affected by advanced CKD in Japan, this oral treatment aims to set a new standard of care. Akebia stands to gain up to $190 million in milestone payments from Mitsubishi Tanabe Pharma Corporation and will receive royalties of up to 20% on sales.

Akebia Therapeutics reported a net loss of $175.8M for Q2 2020, up from $58.2M in Q2 2019, primarily due to a $115.5M non-cash impairment charge on Auryxia. Total revenue decreased to $90.1M from $100.8M year-over-year, driven by lower collaboration revenue. However, net product revenue from Auryxia rose by 5.5% to $30.7M. The company announced that cash reserves as of June 30, 2020, amounted to $295.3M, bolstered by $142.4M from a recent stock offering. Akebia is on track to report top-line data from its Phase 3 PRO2TECT study in September.

Akebia Therapeutics (Nasdaq: AKBA) announced on August 4, 2020, the granting of stock options to four new employees totaling 23,500 shares. The options were granted on July 31, 2020, as part of the company’s Inducement Award Program, complying with Nasdaq Listing Rule 5635(c)(4). Each option has an exercise price of $11.17 per share, matching the stock's closing price on the grant date. Vesting occurs over four years, with 25% vesting after one year and the remaining shares vesting quarterly, subject to continued employment.

Akebia Therapeutics (Nasdaq: AKBA) announced it will report its second quarter financial results on August 10, 2020. The company will not hold a traditional business update call but plans a conference call in September to share top-line results from its PRO₂TECT Phase 3 cardiovascular outcomes studies. These studies involved 3,513 patients and investigated the efficacy of vadadustat for treating anemia due to chronic kidney disease (CKD). The PRO₂TECT database has been locked, marking a key milestone in the development of vadadustat.

Akebia Therapeutics (Nasdaq: AKBA) announced a new investigator-sponsored study to evaluate vadadustat as a potential therapy for acute respiratory distress syndrome (ARDS) in COVID-19 patients. Conducted by UTHealth in Houston, the randomized, placebo-controlled trial aims to enroll up to 300 patients hospitalized for hypoxemia due to COVID-19. The dosing will start within 24 hours of admission and continue for up to 14 days. Vadadustat is also in Phase 3 trials for treating anemia due to chronic kidney disease and is currently approved for that use in Japan.

Akebia Therapeutics, Inc. (Nasdaq: AKBA) announced on July 2, 2020, the grant of stock options to six newly-hired employees totaling 320,000 shares, including 280,000 shares for David Spellman, the new CFO. These options were granted as inducements for employment and comply with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $13.58 per share, reflecting the stock's closing price on the grant date, and will vest over four years.

Akebia Therapeutics has received regulatory approval for vadadustat, an oral therapy for anemia due to chronic kidney disease (CKD), from Japan's Ministry of Health, Labour and Welfare. This milestone allows Akebia's partner, Mitsubishi Tanabe Pharma Corporation (MTPC), to market vadadustat under the name VAFSEO in Japan. The approval follows a successful application filed in July 2019 and enables a $15 million milestone payment to Akebia. Akebia could further earn up to $190 million in additional payments and royalty rates up to 20% on sales in Japan and other Asian countries.